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PROMECH Quality Manual Overview

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0% found this document useful (0 votes)

51 views76 pages

PROMECH Quality Manual Overview

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Abu Umar

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Download as PDF, TXT or read online on Scribd

QM01-QUALITY MANUAL

This Quality Manual meets the requirements of

API SPECIFICATION Q1, 9th EDITION &

ISO 9001:2015

For

The Repair, Remanufacture, Manufacture and Servicing

of Oilfield Equipment and Parts to the requirements of

API PRODUCT SPECIFICATIONS

API 6A; 16A; 16C; API 7-1 and API 20E

At 1st Industrial Estate Dammam Kingdom of Saudi Arabia

And field areas controlled by that facility.

Originated &Reviewed By: Approved By:

MOURAD EL ZANATI TARIQ AL TAWAYAN

QA Manager General Manager

Date: 13th Nov., 2023 Date: 13th Nov., 2023

This document contains information proprietary to PROMECH. Any disclosure or use is expressly prohibited except upon written
permission coming from the company’s Quality Management Representative. Original documents can be distinguished by signatures
of originator, reviewers and approver appearing in Digital Signature.
QM01-QUALITY MANUAL – QUALITY MANAGEMENT
SYSTEM
SUB: TABLE OF CONTENTS SECTION: Preface

Revision 6 Date 13th Nov., 2023 Page 2 of 76

Contents
TABLE OF CONTENTS/ISO AND Q1 reference ......................................................................................................... 6
TABLE OF QUALITY PROCEDURES ......................................................................................................................... 10
DOCUMENT REGISTER .......................................................................................................................................... 11
INTRODUCTION .................................................................................................................................................... 12
COMPANY PROFILE ............................................................................................................................................... 13
CONTROL OF QUALITY MANUAL .......................................................................................................................... 14
1.0 SCOPE OF QUALITY MANUAL (Referring ISO 9001:2015 Clause 1 and Q1 Clause 1).................................. 15
2.0 NORMATIVE REFERENCES (Referring ISO 9001:2015 Clause 2 and Q1 Clause 2)....................................... 16
3.0 TERMS, DEFINITIONS AND ABBREVIATIONS (Referring ISO 9001:2015 Clause 3 and Q1 Clause 3) ........... 17
3.1 TERMS AND DEFINITIONS (In Alphabetical Order) (Referring ISO 9001:2015 Clause 3 and Q1 Clause
3.1) .................................................................................................................................................................... 17
3.2 ABBREVIATIONS: ..................................................................................................................................... 21
4.0 QUALITY MANAGEMENT SYSTEM REQUIREMENTS/CONTEXT OF THE ORGANIZATION (Referring ISO
9001:2015 Clause 4 and Q1 Clause 4) .................................................................................................................. 22
4.1 QUALITY MANAGEMENT SYSTEM (Referring ISO 9001:2015 Clause 4.1 and Q1 Clause 4.1) ................ 22
4.1.1 GENERAL .......................................................................................................................................... 22
4.1.2 QUALITY POLICY AND COMMUNICATION OF QUALITY POLICY (Referring ISO 9001:2015 Clause 5.2
and Q1 Clause 4.1.2) ..................................................................................................................................... 24
4.1.3 QUALITY OBJECTIVES and Planning to Achieve Them (Referring ISO 9001:2015 Clause 6.2 and Q1
Clause 4.1.3) ................................................................................................................................................. 26
4.1.4 QUALITY MANAGEMENT SYSTEM PLANNING (Referring ISO 9001:2015 Clause 6 and Q1 Clause
4.1.4) ............................................................................................................................................................. 27
4.1.5 COMMUNICATION (Referring ISO 9001:2015 Clause 7.4,8.2.1 and Q1 Clause 4.1.5) ..................... 28
4.2 MANAGEMENT RESPONSIBILTY /COMMITMENT AND LEADERSHIP (Referring ISO 9001:2015 Clause 5.1
and Q1 Clause 4.2) ............................................................................................................................................ 29
4.2.1 GENERAL .......................................................................................................................................... 29
4.2.2 ORGANIZATIONAL ROLES , RESPONSIBILITY AND AUTHORITY (Referring ISO 9001:2015 Clause 5.3
and Q1 Clause 4.2.2) ..................................................................................................................................... 30
4.2.3 MANAGEMENT REPRESENTATIVE .................................................................................................... 37
4.3 ORGANIZATION CAPABILITY (Referring ISO 9001:2015 Clause 7.1.1 and Q1 Clause 4.3) .................... 39
4.3.1 PROVISION OF RESOURCES (Referring ISO 9001:2015 Clause 7.1 and Q1 Clause 4.3.1)................. 39
4.3.2 HUMAN RESOURCE (QMS Procedure No. QMSP-01 Competency and Training Procedure).
(Referring ISO 9001:2015 Clause 7.1.2, 7.2, 7.3 and Q1 Clause 4.3.2) ......................................................... 39

Revision 6 Date 13th Nov., 2023 Page 3 of 76

4.3.3 WORK ENVIRONMENT and Infrastructure (Referring ISO 9001:2015 Clause 7.1.3, 7.1.4 and Q1
Clause 4.3.3) ................................................................................................................................................. 40
4.3.4 ORGANIZATIONAL KNOWLEDGE (Referring ISO 9001:2015 Clause 7.1.6) ...................................... 40
4.4 DOCUMENTATION/DOCUMENTED INFORMATION REQUIREMENTS (Referring ISO 9001:2015 Clause
7.5 and Q1 Clause 4.4) ...................................................................................................................................... 41
4.4.1 GENERAL (Referring ISO 9001:2015 Clause 7.5.1, 7.5.2 and Q1 Clause 4.4.1) ................................ 41
4.4.2 PROCEDURES (Referring ISO 9001:2015 Clause 7.5.3 and Q1 Clause 4.4.2) ................................... 41
4.4.3 CONTROL OF DOCUMENTS / Control of Documented Information (QMS Procedure No. QMSP-02
Control of Documents and Records Procedure.) (Referring ISO 9001:2015 Clause 7.5.3 and Q1 Clause
4.4.3, 4.5) ...................................................................................................................................................... 45
4.4.4 USE OF EXTERNAL DOCUMENTS IN PRODUCT REALIZATION (Referring ISO 9001:2015 Clause
[Link] and Q1 Clause 4.4.4) ......................................................................................................................... 45
5.0 PRODUCT REALIZATION/OPERATION (Referring ISO 9001:2015 Clause 8.5, 8.2 and Q1 Clause 5) ........... 46
5.1 CONTRACT REVIEW (Quality Procedure Ref: QMSP-03) (Referring ISO 9001:2015 Clause 8.2.3 and Q1
Clause 5.1) ........................................................................................................................................................ 46
5.1.1 GENERAL (Referring Q1 Clause 5.1.1) .............................................................................................. 46
5.1.2 DETERMINATION OF REQUIREMENTS/REQUIREMENTS FOR PRODUCT AND SERVICES (Referring ISO
9001:2015 Clause 8.2.2 and Q1 Clause 5.1.2) .............................................................................................. 46
5.1.3 REVIEW OF REQUIREMENTS (Referring ISO 9001:2015 Clause 8.2.3 and Q1 Clause 5.1.3) ............ 46
5.2 PLANNING/OPERATIONAL PLANNING AND CONTROL (Referring ISO 9001:2015 Clause 8.1 and Q1
Clause 5.2) ........................................................................................................................................................ 47
5.3 RISK ASSESSMENT AND MANAGEMENT/ACTION TO ADDRESS RISK AND OPPORTUNITY (Quality
Procedure Ref: QMSP-04) (Referring ISO 9001:2015 Clause 6.1 and Q1 Clause 5.3) ...................................... 48
5.4 DESIGN AND DEVELOPMENT OF PRODUCT AND SERVICES (Quality Procedure Ref: QMSP-05) (Referring
ISO 9001:2015 Clause 8.3 and Q1 Clause 5.4) .................................................................................................. 50
5.4.1 DESIGN AND DEVELOPMENT PLANNING (Referring ISO 9001:2015 Clause 8.3.1, 8.3.2, 8.3.4 and Q1
Clause 5.4.1) ................................................................................................................................................. 50
5.4.2 DESIGN AND DEVELOPMENT INPUTS (Referring ISO 9001:2015 Clause 8.3.3 and Q1 Clause 5.4.2).. 51
5.4.3 DESIGN AND DEVELOPMENT OUTPUTS (Referring ISO 9001:2015 Clause 8.3.5 and Q1 Clause 5.4.3)
...................................................................................................................................................................... 51
5.4.4 DESIGN AND DEVELOPMENT REVIEW (Referring ISO 9001:2015 Clause 8.3.4 and Q1 Clause 5.4.4) . 52
5.4.5 DESIGN AND DEVELOPMENT VERIFICATION AND FINAL REVIEW (Referring ISO 9001:2015 Clause
8.3.4 and Q1 Clause 5.4.5) ............................................................................................................................ 52
5.4.6 DESIGN AND DEVELOPMENT VALIDATION AND APPROVAL (Referring ISO 9001:2015 Clause 8.3.4
and Q1 Clause 5.4.6) ..................................................................................................................................... 52
5.4.7 DESIGN AND DEVELOPMENT CHANGES (Referring ISO 9001:2015 Clause 8.3.6 and Q1 Clause 5.4.7)
...................................................................................................................................................................... 53

Revision 6 Date 13th Nov., 2023 Page 4 of 76

5.5 CONTINGENCY PLANNING (Quality Procedure Ref: QMSP-06) (Referring ISO 9001:2015 Clause 6.1.2
and Q1 Clause 5.5) ............................................................................................................................................ 53
5.5.1 GENERAL (Referring Q1 Clause 5.5.1) .............................................................................................. 53
5.5.2 PLANNING OUTPUT (Referring ISO 9001:2015 Clause 6.1.2 and Q1 Clause 5.5.2) ......................... 53
5.6 PURCHASING/EXTERNALY PROVIDED PROCESS, PRODUCT AND SERVICES (Quality Procedure Ref:
QMSP-07) (Referring ISO 9001:2015 Clause 8.4 and Q1 Clause 5.6) ............................................................... 54
5.6.1 PURCHASING CONTROL (Referring ISO 9001:2015 Clause 8.4.1, 8.4.2 and Q1 Clause 5.6.1) ......... 54
5.6.2 PURCHASING INFORMATION (Referring ISO 9001:2015 Clause 8.4.3 and Q1 Clause 5.6.2)........... 56
5.6.3 VERIFICATION OF PURCHASED PRODUCTS OR ACTIVITIES (Quality Procedure Ref: QMSP-08)
(Referring ISO 9001:2015 Clause 8.4.1 and Q1 Clause 5.6.3) ....................................................................... 57
5.7 PRODUCTION AND SERVICING PROVISION (Referring ISO 9001:2015 Clause 8.5 and Q1 Clause 5.7) .. 57
5.7.1 CONTROL OF PRODUCTION AND SERVICING (Quality Procedure Ref: QMSP-09) (Referring ISO
9001:2015 Clause 8.5.1 and Q1 Clause 5.7.1) .............................................................................................. 57
5.7.2 PRODUCT QUALITY PLANS (Referring Q1 Clause 5.7.2) ................................................................... 60
5.7.3 IDENTIFICATION AND TRACEABILITY (Quality Procedure Ref: QMSP-10) (Referring ISO 9001:2015
Clause 8.5.2 and Q1 Clause 5.7.3) ................................................................................................................ 60
5.7.4 PRODUCT INSPECTION/TEST STATUS (Quality Procedure Ref: QMSP-11) (Referring ISO 9001:2015
Clause 8.6 and Q1 Clause 5.7.4) ................................................................................................................... 61
5.7.5 CUSTOMER AND EXTERNAL PROVIDERS -SUPPLIED PROPERTY (Quality Procedure Ref: QMSP-12)
(Referring ISO 9001:2015 Clause 8.5.3 and Q1 Clause 5.7.5) ....................................................................... 61
5.7.6 PRESERVATION OF PRODUCT/OUTPUTS OF PRODUCTION AND SERVICE (Quality Procedure Ref:
QMSP-12) (Referring ISO 9001:2015 Clause 8.5.4 and Q1 Clause 5.7.6) ..................................................... 61
5.7.7 INSPECTION AND TESTING (Quality Procedure Ref: QMSP-11) (Referring ISO 9001:2015 Clause 8.6
and Q1 Clause 5.7.7) ..................................................................................................................................... 62
5.7.8 PREVENTIVE MAINTENANCE (Quality Procedure Ref: QMSP-13) (Referring Q1 Clause 5.7.8) ....... 63
5.8 CONTROL OF TESTING, MEASURING AND MONITORING EQUIPMENT/MONITORING AND MEASURING
RESOURCES (Quality Procedure Ref: QMSP-14) (Referring ISO 9001:2015 Clause 7.1.5 and Q1 Clause 5.8) .. 63
5.9 PRODUCT RELEASE/RELEASE OF PRODUCT AND SERVICE (Quality Procedure Ref: QMSP-11) (Referring
ISO 9001:2015 Clause 8.6 and Q1 Clause 5.9) .................................................................................................. 64
5.10 CONTROL OF NONCONFORMING PRODUCT (OUTPUTS) (Quality Procedure Ref: QMSP-15) (Referring
ISO 9001:2015 Clause 8.7 and Q1 Clause 5.10) ................................................................................................ 64
5.10.1 GENERAL (Referring Q1 Clause 5.10.1) .......................................................................................... 64
5.10.2 NONCONFORMING PRODUCT (Referring ISO 9001:2015 Clause 8.7.1 and Q1 Clause 5.10.1) ..... 65
5.10.3 RELEASE OF NONCONFORMING PRODUCT UNDER CONCESSION (Referring ISO 9001:2015 Clause
8.7.1 and Q1 Clause 5.10.3) .......................................................................................................................... 66
5.10.4 CUSTOMER NOTIFICATION (Referring ISO 9001:2015 Clause 8.7.1 and Q1 Clause 5.10.4) .......... 66

Revision 6 Date 13th Nov., 2023 Page 5 of 76

5.10.5 RECORDS (RETAIN DOCUMENTED INFORMATION) (Referring ISO 9001:2015 Clause 8.7.2 and Q1
Clause 5.10.5) ............................................................................................................................................... 66
5.11 MANAGEMENT OF CHANGE (MOC)/PLANNING OF CHANGE (Quality Procedure Ref: QMSP-16)
(Referring ISO 9001:2015 Clause 6. 3 , Clause 8.5.6 and Q1 Clause 5.11) ....................................................... 66
5.11.1 GENERAL (Referring Q1 Clause 5.11.1) .......................................................................................... 66
5.11.2 MOC IMPLEMENTATION (Referring ISO 9001:2015 Clause 6.3 and Q1 Clause 5.11.2) ................. 67
5.11.3 MOC NOTIFICATION (Referring Q1 Clause 5.11.3) ........................................................................ 67
6.0 QUALITY MANAGEMENT SYSTEM MONITORING, MEASUREMENT, ANALYSIS & IMPROVEMENT (Referring
ISO 9001:2015 Clause 9.1 and Q1 Clause 6) ......................................................................................................... 68
6.1 GENERAL ................................................................................................................................................. 68
6.2 MONITORING, MEASURING AND IMPROVING (Referring ISO 9001:2015 Clause 9.1.1 and Q1 Clause
6.2) .................................................................................................................................................................... 68
6.2.1 CUSTOMER SATISFACTION (Quality Procedure Ref: QMSP-17) (Referring ISO 9001:2015 Clause
9.1.2 and Q1 Clause 6.2.1) ............................................................................................................................ 68
6.2.2 INTERNAL AUDIT (Quality Procedure Ref: QMSP-19) (Referring ISO 9001:2015 Clause 9.2 and Q1
Clause 6.2.2) ................................................................................................................................................. 69
6.2.3 PROCESS EVALUATION (Referring ISO 9001:2015 Clause 9.1.3 and Q1 Clause 6.2.3) .................... 70
6.3 ANALYSIS OF DATA (Quality Procedure Ref: QMSP-17) (Referring ISO 9001:2015 Clause 9.1.3 and Q1
Clause 6.3) ........................................................................................................................................................ 70
6.4 IMPROVEMENT (Referring ISO 9001:2015 Clause 10, 10.3 and Q1 Clause 6.4) ..................................... 70
6.4.1 GENERAL .......................................................................................................................................... 70
6.4.2 CORRECTIVE ACTION (Quality Procedure Ref: QMSP-19) (Referring ISO 9001:2015 Clause 10.2 and
Q1 Clause 6.4.2) ............................................................................................................................................ 71
6.4.3 PREVENTIVE ACTION (Quality Procedure Ref: QMSP-19) ................................................................ 71
6.5 MANAGEMENT REVIEW (Quality Procedure Ref: QMSP-20) (Referring ISO 9001:2015 Clause 9.3 and
Q1 Clause 6.5) ................................................................................................................................................... 72
6.5.1 GENERAL (Referring ISO 9001:2015 Clause 9.3.1 and Q1 Clause 6.5.1) .......................................... 72
6.5.2 INPUT REQUIREMENTS (Referring ISO 9001:2015 Clause 9.3.2 and Q1 Clause 6.5.2) .................... 72
6.5.3 OUTPUT REQUIREMENTS (Referring ISO 9001:2015 Clause 9.3.3 and Q1 Clause 6.5.3) ................ 73
ANNEX A ............................................................................................................................................................... 74
USE OF API MONOGRAM (Quality Procedure Ref: QMSP-21) ......................................................................... 74
DOCUMENT CHANGE HISTORY ............................................................................................................................. 75

Revision 6 Date 13th Nov., 2023 Page 6 of 76

TABLE OF CONTENTS/ISO AND Q1 reference

Quality ISO 9001
API Spec. Q1 Section
Manual Description :2015
No.
Section No. Section No.
Preface Front Page & Statement N/A N/A
Preface Table of Contents N/A N/A
Preface Table of Quality Procedures N/A N/A
Preface Document Register / Holder N/A N/A
Preface Document Change History N/A N/A
Preface Introduction N/A N/A
Preface Company Profile N/A N/A
Preface Control of Quality Manual N/A N/A
1 Scope of Quality Manual 1 1
2 Normative References 2 2
3 Terms, Definitions and Abbreviations 3 3
3.1 Terms and Definitions 3 3.1
3.2 Abbreviations ------ 3.2
Quality Management System
4 Requirements/Context Of The 4 4
Organization
4.1 Quality Management System 4.1 4.1
4.1.1 General 4.1,4.2 4.1.1
Quality Policy And Communication of
4.1.2 5.2 4.1.2
Quality Policy
Quality Objectives And Planning To
4.1.3 6.2 4.1.3
Achieve Them
4.1.4 Planning 6 4.1.4
4.1.5 Communication 7.4,8.2.1 4.1.5
Top Management
4.2 Responsibility/Commitment and 5.1 4.2
Leadership
4.2.1 General 5.1.1 4.2.1
Organizational Roles, Responsibility and
4.2.2 5.3 4.2.2
Authority
4.2.3 Management Representative ------ 4.2.3
4.3 Organization Capability 7.1.1 4.3
4.3.1 Provision of Resources 7.1 4.3.1
7.1.2, 7.2,
4.3.2 Human Resources 4.3.2
7.3

Revision 6 Date 13th Nov., 2023 Page 7 of 76

Quality
ISO 9001:2015 API Spec. Q1
Manual Description
Section No. Section No.
Section No.
4.3.3 Work Environment and Infrastructure 7.1.3, 7.1.4 4.3.3
4.3.4 Organizational Knowledge 7.1.6
Documentation / Documented
4.4 7.5 4.4
Information Requirements
4.4.1 General 7.5.1, 7.5.2 4.4.1
4.4.2 Procedures 7.5.3 4.4.2
Control of Documents and Records/
4.4.3 7.5.3 4.4.3, 4.5
Documented Information
Use of External Documents in Product
4.4.4 [Link] 4.4.4
Realization
5 Product Realization/Operation 8.5, 8.2 5
5.1 Contract Review 8.2.3 5.1
5.1.1 General ------ 5.1.1
5.1.2 Determination of Requirements 8.2.2 5.1.2
5.1.3 Review of Requirements 8.2.3 5.1.3
5.2 Planning/Operational Planning and control 8.1 5.2
Risk Assessment and Management/Action
5.3 6.1 5.3
To address Risk and Opportunity
Design and Development of Products and
5.4 8.3 5.4
Services
8.3.1, 8.3.2,
5.4.1 Design and Development Planning 5.4.1
8.3.4
5.4.2 Design and Development Inputs 8.3.3 5.4.2
5.4.3 Design and Development Outputs 8.3.5 5.4.3
5.4.4 Design and Development Review 8.3.4 5.4.4
Design and Development Verification and
5.4.5 8.3.4 5.4.5
Final Review
Design and Development Validation and
5.4.6 8.3.4 5.4.6
Approval
5.4.7 Design and Development Change 8.3.6 5.4.7
5.5 Contingency Planning 6.1.2 5.5
5.5.1 General ------ 5.5.1
5.5.2 Planning Output 6.1.2 5.5.2
Purchasing/Externally Provided process,
5.6 8.4 5.6
product and services.
5.6.1 Purchasing Control 8.4.2 5.6.1

Revision 6 Date 13th Nov., 2023 Page 8 of 76

Quality
ISO 9001:2015 API Spec. Q1
Manual Description
Section No. Section No.
Section No.
5.6.2 Purchasing Information 8.4.3 5.6.2
Verification of Purchased Products or
5.6.3 8.4.1 5.6.3
Activities
5.7 Production and Servicing Provision 8.5 5.7
5.7.1 Control of Production and Servicing 8.5.1 5.7.1
Validation of Process for Production and
[Link] ------ [Link]
Servicing
5.7.2 Product Quality Plans 5.7.2
5.7.3 Identification and Traceability 8.5.2 5.7.3
5.7.4 Product Inspection / Test Status 8.6 5.7.4
Customer/external providers-supplied
5.7.5 8.5.3 5.7.5
Property
Preservation of Product/Output of
5.7.6 8.5.4 5.7.6
Production And Services
5.7.7 Inspection and testing 8.6 5.7.7
5.7.8 Preventive Maintenance ------ 5.7.8
Control of Testing, Measuring and
5.8 Monitoring Equipment/ Monitoring and 7.1.5 5.8
Measuring resources
Product Release/Release Of product and
5.9 8.6 5.9
services
Control of Nonconforming Product
5.10 8.7 5.10
(Output)
5.10.1 General ------ 5.10.1
5.10.2 Nonconforming Product 8.7.1 5.10.2
Release of Nonconforming Product Under
5.10.3 8.7.1 5.10.3
Concession
5.10.4 Customer Notification 8.7.1 5.10.4
5.10.5 Records 8.7.2 5.10.5
Management of Change (MOC)/Planning
5.11 6.3,8.5.6 5.11
Of Change
5.11.1 General ------ 5.11.1
5.11.2 MOC Implementation 6.3 5.11.2
5.11.3 MOC Notification 6.3 5.11.3
Quality Management System Monitoring,
6 9.1 6
Measurement, Analysis and Improvement
6.1 General ------ 6.1
6.2 Monitoring, Measuring and Improving 9.1.1 6.2
6.2.1 Customer Satisfaction 9.1.2 6.2.1

Revision 6 Date 13th Nov., 2023 Page 9 of 76

Quality
ISO 9001: 2015 API Spec. Q1
Manual Description
Section No. Section No.
Section No.
6.2.2 Internal Audit 9.2 6.2.2
6.2.3 Process Evaluation 9.1.3 6.2.3
6.3 Analysis of Data 9.1.3 6.3
6.4 Improvement 10, 10.3 6.4
6.4.1 General ------ 6.4.1
6.4.2 Corrective Action 10.2 6.4.2
6.4.3 Preventive Action 6.1.2 6.4.3
6.5 Management Review 9.3 6.5
6.5.1 General 9.3.1 6.5.1
6.5.2 Input Requirements 9.3.2 6.5.2
6.5.3 Output Requirements 9.3.3 6.5.3
Annex A Use of API Monogram ------ Annex A

Revision 6 Date 13th Nov., 2023 Page 10 of 76

TABLE OF QUALITY PROCEDURES

Quality
Revision
Manual Description of Procedure Procedure No.
No.
Section No.
4.3.2 Competency, Training and Development QMSP-01 1
4.4.3, 4.5 Control of Documents and Records QMSP-02 5
5.1 Contract Review QMSP-03 3
5.3 Risk Assessment and Management QMSP-04 1
5.4 Design and Development QMSP-05 3
5.5 Contingency Planning QMSP-06 0
5.6 Purchasing QMSP-07 4
5.6.3 Verification of Purchased Products and Activities QMSP-08 1
Control of Production and Servicing / Validation
5.7.1 QMSP-09 4
of Processes
5.7.3 Identification and Traceability QMSP-10 2
5.7.4, 5.7.7,
Inspection and Testing Including Product Release QMSP-11 1
5.9
5.7.5, 5.7.6, Preservation of Product Including Customer
QMSP-12 0
[Link] Supplied Property and Storage and Assessment
5.7.8 Preventive Maintenance QMSP-13 1
Control of Testing, Measuring and Monitoring
5.8 QMSP-14 0
Equipment
5.10 Control of Nonconforming Product QMSP-15 2
5.11 Management of Change Process QMSP-16 1
6.2.1, 6.3 Customer Satisfaction and analysis of data QMSP-17 1
6.2.2 Internal Audit QMSP-18 1
6.4.2, 6.4.3 Corrective and Preventive Action QMSP-19 2
6.5 Management Review QMSP-20 0
Annex A API Monogram Marking QMSP-21 3

Revision 6 Date 13th Nov., 2023 Page 11 of 76

DOCUMENT REGISTER
Document
Holder / Position Revision Date
Register
1 Quality Manager (Hard Copies) 4th January, 2018
\\PROMECH-SRV1\UserShares\common\PROMECH
2 22nd march 2018
QMS\PROMECH QUALITY MANUAL
\\PROMECH-DC\Common\PROMECH QMS\Latest
3 4th January, 2019
quality Manual
\\PROMECH-DC\Common\PROMECH QMS\Latest
4 23rd April,2019
quality Manual
5 Q:\PROMECH QMS\Latest quality Manual 23rd Nov. 2021
6 Q:\PROMECH QMS\Latest quality Manual 13th Nov. 2023

Revision 6 Date 13th Nov., 2023 Page 12 of 76

INTRODUCTION
This Quality Manual satisfies requirements of ISO 9001:2015 and API Specification Q1 latest edition
for the Quality Management System for manufacturing organizations for the Petroleum & Natural Gas
Industry. That may be applied on an International basis to facilitate the consistent and reliable
manufacture of products to specifications prepared for the Oil & Gas Industry.

This Quality Manual promotes the adoption of a process approach when developing, implementing,
and improving the effectiveness of Quality Management System, to enhance customer satisfaction by
meeting customer requirements.

The goal of this Quality Manual is the development of a Quality Management System that provides
for continual improvement, emphasizing defect prevention and reduction of variation and waste in
supply chain and from service provider

Revision 6 Date 13th Nov., 2023 Page 13 of 76

COMPANY PROFILE

PROMECH is a part of Zamil Group Holdings Co. located in 1st Industrial City Dammam, Kingdom of
Saudi Arabia.

The company was established in 2011 and have designed and built a facility equipped with state of
the art equipment for the scope of their activities.

As a result of its establishment of the facility in Saudi Arabia, PROMECH is in the position to serve its
regional customer more effectively by providing better and more comprehensive services. In order to
improve on market position and to better service the customers, PROMECH is constantly training its
employees to cater for future industry demands and challenges. In this manner, it strives to
continuously improve its repair processes and expertise to meet customer requirements and
expectations.

PROMECH Health, Safety and Environmental Management Systems recognizes and promotes
integrated HSEQ as a sound business principle and regards these disciplines as having equal standing
to any other business function.

PROMECH is engaged in repair, remanufacture & manufacture Drill through and Well head
equipment to the specifications of API 6A, 16A, 16C, API 7-1 and API 20E in accordance with the
customer requirements.

Revision 6 Date 13th Nov., 2023 Page 14 of 76

CONTROL OF QUALITY MANUAL

INTERNAL DISTRIBUTION

To use within the internal departments of the company, the Quality Manual is available in company's
common shared folder “Q:\PROMECH QMS\Latest quality Manual” where all shop supervisors,
department heads and managers can access it. The documents will be available as PDF file or scanned
copy to ensure that the texts cannot be edited or deleted. In case of any revisions made in the Quality
Manual, all relevant employees will be informed, and the old Quality Manual will be removed from the
system and will be replaced with the revised one.

EXTERNAL DISTRIBUTION

All external distribution will be regarded as uncontrolled copy and subject to obsolescence.

This document contains information proprietary to PROMECH. Any disclosure or use is expressly
prohibited except upon written permission coming from the company’s Management Representative.

Both above distributions will be controlled by Management Representative.

(Management Representative) Date: November 13, 2023

Revision 6 Date 13th Nov., 2023 Page 15 of 76

1.0 SCOPE OF QUALITY MANUAL (Referring ISO 9001:2015 Clause 1 and Q1

Clause 1)
This Manual defines and documents the controls utilized by PROMECH to cover the scope of the
company, which is:
Manufacture, Repair, Refurbishment and Service of Blowout Preventers, Manifolds, Christmas
Trees, Valves, Threading, Studs, Wellhead and Oilfield Equipment.
This Quality Manual and associated procedures, Work Instructions Forms and other legal
requirements ensures that we shall address customer satisfaction through the effective application of
this system including those processes that address continuous improvements in our services.
Any Processes performed by sub-contractors or sources outside PROMECH that affect product
conformity are controlled in accordance with the requirements of purchasing process established in
this manual.
We are committed to address all clauses of the Specification, which reflects the requirement of API
Specification Q1 latest edition And ISO 9001:2015.
Exclusions
There are no exclusions from ISO 9001 and API Q1 9th Edition within this manual.
Design & Development as per API Advisory 6 for API 6A, 7-1 and 20E products.

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2.0 NORMATIVE REFERENCES (Referring ISO 9001:2015 Clause 2 and Q1

Clause 2)
a) API Specification Q1, Specification for the Quality Management System Requirements for
manufacturing organizations for the petroleum and natural gas industry – 9th Edition, June
2013
b) API 6A / ISO 10423 Spec, Specification for Drilling and Production equipment, Wellhead and
Christmas Tree. – 21st Edition November 2018
c) API 16A – Specification of Drill-Through Equipment- 4th Edition April 2017.
d) API 16C – Choke and Kill Equipment – 3rd Edition- March 2021
e) API Spec 7-1, Rotary Drill Stem Elements- 2nd Edition February 2023
f) API Spec 7-2, Threading and Gauging of Rotary Shouldered Thread Connection -2nd Edition
January 2017

g) ISO 9001:2015 Quality Management Systems Requirements 5th Edition September 2015
h) API 20E– Alloy and Carbon Steel Bolting for Use in the Petroleum and Natural Gas Industries – 2nd Edition-
February 2017

Note: The latest edition of the applicable system & product standards shall be identified, and the
quality system documents shall be updated suitably and implemented.

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3.0 TERMS, DEFINITIONS AND ABBREVIATIONS (Referring ISO 9001:2015

Clause 3 and Q1 Clause 3)
3.1 TERMS AND DEFINITIONS (In Alphabetical Order) (Referring ISO 9001:2015
Clause 3 and Q1 Clause 3.1)
For the purpose of this Quality Manual the terms and definitions given in ISO 9000 AND API Q1 spec.
latest edition shall apply as well as any specific terms and definitions utilised by PROMECH. Here as
follows:

3.1.1 Acceptance Criteria

Specified limits of acceptability to process or product characteristics.

3.1.2 Acceptance Inspection

Demonstrate through monitoring or measuring that the product complies with specified
requirements.

3.1.3 Audit
Systematic examination to determine whether activities and related results conform to the
documented Management System and whether the procedures and work instructions are
implemented effectively and are suitable for achieving PROMECH’s policy statements and
objectives.

3.1.4 Auditor
A person with the competence to conduct an audit that is independent of the area or activities being
audited.

3.1.5 Calibration
Comparison to a standard of known accuracy and making any needed adjustment.

3.1.6 Collection
Process of obtaining, assembling, and / or organizing applicable information with the intent of
meeting the requirements of control of records.

3.1.7 Competence
Demonstrated ability to apply knowledge and skills to the job.

3.1.8 Compliance
Act of process of satisfying the legal and other applicable requirements of a regulation or
regulatory body.

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3.1.9 Continuous Improvement

Process of enhancing the Management System, to achieve improvements in overall performance,
in line with PROMECH’s policy statements.

3.1.10 Contract
Agreed requirements between PROMECH and a customer (note this may take the form of a formal
documented contract, a purchase order or a verbal instruction).

3.1.11 Control Feature

Organization’s documented method to perform an activity under controlled conditions to achieve
conformity to specified requirements.

3.1.12 Corrective Action

The action taken to rectify and close out a non-conformance.

3.1.13 Critical
That deemed by the organization, product specification, or a customer as a mandatory,
indispensable or essential, needed for a stated purpose or task, and requiring specific action.

3.1.14 Customer
Those for whom the service or product is provided to by PROMECH.

3.1.15 Delivery
Point in time and physical location at which the agreed transfer of ownership takes place.

3.1.16 Design Acceptance Criteria- DAC

Defined limits placed on characteristics of materials, products, or services established by the
organization, customer, and / or applicable specification to achieve conformity to the product
design.

3.1.17 Design Validation

Process of proving a design by testing to demonstrate conformity of the product to design
requirements (i.e.) prototype test, functional and/or operational test of production products,
test specified by industry standards and /or regulatory requirements and test performance test
review.

3.1.18 Design Verification

Process of examining the result of a given design or development output to determine
conformity with specified requirements (i.e.) confirming the accuracy of design results through
performance of alternative calculations, review of design output documents independent of
activities of design and development., comparing new designs to similar proven designs.

3.1.19 Employees
Persons employed by PROMECH.

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3.1.20 Environment
Conditions under which work is performed including physical, environmental and other factors (such
as noise, temperature, humidity, lighting and weather).
3.1.21 Filed Non Conformity
Product nonconformity that is detected after delivery or use has started.

3.1.22 First Article

Representative sample of a product, component, or output from a process used to verify that
prescribed activities have satisfied the requirements as specified by the organization. (Includes trial
purchases and prototypes)

3.1.23 Inspection
Examination of a product design, service, process or plant and determination of their conformity with
specific requirements or, on the basis of professional judgment, general requirements.

3.1.24 Inspection body:

The body that performs the inspection, in this case, PROMECH
3.1.25 Interested Parties
Any of the people or Organizations who may be affected by a situation, such as customers,
Employees, Suppliers, Owners, Neighbours, Banks and regulators .

3.1.26 Key Performance Indicator

Quantifiable measure that an organization uses to gauge of compares performance.

3.1.27 Legal Requirements

Obligation imposed on an organization, including those that are statutory or regulatory.

3.1.28 Management
Person of group of people, as defined by the organization, who directs and controls all or part of
a facility, location, department, or other function; has a fiscal responsibility for the organization
and is accountable for ensuring compliance with legal and other applicable requirements.

3.1.29 Manufacturing Acceptance Criteria

Defined limits placed on characteristics of materials, products, and services established by the
organization to achieve conformity to the manufacturing or service requirements.

3.1.30 Non- Conformance

A deviation from the requirements specified in the Management System.

3.1.31 Objective evidence

Data supporting the existence of compliance with a requirement.

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3.1.32 Outsource (Outsource Activity)

Function of process that is performed by an external supplier (external provider) on behalf of the
organization.

3.1.33 Preventive Maintenance

Planned action to minimize the likelihood the likelihood of equipment failure and unscheduled
interruptions.

3.1.34 Preventive Action

The action taken to eliminate the cause of a potential non-conformance from occurring or from
recurring again.

3.1.35 Procedure
Organization`s documented method for performing an activity under controlled condition to
achieve conformity to specified requirements.

3.1.36 Quality
Degree to which a set of inherent characteristics fulfils requirements.

3.1.37 Risk
Situation or circumstances that have both are likelihood of occurring and a potentially negative
consequence.

3.1.38 Service
Performance of an activity by one function or organization for another.

3.1.39 Servicing
Product maintenance, adjustment, repair, and / or on-site installation when installation is required
by applicable product specifications.

3.1.40 Supplier (External Provider)

Vendors and sub-contractors who provide a service or product to PROMECH.

3.1.41 Traceability
Ability to trace the history, application, or location of that which is under consideration.

3.1.42 Validation
Confirmation, through the provision of objective evidence that the requirements for a specific
intended use or application have been fulfilled.
3.1.43 Verification
Confirmation, through the provision of objective evidence that the specified requirements have
been fulfilled.

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3.2 ABBREVIATIONS:
For the purpose of this specification, the following abbreviations shall apply.

API American Petroleum Institute

ASNT American Society for Non-destructive Testing

CAR Corrective Action Report

COC Certificate Of Conformity

DAC Design Acceptance Criteria

ITP Inspection Test Plan

KPI Key Performance Indicator

MAC Manufacturing Acceptance Criteria

MOC Management Of Change

MPS Manufacturing Process Specification

NCR Non Conformance Report

PCP Process Control Plan

QAP Quality Activity Plan

QM Quality Manual

QMS Quality Management System

QP Quality Plan

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4.0 QUALITY MANAGEMENT SYSTEM REQUIREMENTS/CONTEXT OF

THE ORGANIZATION (Referring ISO 9001:2015 Clause 4 and Q1 Clause
4)
4.1 QUALITY MANAGEMENT SYSTEM (Referring ISO 9001:2015 Clause 4.1 and Q1
Clause 4.1)
4.1.1 GENERAL
PROMECH ensures that our QMS for all our products and services provided to our customers are
established, documented, implemented, and maintained at all times for continual improvement and
customer satisfaction in accordance with API Q1 latest edition and ISO 9001:2015.
The effectiveness of the QMS is reviewed at Management Review Meetings during which objectives
and performance indicators are reviewed to monitor the improvements achieved. A specific task of
the Management Review is to monitor all resource needs, both for personnel and equipment for the
immediate and longer-term future.
The Documented management system is designed to meet the requirement of the following users
a) Customers
b) Different Dept. In PROMECH
c) Accreditation Body
d) Other interested Parties

Context of the Organization

PROMECH has determined the external and internal issues that are relevant to the organization and
its strategic direction that affect its ability to achieve the intended result of the management system.
PROMECH established controls to monitor and review the information about these external and
internal issues for both positive and negative factors and conditions relevant to the Management
system which require consideration. This may include external issues arising from legal,
technological, competitive, market, cultural, social and economic environments and security with in
the applicable geographical boundaries.
PROMECH monitor and review the information of the interested parties and their relevant
requirements if any effects or potential effect of PROMECH`s ability to consistently provide products
and services concerning the customer`s applicable and regulatory requirements.

Monitoring of the following interested parties and requirements will be done annually in the MRM.
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Internal and External issues (Referring to ISO 9001:2015 Clause 4.1, 4.2)
Internal:

1. Language Barrier.
2. Culture barriers regarding quality and customer service knowledge.
3. Machining of sophisticated jobs

External:

1. Market competency with similar facilities.

2. Oil and Gas market needs for new quality requirements exceeding the specs and code
requirements.
3. Updating the facility with the necessary cutting edge technology and tools such as CNC and
automation of the production process.
4. Environmental and legal requirements of Kingdom of Saudi Arabia (Customs).

Interested parties:

- API
- Saudi ARAMCO(Arabian-American Oil Company)
- SAIPEM(Società Anonima Italiana Perforazioni E Montaggi)
- Saudi Aramco Nabors Drilling company(SANAD)
- BH (Baker Huges)
- NOV(National Oilwell Vacro)
- Camron
- Hydril Pressure Controlling Arabia Limited (HMH)
- Clients, Potential customers and End users.
- PROMECH Employees

Requirements of the relevant interested parties:

1. Conformity to product specific standards and the Quality management standards of API Q1
for the acquired certificates and product licenses which will be monogramed.
2. Conformity to the customer chosen standards, requirements and needs for their products.
3. Delivery on time.
4. Providing accurate and detailed info about the released products within the limits and the
extents of the contracts.
5. Conforming to ARAMCO manuals and standards where applicable.
6. Clear job descriptions and role identification

Interested parties without an unknown requirement but might have an effect on the system:
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- MODN industrial area government

4.1.2 QUALITY POLICY AND COMMUNICATION OF QUALITY POLICY (Referring ISO 9001:2015
Clause 5.2 and Q1 Clause 4.1.2)

a) Policy for its commitment to quality shall be defined by Top Management and documented and
approved by the General Manager
b) Quality policy includes a commitment to satisfy applicable requirements and continual
improvement of the Quality management system.
c) The General Manager shall review the Quality Policy to ensure that it is appropriate (purpose and
context) to the organization.
d) The General Manager shall review the Quality Policy to ensure that it is the basis for the
development of Quality Objectives
e) The Top Management shall ensure the Quality Policy is communicated, understood,
implemented, and maintained at all relevant functions and levels within PROMECH.
f) The Top Management shall ensure the Quality policy is available to relevant interested parties,
as appropriate.
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QUALITY POLICY

PROMECH `s commitment is to maintain and improve upon their leading position in the provision
of repair, manufacture, refurbishment and servicing of parts and components within the
capabilities of the company.

It is the objective of PROMECH to provide customers with services, which will meet and exceed
the high standards of Quality and Reliability expected, and also meet and exceed the needs and
expectations of our Company and our customer requirements.

To achieve this objective PROMECH will:

• Provide adequate resources and training to ensure the development and
implementation of the Quality System.
• Ensure that all personnel understand and implement the Quality Policy.
• Manage and direct the implementation of the Quality Policy and Quality System.
• Demonstrate its ability to consistently provide product that meets customer and
applicable regulatory requirements.
• Aim to enhance customer satisfaction through the effective application of the
system, including processes or continual improvement of the system and the
assurance of conformity to customer and applicable regulatory requirements.
• This document is the framework on which we define our Quality Objectives

As General Manager I will ensure that this policy is communicated, understood, implemented
and maintained at all levels of the organization.
PROMECH is committed to comply with requirements and continually improve the effectiveness
of Quality Management System.
This Policy will be reviewed annually at a Management Review Meeting to ensure its
effectiveness.
The Management of PROMECH firmly believes that leading by example is the key to Quality.

General
Manager Tariq Al Tawayan Date 13th Nov., 2023
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4.1.3 QUALITY OBJECTIVES and Planning to Achieve Them (Referring ISO 9001:2015 Clause
6.2 and Q1 Clause 4.1.3)
Quality Objectives will be prepared, in consultation with the Department Managers, and approved by
the General Manager.
These objectives will be documented and issued to the Departmental Managers individually including
essential elements to meet product and customer requirements. It was established at relevant
function and levels within PROMECH organization.
It was measured and analyzed periodically to show the continuous improvement of the Company.
These objectives will meet the requirements of the product / service provided and will be measurable
and consistent with the Quality Policy.
Quality objectives for each department will be monitored, communicated and updated on annual
basis to ensure the continual improvement of the Quality management system.

On Quality objective plan PROMECH shall determine “What will be done, what resources will be
required, who will be responsible, when it will be completed, how the result will be evaluated”

PROMECH`s QUALITY OBJECTIVES

PROMECH has set the following as the company objectives:

To fulfil client needs by providing the necessary service delivered on time, and at an agreed price.
To consistently reduce customer complaints and increase customer satisfaction.
To develop a company attitude to quality and ensure all services conform to the agreed specifications.
To ensure the capability and continuous improvement of all work processes through performance
measurement targets.
To ensure that all equipment is maintained as per the planned Preventative Maintenance Schedule.
To ensure that all employees are trained and proficient in their nominated activities and identify
training needs where required for these employees.
To check and inspect all stages of Production from Material Receiving through to Final Inspection and
maintaining records for these inspections to ensure compliance with customer requirements.
To ensure that any problems are highlighted and reported to enable continual improvement.
To maintain the Quality system through the application of regular audit reviews.
To minimize the risk associated with product delivery and product quality.
To ensure a zero accident/incident policy is adhered with.
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4.1.4 QUALITY MANAGEMENT SYSTEM PLANNING (Referring ISO 9001:2015 Clause 6 and Q1
Clause 4.1.4)

Quality Management System Planning will give consideration to the following activities, as appropriate,
in meeting specified requirements:

a) Preparation of Design and Development Plan (as applicable) to ensure all process and standard
requirements are included on the planning stage as specified in API Q1.
b) Preparation of Quality Plans for all manufactured components or as required by customer to meet
API Specification Q1 latest edition and customers’ requirements.
c) The identification and acquisition of any controls processes, equipment (including inspection and
test equipment)
d) Resources and skills that may be needed to achieve the required quality
e) Ensuring the compatibility of the design, the production process, inspection and test procedures
and applicable documentation
f) Installation and Servicing, if required by the client
g) The updating, as necessary of Quality Control inspection and testing techniques including the
development of new procedures and instrumentation
h) The identification of suitable verification of parts in process
i) The clarification of standards of acceptability
j) The identification and preparation of Quality Records
k) Quality Audits
l) The planning of new designs or modifications of existing designs, if needed, shall be conducted

PROMECH Management shall ensure that:

a) Criteria and methods needed for the operation and control of all Quality Management System
processes are determined, managed and effective
b) Planning of the Quality Management System is carried out in order to meet the requirements of
API Specification Q1 latest edition

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4.1.5 COMMUNICATION (Referring ISO 9001:2015 Clause 7.4,8.2.1 and Q1 Clause 4.1.5)

PROMECH determines the internal and external communications relevant to the QMS, including “on
what it will communicate, when to communicate, with whom to communicate, how to communicate,
who communicate”.

[Link] INTERNAL COMMUNICATION

PROMECH ensures that appropriate communication processes are established within the organization
and that communication takes place regarding the effectiveness of the quality management system.
PROMECH established processes that ensures:
a) Importance of meeting customer, legal and other applicable requirements is
communicated at relevant functions within the organization.
b) All managers or department heads are responsible for ensuring that internal
communication processes are established throughout the organisation to ensure correct
and rapid exchange of information. In addition facilities are available to enable swift
communication by e-mail, memo, telecoms or specific official form where relevant. Where
appropriate, lines of communication are indicated in the process procedures and quality
plans.
c) Results of analysis of data are communicated at relevant levels and functions within the
organization. It was communicated through management review meetings and it was
posted on workshop information boards and it is accessible on PROMECH common server.

[Link] EXTERNAL
PROMECH managers and personnel assigned for external communication is required to determine and
implement a process for communicating with external organizations, including customers, to ensure
requirements are understood throughout contract execution and product realization.
These communication process are address:
a) Information regarding the products/services

b) Executions of inquiries, contracts, or order handling and amendments wherein it was

included in Contract Review Procedure which includes the customer communication for
any amendment scope, price or any other issues, including production updates and
delivery time.
c) Provision of product information, including product conformities identified after
delivery to the customer. This was executed through issuance of Product Non
Conformity or Email notification to our customer to ensure that it was communicated.
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d) Feedback and customer complaints. Customer feedback is arranged by the Sales

personnel to send or visit the customer to fill out the Customer Satisfaction Survey to
assess the point of improvement of PROMECH.
e) When required by contract, providing information required by product quality plans
and subsequent changes to those plans. Information for product quality plan is
communicated also by customer visit and / or email notification and communication.
Sample Quality Plan was sent to the customer to assure accuracy of the processes and
finalize through meetings if necessary.
f) Handling or controlling customer property.
g) Establishing specific requirements for contingency actions, when relevant

4.2 MANAGEMENT RESPONSIBILTY /COMMITMENT AND LEADERSHIP (Referring ISO

9001:2015 Clause 5.1 and Q1 Clause 4.2)
4.2.1 GENERAL
The General Manager shall ensure that there are enough resources available (like human resources,
material resources, financial resources, specialized skills, organizational infrastructure, technology, etc.)
to establish, implement, maintain and improve the Quality Management System. The processes for the
above will be covered throughout the Company Quality Management System and throughout the
organization.
PROMECH`s Top Management shall provide evidence of its Leadership and commitment to the
development and implementation of the Quality Management System and continually improve its
effectiveness by:
• Taking accountability for the effectiveness of the quality management system
• Ensuring that the Quality Objectives are established for each department including key
performance indicators for use in data analysis. These objectives will be applicable for all
departments within the Company, where the outcomes of their activities affect quality
• Ensuring the quality policy and quality objectives are established for the quality management
system and are compatible with the context and strategic direction of the organization
• Ensuring the integration of the quality management system requirements into the
organization’s business process
• Communicating the importance of effective quality management system and of conforming to
the quality management system requirements
• Conducting management reviews of PROMECH`s Quality Management System for ensuring
that the quality management system achieves intended result.
• Engaging directing and supporting persons to contribute the effectiveness of the quality
management system
• Promoting improvements and supporting other relevant management roles to demonstrate
their leadership as it applies to their areas of responsibility.
• Promoting the use of risk based thinking.
Top Management shall demonstrate leadership and commitment with respect to customer focus by
ensuring that customer and applicable statutory and regulatory requirements are determined and
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understood and consistently met, the risk and opportunity can affect the conformity of the product
and services and ability to enhance customer satisfaction are determined and addressed, the focus
on enhancing customer satisfaction is maintained.

4.2.2 ORGANIZATIONAL ROLES , RESPONSIBILITY AND AUTHORITY (Referring ISO 9001:2015

Clause 5.3 and Q1 Clause 4.2.2)

Top Management shall ensure Roles, Responsibilities, authorities and accountabilities of personnel
within the scope of this Quality Manual has been defined, documented, communicated and Understood
throughout PROMECH Facility.

This section covers PROMECH's organization structure with defined responsibilities, authorities and
lines of communication for each position addressed in the Quality Manual.

Top management shall ensure that the responsibility and authority for ensuring that the QMS confirms
to the requirement of ISO 9001-2015 and Q1 9th Edition, processes are delivering their intended outputs,
reporting on the performance of the QMS and on opportunities for improvement in particular to top
management, promotion of customer focus throughout the organization and integrity of the QMS is
maintained when changes to the QMS are planned and implemented.

Controls features have been implemented to ensure each of positions identified have the organizational
freedom, resources and authority to implement their responsibilities. However, certain details are
located in relevant Quality Procedures.

An organization chart has been included to graphically describe the organization structure of the
positions addressed (Figure - 1).

General Manager

• Reporting to Company CEO.

• He has the ultimate responsibility, authority and accountability for the commitment in
implementation of Quality Management System.
• Responsible in supervision and co-ordination activities of all departments and department
heads
• Accountable in all contract and tender agreement conflicts.
• Responsible and authorized to approve the Company Quality Policy, Company Quality Manual
and the Company Quality Objectives.
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• Responsible and authorized the appointment of QA Engineer as the Management

Representative. This representative will have functional responsibility to the General Manager
on all items concerning the Quality Management System.
• Responsible and accountable in improving operational systems, processes and policies in
support of organizations mission -- specifically, support better management reporting,
information flow and management, business process and organizational planning.
• Oversee overall financial management, planning, systems and controls.
• Work with sales to determine Pricing.
• Oversee inventory in the plant. Schedule Plant meetings, Safety meetings and Staff meetings.
• Responsible in developing of long-range forecasts and maintain long-range financial plans.

Operation Manager

• Reporting to Company GM.

• He has the responsibility to follow the Quality Management System and industry standards.
• Responsible in supervision and co-ordination activities of all departments (production, quality
control, fitting) and respective department heads
• Accountable to review and approve all contract and tender agreements including conflicts.
• Responsible and accountable in improving operational systems, processes, and policies in
support of organizations mission -- specifically, support better management reporting,
information flow and management, business process and organizational planning.
• Oversee overall production planning, systems, and controls.
• Work with sales to determine Pricing.
• Oversee inventory in the plant. Schedule Plant meetings, Safety meetings and Staff meetings.
• Responsible in developing of long-range forecasts.
• Accountable to achieve company set targets for production.
• Responsible to hire new employees to match quality and production requirements.
• Responsible to enhance business development by adding and increasing business scale and
plant capacity.
• Support sales by attending customer meetings when required.
• Accountable against company set KPIs for manufacturing, fitting and QC and responsible for
monitoring daily, weekly, and monthly plan and targets.
• Reporting KPIs progress and overall efficiency to GM quarterly.
• Responsible to submit weekly/monthly /yearly reports to GM regarding operation issues
(threats, weaknesses, opportunities, and strengths)
• Responsible to develop and provide trainings for the employees covering the industry
standards such as API, ASME, ARAMCO Etc.
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Quality Control Manager/Supervisor

• Reporting to Operation Manger
• Overall responsible and authorized for Quality Control on all projects undertaken within the
workshops & site.
• Responsible and authorized to do review for all quality inspection and test activities.
• Accountable in approval of Product Conformity and standard processes.
• Accountable in approving product for release providing all aspects are satisfactorily concluded.
• Responsible and accountable in establishing and producing quality plans as required.
• Responsible in conducting quality audits, identifying, documenting, and providing solutions for
Non Conformances (NCR's) Corrective Actions (CAR's) & Preventive Actions (PAR's)
• Coordinate; verify and approve all Inspection activities detailed in project Quality Plans and
ITP's.
• Responsible and accountable in interpretation and update of product standard specifications
of all licenses to internal procedures within the production and inspection process.
• Responsible in preparation of Route Cards prior for initialization of the job.

Quality Assurance Manager

• Reporting to General Manager
• Chairing of Management Review Meetings, Quality Meetings.
• Responsible and accountable in maintaining the effectiveness of the Quality Management
System to sustain the API Certificates.
• He is the appointed Management Representative. His responsibility is to ensure that processes
are established, maintained and implemented.
• Responsible in controlling individual training records.
· Accountable in assessment of suppliers and monitoring the supplier`s performance.
• Responsible in verification of quality management system records.
· Liaising directly with Sales, Contracts / Planning, Supply Chain, Production and Quality Control
to implement QMS.
· Consolidation, review and analysis of data came from all departments to identify the
performance of the processes against the approved Quality Objectives.
· Responsible in conducting quality audits, identifying, documenting of Non Conformances
(NCR's) Corrective Actions (CAR's) & Preventive Actions (PAR's).
• Responsible in verification of effectivity of Corrective Actions.

Manufacturing Manager/supervisor

• Reporting to the Operation Manager.

• Responsible and accountable in CNC / Manual Machining and Welding processes.
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• Accountable in work flow by monitoring steps of the process; setting processing variables;
observing control points and equipment; monitoring personnel and resources; studying
methods; implementing cost reductions; developing reporting procedures and systems;
facilitating corrections to malfunctions within process control points; initiating and fostering a
spirit of cooperation within its section.
• Responsible and accountable in process manpower delegation as per the production plan by
scheduling and assigning personnel; accomplishing work results; establishing priorities;
monitoring progress; revising schedules; resolving problems; reporting results of the
processing flow on shift production summaries.
• Responsible in ensuring operation of equipment by calling for repairs; evaluating new
equipment and techniques.
• Provides manufacturing information by compiling, initiating, sorting, and analysing production
performance records and data as part of quality objectives; answering questions and
responding to requests.
• Authorize to create and revise systems and procedures by analysing operating practices,
record-keeping systems, forms of control, and personnel requirements; implementing change
if necessary upon verification and approval of GM, QA Engineer and QC Manager.
• Maintains safe and clean work environment by educating and directing personnel on the use of
all control points, equipment, and resources; maintaining compliance with established policies
and procedures.
• Reporting any non-conformities that occurs within the manufacturing process and providing
root cause and corrective actions.
• Contributes to team effort by accomplishing related results as needed.
• Accomplishes manufacturing staff results by communicating job expectations; planning,
monitoring, and appraising job results; coaching, counselling, and disciplining employees;
initiating, coordinating, and enforcing systems, policies, and procedures.
• Responsible and accountable in welding & fabrication process controls.

Workshop Supervisor

• Reporting to the Operation Manager

• Responsible and accountable in assembly / disassembly, testing, finishing and packaging
processes.
• Accountable in work flow by monitoring steps of the process; setting processing variables;
observing control points and equipment; monitoring personnel and resources; studying
methods; implementing cost reductions; developing reporting procedures and systems;
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facilitating corrections to malfunctions within process control points; initiating and fostering a
spirit of cooperation within its section.
• Responsible and accountable in process manpower delegation as per the production plan by
scheduling and assigning personnel; accomplishing work results; establishing priorities;
monitoring progress; revising schedules; resolving problems; reporting results of the
processing flow on shift production summaries.
• Responsible in ensuring operation of equipment by calling for repairs; evaluating new
equipment and techniques.
• Provides manufacturing information by compiling, initiating, sorting, and analysing production
performance records and data as part of quality objectives; answering questions and
responding to requests.
• Authorize to create and revise systems and procedures by analysing operating practices,
record-keeping systems, forms of control, and personnel requirements; implementing change
if necessary upon verification and approval of GM, QA Engineer and QC Manager.
• Maintains safe and clean work environment by educating and directing personnel on the use of
all control points, equipment, and resources; maintaining compliance with established policies
and procedures.
• Reporting any non-conformities that occurs within the manufacturing process and providing
root cause and corrective actions.
• Contributes to team effort by accomplishing related results as needed.
• Accomplishes manufacturing staff results by communicating job expectations; planning,
monitoring, and appraising job results; coaching, counselling, and disciplining employees;
initiating, coordinating, and enforcing systems, policies, and procedures
• Responsible in preparation and update of time sheets.

Sales Engineer

• Reporting to Sales Manager.

• Responsible in providing Cost Sheet calculation in every job.
• Provides drafts of commercial bids and tenders, estimating the costs of a project and ensuring
that the costs are controlled.

• Responsible in preparation of order acknowledgements for forwarding to the client.

• Authorized to consult with technical staff on various products and applications, manage sub-
contract labour and suppliers, handle complaints from the client, and deal with any issues that
may compromise the project start and completion date, payment of contract, invoicing, and
non-chargeable expenses.
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• Responsible in managing and interpreting customer requirements.

• Receive RFQs and creates Quotations to be sent to customers.

Sales Manager

• Reporting to GM
• Responsible and accountable in searching for new customer who could benefit from your
products and services.
• Responsible in calculation and providing customer quotations.
• Responsible in overseeing, Analyse and Report market fluctuations and business
weaknesses.
• Establishing new, and maintaining existing, relationships with customers.
• Responsible in managing and interpreting customer requirements.
• Persuading clients that a product or service will best satisfy their needs.
• Accountable for analysis of costs and sales
• Responsible in providing Business Development Plan annually to identify and
demonstrate the market demand and establish draft plan for improvement.
• Accountable in providing Customer Satisfaction Rate to ensure continual improvement in
Quality, Delivery, Price and Customer Service.
• Authorized to provide on time updates regarding the jobs and brought up client concerns
and problems.
• Responsible in providing Cost Sheet calculation in every job.
• Provides drafts of commercial bids and tenders, estimating the costs of a project and ensuring
that the costs are controlled.

• Responsible in preparation of order acknowledgements for forwarding to the client.

Contracts / Planning Manager

• Reporting to General Manager

• Responsible and accountable in completion of contract file and conducting contract review &
associated paperwork.

• Responsible in ensuring all order details are communicated to all departments.

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• Responsible in preparation of order acknowledgements for forwarding to the client.

• Ensures that change orders are logged on the system and order paperwork is retained in the file.

• Provides a manufacturing or repair plan to ensure that the committed delivery date was met.

• Accountable in ensuring that change orders are communicated to all departments immediately
upon receipt.

• Responsible in providing customers with delivery and progress updates.

• Authorized to pass completed jobs (including partial deliveries) to accounts for invoicing.

• Participate and lead order handover reviews.

• Monitors WIP through the system and regular liaising with operations. Drives operations to
achieve monthly targets.

• Accountable in Monitoring and reporting of On Time Delivery performance

• Provides General Manager with regular WIP and revenue status updates.

• Provides drafts of commercial bids and tenders, estimating the costs of a project and ensuring
that the costs are controlled.

Supply Chain Manager

• Reporting to General Manager.
• Responsible for ordering inventory, supplies, equipment and services for all departments and
divisions as per the procedure and policy.
• Responsible for securing the best price for all purchases without jeopardizing quality.
• Responsible in supplier`s initial assessment and evaluation.
• Responsible in supplier monitoring as required by the procedure.
• Authorized to blacklist any suppliers that are not following the purchasing requirements as
stated on the purchasing procedure.
• Responsible in meet with suppliers to discuss performance metrics, to provide performance
feedback, or to discuss production forecasts or changes.
• Responsible and accountable in logistics and delivery control.

HR Supervisor
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• Directly reporting to the General Manager and is responsible and accountable for payrolls, all
administration, personnel activities.
• Responsible in scheduling and organizing interviews
• Responsible in participating in applicant interviews.
• Authorized in conducting reference checks on possible candidates.
• Accountable in assessment, investigation and understand causes for staff absences.
• Accountable for decision or giving solutions to resolve chronic attendance difficulties.
• Provide advice and recommendations on disciplinary actions.

4.2.3 MANAGEMENT REPRESENTATIVE

PROMECH Management is ensuring that there are enough resources essential in establishing,
implementing, maintaining and improving the Quality Management System. These resources include
human resources and specialized skill and competencies, company infrastructure, financial resources
and technology. The processes mentioned above will be covered throughout the Company Quality
Management Systems and throughout the organization.
PROMECH is committed to the development and implementation of the QMS and continually
improvement of the Quality Management System effectiveness.
Establishing and Approving Company Objectives. These objectives will be prepared for all departments
within the Company where the outcomes of their activities affect Quality. Review and verify the Key
Performance Indicator results to assess or analyze the effectivity and performance of the mandated
target of measurable Quality Objectives.
Undertaking Management Reviews of the Quality System and its component parts. This will be done
by a number of factors such as Management Review Meetings (at least 12 months), twelve monthly
internal audits (by department) and at yearly external audits as applicable.
Holding Management and Inter-departmental meetings to ensure that communication is developed
between the departments to aid the implementation and maintenance of the quality system.

Management Representative
• The General Manager appointed QA Engineer as Management Representative who is
irrespective to other responsibilities.
• Responsible and accountable in ensuring that process needed for the quality management
system are established, implemented and maintained.
• Responsible in reporting to top management on the performance of the quality management
system and any need for improvement.
• Responsible in ensuring initiation of actions to minimized the likelihood of the occurrence of
nonconformities.
• Ensuring the promotion of awareness of customer requirements throughout the organization.
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Figure 1
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4.3 ORGANIZATION CAPABILITY (Referring ISO 9001:2015 Clause 7.1.1 and Q1

Clause 4.3)
4.3.1 PROVISION OF RESOURCES (Referring ISO 9001:2015 Clause 7.1 and Q1 Clause 4.3.1)
The General Manager is responsible for determining and allocating various resources needed for
establishment, implement, maintain and continual improve the effectiveness of the Quality
Management System requirements.

PROMECH shall consider the capacities of, and constraints on, existing resources; what need to be
obtained from external providers.

The General Manager ensures that the resources needed to achieve the Quality Objectives are identified
and planned.

4.3.2 HUMAN RESOURCE (QMS Procedure No. QMSP-01 Competency and Training Procedure).
(Referring ISO 9001:2015 Clause 7.1.2, 7.2, 7.3 and Q1 Clause 4.3.2)

[Link] GENERAL
PROMECH shall determine and provide the persons necessary for the effective implementation of its
quality management system and for the operation and control of its process.

A documented procedure has been created and maintained for defining and determining personal
competency and identifying training requirements or other actions. This is to achieve the necessary
competency of personnel whose responsibilities fall within the scope of the Quality Management
System.
Training system also has been established to improve the competency of personnel and to equip staff
with proper skills to perform the job effectively and efficiently. Provisions for determining and
documenting the effectiveness of the training shall be included in the Procedure.

[Link] PERSONNEL COMPETENCE

The Personal competency needed for meeting product and customer requirements is based on
appropriate education, training, skills and experience and are determined by PROMECH in the job
description records (Documented information) and maintained for evidence.

[Link] TRAINING AND AWARENESS

a) Quality Manager is the responsible person for providing Quality Management System Training and
its evaluation of effectiveness and The Head of Department is the responsible person for providing
Job training and its evaluation of effectiveness.
b) Head of Department shall ensure that customer-specified training and/or customer-provided
training, when required, is included in the training program
c) Head of department shall ensure that the frequency and content of training is identified
d) Quality Manager and head of department shall ensure that PROMECH personnel are aware of the
relevance and importance of their activities and how they contribute to the achievement of the
company Quality Objectives
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e) PROMECH shall ensure that persons doing work under control of organization are aware of the
quality policy , relevant quality objectives, their contribution to effectiveness of the quality
management system including the benefit of improved performance , the implication of not
conforming with the QMS requirement.
f) The Administration Department shall maintain appropriate records (retain documented
information) of education, training, skills and experience

4.3.3 WORK ENVIRONMENT and Infrastructure (Referring ISO 9001:2015 Clause 7.1.3, 7.1.4
and Q1 Clause 4.3.3)
PROMECH shall determine, provide, manage and maintain the work environment and Infrastructure
needed to achieve conformity applicable to the manufacture/Service of the product. PROMECH shall
ensure that work environment and Infrastructure includes:

a) Buildings, workspace and associated utilities

b) Process equipment and their maintenance (including hardware and software)
c) Supporting services such as transport, communication, information systems, etc.
d) Conditions under which work is performed such as social, psychological, physical, environmental
or other factors
PROMECH shall ensure that there is suitable production and installation equipment to ensure
compliance with applicable specifications, reference standards/codes and quality plans.

PROMECH shall ensure that all key items of Process plant and equipment, having a direct effect on
Product/Process or Service quality, are maintained in order to ensure their continued capability to meet
pre-determined quality standards.

4.3.4 ORGANIZATIONAL KNOWLEDGE (Referring ISO 9001:2015 Clause 7.1.6)

PROMECH shall determine the knowledge necessary for the operation of its process and its to achieve
conformity of product and services. This knowledge shall be maintained and be made available to the
extend necessary. When addressing changing needs and trends, the organization shall consider its
current knowledge and determine how to acquire or access any necessary additional knowledge
required updates.

Organizational knowledge is knowledge specific to the organization, it is generally gained by

experience .This information is used and shared to achieve the organization’s objectives.
Organizational knowledge can based on the internal sources like intellectual property , gained from
experience , lessons learned from failure and successful project, capturing and sharing undocumented
knowledge and experience , the result of improvements in processes/product/services And external
sources like standards, academia, conferences, gathering knowledge from customers or external
providers.
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4.4 DOCUMENTATION/DOCUMENTED INFORMATION REQUIREMENTS (Referring ISO

9001:2015 Clause 7.5 and Q1 Clause 4.4)
4.4.1 GENERAL (Referring ISO 9001:2015 Clause 7.5.1, 7.5.2 and Q1 Clause 4.4.1)
PROMECH`s Quality Management System documentation includes documented information required
by ISO 9001-2015 and Q1 9th Edition and Documented information determined by the organization as
being necessary for the effectiveness of QMS:

When creating and updating documented information, PROMECH shall ensure appropriate
identification and description (title, date, author, or reference number), format and media, review and
approval for suitability and adequacy.

a) Quality Policy statement defined by Top Management & approved by the General Manager. It will
be signed and prominently displayed at all locations. All Managers and supervisors must ensure
that their employees are aware of this Policy and its contents
b) Quality Objective statement prepared, in consultation with the Department Managers and
approved by the General Manager. These objectives will be measured and analyzed annually to
confirm the continual improvement of the organization
c) Quality Manual prepared by Management Representative and reviewed & approved by the
General Manager, that addresses the requirements of API Specification Q1 latest edition. This
Manual is issued and controlled by Company Management Representative. It includes:
1) The scope of the Quality Management System, including justification for any exclusions to
specific Quality Management System elements
2) A description of the sequence and interaction between the processes of the Quality
Management System (Figure - 2)and (Figure 2A)
3) Identification of processes that require validation
4) Reference to documented procedures that control the Quality Management System processes
d) Documented procedures established for the Quality Management System
e) Documents and records (retain documented Information) to ensure the effective planning,
operation and control of its processes and compliance with specified requirements
f) Identification of legal and other applicable requirements to which the organization claims
compliance that are needed to achieve product conformity. Currently, PROMECH is not obliged to
any legal requirements for the scope of work being done.

4.4.2 PROCEDURES (Referring ISO 9001:2015 Clause 7.5.3 and Q1 Clause 4.4.2)
All Quality related procedures referenced within API Specification Q1 latest edition, ISO9001-2015
and applicable to the organization has been established and documented in our Quality
Procedure. It shall be implemented and maintained for continued suitability.
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QMS PROCESS MODEL AND INTERACTION BETWEEN QMS PROCESS (FIGURE 2)

MANAGEMENT REVIEW
CUSTOMER IMPROVEMENT FOR
EFFECTIVENESS CORRECTIVE AND PREVENTIVE
COMPLAINCE WITH LEGISLATION
QUALITY OBJECTIVES AND ACTION STATUS
QUALITY POLICY CHANGES IN LEGISLATION AND CUSTOMER FEED BACK AND
TARGET
STANDARDS COMPLAINTS
QUALITY RESOURCES REQUIRED
RESULTS OF INTERNAL AUDIT PROCESS PERFORMANCE
OBJECTIVES
PRODUCT IMPROVEMENT FOLLOW UP ACTIONS ADEQUACY OF POLICIES
PLANNING RESPONSIBILITY AND ANALISYS OF FILED NON
ACHIEVEMENT ON OBJECTIVES
AUTHORITY CONFORMANCE
TRENDS PRODUCT/SERVICE CONFORMITY
RESPONSIBILITY
AND AUTHORITY DESIGN AND DEVELOPMENT

COMMUNICATION HUMAN RESOURCES,

MEASUREMENT ANALYSIS
INFRA STRUCTURE IMPROVEMENT
QMS MANUAL, PROCEDURE MONITORING AND
AND WORK INSTRUCTIONS MEASUREMENT
WORK ENVIRONMENT
CONTROL OF NON
CONFORMANCE
TREND CHARTS
CUSTOMER NEEDS ANALYSIS OF DATA
IMPROVEMENTS
INTERNAL AND
EXTERNAL ISSUES, CUSTOMER
INPUTS DELIVERY
MARKET CONDITION
OPERATIONS SATISFACTION

REGULATION AND
LEGISLATION

MANGEMENT COMMITMENT CONTRACT REVIEW

CUSTOMER FOCUS PURCHASING
QUALITY POLICY MATERIAL CONTROL
QUALITY OBJECTIVES CALIBRATION OF EQUIPMENTS
RESOURCES AND TRAINING OPERATIONS
RISK AND OPPORTUNITY PROCESS CONTROL
D & D PLANNING D & D INPUT OUTPUT

MANAGEMENT REVIEW MONITORING AND

CORRECTIVE AND PREVENTIVE MEASUREMENT
ACTION ANALYSIS OF DATA
PROCESS EVALUATION AND AUDITS
IMPROVEMENTS SUPPLIER PERFORMANCE
D & D VALIDATION D & D VERIFICATION
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Processes flow (FIGURE 2A)

This document contains information proprietary to PROMECH. Any disclosure or use is expressly prohibited except upon written permission coming from the company’s Quality Management
Representative. Original documents can be distinguished by signatures of originator, reviewers and approver appearing in Digital Signature.
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The Pyramid below (Figure - 3) shows the documentation structure of PROMECH’s Quality
Management System:

DOCUMENTATION STRUCTURE

Quality Manual, Quality

Policy , Quality Objectives

Documented Process
Procedures

Process Flowcharts, Work

Instructions, Drawings

Forms, Records (retain

documented information)

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4.4.3 CONTROL OF DOCUMENTS / Control of Documented Information (QMS Procedure No.

QMSP-02 Control of Documents and Records Procedure.) (Referring ISO 9001:2015 Clause 7.5.3
and Q1 Clause 4.4.3, 4.5)
PROMECH shall maintain a documented procedure for the identification, distribution and control of
documents and Records (retain documented information) required by the Quality Management System,
API Specification Q1 latest edition, ISO9001-2015. The documents include those using within the
organization as well as the documents required from an external origin.

The procedure shall specify responsibilities for approval and re-approval. Management Representative
shall ensure that the documents required by the Quality Management System are reviewed and
approved, identify changes and revision status, remain legible and readily identifiable and are available
where the activity is being performed.

PROMECH’s procedures, work instructions, forms and also the documents of external origin shall be
controlled to ensure that the relevant versions are used and maintained.

The Management Representative shall

a) Maintain a documented procedure to identify the controls and responsibilities needed for the
identification, collection, storage, protection, retrieval, use, retention time and disposition of
records (Documented Information)
b) Establish and control the records (Documented information), including those originated from
outsourced activities to provide evidence of conformity to requirements and PROMECH’s Quality
Management System
c) Ensure that records remain legible, identifiable and retrievable
d) Ensure that records (retain documented information)shall be retained for a minimum of 10 years
or as required by customer, legal and other applicable requirements, whichever is longer
e) Ensure documented information retained as evidence of conformity shall be protected from
unintended alterations.

4.4.4 USE OF EXTERNAL DOCUMENTS IN PRODUCT REALIZATION (Referring ISO 9001:2015

Clause [Link] and Q1 Clause 4.4.4)
The quality manager/supervisor will make sure that for API product or other external specification
requirements, the external documents requirements such as addenda, errata and updates, whenever
they are used in the manufacture of the product are included in product realization process and other
applicable processes. The management review will make sure that only current versions of external
documents are being used in product realization process. He will check this in every six months if any
new revisions of these documents are available. The current revision level of the external documents
will be identified through external document list
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5.0 PRODUCT REALIZATION/OPERATION (Referring ISO 9001:2015 Clause 8.5,

8.2 and Q1 Clause 5)
5.1 CONTRACT REVIEW (Quality Procedure Ref: QMSP-03) (Referring ISO 9001:2015
Clause 8.2.3 and Q1 Clause 5.1)
5.1.1 GENERAL (Referring Q1 Clause 5.1.1)
PROMECH has maintained a documented procedure for the review of requirements related to the
provision of products and required servicing.

5.1.2 DETERMINATION OF REQUIREMENTS/REQUIREMENTS FOR PRODUCT AND SERVICES

(Referring ISO 9001:2015 Clause 8.2.2 and Q1 Clause 5.1.2)
To ensure the customer satisfaction and expectations of quality, the identification and determination
of customer requirements and other applicable requirements is critical.

PROMECH shall determine:

a) Requirements specified by the customer

b) Statutory/Regulatory and other applicable requirements
c) Requirements not stated by the customer but considered necessary by the organization for the
provision of the product
d) PROMECH can meet the claims for the product and services it offers.

PROMECH shall confirm the customer requirements and maintain records (retain documented
information), wherever the customer provides no documented statement of the sufficient
requirements. This will be done by Sales Engineer or Contracts Engineer.

5.1.3 REVIEW OF REQUIREMENTS (Referring ISO 9001:2015 Clause 8.2.3 and Q1 Clause 5.1.3)
PROMECH has established and implemented a procedure for reviewing the requirements related to
provision of products. The Contracts Engineer shall conduct the review of requirements before
committing to supply of product or service to the customer and shall ensure that:

a) All requirements are identified and documented, including the delivery and post-delivery
activities.
b) Requirements not stated by the customer, but necessary for the specified or intended use, when
known.
c) Requirements specified by PROMECH
d) Statutory and Regulatory requirements applicable for the product and service.
e) Contract or order requirements differing from those previously expressed
f) The capability to produce the product and meet the applicable specification and the documented
contractual requirements

PROMECH shall ensure that contract or order requirements differing from those previously defined are
resolved.
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The Customer’s requirements shall be confirmed by PROMECH before acceptance, when the customer
does not provide a documented statement of their requirements.

Any amendments to contract that are identified after contract awarded, shall go through the same
review process as of original contracts. When the contract requirements are changed, the Contracts
Engineer shall ensure that the relevant documents are amended and informed to the relevant
personnel.

The Contracts Engineer shall maintain records (retain documented Information) of the results of the
review, on any new requirements for the product and services including resulting actions.

5.2 PLANNING/OPERATIONAL PLANNING AND CONTROL (Referring ISO 9001:2015

Clause 8.1 and Q1 Clause 5.2)
PROMECH has identified, planned, developed, Implemented and control the processes and documents
needed for product realization to meet the requirements for the provision of product and services. The
planning shall also consider relevant internal and external issues, relevant needs and expectation of
interested parties. Planning of product realization shall be consistent with the requirements of the other
processes of Quality Management System.
In planning, PROMECH shall address the following:
a) Required resources(such as facilities, personnel, process, inspection equipment, etc. required to
achieve quality)and work environment management
b) Product and customer-specified requirements
c) Legal and other applicable requirements
d) Contingencies based on risk assessment
e) Required verification, validation, monitoring, measurement, inspection and test activities specific
to the product and the criteria for product acceptance
f) Management Of Change (MOC)
g) Determining, maintaining and retaining Records (retain documented information) needed to
provide evidence that the product realization processes meet requirements as planned, to
demonstrate the conformity of product and service to their requirements.
The relevant Department Manager or Heads shall document and update the output of planning
whenever any unintended changes occurred, and to take action to mitigate any adverse effect as
necessary.
It shall also be ensured that the plans developed and maintained in a structure suitable for the operation
methods and procedures of PROMECH.
The Quality Plan shall ensure compatibility of the design, the production process, installation, servicing,
inspection, test procedures and the applicable documentation.
The Quality Plan shall reference and identify all the production and inspections stages, together with all
the applicable procedures and quality records required. Also it shall identify suitable verification at
appropriate stages in the realization of the product.
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PROMECH shall ensure that the outsourced process are controlled.

Customer/Contract Specific Quality Plans

Relate to the particular requirements of individual customers or contracts, including delivery and post-
delivery activities (which can include actions under warranty provisions, contractual obligations such as
maintenance services and supplementary services such as recycling or final disposal, if applicable). If
required by a contract or customer a copy of either type of quality plan shall be supplied for the
appropriate approval and insertion of any intervention points.
All control, testing, manufacturing, repair or other related operations are performed in accordance with
drawings, written procedures and specifications. The specific requirements will be detailed in the
Quality Plan.

5.3 RISK ASSESSMENT AND MANAGEMENT/ACTION TO ADDRESS RISK AND

OPPORTUNITY (Quality Procedure Ref: QMSP-04) (Referring ISO 9001:2015 Clause 6.1
and Q1 Clause 5.3)
PROMECH has developed and maintained a documented procedure to identify and control risk and
opportunity associated with the relevant internal and external issues and the relevant requirement of
the relevant interested parties (including impact on delivery and quality of product). The procedure shall
identify the techniques, tools and their application for risk identification, assessment and mitigation.
Risk assessment associated with product delivery shall include:
a) Facility/equipment availability and maintenance
b) Supplier performance and material availability/supply
Risk assessment associated with product quality shall include:
c) Delivery of nonconforming product, if applicable
d) Availability of competent personnel
PROMECH shall determine the Risk and opportunities that need to be addressed to give assurance that
the QMS can achieve its intended result, enhance desirable effects, prevent or reduce undesirable
effects, achieve improvements.
The Quality Manager/supervisor and department manager shall maintain the records (retain
documented information) of risk assessment and management including records of any action taken.
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The flow chart below (Figure - 4) shows the General overview of Quality Risk Management process.

GENERAL OVERVIEW OF QUALITY RISK MANAGEMENT PROCESS (Figure 4)

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5.4 DESIGN AND DEVELOPMENT OF PRODUCT AND SERVICES (Quality Procedure Ref:
QMSP-05) (Referring ISO 9001:2015 Clause 8.3 and Q1 Clause 5.4)
5.4.1 DESIGN AND DEVELOPMENT PLANNING (Referring ISO 9001:2015 Clause 8.3.1, 8.3.2, 8.3.4
and Q1 Clause 5.4.1)
PROMECH has establish, implement and maintain a documented procedure to plan and control the
design and development process that is appropriate to ensure the subsequent provision of the product
and services.
The procedure identifies the following:

a) The plan, including plan updates, used for design and development.
b) design and development stages;
c) resources, responsibilities, authorities and their interfaces to ensure effective
communication;
d) the review, verification and validation activities necessary to complete each design and
development stage;
e) The requirements for final review of the design.
f) The nature, duration and complexity of the design and development activities.
g) The internal and external resource needs for the design and development of product
and services.
h) The need for involvement of the customers and users in the design and development
process.
i) The requirement for subsequent provision of product and services.
j) The level of control expected for the design and development process by customer and
relevant interested parties.
k) The documented information needed to demonstrate that the design and development
requirements has been met.
l) The results to be achieve are defined.

PROMECH identifies the control the controls required to ensure that the design meets the
requirements of Clause 5.4 of this Manual when the design and development activities are performed
in different location.

PROMECH is ensuring that all supplier requirements stated in Clause [Link] of these manual was
applied when design and development are outsourced.
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5.4.2 DESIGN AND DEVELOPMENT INPUTS (Referring ISO 9001:2015 Clause 8.3.3 and Q1 Clause
5.4.2)
PROMECH’s design and development inputs shall be identified and reviewed for adequacy,
completeness and lack of conflict.

PROMECH determines the requirements essential for the specific types of product and services to be
designed and develop.

These include:

a) functional, technical and performance requirements;

b) customer specified requirements;
c) Requirements provided from external sources (standards or codes of practice), including API
product specification.
d) Environmental and operational conditions.
e) Methodology, assumptions and formulae documentation;
f) historical performance and other information derived from previous similar designs and
development activities
g) statutory and regulatory requirements
h) results from risk assessment
i) Potential consequences of failure due to the nature of the product and services.
j) Conflicting design and development inputs shall be resolved.

Records (retain documented information) of design inputs shall be maintained.

5.4.3 DESIGN AND DEVELOPMENT OUTPUTS (Referring ISO 9001:2015 Clause 8.3.5 and Q1
Clause 5.4.3)
PROMECH`s provides a documented design and development output to allow verification against the
design and development input requirements.

Design and Development shall:

a) meet the input requirements for design and development;

b) provide appropriate information for purchasing, production and servicing;
c) identify or reference design acceptance criteria (DAC);
d) include identification of, or reference to, products and / or components deemed critical to the
design;
e) include results of applicable calculation;
f) Specify the characteristics of the product that are essential for its safe and proper provision.
g) Have adequate of the subsequent processes for the provision of product and services.
h) Reference monitoring and measuring requirements, as appropriate and acceptance criteria.

Records (retain documented information) of design outputs shall be maintained.

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5.4.4 DESIGN AND DEVELOPMENT REVIEW (Referring ISO 9001:2015 Clause 8.3.4 and Q1 Clause
5.4.4)
PROMECH shall perform review at suitable stages:

a) to evaluate the suitability, adequacy and effectiveness of the results of the design and
development stages to meet the specified requirements;
b) To identify any problems and propose necessary action.

Department manager or heads should be present during the design and development review. Records
(retain documented information) of the result of the review and any actions shall be maintained.

5.4.5 DESIGN AND DEVELOPMENT VERIFICATION AND FINAL REVIEW (Referring ISO
9001:2015 Clause 8.3.4 and Q1 Clause 5.4.5)
PROMECH ensures that the design and development outputs have met the design and development
inputs requirements.

Design and development verification and final review shall be conducted and documented in
accordance with planned arrangements as mentioned in Cl. 5.4.1 of this manual.

Records (retain documented information) of design and development verification and final review
shall be maintained.

5.4.6 DESIGN AND DEVELOPMENT VALIDATION AND APPROVAL (Referring ISO 9001:2015
Clause 8.3.4 and Q1 Clause 5.4.6)
PROMECH performs design and development validation in accordance with planned arrangements as
mentioned in CL. 5.4.1 of this manual to ensure that the resulting product is capable of meeting the
specified application and intended use.

Validation shall be completed prior to the delivery of the product. Completed design shall approved by
the General Manager after validation. Competent personnel other that the person(s) who develop the
design shall approve the final design.

PROMECH shall determine any problems during validation activities and propose necessary action.

Records (retain documented information) of design and development verification and final review
shall be maintained.
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5.4.7 DESIGN AND DEVELOPMENT CHANGES (Referring ISO 9001:2015 Clause 8.3.6 and Q1
Clause 5.4.7)
Design and Development changes shall be identified by PROMECH. These changes shall be reviewed,
verified and validated as appropriate and approved before implementation.

PROMECH identify, review and control change made during, or subsequent to the design and
development of product and services ensures that the evaluation had no adverse impact on the
conformity to requirements and on the product and / or their constituents parts already delivered.

PROMECH ensures design and development changes, including the changes on the design documents
requires the same controls as the standard design and development requirements.

Records (retain documented information) of design and development changes, review of those
changes, authorization of the changes and any necessary actions shall be maintained.

5.5 CONTINGENCY PLANNING (Quality Procedure Ref: QMSP-06) (Referring ISO

9001:2015 Clause 6.1.2 and Q1 Clause 5.5)
5.5.1 GENERAL (Referring Q1 Clause 5.5.1)
PROMECH has developed and maintained a documented procedure for contingency planning needed
to address risk and opportunity associated with relevant internal and external issues and the relevant
requirement of the relevant interested parties (including impact on delivery and quality of product).
Contingency planning will be based on assessed risks and opportunity, how to integrate and implement
the action into its QMS process (Continual Improvement) , how to evaluate the effectiveness of these
action and output shall be documented and communicated to the relevant personnel and updated as
required. Action taken to address risk and opportunities shall be proportionate to the potential impact
on the conformity of product and service.

5.5.2 PLANNING OUTPUT (Referring ISO 9001:2015 Clause 6.1.2 and Q1 Clause 5.5.2)
PROMECH’s contingency plan shall include:

a) Actions required in response to significant risk scenarios to mitigate effects of disruptive incidents
b) Identification and assignment of responsibilities and authorities
c) Internal and external communication controls
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5.6 PURCHASING/EXTERNALY PROVIDED PROCESS, PRODUCT AND SERVICES (Quality

Procedure Ref: QMSP-07) (Referring ISO 9001:2015 Clause 8.4 and Q1 Clause 5.6)
5.6.1 PURCHASING CONTROL (Referring ISO 9001:2015 Clause 8.4.1, 8.4.2 and Q1 Clause 5.6.1)
[Link] PROCEDURE
PROMECH has developed and maintained a documented procedure to ensure that purchased products
(such as materials, equipment (production/quality), operating supplies, services, etc.) or outsourced
activities conform to specified purchase requirements such as quality, delivery time, packaging, price
payment terms, warranty provisions, etc.

PROMECH shall determine the controls to be applied to externally provided processes, product and
services when: product and services from external providers are intended for information into the
PROMECH’s own product and services; product and services directly to the customers by external
providers on behalf of the PROMECH; a process or a part of process, is provided by an external provider
as a result of decision by the PROMECH.

PROMECH shall ensure that externally provided process, product and services not to adversely affect
the organization’s ability to consistently deliver conforming product and services to its customers.

PROMECH shall ensure that externally provided processes remain within the control of its QMS, define
both the controls that is intends to apply an external provider and those it intends to apply to the
resulting output, take in to consideration: the potential impact of the externally provided processes,
products and services on the organization’s ability to consistently meet customer and applicable
statutory and regulatory requirements and the effectiveness of the controls applied by the external
provider. PROMECH shall determine the verification, or other activities, necessary to ensure that the
externally provided processes, product and services meet requirements.

PROMECH’s purchasing procedure addresses:

a) Determination of the criticality of the activities or products as they are applicable to conformance
to product or customer specifications
b) Initial evaluation and selection of suppliers (External providers). PROMECH performs an annual
supplier evaluation for all critical suppliers listed in approved vendor list based on their ability to
supply products or activities in accordance with PROMECH’s requirements. Also, any new supplier
is evaluated periodically to decide whether to approve or reject them.
c) Type and extent of control applied to the supplier(External providers) based on the criticality of
the product or activity
d) The criteria of supplier(External providers) selection, evaluation & re-evaluation, scope, frequency
and methods for reassessment of suppliers(External providers)
e) Maintaining a list of approved suppliers(External providers) and scope of approval
f) The type and extent of control to be applied to these outsourced processes shall be defined within
the Quality Management System. PROMECH is responsible to control and evaluate all its
outsourced processes and relative suppliers (External providers) provide these services to ensure
their validity and product conformance.
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[Link] INITIAL SUPPLIER EVALUATION – CRITICAL PURCHASES

Quality Engineer along-with concerned department manager / heads is responsible for the initial
supplier evaluation for critical purchases.

For purchase of critical products, components or activities, PROMECH has developed the criteria for the
initial evaluation of suppliers. The criteria shall be site-specific for each supplier and shall include the
following:

a) Verification that the supplier’s Quality Management System conforms to PROMECH’s quality
system requirements specified for all our suppliers;
b) verification of the type and extent of control applied by the supplier, internally and to their
supply chain, in order to meet the organization’s requirements; and
c) Individual supplier assessment for each supplier to ensure the capability of them to meet
PROMECH’s purchasing requirements by any one of the following processes:
1. Assessment of supplier’s final product and evaluation of relevant activities of supplier by
inspecting it on-site or
2. Performing first article inspection to ensure conformance to stated requirements or
3. Identifying how the supplied product conforms to stated requirements when limited by
proprietary, legal and/or contractual arrangements
[Link] INITIAL SUPPLIER EVALUATION – NONCRITICAL PURCHASES
Quality Engineer along-with concerned department manager / workshop manager is responsible for the
initial supplier evaluation for noncritical purchases.

For purchase of noncritical products, components or activities that impact product realization or the
final product, Quality Manager shall ensure that the criteria for evaluation of suppliers by PROMECH
shall meet the requirements of Sec. [Link] or satisfy one or more of the following:

a) Verification that the supplier’s Quality Management System conforms to PROMECH’s quality
system requirements specified for all our suppliers (External providers) or
b) Individual supplier assessment for each supplier to ensure the capability of them to meet
PROMECH’s purchasing requirements or
c) Assessment of the product upon delivery or activity upon completion.
[Link] SUPPLIER REEVALUATION
Quality Assurance Engineer is responsible for re-evaluation of all suppliers, which include both critical
and noncritical purchases.

The organization shall determine the supplier reevaluation frequency based on supplier risk and

supplier quality performance.

For the reevaluation of suppliers of critical products, components or activities, the requirements of

[Link] shall apply.

For the reevaluation of suppliers of noncritical products, components or activities, the

requirements of [Link] shall apply.

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[Link] SUPPLIER EVALUATION – RECORDS

Quality Engineer shall maintain the records (retain documented information) of the results of all
evaluations and any necessary actions arising from the evaluations.
[Link] OUTSOURCING
If PROMECH chooses to outsource any process, activity or service within the scope of our Quality
Management System, the Quality Manager and Quality Engineer shall ensure that all applicable
elements of its Quality Management System are satisfied and shall maintain responsibility for product
conformance to specified requirements.

Subcontractor’s applicable procedures shall be reviewed and approved before outsourcing the activity,
OR PROMECH shall provide our own procedure to the subcontractor to follow with strict compliance. It
shall be ensured in both cases that the procedures and activities are comply with applicable API product
specifications, associated with product realization.

Records (retain documented information) of all outsourced activities shall be maintained by the Quality
Engineer.

5.6.2 PURCHASING INFORMATION (Referring ISO 9001:2015 Clause 8.4.3 and Q1 Clause 5.6.2)
The Supply Chain Supervisor shall ensure the adequacy of purchase orders/requests prior to
communication to the supplier (external providers). Purchasing information provided to the supplier
shall include:

a) The product/activity/services to be purchased including acceptance criteria

b) Requirements for approval of supplier’s procedures, processes and equipment, product and
services, the release of product and service
c) Applicable Specifications, technical data, drawings, inspection instructions, traceability and other
relevant data necessary to ensure the quality of materials, products and/or services
d) Qualification/Competence requirements for supplier’s personnel
e) Quality Management System requirements
f) The external providers’ interaction with PROMECH.
g) Control and monitoring of external providers performance to be applied by PROMECH.
h) Verification or validation activities that the organization, or its customer, intends to perform at
the external providers premises.

The purchasing information shall be documented by the Supply Chain Supervisor and shall be reviewed
and approved by the Department Manager or Heads, General Manager, Accounting Manager. In case
of any urgent requirement and absence of General Manager, it shall be reviewed and approved only by
the Department Manager / Heads & Accounting Manager.
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5.6.3 VERIFICATION OF PURCHASED PRODUCTS OR ACTIVITIES (Quality Procedure Ref:

QMSP-08) (Referring ISO 9001:2015 Clause 8.4.1 and Q1 Clause 5.6.3)
PROMECH has developed and maintained a documented procedure for the verification or other
activities necessary to ensure that purchased products or activities meet specified purchase
requirements.

PROMECH apply the receiving inspection results and data as an effective feature to verify the purchased
product. All products/activities from outside vendors shall be subjected to inspection at the supplier’s
premises or at PROMECH premises in order to perform verification. If verification is performed at the
supplier’s premises, the engineering shop coordinator shall state the intended verification
arrangements and method of product release in the purchasing information. The Quality Engineer &
Department Manager shall provide evidence that purchased products and activities conform to
specified requirements.

The Quality Inspector shall maintain records (retain documented information) of the verification
activities.

5.7 PRODUCTION AND SERVICING PROVISION (Referring ISO 9001:2015 Clause 8.5 and
Q1 Clause 5.7)
5.7.1 CONTROL OF PRODUCTION AND SERVICING (Quality Procedure Ref: QMSP-09)
(Referring ISO 9001:2015 Clause 8.5.1 and Q1 Clause 5.7.1)
[Link] PRODUCTION
PROMECH has developed and maintained a documented procedure that describes controls associated
with the production of products. The procedure includes the following requirements:

a) The availability of information that describes the characteristics of the product to be produced,
the result to be achieved;
b) The availability of suitable work environment and infrastructure for the operation of process.
c) The availability and use of suitable calibrated equipment for production, testing, monitoring and
measurement
d) Maintenance of machines and equipment for ensuring continuous production capability
e) Implementation of product quality plan, when applicable
f) The implementation of monitoring and measurement activities at appropriate stages to verify that
criteria for control of process or outputs, and acceptance criteria for product have been met.
g) The availability of work instructions and acceptance criteria, as necessary
h) Documents needed for the process control
i) Compliance of our products with the relevant quality and inspection plans and/or specifications
j) Implementation of product release, delivery and post –delivery activities
k) The appointment of competent persons, including any required qualification.
l) The validation, and periodic revalidation, of the ability to achieve planned result of the process for
production, where the resulting output cannot be verified by the subsequent monitoring or
measurement.
m) Implementation of action to prevent human error
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n) Ensuring identification and traceability requirements are maintained throughout the production
process
[Link] SERVICING
PROMECH has developed and maintained a documented procedure that describes controls associated
with the servicing of products. The procedure includes the following requirements:

a) Review and implementation of the organization’s customer-specific, product servicing and other
servicing requirements
b) The availability of information that describes the characteristics of the services to be provided, or
the activities to be performed, the result to be achieved
c) The availability of suitable work environment and infrastructure for the operation of process.
d) The implementation of monitoring and measurement activities at appropriate stages to verify that
criteria for control of process or outputs, and acceptance criteria for services, have been met.
e) The availability and use of suitable calibrated equipment for servicing, testing, monitoring and
measurement
f) Maintenance of machines and equipment for ensuring continuous servicing capability
g) Ensuring identification and traceability requirements are maintained throughout the servicing
process
h) The availability of work instructions and acceptance criteria, as necessary
i) Documents needed for the process control
j) Requirements for the product release of the serviced products.
k) The appointment of competent persons, including any required qualification.
l) The validation, and periodic revalidation, of the ability to achieve planned result of the process for
services provision, where the resulting output cannot be verified by the subsequent monitoring or
measurement.
m) Implementation of action to prevent human error
n) The implementation of release, delivery and post-delivery activities.
[Link] PROCESS CONTROL DOCUMENTS
For achieving process control for manufacturing and/or repairing of jobs, PROMECH apply work
instructions, i.e., Route Card, Checklists, applicable drawings or other types of control features required
by the organization and shall include requirements for verifying conformance with applicable product
quality plans, API specifications, other applicable specifications, standards and/or customer
requirements.

The process control documents shall include or reference instructions and acceptance criteria for
processes, tests, inspections and required customer’s inspection hold or witness points.

[Link] PRODUCT REALIZATION CAPABILITY DOCUMENTATION

PROMECH has developed and maintained documentation that includes but is not limited to product
realization plans and records of review/verification, validation of relevant processes, monitoring,
measurement, inspection and test activities. The documentation also includes the criteria for product
acceptance which shows the capability of our organization to satisfy specified product and/or servicing
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requirements as per relevant API specifications, other applicable specifications and/or customer
requirements.
[Link] VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICING (Quality Procedure Ref: QMSP-9)
PROMECH shall validate processes for production and servicing; where the resulting output cannot be
verified by subsequent monitoring or measurement and as a consequence, deficiencies become
apparent only after usage or servicing has been delivered. Validation shall demonstrate the ability of
these processes to achieve planned results. Revalidation is performed periodically, or just in case we
have a nonconforming product.

The processes outsourced by PROMECH which require validation, such as non-destructive examination,
shall be ensured from the supplier to conform to these requirements.
PROMECH shall maintain a documented procedure for review and approval of the validation processes
including:

a) Required equipment
b) Qualification of personnel
c) Use of specific methods, including identified operating parameters
d) Identification of acceptance criteria
e) Requirements for records
f) Revalidation

PROMECH shall validate those processes identified by the applicable product specification as requiring
validation. If these processes are not identified, or there is no product specification involved, the
processes requiring validation shall include, as a minimum, non-destructive examination, welding, and
heat treating and phosphating if applicable to the product.

[Link] POST-DELIVERY ACTIVITIES

PROMECH shall meet the requirements of post-delivery activities associated with the Product and
Services. In determining the extend of post-delivery activities that are required, the organization shall
consider : Statutory and regulatory requirements, the potential undesired consequences associated
with its product and Services, the nature, use and intended life time of its product and services,
customer requirements, customer feedback. Post-delivery can include actions under warranty
provisions, contractual obligations such as maintenance services, and supplementary services such as
recycling or final disposal.

[Link] CONTROL OF CHANGES

PROMECH shall review and control changes for production or service provision, to the extent necessary
to ensure continuing conformity with requirements. PROMECH shall retain documented information
describing the result of the review of changes, the person authoring the change, and necessary actions
arising from the review.
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5.7.2 PRODUCT QUALITY PLANS (Referring Q1 Clause 5.7.2)

The Quality Manager & Department Manager / Heads shall develop a product quality plan when
required by contract that specifies the Quality Management System processes including the product
realization processes and the resources to be applied to a product.
Currently, PROMECH has issued the Quality Plans for:
1) Some manufactured components for API 6A, 16A, 16C,7-1 and 20E Specification as per customer
requirements or when specified as needed by the quality assurance engineer.
2) Recertification of components is upon customer request or needed by contract. Process control route
card is used to satisfy the minimum requirements of quality plan.
The product quality plan required by contract shall include the following as a minimum:
a) Description of product to be manufactured
b) Processes and documentation required, including inspections, tests and records, for conformance
with requirements
c) Identification and reference for the control of outsourced activities
d) Identification of each procedure, specification or other document referenced or used in each
activity.
e) Identification of the required hold, witness, monitor and document review points
The Quality Manager/supervisor and General Manager shall document and approve these product
quality plans and any revisions made to ensure customer requirements are satisfied.
The Quality Manager/supervisor & Department Manager or Heads shall ensure that these product
quality plans and any revisions made shall be communicated to the relevant customer.

5.7.3 IDENTIFICATION AND TRACEABILITY (Quality Procedure Ref: QMSP-10) (Referring ISO
9001:2015 Clause 8.5.2 and Q1 Clause 5.7.3)
PROMECH shall use suitable means to identify outputs when it is necessary to identify outputs when it
is necessary to ensure the conformity of product and service
All materials, services and products of PROMECH requiring identification and traceability by PROMECH,
the customer, and/or the applicable product specifications are controlled as per the procedure
developed and maintained for Identification and Traceability. It shall include the applicable delivery and
post-delivery activities.
For any contract/order that PROMECH receive, a unique job card number is issued for that order, which
will be used from start to completion for the identification, traceability and record retention. PROMECH
control the job card number for each order and maintain its records (retain documented information).
This route card number shall be mentioned throughout the product realization processes where it
includes on all relevant documents such as contract review form, route card, mill test certificates,
inspection reports, COC’s, etc. and these records will be maintained.
All materials/products shall be suitably marked to ensure identification/traceability to be accessed at
any time. If any markings found removed or destroyed, it shall be replaced immediately.
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5.7.4 PRODUCT INSPECTION/TEST STATUS (Quality Procedure Ref: QMSP-11) (Referring ISO
9001:2015 Clause 8.6 and Q1 Clause 5.7.4)
PROMECH has developed and maintained a documented procedure for the identification of product
inspection and/or test status on the basis of monitoring and measurement requirements throughout
the product realization process that indicates the conformity, nonconformity or hold of product with
respect to inspections and/or tests performed. This is to avoid the unintended use of nonconforming
material or product.
Product status with respect to monitoring and measurement requirements shall be identified with
appropriate status tags. The Quality department & Department Manager shall ensure that only product
that meets requirements or that is authorized under concession is released.

5.7.5 CUSTOMER AND EXTERNAL PROVIDERS -SUPPLIED PROPERTY (Quality Procedure Ref:
QMSP-12) (Referring ISO 9001:2015 Clause 8.5.3 and Q1 Clause 5.7.5)
PROMECH has developed and maintained a documented procedure for the identification, verification,
safeguarding, preservation, maintenance and control of customer-supplied property and the property
belonging to external providers, including intellectual property and data while it is under the
organization’s control or being used by organization or incorporation into the product and services.
PROMECH's policy with material supplied by its customer/property belongs to external providers is to
be treated it in the same manner as material supplied by external providers and/or subcontractors.
Customer/External providers supplied materials on receipt, shall be checked by the stores for:
a) Quantity received
b) Its full description and specification
c) Any obvious damage, which may have occurred during transit
Periodic inspection shall be carried out on materials, which may subject to deterioration whilst in
storage to determine their condition. Protection and preservation of customer supplied material in our
possession shall be dealt within section of this manual.
The customer/External providers shall be reported of any loss, damage, defect or unsuitability to the
customer-supplied property/property belongs to external providers. Relevant records (retain
documented information) for the control and disposition of customer-supplied properties shall be
maintained.

5.7.6 PRESERVATION OF PRODUCT/OUTPUTS OF PRODUCTION AND SERVICE (Quality

Procedure Ref: QMSP-12) (Referring ISO 9001:2015 Clause 8.5.4 and Q1 Clause 5.7.6)
[Link] GENERAL
PROMECH has developed and maintained a documented procedure for describing methods and
activities used to preserve the product (Outputs of Production/Services) and constituent parts and its
safe delivery to the intended destination in order to maintain conformity to requirements. Preservation
shall include identification and traceability marks, transportation, handling, packaging and protection
of product, as applicable.
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[Link] STORAGE AND ASSESSMENT (Quality Procedure Ref: QMSP-12)

PROMECH has developed and maintained a documented procedure for identifying the requirements
for storage and assessment.
PROMECH uses only designated storage areas to prevent damage or deterioration of products from
arrival at facility until dispatch. The condition of product or constituent parts held in stock shall be
assessed on a regular interval identified by the procedure. The company also practices a first in first out
(FIFO) method to assure stock rotation when applicable. Relevant records of the results of assessments
shall be maintained.

5.7.7 INSPECTION AND TESTING (Quality Procedure Ref: QMSP-11) (Referring ISO 9001:2015
Clause 8.6 and Q1 Clause 5.7.7)
[Link] GENERAL
PROMECH has developed and maintained a documented procedure for inspection and testing to verify
that product requirements have been met and to maintain control features of inspection and testing
activities as per product quality plan and/or document procedures. The procedure shall include
requirements for in-process and final inspection and testing. Relevant records (retain documented
information) of required inspection and testing shall be maintained.

[Link] IN-PROCESS INSPECTION AND TESTING

The Quality Department shall inspect and/or test the product at planned stages as required by the
product quality plan, process control documents and/or documented procedures.
Any product found to be non-conforming, either through operation, inspection or test; will be
immediately withheld from further processing by the Quality Department/Production Supervisor until
corrective action is taken. Evidence of relevant actions taken as per the acceptance criteria shall be
maintained.

[Link] FINAL INSPECTION AND TESTING

The Quality Department shall perform all final inspection and testing in accordance with the product
quality plan and/or documented procedures to validate and document conformity of the finished
product to the specified requirements. The final acceptance inspection will be performed by Q.A / Q.C
inspector, other than those who performed or directly supervised the production of the product, at
planned stages of the product realization process.
If an item is reworked after failing final inspection, then a repeat final inspection and testing shall be
performed after any applicable rework.
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5.7.8 PREVENTIVE MAINTENANCE (Quality Procedure Ref: QMSP-13) (Referring Q1 Clause

5.7.8)
PROMECH has developed and maintained a documented procedure for the establishment of preventive
maintenance for equipment used in product realization. The procedure identifies the following
requirements:
a) Type of equipment to be maintained
b) Frequency
c) Responsible personnel
Relevant records (retain documented information) of preventive maintenance shall be maintained.

5.8 CONTROL OF TESTING, MEASURING AND MONITORING EQUIPMENT/MONITORING

AND MEASURING RESOURCES (Quality Procedure Ref: QMSP-14) (Referring ISO 9001:2015
Clause 7.1.5 and Q1 Clause 5.8)
PROMECH has determined the testing, monitoring and measurement requirements and the associated
equipment needed to provide evidence of conformity to those requirements.
PROMECH has developed and maintained a documented procedure for ensuring that testing,
measurement and monitoring equipment (equipment owned by PROMECH, provided on loan, provided
by client, third-party or proprietary) is controlled, calibrated and maintained. The Quality Department
shall also verify for the outsourced equipment that the equipment is suitable for the requirement and
provide evidence of conformity. Equipment shall be used in a method, which ensures that measurement
uncertainty is known, and is consistent with monitoring and measurement requirements.
The calibration and maintenance of all equipment shall either be undertaken by contractors who are
approved, accredited and competent to do so or by internal staff competent to undertake calibration.

Quality Department shall ensure that equipment shall be uniquely identifiable and be capable of
achieving the accuracy required, and shall comply with the standard specifications relevant to the tests
carried out.
The procedure shall include requirements for the specific equipment type that addresses:

a) Unique identifier for equipment

b) Calibration status of each equipment
c) Equipment traceability to international or national measurement standards; where no such
standards exist, the basis used for calibration or verification shall be recorded
d) Frequency of calibration, at specific intervals or prior to use
e) Calibration or verification method, including adjustments and readjustments, as necessary
f) Acceptance criteria
g) Awareness of control and segregation of equipment identified as out-of-calibration in order to use
unintended use.
h) When an equipment is found to be out of calibration, an assessment of the validity of previous
measurements and actions to be taken on the equipment and product, including maintaining
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records(retain documented information) and evidence of notification to the customer if suspect

product has been shipped

Testing, measuring and monitoring equipment shall:

1) be calibrated or verified, or both, against measurement standards

2) have the calibration status identifiable by the user for the activities being performed at all times
3) be safeguarded from adjustments that would invalidate the measurement result or the calibration
status
4) be protected from damage and deterioration during handling, maintenance and storage
5) be used under environmental conditions that are suitable for the calibrations, inspections,
measurements and tests being carried out

When used in the testing, monitoring or measurement of specified requirements, the ability of
computer software to satisfy the intended application shall be confirmed prior to initial use and
reconfirmed as necessary.

Quality Department shall maintain a registry of the required testing, measurement and monitoring
equipment used to determine product conformity to requirements that includes a unique identification,
specific to each piece of equipment.

Relevant records (retain documented information) of the results of calibration and verification shall be
maintained by Quality Department.

5.9 PRODUCT RELEASE/RELEASE OF PRODUCT AND SERVICE (Quality Procedure Ref:

QMSP-11) (Referring ISO 9001:2015 Clause 8.6 and Q1 Clause 5.9)
PROMECH has developed and maintained a documented procedure to ensure release of product to the
customer shall not proceed until the planned arrangements have been satisfactorily completed, unless
otherwise approved by a relevant authority and, where applicable, approved for release by the
customer under concession.
Relevant records (retain documented information) to enable identification of the individual releasing of
the product shall be maintained. Documented information shall include: evidence of conformity with
the acceptance criteria, traceability to the persons authorizing the release

5.10 CONTROL OF NONCONFORMING PRODUCT (OUTPUTS) (Quality Procedure Ref:

QMSP-15) (Referring ISO 9001:2015 Clause 8.7 and Q1 Clause 5.10)
5.10.1 GENERAL (Referring Q1 Clause 5.10.1)
PROMECH has developed and maintained a documented procedure for identifying the controls and
related responsibilities and authorities to address nonconforming product (Outputs).
NONCONFORMING PRODUCT/SERVICES – DURING PRODUCT/SERVICE REALIZATION
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SUB: PRODUCT REALIZATION SECTION: 5

Revision 6 Date 13th Nov., 2023 Page 65 of 76

Whenever any suspected nonconformity product/Services is identified during product/service

realization, it shall be notified to the Quality Department directly as soon as possible to take the
necessary actions.
PROMECH procedure for the nonconforming product/services identified during product/service
realization shall include:
a) Identification of product/services to prevent unintended use or delivery shall be ensured by
Quality Manager, Quality Engineer and Production Heads.
b) Addressing the detected nonconformity
c) Taking action to preclude its original intended use or delivery
d) Authorizing its use, release or acceptance under concession by the Quality Manager and, where
applicable, by the customer
When nonconforming product/Service is corrected, Quality Manager shall ensure it shall be subjected
to re-verification to demonstrate conformity to the requirements.
NONCONFORMING PRODUCT/SERVICES – AFTER DELIVERY
PROMECH procedure for the nonconforming product /services identified after delivery shall include:
a) Identifying, documenting and reporting non-conformances or product/Service failure identified
after delivery
b) Ensuring the analysis of product/Service non-conformance or failure, provided the product or
documented evidence supporting the nonconformity is available to facilitate the determination of
the cause
c) Taking action by the Quality Manager/supervisor appropriate to the effects, or potential effects,
of the non-conformance when nonconforming product/Service is detected after delivery

5.10.2 NONCONFORMING PRODUCT (Referring ISO 9001:2015 Clause 8.7.1 and Q1 Clause
5.10.1)
PROMECH shall address nonconforming product by performing one or more of the following:
a) Repair or rework with subsequent inspection to meet specified requirements
b) Re-grade for alternative applications
c) Segregation , containment, return or suspension of product and service
d) Release under concession
e) Reject/hold or scrap
f) Informing the customer
1. In case of supplier part rejection, the Quality personnel records the deviation and required
information of the materials/ parts on the nonconformity report.
2. Materials/ products that do not meet API requirements are not monogrammed.
3. Rework materials are identified as per the identification mechanism documented in Section 5.7.3
4. Records are maintained identifying the nature of the nonconformities and subsequent actions
taken, including concessions obtained.
5. When nonconforming product is corrected it is re-verified to ensure conformity to the
specifications.
QM01-QUALITY MANUAL – QUALITY MANAGEMENT SYSTEM
SUB: PRODUCT REALIZATION SECTION: 5

Revision 6 Date 13th Nov., 2023 Page 66 of 76

6. When nonconforming product is identified after delivery or when in use, established procedures
dictate corrective actions appropriate to the effects or potential effects of the nonconformity.

5.10.3 RELEASE OF NONCONFORMING PRODUCT UNDER CONCESSION (Referring ISO

9001:2015 Clause 8.7.1 and Q1 Clause 5.10.3)
The evaluation and release under concession of nonconforming product that does not satisfy
Manufacturing Acceptance Criteria (MAC) shall be permitted when organization’s Quality Manager and
the customer, where applicable, have authorized the release provided that:
a) Products continue to satisfy applicable design acceptance criteria (DAC) and/or customer criteria;
or
b) The violated MAC are categorized as unnecessary to satisfy the applicable DAC and/or customer
criteria; or
c) The DAC are changed and the products satisfy the revised DAC and associated MAC requirements
The Quality Manager/supervisor & Production Supervisor / Heads shall document concessions.

5.10.4 CUSTOMER NOTIFICATION (Referring ISO 9001:2015 Clause 8.7.1 and Q1 Clause 5.10.4)
In case of any product which does not conform to DAC or contract requirements and that have been
delivered to customer, PROMECH shall notify the customer and records shall be maintained for such
notifications.

5.10.5 RECORDS (RETAIN DOCUMENTED INFORMATION) (Referring ISO 9001:2015 Clause

8.7.2 and Q1 Clause 5.10.5)
Relevant records (retain documented information) for the nature of nonconformities and any
subsequent actions taken, including concessions obtained, identifies the authority deciding the action
in respect of the non-conformity and shall be maintained by the Quality Manager.

5.11 MANAGEMENT OF CHANGE (MOC)/PLANNING OF CHANGE (Quality Procedure

Ref: QMSP-16) (Referring ISO 9001:2015 Clause 6. 3 , Clause 8.5.6 and Q1 Clause 5.11)
5.11.1 GENERAL (Referring Q1 Clause 5.11.1)
PROMECH shall maintain a process for MOC. The Management Representative shall ensure that the
integrity of the Quality Management System is maintained when changes to the Quality Management
System are planned and implemented.
For MOC, PROMECH shall identify the potential risks (consequences) associated with the change and
any required approvals prior to the introduction of such changes.
PROMECH shall consider the purpose of the change, the availability of resources and the allocation or
reallocation of responsibilities and authorities.
QM01-QUALITY MANUAL – QUALITY MANAGEMENT SYSTEM
SUB: PRODUCT REALIZATION SECTION: 5

Revision 6 Date 13th Nov., 2023 Page 67 of 76

PROMECH shall review and control the changes for production or service provision if the change is a
considered a major or a critical change that will have a high optional impact of the product quality and
or integrity. Documented info is retained as stated in the quality procedures.

Relevant records (retain documented information) of MOC activities shall be maintained by the
Management Representative. Showing the results of the review necessary actions and the person
authorized the change.

5.11.2 MOC IMPLEMENTATION (Referring ISO 9001:2015 Clause 6.3 and Q1 Clause 5.11.2)
PROMECH shall use the MOC process for any of the following that may negatively impact the quality of
the product:
a) Changes in the organizational structure
b) Changes in key or essential personnel
c) Changes in critical suppliers
d) Changes to the management system procedures, including changes resulting from corrective and
preventive actions
5.11.3 MOC NOTIFICATION (Referring Q1 Clause 5.11.3)
PROMECH shall notify relevant personnel, including the customer when required by contract, of the
change and residual or new risk due to changes that have either been initiated by the organization or
requested by the customer.
QM01-QUALITY MANUAL – QUALITY MANAGEMENT SYSTEM
SUB: Quality Management System Monitoring, Measurement, Analysis,
SECTION:6
and Improvement

Revision 6 Date 13th Nov., 2023 Page 68 of 76

6.0 QUALITY MANAGEMENT SYSTEM MONITORING, MEASUREMENT,

ANALYSIS & IMPROVEMENT (Referring ISO 9001:2015 Clause 9.1 and Q1 Clause 6)
6.1 GENERAL
The General Manager & Quality Manager shall plan and implement the monitoring, measurement,
analysis and improvement processes needed to ensure conformity of the Quality Management System
to the requirements of API Specification Q1 latest edition and ISO 9001-2015 to continually improve the
effectiveness of the Quality Management System.

The General Manager & Quality Manager shall ensure that the Quality Management System monitoring,
measurement, analysis and improvement shall include determination of applicable methods, including
techniques for the analysis of data and the extent of their use.

The below area should be monitor and measure, the result from monitoring and measurement shall be
analysed and evaluated. PROMECH shall retain appropriated documented information as evidence of
result.

a) Customer Satisfaction
b) Conformity to product/Service requirement
c) Field Nonconformities (Product or services failure identified after delivery or its use)
d) Characteristics and trend of process
e) Supplier performance
f) Compliance with Quality requirement and Objective

Data may be collected monthly, quarterly or annually depend on factors.

6.2 MONITORING, MEASURING AND IMPROVING (Referring ISO 9001:2015 Clause 9.1.1
and Q1 Clause 6.2)
6.2.1 CUSTOMER SATISFACTION (Quality Procedure Ref: QMSP-17) (Referring ISO 9001:2015
Clause 9.1.2 and Q1 Clause 6.2.1)
PROMECH has developed and maintained a documented procedure to measure customer satisfaction.
The procedure shall address the frequency of measurement, obtaining customer feedback, key
performance indicators (KPIs) and other information that the organization has satisfied customers in
meeting identified requirements.

Areas to be analysed for Customer Satisfaction:

a) Feedback on all aspects of product and service

b) Customer needs & contract obligation
c) Service delivery data, including quotations, delivery times etc.
d) Customer perception of company
e) Levels of professionalism within the company

Relevant records (retain documented Information) of the results of customer satisfaction shall be
maintained.
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SECTION:6
and Improvement

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6.2.2 INTERNAL AUDIT (Quality Procedure Ref: QMSP-19) (Referring ISO 9001:2015 Clause 9.2
and Q1 Clause 6.2.2)
[Link] GENERAL
PROMECH has developed and maintained a documented procedure to define responsibilities for
planning, conducting, documenting, and reporting internal audits. Management Representative shall
ensure that internal audits of all processes of the Quality Management System are programmed at
planned intervals of at least 12 months, in accordance with the requirements of API Specification Q1
latest edition, ISO9001-2015 and relevant procedure of PROMECH, and are carried out by trained
auditors. This shall be ensured by the Management Representative by identifying the audit criteria,
scope, frequency and methods.
Audits shall verify that the Quality Management System is effectively implemented and maintained and
conforms to the requirements of API Specification Q1 latest edition And ISO9001-2015.
Management Representative shall plan the internal audits, taking into consideration the results of
previous audits, importance and criticality of the process being audited and changes affecting the
organization.
Management Representative shall ensure any outsourced activities that impact the quality of the
product and that are performed at the PROMECH facility is included as part of the internal audit of the
organization.

[Link] PERFORMANCE OF INTERNAL AUDIT

Management Representative shall ensure that internal audits are performed by competent personnel
independent of those who performed or directly supervised the activity being audited to ensure
objectivity and impartiality of the audit process. Records (retain documented Information) of the audits
and their results shall be maintained by Management Representative and the records shall provide
objective evidence that the Quality Management System is implemented and maintained.
Management Representative shall ensure that all processes of the Quality Management System
required for meeting API Specification Q1 latest edition shall be audited prior to claiming conformance
to the requirements of API Specification Q1 latest edition.

[Link] AUDIT REVIEW AND CLOSURE

Management Representative shall identify the response times for addressing the detected
nonconformities. The concerned Department Head responsible for the area being audited shall ensure
that any necessary corrections without undue delay and corrective actions follow the requirements of
Corrective Action mentioned in Sec. 6.4.2. The results of internal audits and the status of corrective
actions shall be reported in the management review. Relevant records (retain documented information)
of internal audits shall be maintained by the Management Representative.
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SECTION:6
and Improvement

Revision 6 Date 13th Nov., 2023 Page 70 of 76

6.2.3 PROCESS EVALUATION (Referring ISO 9001:2015 Clause 9.1.3 and Q1 Clause 6.2.3)
Department Managers / Heads & Quality Department shall apply suitable evaluation methods to
demonstrate the ability of the Quality Management System processes to achieve planned results,
including conformity to product requirements. Correction and corrective action shall be taken as
appropriate, when planned results are not achieved. It shall be ensured that performance of internal
audits and management reviews satisfy this requirement.

6.3 ANALYSIS OF DATA (Quality Procedure Ref: QMSP-17) (Referring ISO 9001:2015
Clause 9.1.3 and Q1 Clause 6.3)
PROMECH has developed and maintained a documented procedure for the identification, collection and
analysis of data to demonstrate the suitability and effectiveness of the Quality Management System.
Management Representative shall determine the analysis shall include data generated from monitoring
and measurement, internal audits, management reviews and other relevant sources.
The data analysis output shall provide information relating to:
a) The Degree Of Customer satisfaction
b) Conformity to product and Service requirements
c) Nonconformities and product failures identified after delivery or use, provided the product or
documented evidence is available to facilitate the determination of the cause.
d) Characteristics and trends of processes and products including opportunities for preventive action
(the effectiveness of action taken to address risk and opportunity)
e) Supplier (external providers) performance
f) Quality Objectives (The performance and effectiveness of Quality management system)
g) If planning has been implemented effectively
h) The needs for improvements to the quality management system
Management Representative shall use data to evaluate where continual improvement of the
effectiveness of the Quality Management System can be made.

6.4 IMPROVEMENT (Referring ISO 9001:2015 Clause 10, 10.3 and Q1 Clause 6.4)
6.4.1 GENERAL
PROMECH shall determine and select opportunities for improvement and implement any necessary
action to meet customer requirement and enhance customer satisfaction. These shall include improving
product and service meet requirement as well as to address future needs and expectations; correcting,
preventing or reducing undesired effects; improving the effectiveness of the Quality Management
System through the use of:
a) Quality Policy
b) Quality Objectives
c) Audit results
d) Analysis of data
e) Corrective and preventive actions (risk assessment), and
QM01-QUALITY MANUAL – QUALITY MANAGEMENT SYSTEM
SUB: Quality Management System Monitoring, Measurement, Analysis,
SECTION:6
and Improvement

Revision 6 Date 13th Nov., 2023 Page 71 of 76

f) Management review
Improvement can include correction, corrective action, continual improvement, breakthrough change,
and innovation and re organization.
PROMECH shall continually improve the suitability, adequacy, and effectiveness of the QMS. PROMECH
shall consider the result of analysis and evaluation, and output from management review, to determine
there are needs or opportunities that shall be addressed as part of continual improvement.

6.4.2 CORRECTIVE ACTION (Quality Procedure Ref: QMSP-19) (Referring ISO 9001:2015 Clause
10.2 and Q1 Clause 6.4.2)
PROMECH has developed and maintained a documented procedure to correct nonconformities and to
take corrective actions both internally and within the supply chain. This is determined by Quality
Manager & Department Heads for eliminating the causes of nonconformities in order to minimize the
likelihood of its recurrence. Concerned Department Head shall ensure that corrective actions taken shall
be appropriate to the effects of the nonconformity encountered.
The procedure identifies requirements for:
a) Reviewing a process nonconformity including customer complaints
b) Determining and implementing corrections and deal with the consequences
c) Evaluate the need for action to eliminate the causes of the non-conformity, in order that it does
not recur or occur elsewhere by reviewing and analysis the non-conformity, determining the cause
of non-conformity, determining similar non-conformity exist or could potentially occur.
d) Implementing corrective action.
e) Identifying the timeframe and responsible person(s) for addressing corrections and corrective
action
f) Verification of the effectiveness of corrections and corrective actions taken
g) Update risk and opportunities during planning, if necessary
h) Management Of Change (MOC) when the corrective actions require new or changed controls
within the Quality Management System
Relevant records (retain documented information) of the activities for control of a nonconforming
process shall be maintained. Quality Manager shall ensure that records (retain documented
information) shall identify the nature of non-conformity and activities performed to verify effectiveness
(result) of the corrective actions taken.

6.4.3 PREVENTIVE ACTION (Quality Procedure Ref: QMSP-19)

PROMECH has developed and maintained a documented procedure to determine and implement
preventive actions both internally and within the supply chain. This is determined by Quality Manager
& Department Heads for eliminating the causes of potential nonconformities in order to minimize the
likelihood of their occurrence. Concerned Department Head shall ensure that preventive actions taken
shall be appropriate to the effects of the potential problems.
The procedure identifies requirements for:
QM01-QUALITY MANUAL – QUALITY MANAGEMENT SYSTEM
SUB: Quality Management System Monitoring, Measurement, Analysis,
SECTION:6
and Improvement

Revision 6 Date 13th Nov., 2023 Page 72 of 76

a) Identifying opportunities for improvements

b) Identifying a potential nonconformity and its potential causes
c) Evaluating the need for preventive action, including any immediate or short-term action required,
to prevent occurrence of a nonconformity.
d) Identifying the timeframe and responsible person(s) for implementing a preventive action
e) Reviewing the effectiveness of the preventive actions taken
f) Management Of Change (MOC) when the preventive actions require new or changed controls
within the Quality Management System
Relevant records (retain documented information) of the activities for control of potential process
nonconformities shall be maintained.

6.5 MANAGEMENT REVIEW (Quality Procedure Ref: QMSP-20) (Referring ISO

9001:2015 Clause 9.3 and Q1 Clause 6.5)
6.5.1 GENERAL (Referring ISO 9001:2015 Clause 9.3.1 and Q1 Clause 6.5.1)
The General Manager, department managers and Heads shall review PROMECH’s Quality Management
System at least every 12 months to evaluate the Quality Management System’s continuing suitability,
adequacy and effectiveness. This review shall include assessing opportunities for improvement and the
need for changes to the Quality Management System, including the Quality Policy and Quality
Objectives.
6.5.2 INPUT REQUIREMENTS (Referring ISO 9001:2015 Clause 9.3.2 and Q1 Clause 6.5.2)
Management Representative shall ensure the input to management review shall include, as a minimum:
a) Effectiveness of actions resulting from previous management reviews
b) Results of audits
c) Monitoring and measurement results
d) Changes (in internal and external issues) that could affect the Quality Management System,
including changes to legal and other applicable requirements
e) Analysis of customer satisfaction
f) Process performance
g) Results of risk assessment
h) Status of corrective and preventive actions
i) Analysis of supplier (external providers) performance
j) Review of the analysis of product conformity, including nonconformities identified after delivery
or use
k) Recommendations(opportunity) for improvement
l) Feedback from relevant interested parties.
m) The adequacy of resources
n) The effectiveness of action taken to address risk and opportunities.
QM01-QUALITY MANUAL – QUALITY MANAGEMENT SYSTEM
SUB: Quality Management System Monitoring, Measurement, Analysis,
SECTION:6
and Improvement

Revision 6 Date 13th Nov., 2023 Page 73 of 76

6.5.3 OUTPUT REQUIREMENTS (Referring ISO 9001:2015 Clause 9.3.3 and Q1 Clause 6.5.3)
The output from the management review shall include a summary assessment of the effectiveness of
the Quality Management System in order to meet the customer requirements, the assessment shall
include any required changes to the processes (QMS) and any decisions and actions related to
opportunity for improvement, required resources and improvement to products.
General Manager shall review and approve the output of management reviews.
Management reviews shall be documented and records (retain documented information) of these
reviews shall be maintained by the Management Representative.
QM01-QUALITY MANUAL – QUALITY MANAGEMENT
SYSTEM
SUB: Annexure SECTION: Annex A

Revision 6 Date 13th Nov., 2023 Page 74 of 76

ANNEX A
USE OF API MONOGRAM (Quality Procedure Ref: QMSP-21)
PROMECH has developed and maintained a documented procedure for API monogram and marking as
per the requirements specified in API Product Specification to be used for API monogram application.
Quality Manager or his designee is responsible for applying the API monogram and removing, if any
product found to be nonconforming with API specified requirements, after the application of API
monogram.
Quality Manager shall ensure that the API monogram shall be applied at the licensed facility only.
QM01-QUALITY MANUAL – QUALITY MANAGEMENT
SYSTEM
SUB: Annexure SECTION: Annex A

Revision 6 Date 13th Nov., 2023 Page 75 of 76

DOCUMENT CHANGE HISTORY

Rev No. Date Page Description of Change

-Re-Issue - Total revision of Quality Manual to integrate the

requirements of ISO 9001:2015 and verify the suitability of
requirements as per API Q1 9th Edition.

Aug 16, - Removal also of the embedded mandatory procedures in

0 N/A
2017 QMS on previous issues, the Quality Manual revision # was
changed to “0” including all mandatory procedures listed on
the Table of Quality Procedures (Page 6).

- Previous revisions were archived.

-Adding document Number.

-Editing (Elaborating) interested parties for ISO 9001:2015.

-Grammatical and spelling revisions.

Jan 04,
1 N/A
2018
-Organizational Chart Update.

-Procedures revision numbers update.

-Elaborating on ISO 9001:2015 8.5.6 Control of changes

March Adding parties without unidentified interests’ section

2 Page 20
22,2018
-Updating job responsibilities adding route cards to quality
supervisor and removing it from workshop supervisor.
-Adding API advisory 6 D&D exclusions.
-updating server network location.
-Procedure Numbers revisions update.
11,12,28,30
4th Jan -Figure 2A addition.
3 ,34,39,56,5
2019 -Adjust wording of 5.7.2 ,1)
8,62
-[Link] adding “when applicable” in P1
-Adding to 5.10.2 ,e) “/hold”
-general grammatical and formatting changes
QM01-QUALITY MANUAL – QUALITY MANAGEMENT
SYSTEM
SUB: Annexure SECTION: Annex A

Revision 6 Date 13th Nov., 2023 Page 76 of 76

23rd April Changes to include changes of QMS planning and document

4 8,73
2019 change history to last page
Changes to include API 20E in normative reference
Updating scope as per the most recent scope
23rd Nov.
5 All Updating of new server location
2021
Updating organizational Chart
Editorial changes (Hyperlinks additions)
Adding Operation Manger
23rd Nov. Updating titles of positions
6 All
2023 Updating organizational Chart
General Editorial Changes

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