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14 Steps to Build Up Effective Quality Management

System (QMS) according to ISO 9001:2015

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2020
 Introduction
• IIJRA is platform providing efficient and professional templates in a
simplified format to make it easy for customers to implement with high
efficiency, saving effort, time and money.

• In quality management, it’s a popular saying that if something is not

written, it didn't happen. Businesses which follow a management system
need a well-conceived and systematized Quality Management System
(QMS). Many organizations failed to manage a QMS while others
managed it well.

• QMS consists of written and controlled guidelines and procedures that

form a foundation for all procedures. An organized QMS ascertains the
steps for key processes and forms methods in preventing failures in a
timely manner. QMS is organized to protect the brand, organization
processes, and the customers' interest.

• This guide to implementing an ISO 9001:2015 Quality Management

System (QMS) was prepared by IIJRA Management. The guide is based on
our experiences and research assisting many small, medium and large
companies in Saudi Arabia through the complete implementation process
from start to successful registration.

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 About Us
• In IIJRA platform, we work closely with our clients to enhance their capabilities and add value to
their organizations.

• We are distinguished by: long experience, use of effective and modern tools, diversity, long-term
relationship with our clients and strategic partnership.

• At IIJRA, we focus on strategic and operational solutions by providing digital solutions such as:
templates, plans, procedures, forms and professional presentations in many areas including:
Strategic Management, Organizational Structure and Development, Project Management,
Maintenance & Operation Management, Engineering Management, Human Resource Management,
Training and Development, Quality Management System, Safety and Health & Environment
Management System and ISO 9001, 45001 & 14001 Certifications.

• Our products are designed as efficient and professional templates that cover the complete
requirements in a simplified format to make it easy for customers to implement with high efficiency,
saving effort, time and money.

• We are your comprehensive source, and your right stop for obtaining ISO certifications. Our products
are designed to work integrated and interconnected with each other, so if you need to implement
more than one standard such as ISO 9001, ISO 45001 and ISO 14001, you can easily integrate them
now or in the future. They can be used as building blocks to build an integrated standard system.

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Products Range & Services
• Ready-made Templates

• Online Consultation

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Quality Templates

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Strategy Templates

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Online Consultation

• Provide Customized Templates

• Review your current Quality, Strategy

and OH&S Systems

• Conduct Assessments and Audits

• Establish Management Systems of new

Firms

• Restructure the current systems

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Visit Our Platform

www.iijra.com
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Section 1: General Concepts

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What Is A Quality Management System?

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 ISO 9000 Family

00
ISO 9000
QMS Fundamentals
& Vocabulary

01
ISO 9001
Q.M.S.
Requirements

02
ISO 9002
Models of QMS

04
ISO 9004
Guidelines on
Performance

11
Improvement ISO 9011
Auditing
of quality management
systems

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Quality Management Principles

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PCDA Concept

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Levels of Documentations
Quality Policy and Objectives
1
Quality Manual

2
Business Processes and Procedures
3
Work Instructions
4

5 Documents, Records and

Forms
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Section 2: The 14 Steps

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 Implementation Steps
Top management commitment Document control

Establish implementation team Implementation

Start QMS awareness programs Internal quality audit

Provide Training Management review

Conduct initial Gap Analysis Pre-assessment audit

Create a documented
implementation plan Certification and registration

Develop quality management system

documentation Continual Improvement

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Step 1: Top Management Commitment

• Communicating to the organization the importance of

meeting customer as well as statutory and regulatory
requirements.

• Defining the organization's quality policy and make this

known to every employee,

• Ensuring that quality objectives are established at all

levels and functions,

• Ensuring the availability of resources required for the

development and implementation of the quality
management system

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Step2: Establish Implementation Team

• Quality Team
 Leading Implantation Team, Conduct Internal Audits and Management Review
 Team: Quality Manager, Quality Administrators and QMR

• Implementation Team
 One from each department shall be selected and assigned to the project
 The potential member shall have awareness about Quality Management Systems
 Project Management Team will provide training for the Implementation Team
 Team will help in drafting the processes, forms and work instructions
 Team: Head of Departments and Department Personnel's.

• Review and Approval Team

 Head of the Department, Process Owners (Initial)
 Quality Manager (Review 1)
 Directors (Review 2)
 Top Management (Approval)

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 Step3: Start QMS Awareness Programs

• QMS awareness programs should be conducted to communicate

to the employees:

 the aim of the quality management system;

 the advantage it offers to employees, customers and the
organization;
 how it will work;
 and their roles and responsibilities within the system.
 Attendance of meeting should be recorded.

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 Step 4: Provide Training

• Training programs should be structured for different categories of employees - senior

managers, middle-level managers, supervisors and workers.

• Session include:
 Company QMS overview
 Business Work Processes Training
 How to use the systems
 Implementation Plan
 Lead Audit
 Internal Audit

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 Step 5: Conduct Initial Gap Analysis

• Compare the organization’s existing quality management system (if any) with the
requirements of the standard (ISO 9001:2015)

• How To Do a Gap Analysis For ISO 9001 In 6 Steps

 Assign (or hire) someone to oversee the gap analysis
 Create a gap analysis checklist
 Schedule the gap analysis
 Conduct the gap analysis
 Examine the results of the gap analysis
 Set up your plan for improving your quality management system

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 Step 6: Create a Documented
Implementation Plan
• Consider the results of your gap analysis from Step 5 and
certification timeline and answer these questions:

 When will you start your QMS implementation project?

 When do you want/need to complete implementation?
 What gaps exist in your existing QMS and how long will they
take to address?
 What resources are available or lacking?
 Do we need a consultant? Or
 Do we need ready QMS Templates?
Who is your project manager?
Who makes up Top Management at your organization?

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Step 7: Develop Quality Management
System Documentation
Quality
Policy and
Objectives

Quality
Management
Manual

Business and
Operations Manuals

Handbooks

Forms and Records

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 Step 8: Document Control

• Once the necessary quality management system documentation has been generated, a
documented system must be created to control it.
• Control is simply a means of:
 managing the creation,
 approval,
 distribution,
 revision,
 storage,
 and disposal of the various types of documentation.

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 Step 9: Implementation

 Ensure Completion of all Steps 1-8

 Launch Your Quality Management System
 Conduct final awareness session for all levels
 Disturb the final version of QMS
 Meet with Process Owners / Department Personnel to help
them in the implementation
 Check the shared processes and the interaction between
them
 Monitoring the implementation
 Fine-tune QMS as required

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 Step 10: Internal Quality Audit

• Internal Audit is to conform to the planned arrangements, to the requirements of the

standard (ISO 9001:2015) and to the quality management system requirements established
by your organization, and is effectively implemented and maintained.

• Requirement of Internal Audit:

 Audit Plan and Program
 Audit Notification
 Opening Meeting
 Conducting audit
 Closing Meeting
 Reporting
 Corrective Action and Follow up

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 Step 11: Management Review

• The management reviews are conducted to ensure the continuing

suitability, adequacy and effectiveness of the quality management
system.

• The review should include assessing opportunities for

improvement and the need for changes to the quality management
system, including the quality policy and quality objectives.

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 Step 12: Pre-assessment Audit

• A pre-assessment audit should be arranged with an independent and qualified

auditor. The pre-assessment audit would provide a degree of confidence for
formally going ahead with an application for certification

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Step 13: Certification and Registration

Application & Mandatory Pre- Advanced

Contract Training Assessment Training:
(Basic) Lead Auditor

Stage 2 Stage 1
Certificate
Assessment Assessment
of Approval

Surveillance Certificate
Visits Renewal

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 Step 14:Continual Improvement

• Certification to ISO 9000 should not be an end

• The organization must continually seek to improve the effectiveness and suitability
of the quality management system through the use of:

 Quality policy
 Quality objectives
 Audit results
 Analysis of data
 Corrective and preventive actions
 Management review

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Finally………………………
• All the templates needed to execute this plan are available on our
websites.

www.iijra.com

info@iijra.com

@iijra1

https://www.linkedin.com/in/iijra

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