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QUALITY

MANAGEMENT
SYSTEM MANUAL

WIKA SAUDI ARABIA LLC


AND
WIKA SAUDI ARABIA SERVICES LLC
Al Esnad Street Majlis Attaaon Plan SH. KH 564
Al Khobar, Eastern Province
Kingdom of Saudi Arabia

In compliance with:
ISO 9001:2015 QMS /CSA/EN 80079-34

Manual No.: QMS-01


Issue No.: 01
Revision No.: 00
Issued Date 15.07.2018

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE
PROPERTY OF WIKA SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF
THE QUALITY MANAGER OF WIKA SAUDI ARABIA IS PERMITTED.
ISSUE 01
INDEX REVISION 00
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA O.
DOC.N QMS-01-A PAGE 1 of 1

SECTION DESCRIPTION
0.1 COVER PAGE
0.2 FOREWORD
01 ISSUE FORMAT
02 AMENDMENT INDEX
03 QUALITY POLICY
04 CONTEXT OF THE ORGANIZATION
05 LEADERSHIP
06 PLANNING
07 SUPPORT
08 OPERATION
09 PERFORMANCE EVALUATION
10 IMPROVEMENT
11 MASTER LIST OF DOCUMENTS
12 MASTER LIST OF WORK INSTRUCTIONS

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE
PROPERTY OF WIKA SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF
THE QUALITY MANAGER OF WIKA SAUDI ARABIA IS PERMITTED.
ISSUE 01
COVER PAGE REVISION 00
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-0.1 PAGE 1 of 1

QUALITY MANAGEMENT SYSTEM


MANUAL
WIKA SAUDI ARABIA LLC
AND

WIKA SAUDI ARABIA SERVICES LLC


Al Esnad Street Majlis Attaaon Plan SH. KH 564
Al Khobar, Eastern Province
Kingdom of Saudi Arabia
In compliance with

ISO 9001:2015 QMS/CSA/EN 80079-34


Scope
The scope of this manual is to define the processes and procedures for
the organizational activities mentioned below:
DESIGN, MANUFACTURE, CALIBRATION AND SERVICING OF
TEMPERATURE INSTRUMENTATION
MANUFACTURE, ASSEMBLY, CALIBRATION AND SERVICING OF
PRESSURE INSTRUMENTATION
Exclusions
NONE

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
FOREWARD REVISION 00
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-0.2 PAGE 1 of 1

The scope of our Quality Management System is the design, manufacture, calibration and
servicing of temperature instrumentation; as well as the manufacture, assembly, calibration
and servicing of pressure instrumentation.
We design temperature sensors and pressure gauge dials to meet customer requirements and
in compliance with international standards.
The calibration laboratory has been established for the precise calibration of pressure and
temperature measuring instruments.
The laboratory is equipped with highly sophisticated primary and secondary standards for the
calibration of pressure measuring instruments.
To meet the needs and expectations of interested parties, WIKA Saudi Arabia consistently
supplies high quality products and will continually strive to improve performance.
Our management system has been developed to meet the custom nature of our business and
the specific requirements of ISO 9001:2015 QMS,CSA and EN 80079-34.
NOTE: Requirements in this Quality Manual responding to potentially explosive
atmospheres Application of Quality systems are underlined.

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
ISSUE FORMAT REVISION 00
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-01 PAGE 1 of 1

WIKA SAUDI ARABIA, Al Esnad Street Mjlis Attaaon Plan SH. KH 564, Al Khobar, Eastern Province

Kingdom of Saudi Arabia

Quality Manual Received Format

 This Copy of the QMS Manual is a Controlled copy


This Copy of the QMS Manual is only for Information

Manual No. : QMS-01 Issue 01

Please exchange the attached Parts/Appendixes: ...............................................................

Please take out the following Parts/Appendixes: ...............................................................

Please destroy the old parts/ Appendixes.

Please send the old parts/Appendixes back to WIKA Saudi Arabia

Please send one Copy of this Received Format as an acknowledgement of receipt to the undersigned
within the next 5 Days to WIKA Saudi Arabia.

Head of the Quality Assurance Department

Receiving Confirmation

I hereby confirm that I have received the above-mentioned Sections and I have taken Action as per above-
mentioned advise.

Stamp Sign Date

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE, OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE Q.A. MANAGER OF WIKA SAUDI
ARABIA IS PERMITTED.
ISSUE 01
AMENDMENT INDEX REVISION 00
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-02 PAGE 1 of 1

CHANGE
DATE OF AMENDMENT MADE
NO. NOTE REASONS BY APPROVED
AMENDMENT IN
NO.

ISO 9001:2015
Quality manual
1 1 15.07.2018 Certification and QM GM
established
compliance
WI 013 and WI 4054
2 2 23.04.2019 QMS-01-12 included, obsolete QM GM
documents removed
WI 4029 - 12 obsolete
documents removed
3 10 08.02.2020 QMS-01-12 QM GM
and replaced by rev
13 document
1501240, 6900208,
11353732, 11405422,
4 20.07.2020 QMS-01-12 QM GM
11405449-Germany
WI revised
11353732-Germany
5 18.08.2020 QMS-01-12 QM GM
WI revised

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
QUALITY MANAGEMENT REVISION 00
SYSTEM MANUAL ISSUE DT. 15.07.2018

DOC.NO. QMS-01-03 PAGE 1 of 2


WIKA SAUDI ARABIA

Quality Policy
WIKA Saudi Arabia is committed to it corporate Quality guidelines which include the
following.
Compliance
WIKA undertakes to comply with legal and official requirements in order to ensure
product conformity. This includes, but not limited to, ISO 9001:2015 and CSA
Standards.
Customer orientation
It is our aim to have enthusiastic customers. Our customers define the benchmark for
our quality. This is the reason why our customer's requirements and the high quality
of our products are the benchmark for our actions. All employees of WIKA contribute
in the overall performance of the company with respect to quality and customer
satisfaction.
Quality responsibility
Our demand for quality refers not only to our products, but also to the way we deal
with employees, customers and suppliers.
Staff responsibility
All WIKA employees align themselves with the requirements of the customers, with
the product utilization, with our responsibility for the environment as well as with what
is feasible both in technical and economic terms.
Each employee of the company contributes in her/his place to the realization of our
quality goals. All departments and functional areas within the WIKA hierarchy share
the responsibility, while every single employee is responsible for the quality of her/his
working quality and performance.
The accomplishment of our quality goals is an important management task.
Special importance is attached to the quality of their work when the employees are
assessed for their performance.
Cooperation with suppliers
In order to be a creative and innovative partner for our customers, we expect our
suppliers to maintain a high quality responsibility, which we support as their partner.
Continuous improvement
Not only the faults themselves, but the causes of such faults have to be eliminated.
Prevention of faults takes precedence over the elimination of faults.

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE
PROPERTY OF WIKA SAUDI ARABIA. NO REPRODUCTION, USE, OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF
THE Q.A. MANAGER OF WIKA SAUDI ARABIA IS PERMITTED.
QUALITY MANAGEMENT REVISION 00
SYSTEM MANUAL ISSUE DT. 15.07.2018

DOC.NO. QMS-01-03 PAGE 2 of 2


WIKA SAUDI ARABIA

To maintain the effectiveness of the management system and to achieve continuous


quality improvement, and thus also a reduction of costs and an increase in cost-
effectiveness, periodic Internal Audits and Managements Review Meetings are
conducted.
This Quality Policy is available to interested parties through our corporate website. It
shall be communicated throughout the organization and reviewed annually for
continuing suitability.

Omer Mohammed
General Manager

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE
PROPERTY OF WIKA SAUDI ARABIA. NO REPRODUCTION, USE, OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF
THE Q.A. MANAGER OF WIKA SAUDI ARABIA IS PERMITTED.
ISSUE 01
CONTEXT OF THE
REVISION 00
ORGANIZATION
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-04 PAGE 1 of 6

4.1. Understanding the Organization and its context


WIKA SAUDI ARABIA has determined external and internal issues that are relevant to its
purpose and its strategic direction and that affect its ability to achieve the intended result(s) of
its integrated management system. Both positive and negative factors or conditions have been
considered. These factors are reviewed annually.
This information is reviewed on an annual basis through management review meetings and/ or
WSA 007 Risk and Opportunity Register.
4.1.1. External Context
 Political – Regional political issues affect WIKA SAUDI ARABIA's sales and deliveries.
 Economic – Demand for WIKA products is dependent on the economic conditions in
region it operates in. It serves oil & gas, water and power sectors. There are several
number of competitors in the region for WIKA products. Alternative products with
similar applications are available.
 Social – are no known cultural aspects that affect this industry.
 Technological – Threat of new technology disrupting this industry is constant and
WIKA is continuously innovating its product line.
 Legal – WIKA SAUDI ARABIA complies with applicable statutory or regulatory
requirements specific to the manufacture of WIKA products.
4.1.2. Internal Context
Vision - We contribute to our customers' success by providing superior instrumentation
solutions.
Guidelines:
 We achieve high customer satisfaction through reliability, quick reaction times and
quality.
 To ensure our company's success, we are working continuously at improving the
knowledge, skills and motivation of our employees.
 We constantly endeavour to improve our processes, products and our service.
 We are committed to our social responsibility, to safe workplaces and a clean
environment.
4.2. Understanding the needs and expectations of interested parties
WIKA SA has determined the following interested parties that are relevant to the integrated
management system. WIKA SAUDI ARABIA monitors and review information about these
interested parties and their relevant requirements.

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
CONTEXT OF THE
REVISION 00
ORGANIZATION
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-04 PAGE 2 of 6

NO. INTERESTED PARTY NEEDS & EXPECTATIONS

INTERNAL STAKEHOLDERS

1 Employees Training and resources to carry out their job

2 Managers, Heads Authorities to make decisions

3 Owners, Directors Meeting objectives and ensure customer


satisfaction
Shareholders
Return on investment

EXTERNAL STAKEHOLDERS

1 Vendors & External service Complete information on required materials


providers, consultants, third and services
party inspectors, WIKA
subsidiaries

2 Government bodies such as Meet regulatory & statutory requirements


SAGIA

3 Customers  Meet customer requirements in terms of


product quality and timely delivery.
 Support on how to apply the product for the
intended application
 Each customer category has a different
need and expectation (1) MRO (end user)
(2) Projects/ EPC (3) Traders/ distributors
(4) Instrumentation company

4 Creditors, Banks Operate a sustainable business

4.3. Determining the scope of the integrated management system


The scope of this manual is to define the processes and procedures for WIKA SAUDI
ARABIA's activities mentioned below:
DESIGN, MANUFACTURE, CALIBRATION AND SERVICING OF TEMPERATURE
INSTRUMENTATION. MANUFACTURE, ASSEMBLY, CALIBRATION AND SERVICING OF
PRESSURE INSTRUMENTATION
The scope will also include outsourced activities; and sites managed by, or worked on,
activities carried out by WIKA SAUDI ARABIA staff and directly employed contractors.
No exclusions to the standard requirements apply.

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
CONTEXT OF THE
REVISION 00
ORGANIZATION
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-04 PAGE 3 of 6

4.4. Integrated management system and its processes


The Organization has established and implemented an integrated management system as
described in QMS-01 and its sections. The following processes have been identified:

# PROCESS INPUTS EXPECTED OUTPUTS


1 The WIKA Integrated Customer and other  Customer satisfaction
Management System requirements  Quality Assurance
– Top-Level Process
 Control of non
MR/ QAQC Process conforming outputs
 Compliance with legal
and other requirements
2 Quotation Process Customer enquiry Quotation
(Sales)
3 Order Entry Process Customer PO Sales Order
(Sales)
4 Manufacturing Process Work Order Finished goods
5 Design Process Customer requirements Approved drawing
6 Purchasing Process Purchase request Delivery order
7 Job Completion Finished goods Despatch/ Shipping
Process
8 Human Resource Manpower needs Recruitment and Training
Competence
requirements

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
CONTEXT OF THE
REVISION 00
ORGANIZATION
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-04 PAGE 4 of 6

Figure 1: Top Level Processes

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SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
CONTEXT OF THE
REVISION 00
ORGANIZATION
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-04 PAGE 5 of 6

Figure 2: Process interaction


Each process has defined performance indicators documented in WSA 010 Quality
Objectives and Action Plan.
The process owners are responsible for determining resources required for their processes.
Additional responsibilities and authorities for the processes are documented in the
procedures. Process owners or functional heads are responsible for implementing any
changes and improving the processes.
Risks and opportunities related to the processes are addressed in WSA 007 Risk and
Opportunity Register.

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
CONTEXT OF THE
REVISION 00
ORGANIZATION
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-04 PAGE 6 of 6

Procedures to support the operation of the processes and records for evidence of action are
determined. List of procedures is available in QMS-01-11 Master List of Documents and
other formats in use are available in WSA 004 Master list of forms.
4.5. ATEX/IECEx/CSA
WIKA SAUDI ARABIA established the Quality Management System (QMS-01) that is
documented in this manual and associated procedures. WIKA SAUDI ARABIA has
implemented and maintains this Quality Management System. This QMS ensures that
products with an Ex certificate are manufactured in compliance with the certificate.
WIKA SAUDI ARABIA's QMS guarantees that equipment, protective system or
component confirms to the types described in the Ex certificate. All data requirements
and provision adopted by WIKA SAUDI ARABIA are systematically brought together
and documented in a systematic and orderly manner in the form of written policies,
procedure, and work instruction. The quality system documentation permits a
consistent interpretation of quality programs, plans, manuals, and records.
WIKA SAUDI ARABIA shall facilitate an arrangement, whereby the notified body may
audit aspects of the supplier’s operations affecting the protection concept of products
confirming to ATEX/IECEx/CSA.

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
LEADERSHIP REVISION 00
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-05 PAGE 1 of 6

5.1. Leadership and commitment


The senior managers of WIKA SAUDI ARABIA (top management) are fully committed to the
development, implementation and continual improvement of the QMS.
Top management participates in the management reviews and demonstrates its commitment
to the IMS by providing adequate resources in terms of trained manpower and a suitable
environment for conducting its operations.
5.1.1. General
a) Top management is accountable for the effectiveness of the quality management system.
Top management participates in the Management Review meetings to evaluate the
effectiveness of the QMS. Refer Section 9.3.
b) Top management reviews and approves the QMS-01-03 Quality Policy and WSA 010
Quality Objectives and Action Plan to ensure they are in line with the context and
strategic direction of the Organization.
c) The integrated management system requirements are integrated into the Organization’s
business processes. Key processes have operating procedures. Refer QMS-01-11 Master
List of Documents.
d) Top management promotes the process approach and risk-based thinking. Identified risks
are listed in WSA 007 Risk and Opportunity Register.
e) Top management ensures that the resources needed for the quality management system
are available. Process owners and functional heads are empowered to highlight resource
needs as required in meetings.
f) Top management communicates the importance of effective integrated management and
of conforming to the integrated management system requirements through staff meetings
and management review meetings.
g) Internal audits are planned to ensure that the integrated management system achieves its
intended results.
h) Top management engages, directs and supports persons to contribute to the effectiveness
of the integrated management system through staff meetings.
i) Top management promotes improvement by planning to increase product portfolio as per
customer and market needs.
j) Top management supporting employees to demonstrate their leadership in their areas of
responsibility.
5.1.2. Customer focus
The management team shall ensure that customer’s requirements, relating to individual
contracts, are understood and upheld with each product delivered. Customer satisfaction
surveys and feedback will be used to examine relevant activities and improve corporate
performance.
Customer requirements are determined and understood by the Sales Team and documented
in Quotation.

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
LEADERSHIP REVISION 00
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-05 PAGE 2 of 6

Applicable statutory, regulatory and other requirements are reviewed periodically.


Risks and opportunities that can affect conformity of products and services and the ability to
enhance customer satisfaction are addressed in WSA 007 Risk and Opportunity Register.
5.2. Policy
5.2.1. Establishing the policy
The Organization has established its policy (QMS-01-03 Quality Policy) in order to ensure
customer satisfaction in every order that we process by meeting customer requirements for
product quality and delivery schedule.
The policy is implemented across all of WIKA SAUDI ARABIA’s activities and locations to
continually improve the effectiveness of the QMS.
The Policy is reviewed annually as part of the management review. The re-approval of the
Policy shall be recorded in the minutes of the management review.
QMS-01-03 Quality Policy shall provide the framework to establish Quality objectives.
5.2.2. Communicating the policy
QMS-01-03 Quality Policy is a public document and shall be shall be available to interested
parties as below:
 Internal interested parties – policy is displayed within premises and communicated
during induction for new employees
 External interested parties – Corporate policy can be downloaded from Wika website.
Customers and other visitors can view the policy in our premises. Suppliers are given a
copy of the policy during the supplier selection process.
The policy is also a part of each employee’s training and teaching thus ensuring that every
person employed is aware of and understands the policy.
5.3. Organizational roles, responsibilities and authorities
Organizational roles, responsibilities and authorities are communicated via the procedures,
organisation chart and job descriptions. The following are the key responsibilities and
authorities:

NO DESCRIPTION RESPONSIBLE PERSON(S)


a) Ensuring that the quality management system Quality Manager
conforms to the requirements of this
International Standard
b) Ensuring that the processes are delivering their Process owners and functional
intended outputs heads
c) Reporting on the performance of the integrated Quality Manager
management system and on opportunities for
THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
LEADERSHIP REVISION 00
ISSUE DT. 15.07.2018
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improvement to top management


d) Ensuring the promotion of customer focus Quality Manager
throughout the Organization Functional heads
e) Ensuring that the integrity of the quality Quality Manager
management system is maintained when Process owners and functional
changes to the quality management system are heads
planned and implemented.
g) Authorized Person for IECEx/CSA Zeyaul Haque,Technical Manager

The Top Management of WIKA SAUDI ARABIA assumes accountability for the quality
management system. The Quality Manager has been delegated the following responsibilities
through an appointment letter signed by the top management:
a) Ensure that the quality management system is established, implemented and
maintained in accordance with the requirements of ISO 9001:2015/EN 80079-34
International Standard;
b) Ensure the promotion of customer focus throughout the organization;
c) In association with the functional heads and process owners, ensure compliance with
the organization’s and other requirements;
d) Monitor effectiveness of the management system through audits and non-conformance
analysis reports;
e) Report on the performance of the quality management system to the top management
for review, including recommendations for improvement;
f) Ensure that the integrity of the quality management system is maintained when
changes to the integrated management system are planned and implemented.
g) Liaise with external interested parties on matters relating to the quality management
system
5.3.1. Key Responsibilities
All individuals within the Company are responsible for quality. Each has the authority and
responsibility to identify nonconforming product, and to prevent nonconforming products and
services from being moved forward in the process and/or being delivered to the customer,
until the non-conformance has been corrected. Each has the responsibility to bring any
environment and health & safety risks, incidents and/or violations to the notice of either the
Management Representative or Safety Representative.
Responsibility and authority are also detailed within each work procedure.
a) GENERAL MANAGER
 Is responsible for the overall Quality Program and the efficient operation of WIKA
SAUDI ARABIA;

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
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LEADERSHIP REVISION 00
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WIKA SAUDI ARABIA DOC.NO QMS-01-05 PAGE 4 of 6

 Is response, in co-operation with department heads, as necessary, to settle any quality


related issues;
 Is responsible for ensuring that appropriate resources are allocated and that quality
objectives are achieved with the understanding that planning, control and improvement
will lead directly to improvement in quality performance.
 In cooperation with the Quality Manager shall conduct periodic management reviews of
the Quality Management System as specified in this manual to ensure the continued
effectiveness of the system. The GM shall review the reports of all the Management
review meetings.
b) PRODUCTION MANAGER
 Reports directly to the General Manager and is responsible for ensuring that all
production employees within WIKA SAUDI ARABIA have the necessary training,
qualifications, guidance and tools to perform their jobs in a consistent, accurate safe
manner.
 Is responsible for ensuring that management is provided with accurate and relevant
manufacturing data and assists in the analysis of this information.
 Has the authority to co-authorize procedures, documents and disposition non-
conformance related to manufacturing.
 Is responsible to ensure that all products meet jurisdictional requirements, when
applicable.
 Assist in stores and shipping activities
c) INTERNAL SALES
 Reports directly to the General Manager
 Preparing Quotes & Handling Orders
 Handling all the Sales Related- Axapta Issues/TP related issues
 Monthly follow up for high value quotes
 Evaluating enquiry and selecting right products/model according to customer
specifications and generating quotations.
 Preparing cost analysis for orders and appropriately maintaining margin targets for
quote/orders as per company’s set directives.
 Responding technical queries and finalization of purchase order technically as well as
commercially
 Liaise with external sales for order finalization and following up quotes.

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
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 Evaluating the purchase order sent by the customers and placing them accordingly
accentuating the line items and quantities.
 Sending Order Acceptance to the customers.
 Placing the orders to the suppliers/manufacturing within 3 working days
 Assist in external sales and purchasing activities.
d) QUALITY MANAGER (QM)
 As defined in the Appointment Letter.
 Is in charge of Customer Complaints and NCR’s
 Is responsible for product inspection at receiving, in process and final stage.
 Managing Customer/ Third Party inspection.
 Responsible for analyzing NCR’s & Customer complaints for continual improvement.
e) Ex Authorized Person
Ex authorized person shall be responsible to ensure the following requirements
are met
 A effective coordination of activities with respect to Ex products
 The liaison with the issuer of the certificate (when not issued by the
manufacture) with respect to any proposed change to the design defined in the
certificate and the technical documentation
 The liaison with the body responsible the verification of quality management
system with respect to intended updating of the quality management system
 The authorization of the initial approval and changes to the related drawings,
wherever appropriate
 The authorization of concessions
 The accuracy of relevant information regarding Ex product given to the
customer for any sales literature and installation instructions (which shall
include applicable specific conditions use and any schedule of limitations).
 The effective coordination of manufacturing processes related to Ex products
including externally provided products, services and processes.
 Responsible for the verification of the QMS of each certificate
 Responsible for checking the validity of all Ex related certificates, standards,
regulations and other external specifications

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
LEADERSHIP REVISION 00
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5.3.2. Delegation of Authorities


The following authorities have been delegated:
1. General
1.1. Signing authority on behalf of the company – General Manager
1.2. Signing of contracts/ agreements for sales and purchases – General Manager
2. Quality
2.1. Responding to customer complaints – Quality Manager/ Production Manager
2.2. Deciding on action to be taken on non conforming outputs – Quality Manager/
Production Manager
2.3. Release of goods (QC) – Quality Manager/ Production Manager
2.4. Reviewing and approving changes in documents - Quality Manager
2.5. Reviewing and approving changes that can affect the quality management system -
Quality Manager
2.6. Communicating with external interested parties on performance of quality matters –
Quality Manager
3. HR
3.1. Approving leaves and new hires – General Manager
4. Commercial
4.1. Approval of expenses and credit notes - General Manager
4.2. Approving high value quotes – General Manager
4.3. Approving new vendor – General Manager/ Quality Manager/ Production Manager
4.4. Bank account authorizations – General Manager

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
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The process owners and functional heads are responsible for planning. Planning inputs
include organisational strategy, business objectives, customer feedback, statutory and
regulatory requirements and lessons learned through the examination of corrective action
data.
Planning outputs is represented through investment in training, introduction of new vendors
and changes to documentation when required by change to legislation.
6.1. Actions to address risks and opportunities
WIKA SAUDI ARABIA has considered the issues referred to in Section 4.1 and the
requirements referred to in Section 4.2 to determine the risks and opportunities affecting it.
When planning for the quality management system, WIKA SAUDI ARABIA has considered the
issues that need to be addressed to:
a) Give assurance that the integrated management system can achieve its intended result(s);
b) Enhance desirable effects;
c) Prevent, or reduce, undesired effects;
d) Achieve improvement.
WIKA SAUDI ARABIA has planned actions to address these risks and opportunities and
integrated them within the quality management system processes. They are implemented
through operating procedures and additional roles and responsibilities for key personnel.
Actions taken to address risks and opportunities shall be proportionate to the potential impact
on the conformity of products and services.
Refer WSA 007 Risk and Opportunity Register.
6.2. Quality objectives and planning to achieve them
The business objectives of WIKA SAUDI ARABIA provide effective assurance that all products
and services provided, meet the intent and detailed requirements of each contract placed with
it by following the following principles:
 Customer satisfaction is top priority for all employees
 Product Quality shall be ensured by having zero reject
 On Time Delivery shall be ensured by continuously monitoring progress of each
customer order
 Ability to implement
 Options relating to technological advancement
 The views of interested parties
 The organisational objectives, financial, operational and business requirements
WIKA SAUDI ARABIA has established Quality objectives at relevant functions, levels and
processes needed for the integrated management system. The Quality objectives are

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measurable and take into account applicable requirements. Responsibilities to meet objectives
are determined and communicated to the employees. They are reviewed annually during
Management Review.
Refer WSA 010 Quality Objectives and Action Plan.
Plans and Objectives to improve performance are established and reviewed within the
Management Review process.
6.3. Planning of changes
When WIKA SAUDI ARABIA determines the need for changes to the quality management
system, the changes shall be carried out in a planned manner.
a) It is the responsibility of the process owner/ functional head to evaluate the potential
consequences of the change.
b) The Management Team shall review the impact of all changes on the organization’s
integrated management system. Any approved changes shall be updates in the quality
management system.
c) The changes shall be communicated to all those who are impacted before
implementation and also during the management review meeting. The process owner
shall be responsible for implementing the change.
d) Top management shall approve additional resources required for the change.
e) Where a request for change has been assessed and considered inappropriate,
impractical or unjustified the change initiator is informed.
The following authority levels apply to changes depending on its risk and impact to the
business. No change may be initiated without authorisation.
a) Minor change – authorised by process owner or functional head (low risk and low
impact to the business)
b) Major change – authorised by top management (high risk and/or high impact to the
business)
Records of changes and authorisations are recorded in WSA 008 Management of Change.

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
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7.1. Resources
7.1.1. General
WIKA SAUDI ARABIA has determined and provided the resources needed for the
establishment, implementation, maintenance and continual improvement of the integrated
management system. These include manpower, supporting services, Information and
communication technology, etc.
7.1.2. People
The Organization has determined and provided the persons necessary for the effective
implementation of its integrated management system and for the operation and control of its
processes. These are the functional heads. Refer WSA 048 Organization Chart.
7.1.3. Infrastructure
The Organization has determined, provided and maintained the infrastructure necessary for
the operation of its processes and to achieve conformity of products and services. This
includes, but not limited to:
a) Buildings and associated utilities;
b) Equipment including production infrastructure.
c) Information and communication technology, hardware and software is managed.
Management ensures that a good communication system exists within the company and
between its customers and external service providers. The use of phones, faxes and e-mails
are considered acceptable ways of implementing this requirement.
7.1.4. Environment for the operation of processes
WIKA SAUDI ARABIA has determined, provided and maintained the environment necessary
for the operation of its processes and to achieve conformity of products and services.
The organization ensures a non-discriminatory work environment.
To provide a working environment that is conductive to product/ process efficiency, WIKA
SAUDI ARABIA manages dust and noise by providing suitable personal protective equipment
to those exposed. Temperature and humidity in the production area cannot be controlled.
It is WIKA SAUDI ARABIA’s policy to ensure that its work environment is fully compliant with
relevant Health and Safety standards and legislation requirements.
7.1.5. Monitoring and measuring resources

7.1.5.1. General
WIKA SAUDI ARABIA has determined and provided the resources needed to ensure valid and
reliable results when monitoring or measuring is used to verify the conformity of products and
services to requirements. WIKA SAUDI ARABIA retains documented information as evidence
of fitness for purpose of the monitoring and measurement resources. Refer PI 011 Procedure
for Handling of Test gauges and Equipment for Calibration.

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SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
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Subcontractors providing calibration services shall be an accredited calibration


authority, registered with a third party in accordance with an internationally recognized
standard. A registration certificate bearing the accreditation logo shall be obtained and
maintained on file.
Where a calibration certificate does not bear the accreditation logo of a national
accreditation authority then each calibration certificate shall include at least the
following information:
 An unambiguous identification of the item calibrated ,
 Evidence that the measurements are traceable to international or national
measurement standards,
 The method of calibration,
 A statement of compliance with any relevant specification,
 The calibration results ,
 The uncertainty of measurements, where necessary,
 The environmental conditions , where relevant ,
 The date of the calibration,
 The signature (or stamp ) of the person under whose authority the certificate
was issued,
 The name and address of the issuing organization and the date of issue of the
certificate,
 A unique identification of the calibration certificate.

7.1.5.2. Measurement traceability


WIKA SAUDI ARABIA ensures that all monitoring and measuring equipment are controlled.
This includes calibration and servicing of equipment on a periodic basis. This is done by:
 Calibrating all measuring devices at specified intervals (annually) against
measurement standard traceability to international or national measurement standards.
Records are retained for the same.
 Monitoring and measuring devices shall be adjusted or readjusted as necessary.
 Monitoring and measuring devices shall have identification in order to determine their
calibration status. A sticker shall also be placed on the equipment to show the last
calibration date and next calibration due date.
 Measuring equipment shall be safeguarded from adjustments that would invalidate the
measurement result. Only authorised warehouse personnel are permitted to use the
measuring equipment.
 Monitoring and measuring devices shall be protected from damage and deterioration
during handling, maintenance and storage.

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
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 Checking the validity of previous measuring results when equipment is found not to
conform to requirements.
 WIKA SAUDI ARABIA shall take appropriate action on equipment when it is found not
to conform to requirements. This shall include recalibration of the equipment.

7.1.6. Organizational knowledge


WIKA SAUDI ARABIA has determined the knowledge necessary for the operation of its
processes and to achieve conformity of products and services.
This knowledge shall be maintained by each process owner and be made available to the
team members through the use of a common shared folder and Intranet.
WIKA SAUDI ARABIA has a policy to build its expertise by retaining its competent staff. Our
employee assets are as below:
 General Manager – knowledge about organizational context specific to Saudi Arabia,
economy, local oil & gas companies and government regulations;
 Quality Manager – knowledge about quality requirements of various international
standards, ATEX/IECEx/CSA gained through experience and attending various
training programs internally and from head office;
 Production Manager – knowledge about WIKA products, pressure and temperature
instrumentation, calibration services;
 Sales - knowledge about WIKA products and services, knowledge about Axapta
software, knowledge about key suppliers, knowledge of various customer categories
and their specific needs and expectations;
 Technicians – working knowledge of technical standards and equipment.
Our global knowledge assets are shared with our team through training programs and easily
accessible via the intranet. These include the following:
 Work Instructions provided by WIKA head office and its subsidiaries;
 Various product approvals based on EU declarations of conformity;
 Access to expertise from manpower across the WIKA network;
When addressing changing needs and trends, WIKA SAUDI ARABIA shall consider its current
knowledge and determine how to acquire or access any necessary additional knowledge and
required updates.
7.2. Competence
WIKA SAUDI ARABIA shall:
a) Determine the necessary competence of person(s) doing work under its control that
affects the performance and effectiveness of the integrated management system.
Refer WSA 047 Job Descriptions for minimum competency requirements.

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
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b) Ensure that these persons are competent on the basis of appropriate education,
training, or experience. Refer PI 003 - Staff Training.
c) Take actions to acquire the necessary competence through training and other means.
d) Evaluate the effectiveness of the actions taken.
e) Retain documented information relating to the qualifications and experience as
evidence of competence.
7.3. Awareness
WIKA SAUDI ARABIA ensures that persons doing work under the Organization’s control are
aware of the following through staff briefings or new employee orientation programs:
a) The Quality policy;
b) Relevant Quality objectives;
c) Their contribution to the effectiveness of the quality management system, including the
benefits of improved performance;
d) The implications of not conforming with the quality management system requirements.
Ex authorized person shall train all involved in IECEx production annually.
Refer PI 003 - Staff Training.
7.4. Communication
Top management ensures that internal lines of communication and method of information
transfer are available. Methods of communication may include, but not limited to: Telephone,
Fax, E-mail, meetings and notice boards.
Internal Communication is achieved through a combination of different mechanisms, including:
 Regular Staff Team Meetings;
 Management Review Meetings;
 Briefings and Reviews;
 Emails
The following table describes key elements of the communication plan.
WHAT TO WHEN – WHOM - HOW – MODE OF WHO IS
COMMUNICATE HOW TARGET COMMUNICATION RESPONSIBLE
OFTEN AUDIENCE
Customer As Customers Emails to be Sales or
notification/ applicable printed or saved Production
approval for against the order. heads
changes to sale
or production
plans, product
obsolescence.
Records
required.
Organizational Annually Top Emails and General
THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
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objectives, management meetings Manager


strategy, review,
budget, etc.
Organisation’s As General Email, personal Sales Team
products and required public, meetings, etc.
services prospective
customers
Related to – As Employees Emails and Quality
Quality, required meetings Manager
Environment,
Health & Safety
Internal and external communication relating to Ex Products shall be controlled.
Top Management will ensure that internal lines of communication and method of information
transfer between the employees are made available. Methods of communication may include,
but not limited to: Telephone, Fax, E-mail, meetings and notice boards.
The Quality Manager shall provide information on best practice, share information and update
staff on changes to policies and procedures.
Quality Manager shall also make sure that all employees are communicated with recent
change in any legal or operational procedure.
Internal Communication is achieved through a combination of different mechanisms, including:
o Regular Staff Team Meetings;
o Management Review Meetings;
o Briefings and Reviews;
Records are retained of all important communication.
7.5. Documented information
7.5.1. General
WIKA SAUDI ARABIA’s quality management system includes:
a) Documented information required by this International Standard like Quality Policy,
Objectives and performance indicators, Quality Management System Manual, Quality
Management procedures, documents and records;
b) Documented information determined by WIKA SAUDI ARABIA as being necessary for
the effectiveness of the quality management system like standard operating
procedures.
c) Equipment documents and manufacturer’s documents for products confirming
to ATEX/IECEx/CSA
A list of these documents is available in QMS-01-11 Master List of Documents.
7.5.2. Creating and updating
When creating and updating documented information, WIKA SAUDI ARABIA ensures that:
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a) Documents are identified with a unique number, title and issue date
b) Language used is English. Documents are retained in electronic version and printed
copies are treated as uncontrolled.
c) All documents are reviewed and approved for suitability and adequacy. Level 1 and 2
documents include the name of the approving authority.
d) For Product confirming to ATEX/IECEx/CSA: For ATEX/IECEx/CSA related
product confirming to AEX 94/9/EC or CSA, please refer to Sec 4.4 of Procedure
PI 002 Document control
Refer QMS-01-11 Master List of Documents, which is a master list of all documents and
their current revision status issued for use within the QMS
7.5.3. Control of documented information
Documented information required by the quality management system and by this International
Standard are controlled to ensure:
a) It is available and suitable for use, where and when it is needed;
b) It is adequately protected (e.g. from loss of confidentiality, improper use, or loss of
integrity).
c) WIKA SAUDI ARABIA procedure PI 002 defines a system for controlling
documentation of products that have an EC type/CSA examination certificate.
d) WIKA SAUDI ARABIA maintains documents such as data sheet and sales
literature for products confirming to ATEX/IECEx/CSA.
Refer PI 002 Document control.
For the control of documented information, WIKA SAUDI ARABIA has addressed the following
activities through PI 002 Document Control, which specifies:
a) Distribution, access, retrieval and use;
b) Storage and preservation, including preservation of legibility;
c) Control of changes (e.g. version control);
d) Retention and disposition.
Documented information of external origin determined by WIKA SAUDI ARABIA to be
necessary for the planning and operation of the integrated management system are identified
in QMS-01-11 Master List of Documents and are controlled.
Documented information retained as evidence of conformity is protected from unintended
alterations.
All records retained are listed in QMS-01-11 Master List of Documents along with their
individual retention times. Records may be retained in either hard copy or electronic format.

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SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
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8.1. Operational planning and control


WIKA SAUDI ARABIA plans for the procurement and delivery of products as per quoted terms
to the Customer. This is followed up through weekly meetings to check progress as per plan.
WIKA SAUDI ARABIA has planned and implemented the processes needed to meet the
requirements for the provision of products and services by:
a) Determining the requirements for the products and services are determined through (a)
Specifying full description of item, carrying out a thorough contract review on every
order to check technical and commercial specifications. Refer PI 004 Handling of
Enquiries Orders (b) review of requirements through design process if applicable.
Refer PI 005 Design and Development (c) Placing orders with approved vendors or
service providers. Refer PI 006 Purchase of Materials (d) Mentioning product
specification and tolerances. Refer PI 009 Work Order Processing for Production.
b) Establishing criteria for:
i. The processes are monitored in line with the set performance indicators. Refer
WSA 010 Quality Objectives and Action Plan
ii. The acceptance of products and services is documented in the Quotation. The
criteria for acceptance of goods shall be as per details specified in the
quotation submitted to the Customer for approval prior to accepting the order.
Unless specified by the customer no third part inspections are carried out.
iii. For products confirming to CSA/IECEx, WIKA determines the product
category and marking required by the customer.
iv. The review shall ensure that the customer requirements are compatible
with the Ex certificate.
c) Additional resources needed to achieve conformity to the product and service
requirements are determined during the sales process. Refer PI 004 Handling of
Enquiries Orders
d) Control of the processes is by monitoring against the performance indicators. All
production activities have documented Work Instructions. Key performance
Indicators for production include First Pass Yield Rate, process time for Work Order
and On Time Delivery (OTD).
e) Confidence that the processes have been carried out as planned is through Sales
Order Confirmation and Acknowledgement
f) Conformity of products and services to their requirements is demonstrated through
correct product ordering, quality control and control of non-conforming outputs. Refer
PI 014 Procedure for Final inspection of Instruments, PI 015 Dispatch of Finished
goods and PI 021 Control of Non-conforming product.
g) Information in Annex A for control and acceptance processes for Ex products is
to be mentioned to ensure compliance with the certificate.
WIKA SAUDI ARABIA shall control planned changes and review the consequences of
unintended changes, taking action to mitigate any adverse effects. Refer WSA 008
Management of Change.
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SAUDI ARABIA IS PERMITTED.
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WIKA SAUDI ARABIA shall ensure that outsourced processes are controlled. WIKA has
identified the following outsourced process:
 Transportation and Maintenance, which is controlled through our supplier selection and
monitoring.
 Calibration, which is controlled by Production Manager and Head Office for master
instruments.
IT and HR is supported by our Middle East office. No process, or part of a process, is provided
by an external provider.
8.2. Requirements for products and services
8.2.1. Customer communication
WIKA SAUDI ARABIA engages in customer communication with the overall aim of meeting
their requirements. Customer communication includes, but are not limited to:
a) Providing information relating to products and services;
b) Handling enquiries, contracts or orders, including changes;
c) Obtaining customer feedback relating to products and services, including customer
complaints;
d) Handling or controlling customer property (for repairs);
e) Establishing specific requirements for contingency actions, when relevant.
WIKA SAUDI ARABIA records all customer enquiries. An order acceptance is issued to the
Customer after verifying that all product requirements and contractual obligations are defined
and can be met. Where appropriate, further negotiations and resolutions with the Customer
are also recorded.
8.2.2. Determining the requirements for products and services
WIKA SAUDI ARABIA has established a sales process for identifying customer requirements
that determine:
a) The requirements for the products and services are defined, including:
o any applicable statutory and regulatory requirements;
o those considered necessary by the organization;
b) The organization can meet the claims for the products and services it offers.
Refer PI 004 Handling of Enquiries Orders.
8.2.3. Review of the requirements for products and services
WIKA SAUDI ARABIA ensures that it has the ability to meet the requirements for products and
services to be offered to customers. WIKA SAUDI ARABIA conducts a review before
committing to supply products and services to a customer, to include:
a) Requirements specified by the customer, including the requirements for delivery and
post-delivery activities;
b) Requirements not stated by the customer, but necessary for the specified or intended
use, when known;
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c) Requirements specified by WIKA;


d) Statutory and regulatory requirements applicable to the products and services;
e) Contract or order requirements differing from those previously expressed.
WIKA SAUDI ARABIA ensures that contract or order requirements differing from those
previously defined are resolved.
The customer’s requirements shall be confirmed by WIKA SAUDI ARABIA before acceptance,
when the customer does not provide a documented statement of their requirements.
WIKA SAUDI ARABIA retains documented information:
a) On the results of the review;
b) On any new requirements for the products and services.
Customer requirements, including any requested changes, are reviewed before a commitment
to provide services to the customer. The results of the review and subsequent follow-up
actions are recorded and the information disseminated to all relevant personnel. Any changes
in the customer requirements are fully reviewed and necessary amendments are made and
communicated to the concerned personnel.
The review shall ensure that any stated customer requirement is compatible with the
certificate e.g. equipment group, temperature class, Type of Protection, Equipment
Protection Level (EPL) and ambient temperature range
Implementation is by the following documents PI 004 Handling of Enquiries Orders.
8.2.4. Changes to requirements for products and services
WIKA SAUDI ARABIA ensures that relevant documented information is amended, and that
relevant persons are made aware of the changed requirements, when the requirements for
products and services are changed.
The Ex authorized person shall be involved in any changes (e.g. changes to the
manufacturer’s documentation, quality management system or marketing documents)
that could affect Ex Product compliance.
8.3. Design and development of products and services
The Design process ensures that the company is able to plan and control its design and
development stages to review, verify and validate the design as appropriate and that the
responsibilities and authorities for design are established. Refer PI 005 Design and
Development.
Not within the Scope of EN 80079-34
Responsibilities
The Production Manager is responsible for design. Refer PI 005 Design and Development
and WSA 031 Master List of External Documents.
Description

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 The responsibilities and actions required for controlling the design, distribution and
correction of drawings for the manufacture of temperature sensors and pressure gauge
dials to meet customer requirements in compliance with international standards are
clearly defined and documented in PI 005 Design and Development.
 The design process ensures that WIKA SAUDI ARABIA is able to plan and control its
design and development stages to review, verify and validate.
 WIKA SAUDI ARABIA’s system guarantees that no factor (type, characteristics,
position etc.) taken into account when the EC type/CSA examination was
conducted is modified without the endorsement of the notified body, which
issued the Ex certificate.
8.4. Control of externally provided processes, products and services
8.4.1. General
WIKA SAUDI ARABIA ensures that externally provided processes, products and services
conform to requirements. WIKA SAUDI ARABIA has determined the controls to be applied to
externally provided processes, products and services when:
a) Products and services from external providers are intended for incorporation into WIKA
SAUDI ARABIA's own products and services;
b) Products and services are provided directly to the customer(s) by external providers on
behalf of WIKA SAUDI ARABIA;
No process, or part of a process, is provided by an external provider.
WIKA SAUDI ARABIA has determined criteria for the evaluation, selection, monitoring of
performance, and re-evaluation of external providers, based on their ability to provide
processes or products and services in accordance with requirements. WIKA SAUDI ARABIA
retains documented information of these activities and any necessary actions arising from the
evaluations.
All raw material, components related for assembly of IECEx/CSA products are
procured from WIKA MIDDLE EAST FZE.It’s the responsibility of WIKA SAUDI ARABIA
to inform WIKA Canada/WIKA MIDDLE EAST if any non-conformities found related to
these supplies.
Specific requirements (for process control, testing or inspection) pertaining to
subcontracted product affecting conformance with CSA/IECEx.
Refer PI 006 Purchase of Materials.

8.4.2. Type and extent of control


WIKA SAUDI ARABIA ensures that externally provided processes, products and services do
not adversely affect WIKA SAUDI ARABIA’s ability to consistently deliver conforming products
and services to its customers.

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
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WIKA SAUDI ARABIA DOC.NO QMS-01-08 PAGE 5 of 10

WIKA SAUDI ARABIA:


a) Ensures that externally provided processes remain within the control of its quality
management system;
b) Defines both the controls that it intends to apply to an external provider and those it
intends to apply to the resulting output;
c) Takes into consideration:
i. The potential impact of the externally provided processes, products and
services on WIKA SAUDI ARABIA’s ability to consistently meet customer and
applicable statutory and regulatory requirements;
ii. The effectiveness of the controls applied by the external provider;
d) Determines the verification, or other activities, necessary to ensure that the externally
provided processes, products and services meet requirements.
The criteria for selection, evaluation and re-evaluation are based in the PI 006 Purchase of
Materials. Only those sources satisfying Company requirements are included in WSA 017
List of Approved Suppliers.
8.4.3. Information for external providers
WIKA ensures the adequacy of requirements prior to its communication to the external
provider. WIKA communicates to external providers its requirements for:
a) The processes, products and services to be provided;
b) The approval of:
a. Products and services;
b. Methods, processes and equipment;
c. The release of products and services;
c) Competence, including any required qualification of persons;
d) The external providers’ interactions with WIKA SAUDI ARABIA;
e) Control and monitoring of the external providers’ performance to be applied by WIKA
SAUDI ARABIA;
f) Verification or validation activities that WIKA SAUDI ARABIA, or its customer, intends
to perform at the external providers’ premises.
These specifications are noted in the quotation and in the purchase order to subcontractors
where required. Refer PI 006 Purchase of Materials
8.4.4. Additional requirements for IECEx/CSA purchasing information
 WIKA SAUDI ARABIA's Procedure for Purchase of Materials PI 006 details the
purchasing information requirements , including the method by which
documents (e.g. technical specifications ) stated in a particular purchase order
remain traceable to the order.
 While manufacture, testing and final inspection may be sub-contracted, the
responsibility for ensuring conformance with the Ex certificate shall not be sub-
contracted

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
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ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-08 PAGE 6 of 10

 Suppliers that provide a product, process or service that can affect the product’s
compliance with the Ex certificate, shall only be selected after an evaluation has
demonstrated that they have the capability of ensuring compliance with all
specified requirements
 Documented objective evidence that the supplier can provide a product, process
or service that is fit for its purpose shall be made by one or more of the
following methods
 The supplier has an acceptable Ex quality system (quality system as per IEC
80079-34)
 The supplier has a quality system certificate in accordance to the appropriate
standard and with an acceptable scope (A certificate issued by an accredited
body which can demonstrate that it operates in compliance with ISO/IEC 17021
is acceptable; depending on the nature of the product, process, or Service, a
quality system in accordance with ISO 9001:2015 may not be sufficient.
 A documented site assessment to ensure that all relevant controls are available,
documented, understood and effective.
 Supplier providing calibration services (including verification on measuring
devices by comparison with calibrated equipment) shall be evaluated on their
ability to meet stated requirements.
8.4.5. Verification of purchased product
 For items affecting the protection concept, where conformance can not be
verified after manufacture (e.g. encapsulated assemblies), then a quality plan
shall be produced and approved.
 WIKA SAUDI ARABIA Procedure for Receipt and Handling of Incoming material
PI 007 details verification of purchased product including special requirements
of a purchased product or service affecting conformance to CSA/IECEx.
 WIKA Middle East shall supply the product with inspection certificates/Certificate of
Conformance.
 WIKA SAUDI ARABIA shall only verify the quantity.
8.5. Production and service provision
8.5.1. Control of production and service provision
WIKA SAUDI ARABIA maintains a set of Work Instructions that covers all aspects of the
production, inspection and testing related to Pressure and Temperature instrumentation and
manufacturing of Orifice Plates under controlled conditions. Controlled conditions includes:
a) Quotations and Work Orders contain documented information that defines:
a. The characteristics of the products to be produced, the services to be provided,
or the activities to be performed;

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
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ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-08 PAGE 7 of 10

b. The results to be achieved;


b) The availability and use of suitable monitoring and measuring resources as
documented in the WSA 042 Calibration Register (Master list of Measuring
Instruments);
c) The implementation of monitoring and measurement activities at appropriate stages to
verify that criteria for control of processes or outputs, and acceptance criteria for
products and services, have been met;
d) The use of suitable infrastructure and environment for the operation of processes;
e) The appointment of competent persons, including any required qualification;
f) The validation, and periodic revalidation, of the ability to achieve planned results of the
processes for production and service provision, where the resulting output cannot be
verified by subsequent monitoring or measurement;
g) The implementation of actions to prevent human error;
h) The implementation of release, delivery and post-delivery activities.
i) The WIKA shall provide procedures, production equipment, working
environments and inspection/testing facilities that together provide assurance
with respect to the compliance of the Ex Product with its technical
documentation.
8.5.2. Identification and traceability
WIKA SAUDI ARABIA uses suitable means to identify outputs when it is necessary to ensure
the conformity of products and services. Products are marked with unique serial numbers.
The product is identified with status with respect to monitoring and measurement
requirements during all stages of production, testing, final inspection and repair.
Traceability for product is implemented with respect to the final product and its
significant parts

8.5.3. Property belonging to customers or external providers


WIKA SAUDI ARABIA exercises care with property belonging to customers or external
providers while it is under its control or being used by WIKA SAUDI ARABIA.
WIKA SAUDI ARABIA identifies, verifies, protects and safeguards customers’ or external
providers’ property provided for use or incorporation into the products and services.
When the property of a customer or external provider is lost, damaged or otherwise found to
be unsuitable for use, WIKA SAUDI ARABIA shall report this to the customer or external
provider and retain documented information on what has occurred.
It is the responsibility of the WIKA SAUDI ARABIA to verify the compatibility of a
product supplied by a customer or an external provider with the requirements of the
certificate.

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
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ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-08 PAGE 8 of 10

8.5.4. Preservation
The product is preserved at all stages; products and materials are handled, stored and
transported appropriately to prevent damage or deterioration. This is done by:
 Effective communication between Store personnel and material handlers;
 Use of suitable equipment for goods movement
Our product confirming to CSA/IECEx are subassemblies that we incorporates into end
products that also confirms to CSA/IECEx. As a result, we provide instructions to the
end user.

8.5.5. Post-delivery activities


WIKA SAUDI ARABIA meets requirements for post-delivery activities associated with the
products and services where specifically agreed. In determining the extent of post-delivery
activities that are required, WIKA SAUDI ARABIA provides product warranty considering:
a) Statutory and regulatory requirements;
b) The potential undesired consequences associated with its products and services;
c) The nature, use and intended lifetime of its products and services;
d) Customer requirements;
e) Customer feedback.
8.5.6. Control of changes
WIKA SAUDI ARABIA controls changes for production or service provision by communicating
internally and externally to vendors and external service providers.
WIKA SAUDI ARABIA retains documented information describing the results of the review of
changes, the person(s) authorizing the change, and any necessary actions arising from the
review.
The Ex authorized person shall be involved in changes (e.g. changes to the
manufacturer’s documentation, quality management system or marketing documents)
that could affect Ex Product compliance.

8.6. Release of products and services


WIKA SAUDI ARABIA has implemented planned arrangements, at appropriate stages, to
verify that the product and service requirements have been met.
The release of products and services to the customer shall not proceed until the planned
arrangements have been satisfactorily completed, unless otherwise approved by a relevant
authority and, as applicable, by the customer.
WIKA SAUDI ARABIA retains documented information on the release of products and
services through (a) signed by the Authorized Person (b) approved in Axepta that includes:
a) Evidence of conformity with the acceptance criteria;

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
OPERATION REVISION 00
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-08 PAGE 9 of 10

b) Traceability to the person(s) authorizing the release.


Refer PI 014 Procedure for Final inspection of Instruments.
For products confirming to CSA/IECEx, where routine tests are required by the Ex
certificate and the equipment documents, then those tests shall be performed as
specified with no sampling techniques being permitted.
8.7. Control of nonconforming outputs
WIKA SAUDI ARABIA ensures that outputs that do not conform to their requirements are
identified and controlled to prevent their unintended use or delivery. A separate area has been
identified for nonconforming outputs in the Warehouse.
WIKA SAUDI ARABIA also initiates appropriate action based on the nature of the
nonconformity and its effect on the conformity of products and services. This shall also apply
to nonconforming products and services detected after delivery of products, during or after the
provision of services.
A documented procedure (PI 021 Control of NC product) provides the processes for dealing
with non-conforming products in one or more of the following ways:
a) Correction - taking action to eliminate the nonconformity
b) Segregation, containment, return or suspension of provision of products and services;
c) Informing the customer;
d) Obtaining authorization for acceptance under concession.
Non-conforming items, which have been reworked or repaired, shall be subject to re-
inspection in accordance with the customer’s specifications.
Details of the non-conformance are recorded in WSA 002 Corrective Action Request and
WSA 005 Corrective Action Log that:
a) Describes the nonconformity;
b) Describes the actions taken;
c) Describes any concessions obtained;
d) Identifies the authority deciding the action in respect of the nonconformity.
All non-conforming products will be identified and segregated to prevent unauthorized use,
shipment to customer or mixing with conforming items.
CSA/IECEx specified Product that does not conform to specified requirements while in
process shall be positively identified and segregated in accordance with
Procedure PI 021 Control of Nonconforming Product.
WIKA SAUDI ARABIA maintains a system such that in the event of product confirming
to the CSA/IECEx directive not complying with the EC type/CSA examination certificate
and having been supplied, then the customer can be identified.
Where it is discovered that nonconforming product has been supplied to a customer,
WIKA SAUDI ARABIA will take action appropriate to the degree of risk. Where unsafe,
nonconforming product has been supplied to customer, WIKA SAUDI ARABIA will
THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
OPERATION REVISION 00
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-08 PAGE 10 of 10

inform its customer in writing, where the product confirms to CSA/IECEx , then the
notified body responsible for the quality notification will also be notified.
WIKA SAUDI ARABIA maintains a system such that in the event of product not
complying with the Ex certification documents and having been supplied to WIKA
SAUDI ARABIA‘s customer , items can be identified , located and withdrawn from
service.
For all non conforming product conforming to the CSA/IECEx directive, WIKA SAUDI
ARABIA shall maintain, for a minimum of 10 years, records of:
 Serial No. or identification of products supplied
 Customer who received the product
 Action taken to inform customers and relevant notified body in the case of
unsafe nonconforming product
 Action taken to implement corrective and preventive action.
Concessions for product that take the product outside the design as defined in Ex
certificate and technical documentation are not permitted.

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
PERFORMANCE EVALUATION REVISION 00
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-09 PAGE 1 of 4

9.1. Monitoring, measurement, analysis and evaluation


WIKA SAUDI ARABIA has in place various monitoring and measurement activities to ensure
product and service compliance and to identify potential improvements in its products,
services and IMS.
9.1.1. General
WIKA SAUDI ARABIA:
a) Monitors, measures and improves the products and processes used.
b) Ensures conformity of the QMS
c) Continually improves the effectiveness of the QMS.
Monitoring is an on-going activity. Data analysis is done at least once a year and discussed
during management review meetings.
WIKA SAUDI ARABIA evaluates the performance and the effectiveness of the quality
management system through data analysis of:
a) Quality objectives and key performance indicators
b) Vendor and service provider performance
9.1.2. Customer satisfaction
WIKA SAUDI ARABIA monitors customers’ perceptions of the degree to which their needs
and expectations have been fulfilled. The method used may include one or more of the
following:
 WSA 015 Customer Satisfaction Survey Form;
 Customer Complaints;
 Customer Compliments and Appreciation letters;
 Levels of Repeat Orders;
 Numbers of New Customers;
 Growth of Existing Customers;
 On-time delivery of Products and Services;
 Numbers of Credit Notes issued;
 Numbers of Contractual Disputes.
For products with confirming to CSA/ATEX 94 / 9 / EC, customer requirements include
compliance with the EC type/CSA examination certificate.

9.1.3. Analysis and evaluation


WIKA SAUDI ARABIA collects and analyses appropriate data to demonstrate the suitability
and effectiveness of the QMS. The data shall be used to evaluate the continual improvement
and effectiveness of the implementation of the QMS.
The data includes the following:
 Customer satisfaction

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
PERFORMANCE EVALUATION REVISION 00
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-09 PAGE 2 of 4

 Vendor performance including conformity to product requirements


 Characteristics and trends of processes and products including opportunities for
improvement.

9.2. Internal audit


WIKA SAUDI ARABIA conducts internal audits at planned intervals to provide information on
whether the quality management system:
a) Conforms to:
a. WIKA SAUDI ARABIA’s own requirements for its quality management system;
b. The requirements of this International Standard;
b) Is effectively implemented and maintained.
Audits are scheduled throughout each year to cover the full scope of the QMS. Auditors
conduct audits, as far as possible, independently of their particular areas of work and
responsibility. The Management prepares the annual audit schedule and auditors are then
required to arrange, conduct, report and follow-up on their assigned audits.
The results of audits (WSA 053 Internal Audit Report) are collated and reported to the Top
Management for discussion and follow-up during Management Review Meetings to ensure
any areas for concern and particular opportunities for improvement are addressed. The Top
Management shall also ensure that actions are taken without undue delay to eliminate
detected non-conformities and their causes. Follow-up activities shall include verification of the
action taken along with verification results.
The audit process is fully defined in PI 016 Internal Audit. At no time shall an auditor audit
his/her own work.
WIKA SAUDI ARABIA conducts internal audits of the Quality management system to
determine whether the quality system:
 Confirms to the planned arrangements, to the requirements of ISO 9001:2015
standard, CSA/ATEX/IECEx EN 80079-34 “Potentially explosive atmosphere –
Application of quality system”
 Is effectively implemented and maintained
The audit program shall address the effectiveness of the elements of the quality
management system as described in this document to ensure that the Ex products are
in conformity with the certificate.
One method of demonstrating effectiveness is the use of vertical auditing whereby an
Ex Product awaiting dispatch is used to prove the system. The auditor examines all
aspects of the system associated with the production of that Ex Product from a
certification viewpoint. This normally includes appropriate documentation (drawings,
inspection checklists, test records, material certificates etc.), Ex Product identification,
handling, storage, training of staff and any other elements of the system which can
affect the compliance of the Ex Product to the certification parameters.

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
PERFORMANCE EVALUATION REVISION 00
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-09 PAGE 3 of 4

9.3. Management review


9.3.1. General
Top management shall review WIKA SAUDI ARABIA’s quality management system, at
planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment
with its strategic direction.
As a minimum, an annual management review, under the responsibility of the Top
Management, of the overall assurance system will be held to ensure that the objectives of the
system are being fully met and to ensure the continuing effectiveness of the quality
management system. Minutes will be taken which will form part of the system records. Copies
of the minutes shall be dispatched to all concerned personnel. Refer WSA 009 Management
Review Minutes.
The maximum intervals between reviews shall not exceed 14 months and Ex authorized
person shall participate in this review.
9.3.2. Management review inputs
The management review shall be planned and carried out taking into consideration:
a) The status of actions from previous management reviews;
b) Changes in management system including:
a. external and internal issues that are relevant to the integrated management
system;
b. the needs and expectations of interested parties;
c. risks and opportunities;
d. the extent to which Quality objectives have been achieved;
c) Information on the performance and effectiveness of the quality management system,
including trends in:
a. Customer satisfaction and feedback from relevant interested parties;
b. The extent to which Quality objectives have been met;
c. Process performance and conformity of products and services;
d. Nonconformities and corrective actions;
e. Monitoring and measurement results;
f. Audit results;
g. The performance of external providers;
d) The adequacy of resources;
e) Relevant communication(s) from interested parties, including complaints;
f) The effectiveness of actions taken to address risks and opportunities;
g) Opportunities for continual improvement.
h) ATEX/IECEx - statutory and regulatory requirements, markings on ATEX/IECEx
products, overall effectiveness of the QMS with respect to products intended for
use in potentially explosive atmospheres.

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
PERFORMANCE EVALUATION REVISION 00
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-09 PAGE 4 of 4

Refer WSA 009 Management Review Minutes.


9.3.3. Management review outputs
The outputs of the management review shall include decisions and actions related to:
a)Opportunities for improvement;
b)Any need for changes to the integrated management system;
c)Resource needs.
d)Conclusions on the continuing suitability, adequacy and effectiveness of the integrated
management system;
e) Decisions related to continual improvement opportunities;
f) Decisions related to any need for changes to the environmental management system,
including resources;
g) Actions, if needed, when Quality objectives have not been achieved;
h) Opportunities to improve integration of the quality management system with other
business processes, if needed;
i) Any implications for the strategic direction of the organization.
WIKA SAUDI ARABIA retains documented information as evidence of the results of
management reviews. Refer WSA 009 Management Review Minutes

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
IMPROVEMENT REVISION 00
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-10 PAGE 1 of 2

10.1. General
WIKA SAUDI ARABIA determines and selects opportunities for improvement and implements
any necessary actions to meet customer requirements and enhance customer satisfaction.
These include:
a) Improving products and services to meet requirements as well as to address future
needs and expectations;
b) Correcting, preventing or reducing undesired effects through a risk management
approach;
c) Improving the performance and effectiveness of the quality management system.
10.2. Nonconformity, corrective and preventive action
When a nonconformity occurs, including any arising from complaints, WIKA SAUDI ARABIA
shall:
a) React to the nonconformity and, as applicable:
1) Take action to control and correct it;
2) Deal with the consequences;
b) Evaluate the need for action to eliminate the cause(s) of the nonconformity, in order
that it does not
c) Recur or occur elsewhere, by:
d) Reviewing and analysing the nonconformity;
e) Determining the causes of the nonconformity;
f) Determining if similar nonconformities exist, or could potentially occur;
g) Implement any action needed;
h) Review the effectiveness of any corrective action taken;
i) Update risks and opportunities determined during planning, if necessary;
j) Make changes to the integrated management system, if necessary."
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
WIKA SAUDI ARABIA retains documented information (WSA 002 Corrective Action
Request) as evidence of:
a) The nature of the nonconformities and any subsequent actions taken;
b) The results of any corrective action.
A documented procedure describes the method of application of corrective/ preventive actions
and the subsequent review of their effectiveness. Refer PI 013 Corrective & Preventive
Action.
Where, as result of corrective action implementation, a change is required within the QMS,
such change will itself be reviewed for effectiveness at review meetings.
Whenever a corrective or preventive action is raised, an agreed time line for file closure shall
be agreed. The timeframe can be affected by the seriousness of the non-conformance,
potential non-conformance, or the workload involved in the change.

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
IMPROVEMENT REVISION 00
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-10 PAGE 2 of 2

10.3. Continual improvement


The Organization strives to continually improve the suitability, adequacy and effectiveness of
the integrated management system. Identified needs or opportunities are addressed as part of
continual improvement.
Corrective Actions form an integral part of the improvement activities, along with customer
feedback, customer complaints, internal and third party audit results and the management
review.
Also refer EN 80079-34

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
MASTER LIST OF
REVISION 00
DOCUMENTED PROCEDURES
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-11 PAGE 1 of 1

NO. TITLE REV. DATE REV. NO.

PI 001 Procedure for Documentation 15.07.2018 00

PI 002 Procedure for Document Control 15.07.2018 00

PI 003 Staff Training 15.07.2018 00

PI 004 Handling of Enquiries and Orders 15.07.2018 00

PI 005 Design and Development 15.07.2018 00

PI 006 Purchase of Materials 15.07.2018 00

PI 007 Procedure of Receipt and handling of Incoming Material 15.07.2018 00

PI 008 General Instructions for Pressure Calibrations 15.07.2018 00

PI 009 Internal Order sheet Processing for Production 15.07.2018 00

PI 010 Handling of Calibration Items 15.07.2018 00

Procedure for Handling of Test gauges and Equipment 15.07.2018 00


PI 011
for Calibration

PI 012 Handling of Material for Repair work 15.07.2018 00

PI 013 Corrective and Preventive action 15.07.2018 00

PI 014 Procedure for Final inspection of Instruments 15.07.2018 00

PI 015 Dispatch of Finished goods 15.07.2018 00

PI 016 Internal Audit 10.06.2019 01

PI 017 Welding Process 15.07.2018 00

PI 018 General Instructions for Temperature Calibrations 15.07.2018 00

PI 019 Control of Records 15.07.2018 00

PI 020 Handling of Customer Complaints 15.07.2018 00

PI 021 Control of Non-conforming product 15.07.2018 00

PI 022 Risk Assessment Procedure 15.07.2018 00

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
MASTER LIST OF WORK
REVISION 04
PROCEDURES
ISSUE DT. 18.08.2020
WIKA SAUDI ARABIA DOC.NO QMS-01-12 PAGE 1 of 4

NO. WORK CENTRE TITLE REVISION DATE REVISION NO.

Adjustment and Calibration of


WI 001 PWS 15.07.2018 0
Dial Pressure Gauges

Overpressure protection for


WI 002 PWS 15.07.2018 0
SS-Pressure gauges

Operation and Calibration of


WI 003 PWS 15.07.2018 0
the Helium Leak-Detector

Handling of Instruments for


WI 004 PWS 15.07.2018 0
Oxygen Use

WI 005 PWS Cleaning of parts 15.07.2018 0

Filling and Closing of Dial


WI 006 PWS 15.07.2018 0
Gauges

Exchange of Dials at Pressure


WI 007 PWS 15.07.2018 0
Gauges Type 1 and 213.53.63

Pointer Offset for filled type


WI 008 PWS 15.07.2018 0
Dial Gauges <= 6 bar

Calibration and adjustment of


WI 009 PWS 15.07.2018 0
WIKA-transmitters

WI 010 PWS Non-linear Dial Divisions 15.07.2018 0

WI 011 PWS Hydrostatic Pressure Tests 15.07.2018 0

PWS/ET Quality Control Process


WI 012 15.07.2018 0
SHOP/QC Flow/Inspection Plan

WI 013 ET SHOP Welded bushing pressure test 28.02.2019 0

Tightening torques for screw


1501240 PWS 23.06.2020 17
connections for gauges

Filling Instruction for Pressure


6900208 PWS 24.06.2020 15
Gauges

WI-2 Using of the Pointer


11353732 PWS 13.08.2020 6
Shooting-on Pistol

Assembly of Bourdon Tube


11405422 PWS 23.06.2020 5
Pressure Gauges in CoE SSG

11405449 PWS Adjustment of Bourdon Tube 23.06.2020 7

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
MASTER LIST OF WORK
REVISION 04
PROCEDURES
ISSUE DT. 18.08.2020
WIKA SAUDI ARABIA DOC.NO QMS-01-12 PAGE 2 of 4

Measuring gauges in COE


SSG

WIKA CANADA WORK INSTRUCTIONS

Sensors with Solid (Bare)


WI 4476 ET SHOP 25.04.2017 2
Leads

Assembly Instructions for


HT/UT RTD's or
WI 4468 ET SHOP 09.06.2011 1
Thermocouples with Flex
Armour

Grounded Thermocouples: In-


WI 4051 ET SHOP 25.04.2018 5
process Bench Test

Standards for Flex Armour to


WI 4049 ET SHOP 25.04.2017 5
Transition Crimp

Assembly Instructions for


WI 4037 ET SHOP 16.08.2004 3
Series 7T Terminal Block

Standard Method for


WI 4035 ET SHOP Connecting Lead Wires to 05.07.2018 7
RTD Elements

Ultra High Temperature (UT)


and High Temperatures (HT)
WI 4029 ET SHOP 16/05/2019 13
Resistance Temperature
Detectors

Assembly Instructions for


Series 7T Terminal Block
WI 4024 ET SHOP Assemblies RTD & 12.10.2005 1
Thermocouple Transmitter
Assemblies

Attaching MI Cable (MgO) and


WI 4023 ET SHOP 25.04.2017 4
MgO Filled Tubes

Resistance Temperature
WI 4017 ET SHOP Detectors (RTD’s) In-process 25.04.2017 6
Bench Test

Shock Test of a Grounded T/C


WI 4011 ET SHOP 25.04.2017 4
Junction

WI 4033 ET SHOP RTD Low Temp. (LT): (B.O.M. 17.12.2018 7

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
MASTER LIST OF WORK
REVISION 04
PROCEDURES
ISSUE DT. 18.08.2020
WIKA SAUDI ARABIA DOC.NO QMS-01-12 PAGE 3 of 4

and assembly instructions).

Ungrounded Thermocouples:
WI 4007 ET SHOP 28.11.2018 8
In-process Bench Test

Flash Cutter: Instructions for


WI 4005 ET SHOP use of "Ewald Model # 25.04.2017 3
SS486/952-S"

Silver Brazing; Lead Wire to


WI 4004 ET SHOP Conductor/Terminalposts; 05.07.2017 5
Tubing Joints

Flash Stripper: Instructions for


WI 4003 ET SHOP use of "Ewald Model # 25.04.2017 3
SS41AP"

RTD Element: (Lead Isolation


WI 4002 ET SHOP 25.04.2017 5
procedure)

Measuring and Cutting MI


WI 4000 ET SHOP 25.04.2017 4
Cable or Tubing for Sensors

Probe Shop Inspection


WI 3023 ET SHOP 20.04.2017 6
Record: Std. Procedure

Final Insp.: General


WI 3011 ET SHOP 20.04.2017 6
instructions & procedures

Final Insp.: Grounded T/C


WI 3004 ET SHOP 24.01.2017 6
probes and assy.'s

Male to Female Inline


MR 4053 ET SHOP 25.04.2017 4
Transition Procedure

Standards for LT RTD End


MR 4048 ET SHOP 25.04.2017 3
Caps

Standards for Grounded T/C


MR 4046 ET SHOP 25.04.2017 4
Junctions

Cut Lengths for


MR 4040 ET SHOP Thermocouples and RTD 25.04.2017 18
Assemblies

MR 4029 ET SHOP Epoxy Loctite E-30CL 25.04.2017 3

MR 4023 ET SHOP Standards: Ungrounded T/C 25.04.2017 5

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.
ISSUE 01
MASTER LIST OF WORK
REVISION 04
PROCEDURES
ISSUE DT. 18.08.2020
WIKA SAUDI ARABIA DOC.NO QMS-01-12 PAGE 4 of 4

Junctions

Weld Filler Metals (non-


MR 4022 ET SHOP 25.04.2017 5
pressure applications)

Standard Lead Wire


MR 4021 ET SHOP 17.12.2018 6
Connections

Standard Bending Dimensions


MR 4020 ET SHOP 25.04.2017 10
for Tubing and MI Cable

Minimum Insulation
MR 3000 ET SHOP Resistance for MI Cable & 15.05.2013 2
Probes

Lead wire isolation inside


WI 4054 ET SHOP transitions for RTDs and 05.07.2017 0
Thermocouples

THIS DOCUMENT AND THE INFORMATION CONTAINED WITHIN ARE CONFIDENTIAL AND REMAIN THE EXCLUSIVE PROPERTY OF WIKA
SAUDI ARABIA. NO REPRODUCTION, USE OR DISCLOSURE WITHOUT WRITTEN PERMISSION OF THE QUALITY MANAGER OF WIKA
SAUDI ARABIA IS PERMITTED.

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