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WIKA SA - Quality Manual
WIKA SA - Quality Manual
MANAGEMENT
SYSTEM MANUAL
In compliance with:
ISO 9001:2015 QMS /CSA/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
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
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
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.
Receiving Confirmation
I hereby confirm that I have received the above-mentioned Sections and I have taken Action as per above-
mentioned advise.
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
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
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
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
INTERNAL STAKEHOLDERS
EXTERNAL STAKEHOLDERS
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
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
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 5 of 6
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
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
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.
ISSUE 01
LEADERSHIP REVISION 00
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-05 PAGE 4 of 6
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 5 of 6
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
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-05 PAGE 6 of 6
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
PLANNING REVISION 00
ISSUE DT. 15.07.2018
WIKA SAUDI ARABIA DOC.NO QMS-01-06 PAGE 1 of 2
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
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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WIKA SAUDI ARABIA DOC.NO QMS-01-06 PAGE 2 of 2
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.
ISSUE 01
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WIKA SAUDI ARABIA DOC.NO QMS-01-07 PAGE 1 of 6
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.
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
SUPPORT REVISION 00
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WIKA SAUDI ARABIA DOC.NO QMS-01-07 PAGE 2 of 6
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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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.
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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WIKA SAUDI ARABIA DOC.NO QMS-01-07 PAGE 4 of 6
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
SAUDI ARABIA IS PERMITTED.
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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.
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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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;
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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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 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.
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
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WIKA SAUDI ARABIA DOC.NO QMS-01-08 PAGE 5 of 10
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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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
OPERATION REVISION 00
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WIKA SAUDI ARABIA DOC.NO QMS-01-08 PAGE 7 of 10
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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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.
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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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
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
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
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
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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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
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
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
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
Resistance Temperature
WI 4017 ET SHOP Detectors (RTD’s) In-process 25.04.2017 6
Bench Test
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
Ungrounded Thermocouples:
WI 4007 ET SHOP 28.11.2018 8
In-process Bench Test
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
Minimum Insulation
MR 3000 ET SHOP Resistance for MI Cable & 15.05.2013 2
Probes
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.