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QUALITY MANUAL
Reason for Revisions and Sections Affected:
Revision B / 6.24.2014 Added: PR-02-0005 to Procedure Table – Section: 2.0, Added: PR-02-0005 to Process Interaction Model –
Section: 4.2.1.2, Added: ISO Authority Matrix (FM-03-0045) and Job Descriptions (FM-03-0022) – Section: 5.5.1, Added: Engineering
Change Request Process (PR-02-0005) – Sections: 7.2.2, 7.3.1, 7.3.2, 7.3.3, 7.3.4, 7.3.5, 7.3.6, 7.3.7.
Revision D / 11.06.2014 Section 2.0: Added: Work Instructions to Figure: 3, Added 4.2.3.2: and Technical
Publication/Documentation Work Instructions (WI-01-0001). Added 7.5.5: (WI-01-0002 Storage and Preservation of the CD-52
Bandit) Added 7.2.2 and 7.2.3: Absent Sales Representative – Critical Shipments (WI-01-0003)
Revision E / 11.19.2014 Section 2.0: Added: WI-01-0004 Control Plan Instructions to Figure 3 and 7.1.
Revision F / 1.28.2015 Added Sales Associates and deleted Domestic and International Sales from Organizational Chart FC-01-
0001 Rev. E. Section 2.0: Added: WI-01-0005 Failure Modes and Effects Analysis to Figure 3 and 7.3.4.
Revision H / 3.12.2015 Updated Figure 3 and 7.2.3 Added: Return Merchandise Authorization (WI-01-0006)
Revision J / 3.26.2015 Added: WI-01-0007 Positive Material Identification to Figure 3 and 7.5.3.
Revision K / 7.06.2015 Added: WI-01-0008 CDI Drawing Guidelines to Figure 3 and 7.3.7.
Revision M / 12.16.2016 Updated Manual to meet 9001:2015 requirements; Figure 2, was changed from 2008 to 2015 Quality
Management System, Section 1.0, was changed from 2008 to 2015, section 4.2 was changed from 2008 to 2015, section 4.2.4 was
changed from 2008 to 2015 and section 4.2.4.4 was changed from 2008 to 2015.
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Approvals
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President
Vice President of
Administrative General Vice President of Sales
Research and
Manager and Marketing
Development
Engineering
Production Manager
Manager
Chef BDM/Sales Manager
Manufacturing
Supervisor
IT Manager Design Engineers
HR/Accounting Sales Associate
Manager
Electronic and
Mechanical
Quality Assurance/ Assemblers Sales/Marketing
Production Engineer
Safety Manager Coordinator
HR/Accounting
Machine Shop Assistant
Manager
Technical Writer
Receptionist
Machinists
Applications
Developer
Technicians
Draftsman
Purchasing Agent
R/D Technician
Warehouse/Shipping Rev. H
and Receiving Clerk
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1.0 SCOPE
1.1 Introduction
The objective of the quality management system is to provide CDI with methods to effectively determine customer
requirements, create solutions to meet those requirements, and manufacture goods conforming to those requirements.
The following sections (1-8) of this Quality Manual describe our organization’s conformance to the requirements of the ISO
9001:2015 and ISO/IEC 80079-34 standards. Each element reflects our organization’s vision of quality as seen through the
requirements of the standard, the needs of our customers, and our internally defined quality goals and objectives.
This Quality Manual is a controlled document and is intended to be part of the total quality system documentation. It has
been prepared, and is maintained by the Quality Assurance Manager. All suggestions for revisions to this document should
be forwarded to the Quality Assurance Manager. In addition to any revision requests, this manual is reviewed yearly by the
Quality Assurance Manager. Changes in requirements or context must be agreed to and approved by Senior Management.
This Quality Manual is based on and must be read in conjunction with ISO 9001:2015, 80079-34 and ATEX/IECEX Directive
2014/34/EU.
CDI’s Quality Management System documentation ensures the effective operation and control of our business processes.
Our Quality Management System documentation is designed to meet the requirements of ISO 9001:2015 as well as
ATEX/IECEX certification and to be appropriate to our organization’s size and type. It does not preclude the use of other
quality systems that are compatible with the objectives of ISO 9001:2015/ATEX/IECEX and provides equivalent results. The
purpose of this Standard is to establish requirements to ensure “good” manufacturing practices are applied that are
appropriate for products intended for use in or associated with explosive atmospheres.
Manufacturers Quality Requirements are an integral part of most certification schemes and as such this Standard has been
prepared with the ATEX/IECEX Equipment Certification Scheme requirements in mind and is intended to support the
ATEX/IECEX and ISO 9001:2015 scheme requirements (2014/34/EU Annex X) for a manufacturers quality system and can be
applied in other National or Regional Certifications Schemes that relate to the manufacture of explosion protected
equipment.
The Quality Manual (level 1 documentation) contains not only the Quality Policy, but also all policies relating to the
requirements of ISO 9001:2015 and ATEX/IECEX directive 2014/34/EU.
Operating procedures (level 2 documentation) describe how Quality Management System processes are conducted in
compliance with the stated policies and as required by ISO 9001:2015. The majority of the level 2 and 3 documents are
maintained on the CDI computer network.
Work Instructions, specifications and quality records (level 3 documentation) describe in detail how activities affecting
quality are performed. The work instructions, drawings, as well as any forms used in conjunction with the Quality
Management System are included in third level documentation.
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The approval, issue and control of this Quality Manual, the Operating Procedures, the Quality Policy and all quality system
documentation are detailed in the Document Control Procedure (PR-02-0006).
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Level I (QMS)
Level II Procedures
Flowcharts
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3.1.5 Manufacturer
Organization, situated at a stated location or locations, that carries out or controls such stages in the
manufacture, assessment, handling and storage of a product that enables it to accept responsibility for
continued compliance of the product with the relevant requirements and undertakes all obligations in
that connection.
3.1.6 Contract
Requirements forming an agreement between a manufacturer and a customer and transmitted by any
appropriate means.
3.1.8 Product
The term “product” covers ATEX/IECEX and/or CSA/UL equipment, protective systems, safety devices,
ATEX/IECEX and/or CSA/UL components and their combinations, as well as any other equipment that the
company manufactures or software and service.
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• A general description.
• Design and manufacturing drawings and layouts of components, sub-assemblies, circuits, work
instructions, etc.
• Descriptions and explanations necessary for the understanding of drawings and layouts and the
operation of the product.
• A list of the standards referred to in the ATEX/IECEX and/or CSA/UL certificate, applied in full or
in part, and descriptions of the solutions adopted to meet the requirements of the Standards;
• Results of design calculations made, examinations carried out, etc.
• Test reports.
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These processes shall be managed by CDI in accordance with the requirements of the International Standard.
Where CDI chooses to outsource any process that affects product conformity to requirements, CDI shall ensure
control over such processes. The type and extent of control to be applied to these outsourced processes shall be
identified within the quality management system.
Processes needed for the Quality Management System referred to above should include
processes for management activities, provision for resources, product realization,
measurement, analysis and improvement.
An “outsourced process” is a process that the organization needs for its Quality
Management System and which CDI chooses to have performed by an external party.
Ensuring control over outsourced processes does not absolve CDI of the responsibility of
conformity to all customer, statutory and regulatory requirements.
The type and extent of control to be applied to outsourced process can be influenced by
factors such as:
The potential impact of the outsourced process on CDI’s capability to provide product
that conforms to requirements,
The degree to which the process is shared,
The capability of achieving the necessary control through the application of 7.4
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1. By providing customers with high quality pipeline pig tracking and communications solutions and services which meet
customer requirements and are fit for purpose.
2. By operating the business and its systems as required by ISO 9001: 2015.
3. By enhancing the skills of management and staff through regular review and by pursuing an on-going training program, the
objective of which is to prepare staff to perform their work more effectively and safely.
4. By promoting a culture of continual quality improvements and through the philosophy of getting things done on time and
“right the first time”.
5. By promoting the quality management systems and ensuring implementation is achieved by regular internal auditing,
management review, corrective and preventive actions.
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Quality objectives are derived from the Quality Policy. Quality objectives have been established to
continually improve the Quality Management System (QMS) as a whole as well as each management
process, extending to processes involved with meeting product requirements. Quality objectives are
measurable, so that they can be analyzed during Management Review to determine the degree to which
they are met.
CDI shall establish and maintain a Quality Manual including details and justification for
any exclusion (QM-01-0001).
References to procedures for the Quality Manual.
Description of the interaction between processes.
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Human Resources
CDI PR-02-0019 RESOURCE MANAGEMENT, Sales
PR-02-0019 RESOURCE MANAGEMENT,
FACILITY MANAGEMENT Information Services PR-02-0002 QUOTATION
AND WORK ENVIRONMENT PROCEDURE
FACILITY MANAGEMENT PR-02-0006 DOCUMENT AND ORDER ENTRY,
PR-02-0014 COMPETENCE AWARENESS
AND WORK ENVIRONMENT PROCEDURE CONTROL PROCEDURE PR-02-0011 CONTRACT
AND TRAINING PROCEDURE PR-02-0007 RECORDS
REVIEW PROCEDURE
MANAGEMENT PROCEDURE
Shipping Packaging
Customers PR-02-0015 CUSTOMER PROPERTY,
PR-02-0015 CUSTOMER PROPERTY,
HANDLING, STORAGE, PACKAGING,
PR-02-0033 CUSTOMER HANDLING, STORAGE, PACKAGING,
PRESERVATION, DELIVERY
PRESERVATION, DELIVERY
SATISFACTION PROCEDURE
AND PROTECTION PROCEDURE
AND PROTECTION PROCEDURE
FC-02-0003 Rev. C
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This Quality Manual contains a description of the scope of the Quality Management System. This
manual references procedures that describe the sequence and interaction between the
processes of the Quality Management System.
4.2.3.2 Equipment documents and manufacturer’s documents shall be controlled by the Document
Control Procedure (PR-02-0006) and Technical Publication/Documentation Work Instructions
(WI-01-0001).
4.2.3.3 Documented procedures shall ensure that information contained within the manufacturer’s
documents is compatible with equipment documents. The manufacturer shall not initially
approve or subsequently amend related drawings unless they are in compliance with the
schedule drawings.
4.2.3.4 The quality system shall ensure that no factor (type, characteristic, position etc.) defined within
the ATEX/IECEX certificate and technical documentation (e.g. schedule drawings) is modified.
4.2.3.5 There is a documented system that refers all related drawings to the relevant schedule
drawings. The drawing schedule is kept updated and is controlled by the engineering
department.
4.2.3.6 Where there are common schedule drawings associated with more than one ATEX/IECEX
certificate, there shall be a documented system to ensure simultaneous supplementary action in
the event of an amendment to such drawings as described in Document Control Procedure (PR-
02-0006).
4.2.3.7 CDI also has drawings for equipment not intended for use in potentially explosive atmospheres.
4.2.3.8 CDI documents contain responsibility for the quality system of each ATEX/IECEX certificate.
4.2.3.9 Where equipment documents or CDI’s documents are passed to a Third party, they shall be
provided in a way that is not misleading.
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4.2.3.10 CDI management system and all important information sources are controlled by the Document
and Data Control Procedure (PR-02-0006), which ensures that outdated or inaccurate
information is not used and that appropriate information is available where it is needed. All
documentation is reviewed and approved prior to use and changes to documentation are also
reviewed, approved, and controlled. Such documents are maintained in such a manner as to
ensure that they remain legible, readily identifiable and retrievable. Any such documents that
become obsolete are disposed of or marked to prevent unintended use.
4.2.3.11 The Management Representative maintains a master file of all level one and level two
documentation, as well as any forms. The most current version of any such document will be
maintained in the master file, which will also indicate any further distribution of such documents.
The Management Representative also maintains the electronic originals of such documentation
as described in Document Control Procedure (PR-02-0006).
4.2.4 Control of Records
4.2.4.1 CDI maintains quality records in order to provide evidence of conformance to requirements as
well as to provide evidence of the effective operation of the quality management system. Any
records defined as quality records are controlled according to the Document Control Procedure
(PR-02-0006), with use of Record Management Procedure (PR-02-0007). Such records are
detailed on the Record Retention Log Form (FM-03-0061), which indicates the individual
responsible for the records, storage locations, and periods of retention. Retention periods are
specified to ensure that the records are being maintained to meet specific business, client,
regulatory, and quality system requirements.
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4.2.4.3 Quality Records are maintained and filed in a manner that ensures that they are readily available
and protected from loss, damage, and deterioration as depicted in the Records Management
Procedure (PR-02-0007).
Hard copy records are periodically reviewed and disposed of in accordance with internal and
legal retention requirements. Records are only destroyed with the authorization of the
Management Representative and the Vice-President of Engineering. Quality Records are retained
in accordance with the Records Management Procedure (PR-02-0007).
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Top management shall provide evidence of its commitment to the development and implementation of the
Quality Management System and continually improving its effectiveness by:
Communicating to the organization the importance of meeting customer as well as statutory and
regulatory requirements,
Establishing the Quality Policy (see 5.3)
Ensuring the quality objectives are established (see 4.2.1.2),
Conducting management reviews, Management Review System (PR-02-0004), and
Ensuring the availability of resources (see 6.0)
5.2 Customer Focus
Top Management shall ensure that the customer requirements are determined and are met with the aim
of enhancing customer satisfaction.
5.3 Quality Policy
Top management shall ensure that the quality policy:
Is appropriate to the purpose of the CDI organization,
Includes a commitment to comply with requirements and continually improve the effectiveness of the
quality management system,
Provides a framework for establishing and reviewing quality objectives,
Is communicated and understood within the CDI organization, and
Is reviewed for continuing suitability.
5.4 Quality Management Planning
5.4.2 Quality Management System Planning
Top management shall:
Ensure QMS planning is carried out in order to meet clause 4.1 requirements as well as
quality objectives
The integrity of the quality management system is maintained when changes to the
quality management system are planned and implemented.
Top management shall insure that quality objectives, including those needed to meet
requirements for product, are established at relevant functions and levels within the CDI
organization. The quality objectives shall be measurable and consistent with the quality
policy.
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A document specifying the process of the Quality Management System and the resources to be applied to a
specific product, project or contract, can be referred to as a quality plan.
Planning of Product Realization Procedure (PR-02-0021), Control Plan Instructions (WI-01-0004)
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Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).
Where the customer provides no documented statement of requirement, the customer requirements
shall be confirmed by CDI before acceptance.
Where the product requirements are changed, CDI shall ensure that relevant documents are amended
and that relevant personnel are made aware of the changed requirements per Design and Development
Procedure (PR-02-0012) and Engineering Change Request Process (PR-02-0005).
CDI shall ensure that any stated customer requirement is compatible with the Ex certificate e.g.
equipment group, temperature class, type of protection, EPL and ambient temperature range.
Contract Review Procedure (PR-02-0011) Absent Sales Representative – Critical Shipments (WI-01-0003)
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CDI shall manage the interfaces between different groups involved in design and development to ensure
effective communication and clear assignment of responsibility.
Planning output shall be updated, as appropriate, as the design and development progresses.
The inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in
conflict with each other.
Design and Development Procedure (PR-02-0012) and Engineering Change Request Process
(PR-02-0005)
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Information for production and service provision can include details for the preservation of
product.
Design and Development Procedure (PR-02-0012) and Engineering Change Request Process
(PR-02-0005)
Participants in such reviews shall include representatives of functions concerned with the design and
development stage(s) being reviewed. Records of the results of the reviews and necessary actions shall be
maintained (see 4.2.4).
Design and Development Procedure (PR-02-0012) and Engineering Change Request Process
(PR-02-0005) Failure Modes and Effects Analysis (WI-01-0005)
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CDI shall evaluate and select suppliers based on their ability to supply product in accordance with CDI’s
requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of results
of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4).
b) 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:
1) 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,
the supplier has a quality system certificate in accordance to the appropriate standard and
with an acceptable scope,
a documented site assessment to ensure that all relevant controls are available,
documented, understood and effective.
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3) where the features affecting the type of protection cannot be verified at a later stage, e.g.
encapsulated intrinsically safe circuits, then the product, process or service shall only be accepted by
one of the following methods:
CDI can demonstrate that the control process implemented by the subcontractor ensures Ex
compliance,
the body responsible for the verification of the quality system performs periodic audits at
the sub-contractors.
c) suppliers not used for a period exceeding one year shall be re-evaluated in accordance with 7.4.1 b)
prior to the placing of a contract or a purchase order;
d) requirements b) and c) are not mandatory for products, processes or services where CDI verifies
conformance in accordance with 7.4.3;
e) the ongoing ability of the supplier to provide conforming product, process or service shall be
reviewed at periods not exceeding one year;
f) CDI shall facilitate an arrangement whereby the body responsible for the verification of the Ex quality
system may also verify aspects of any supplier’s operation that affects the type of protection.
7.4.2 Purchasing Information
Purchasing information shall describe the product to be purchased, including where appropriate,
Procurement and Supplier Management Procedure (PR-02-0003):
Requirements for qualification of personnel, and
Quality Management System requirements.
b) for items where conformance cannot be verified after manufacture (e.g. encapsulated
intrinsically safe circuits), the purchasing information shall set out the specific quality procedures,
resources and sequence of activities relevant to the particular item;
c) CDI shall define the method by which documents, e.g. technical specifications, stated in a particular
purchase order remain traceable to the order;
d) where CDI does not provide such documents with subsequent orders, then CDI shall have procedures
for ensuring that suppliers have current copies of documents and that their integrity be maintained.
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b) when deciding what type of verification is required for a particular purchased product, CDI shall
consider the nature of the purchased product, the supplier and how critical it is to the type of
protection..
c) where the supplier has been evaluated, and documented objective evidence has been
obtained to demonstrate that the supplier is fully capable of producing and verifying the product or
service, no further verification of the product or service is required, provided a declaration of
conformity according to ISO/IEC 17050-1 is supplied with each batch or product;
d) where the Ex certificate specifies routine tests or inspections, these shall be carried out
on each product. They may be carried out by either the supplier or CDI. When carried out by the
supplier, this shall be specified on the purchasing documents, e.g. by a quality plan, and confirmed by
the supplier, e.g. by a declaration of conformity according to ISO/IEC 17050-1 including test results, if
required;
e) where verification of a purchased product cannot be carried out after manufacture, e.g. the internal
parts of encapsulated intrinsically safe circuits, then the product shall only be accepted if supplied
with a declaration of conformity according to ISO/IEC 17050-1. This shall specifically state compliance
to the purchase documents, e.g. a quality plan that lists the factors that together demonstrate
conformity of the product;
f) where sample inspections or tests are permitted they shall be conducted in a manner which
demonstrates conformity of the entire batch;
h) where CDI chooses not to carry out inspections and tests on his own premises, then inspections and
tests shall be performed on the supplier’s premises under the responsibility of CDI;
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i) where a supplier provides product with evidence of conformity applicable to use in an explosive
atmosphere (e.g. Ex certificate), then further verification is not required unless CDI considers it
necessary;
j) where verification of a purchased product relates to the material (metals, alloys, non
metallic parts, resins and similar), a specific analysis certificate or declaration shall be
supplied.
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
CDI shall plan and carry out production and service provision under controlled conditions. Controlled
conditions shall include, as applicable:
The availability of information that describes the characteristics of the product,
The availability of work instructions, as necessary,
The use of suitable equipment,
The availability and use of monitoring and measuring equipment,
The implementation of monitoring and measurement, and
The implementation of product release, delivery and post-delivery activities.
CDI shall provide procedures, production equipment, working environments and inspection/testing
facilities that together provide assurance with respect to the compliance of the product with the type as
described in the Ex certificate.
Where a process can affect the integrity of a type of protection, and where the resulting
integrity cannot be verified after manufacture (e.g. the environmental conditions required for
curing an encapsulant), that specific process shall be measured or monitored and documentary evidence
shall be maintained to demonstrate compliance with required parameters.
Inspection and Testing Procedure (PR-02-0013)
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CDI shall identify the product status with respect to monitoring and measurement requirements
throughout product realization.
Where traceability is a requirement, CDI shall control the unique identification of the product and
maintain records (see 4.2.4).
CDI shall establish and maintain procedures for product identification during all stages of production,
testing, final inspection and placing on the market; traceability is required with respect to the final
product and its significant parts for Ex certification.
Traceability can be achieved using serial number, batch or other acceptable method.
(WI-01-0007) Positive Material Identification
It is the responsibility of CDI to verify the compatibility of the customer supplied product with the
requirements of the Ex certificate.
(PR-02-0015 Customer Property, Handling, Storage, Packaging, Preservation, Delivery and Protection
Procedure)
CDI shall provide customers with instructions prepared in accordance with the relevant standards or
statutory and regulatory requirements.
(PR-02-0015 Customer Property, Handling, Storage, Packaging, Preservation, Delivery and Protection
Procedure)(WI-01-0002 Storage and Preservation of the CD-52 Bandit)
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CDI shall establish processes to ensure that monitoring and measurement can be carried out and are
carried out in a manner that is consistent with the monitoring and measuring requirements, Inspection
and Testing Procedure (PR-02-0013).
Where necessary to ensure valid results, measuring equipment shall:
Be calibrated or verified, or both, at specified intervals, or prior to use, against measurement
standards traceable to international or national measurement standards. Where no such
standard exists, the basis used for calibration or verification shall be recorded (see 4.2.4).
Be adjusted or re-adjusted as necessary,
Have identification in order to determine its calibration status,
Be safeguarded from adjustments that would invalidate the measurement results,
Be protected from damage and deterioration during handling, maintenance and storage.
In addition, CDI shall assess and record the validity of the previous measuring results when the equipment
is found not to conform to requirements. CDI shall take appropriate action on the equipment and any
product affected.
Records of the results of calibration and verification shall be maintained (see 4.2.4).
When used in the monitoring and measurement of specified requirements, the ability of computer
software to satisfy the intended application shall be confirmed. This shall be prior to the initial use and
reconfirmed as necessary.
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This shall include determination of applicable methods, including statistical techniques and the extent of
their use. Inspection and Testing Procedure (PR-02-0013)
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
As one of the measurements of the performance of the quality management system, CDI shall monitor
information relating to customer perception as to whether CDI has met customer requirements. The
methods for obtaining and using this information shall be determined. Customer Satisfaction Procedure
(PR-02-0033)
8.2.2 Internal Audit
CDI shall conduct internal audits at planned intervals to determine whether the Quality Management
System should be evaluated:
Conforms to the arrangements (see 7.1), of the requirements of the International Standard
and to the Quality Management System requirements established by CDI, and
Is effectively implemented and maintained.
An audit program shall be planned, taking into consideration the status and importance of the process
and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and
methods shall be defined. This selection of auditors and conduct of audits shall ensure objectivity and
impartiality of the audit process. Auditors shall not audit their own work.
A documented procedure shall be established to define the responsibilities and requirements for planning
and conducting audits, establishing records and reporting results.
Records of the audits and their results shall be maintained (see 4.2.4).
The management responsible for the area being audited shall ensure that any necessary corrections and
corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.
Follow-up activities shall include the verification of the actions taken and the reporting of verification
results (see 8.5.2).
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The audit program shall address the effectiveness of the elements of the quality system as described in
this standard to ensure that the products are in conformity with the Ex certificate. The maximum period
between audits should normally be 12 months and shall not exceed 14 months.
Internal Audit Procedure (PR-02-0008)
8.2.3 Monitoring and Measuring of Processes
CDI shall apply suitable methods for monitoring and. Where applicable, measurement of the Quality
Management System processes. These methods shall demonstrate the ability of the processes to achieve
planned results. When planned results are not achieved, correction and corrective action shall be taken as
appropriate. Inspection and Testing Procedure (PR-02-0013)
8.2.4 Monitoring and Measurement of Product
CDI shall monitor and measure the characteristics of the product to verify that the product requirements
have been met. This shall be carried out at appropriate stages of the product realization process in
accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria
shall be maintained.
Records shall indicate the person(s) authorizing release of the product for delivery to the customer (see
4.2.4). The release of the product and delivery of service to the customer shall not proceed until the
planned arrangements (see 7.1) have been satisfactorily complete, unless otherwise approved by a
relevant authority and, where applicable, by the customer.
Where routine tests are required by the Ex certificate and by the technical documentation, these tests
shall be performed as specified. Unless specifically permitted by the Ex certificate and the technical
documentation, statistical methods shall not be used.
Where practicable, the label bearing the marking data shall not be affixed until the final inspection and
testing has been satisfactorily completed.
Inspection and Testing Procedure (PR-02-0013)
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The database shows all due and past-due calibration requirements. Each piece of equipment is due for
calibration based on the lead-time defined for the instrument. Each piece of equipment should be
serviced based on the service description. The records are maintained by the Engineering department.
Any equipment that is past the calibration due date must be pulled from production and kept in a secure
area until it is calibrated. Equipment Calibration Procedure (PR-02-0017)
Where applicable, CDI shall deal with nonconforming product by one or more of the following ways:
By taking action to eliminate the detected nonconformity,
By authorizing its use, release or acceptance under concession by a relevant authority and,
where applicable, by the customer,
By taking action to preclude its original intended use or application,
By taking action appropriate to the effects, or potential effects, of the nonconformity when
nonconforming product is detected after delivery or use has started.
a) CDI shall maintain a system such that in the event of the product not complying with the Ex certificate, and
having been supplied, then the CDI’s customer can be identified;
b) CDI shall take action, appropriate to the degree of risk, where a nonconforming product has been supplied to
a customer;
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c) where an unsafe nonconforming product has been supplied to a customer, CDI shall inform the customer, in
writing as well as the body responsible for the verification of the quality system, and the issuer of the Ex
certificate;
d) where it is not possible to trace the unsafe, nonconforming product (e.g. product supplied via a distributor, or
for high volume products such as cable glands) then a notice shall be placed in appropriate publications
providing recommended action to be taken;
e) for all nonconforming product that has been supplied to a customer, CDI shall maintain, for a minimum period
of 10 years, records of:
serial numbers or identification of products supplied;
the customer who received the product;
the action taken to inform customers and the body responsible for the verification of the quality
system in the case of unsafe nonconforming product;
the action taken to implement corrective and preventative action;
f) concessions for the product that take it outside the design, as defined in the Ex certificate and technical
documentation, are not permitted.
Control of Nonconforming Product (PR-02-0009)
8.4 Analysis of Data
CDI shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness
of the Quality Management System and to evaluate where continual improvement of the effectiveness of
the Quality Management System can be made. This shall include data generated as a result of monitoring
and measurement and from other relative sources. The analysis of data shall provide information relating
to:
Customer satisfaction (see 8.2.1)
Conformity to product requirements (see 8.2.4),
Characteristics and trends of processes and products, including opportunities for
preventive action (see 8.2.3 and 8.2.4), and
Suppliers (see 7.4).
Continual Improvement and Data Analysis Procedure (PR-02-0016)
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8.5 Improvement
8.5.1 Continual Improvement
CDI shall continually improve the effectiveness of the Quality Management System through the
use of the quality policy, quality objectives, audit results, analysis of data, corrective and
preventative actions and management review.
Continual Improvement and Data Analysis Procedure (PR-02-0016)
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Revision B/6.24.2014 Added: PR-02-0005 to Procedure Table – Section: 2.0, Added: PR-02-0005 to Process Interaction
Model – Section: 4.2.1.2, Added: ISO Authority Matrix (FM-03-0045) and Job Descriptions (FM-03-0022) – Section: 5.5.1, Added:
Engineering Change Request Process (PR-02-0005) – Sections: 7.2.2, 7.3.1, 7.3.2, 7.3.3, 7.3.4, 7.3.5, 7.3.6, 7.3.7.
Revision D / 11.06.2014 Section 2.0: Added: Work Instructions to Figure: 3, Added 4.2.3.2: and Technical
Publication/Documentation Work Instructions (WI-01-0001). Added 7.5.5: (WI-01-0002 Storage and Preservation of the CD-52
Bandit) Added 7.2.2 and 7.2.3: Absent Sales Representative – Critical Shipments (WI-01-0003)
Revision E / 11.19.2014 Section 2.0: Added: WI-01-0004 Control Plan Instructions to Figure 3 and 7.1.
Revision F / 1.28.2015 Added Sales Associates and deleted Domestic and International Sales from Organizational Chart
FC-01-0001 Rev. E. Section 2.0: Added: WI-01-0005 Failure Modes and Effects Analysis to Figure 3 and 7.3.4.
Revision H / 3.12.2015 Updated Figure 3 and 7.2.3 Added: Return Merchandise Authorization (WI-01-0006)
Revision J / 3.26.2015 Added WI-01-0007 Positive Material Identification to Figure 3 and 7.5.3.
Revision K / 7.06.2015 Added: WI-01-0008 CDI Drawing Guidelines to Figure 3 and 7.3.7.
Revision M / 12.16.2016 Updated Manual to meet 9001:2015 requirements; Figure 2, was changed from 2008 to 2015
Quality Management System, Section 1.0, was changed from 2008 to 2015, section 4.2 was changed from 2008 to 2015, section
4.2.4 was changed from 2008 to 2015 and section 4.2.4.4 was changed from 2008 to 2015.
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