CPN Electronics Quality Manual

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ISO 9001:2000 QUALITY SYSTEM MANUAL

QMS Rev.: 2 Originator: Quality Control Manager Page 1 of 32

4880 North Hiatus Road Sunrise, Florida 33351

Phone: 954-746-8081 Toll Free: 800-323-5845 Fax: 954-746-8084


Website: www.cpnelectronics.com E-mail: [email protected]

ISO 9001
Quality Management System
QMS Manual
CPN Electronics Proprietary Information
The information contained in this document is CPN Electronics proprietary information and is disclosed
in confidence. It is the property of CPN Electronics and shall not be used, disclosed to others or
reproduced without express written consent of CPN Electronics. If consent is given for reproduction in
whole or in part, this notice shall appear in any such reproduction in whole or in part.

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Quality System Manual Revisions

REV. PAGES CHANGE REQUEST # DATE AUTHORIZED BY

0 All Initial Release 4/9/04 E. Coughlin


1 Page 4 & 5 DCR004-06 6/26/06 E. Coughlin
2 Page 6 DCR036-07 9/17/07 E. Coughlin

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Introduction

CPN Electronics developed and implemented a Quality Management System in


order to document the company’s best business practices, better satisfy the
requirements and expectations of its customers and improve the overall
management of the company.
The Quality Management System of CPN Electronics meets the requirements of the
international standard ISO 9001 (2000). This system addresses the production,
installation, and servicing of the company’s products.
The manual is divided into eight sections that correlate to the Quality Management
System sections of ISO 9001 - 2000. Each section begins with a policy statement
expressing CPN Electronics’ obligation to implement the basic requirements of the
referenced Quality Management System section. Each policy statement is followed
by specific information pertaining to the procedures that describe the methods used
to implement the necessary requirements.
This manual describes the Quality Management System, delineates authorities, inter
relationships and responsibilities of the personnel responsible for performing within
the system. The manual also provides procedures or references for all activities
comprising the Quality Management System to ensure compliance to the necessary
requirements of the standard.
This manual is used internally to guide the company’s employees through the
various requirements of the ISO standard that must be met and maintained in order
to ensure customer satisfaction, continuous improvement and provide the necessary
instructions that create an empowered work force.
This manual is used externally to introduce our Quality Management System to our
customers and other external organizations or individuals. The manual is used to
familiarize them with the controls that have been implemented and to assure them
that the integrity of the Quality Management System is maintained and focused on
customer satisfaction and continuous improvement.

General Manager:

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Quality Manual Distribution


The Quality Manual shall be distributed to the following:

Manual Number With / Location


1 Document Control
2 CPN Server

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Section 1: Scope

1.1 General
The quality manual outlines the policies, procedures and requirements of the Quality
Management System. The system is structured to comply with the conditions set
forth in the International Standard ISO 9001:2000 to distribute as well as assemble
and package a line of connectors to military and commercial specifications.

1.2 Application
CPN Electronics has determined that the following requirements are not applicable to
the operations at this site and are documented as exclusions:

Section 7.3, Design and / or Development, including all subsections.


Justification: CPN Electronics does not design or develop products. The
original product manufacturer specifies all principal product characteristics, and
the contract clearly sets forth the specifications.

Service Provision part of section 7.5, included in all subsections.


Justification: CPN Electronics does not provide service.

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Section 2: Normative Reference

2.0 Quality Management System References


The following documents were used as reference during the preparation of the
Quality Management System:
American National Standard ANSI/ISO/ASQ Q9000-2000, Quality
Management Systems - Vocabulary.
American National Standard ANSI/ISO/ASQ Q9001-2000, Quality
Management Systems – Requirements
American National Standard ANSI/ISO/ASQ Q9004-2000, Quality
Management Systems – Guidelines for performance Improvements

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Section 3: Definitions

3.0 Quality Management System Definitions


This section is for definitions unique to CPN Electronics.

Customer owned property - Any type of instrumentation, accessories,


manuals, or shipping containers that belong to a customer.
Customer supplied product - Any type of service or material supplied to be
utilized in the manufacture, modification or repair of customer-owned property.
Product – The end item result of meeting all contract terms and conditions.
(eg: manufactured goods, merchandise, services etc.).
Quality Records – Documentation of those activities wherein records of said
activities must be maintained will be specified in the procedure or work instruction
level documents, as applicable.

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Section 4

Quality Management
System

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4.1 General requirements


CPN Electronics has established, documented and implemented a Quality
Management System (QMS) in accordance with the requirements of ISO 9001:2000.
The system is maintained and continually improved through the use of the quality
policy, quality objectives, audit results, analysis of data, corrective and preventive
action and management review.
To design and implement the QMS CPN Electronics has:
• Identified the processes needed for the QMS and their application
throughout the organization and documented them on the Process Flow
Diagram at the end of this section of the Quality Manual
• Determined the sequence and interaction of these processes, and
illustrated them on the Process Flow Diagram
• Determined criteria and methods needed to ensure that the operation and
control of the processes are effective, and documented them in quality
plans, work instructions and the Measuring, Monitoring and Analysis
Table
• Ensured the continuing availability of resources and information
necessary to achieve planned results and continual improvement of these
processes
• Established systems to monitor, measure and analyze these processes,
and
• Established processes to identify and implement actions necessary to
achieve planned results and continual improvement of these processes

4.2 Documentation Requirements


4.2.1 General
The QMS documentation includes:
• A documented Quality Policy
• This Quality Manual
• Documented Procedures
• Documents identified as needed for the effective planning, operation and
control of our processes, and
• Quality Records

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4.2.2 Quality manual


This Quality Manual has been prepared to describe CPN Electronics’ QMS. The
scope and permissible exclusions of the QMS are described in section one of this
manual. Each section of the manual references documented QMS procedures
relating to the requirements outlined in that section. The Process Flow Diagram at
the end of section 4 provides a description of the interaction between the processes
of the QMS system.

4.2.3 Control of documents


All of the QMS documents are controlled according to the Document Control
Procedure (AP-423). This procedure defines the process for:
• Approving documents for adequacy prior to issue
• Reviewing and updating as necessary and re-approving documents
• Ensuring that changes and current revision status of documents are
identified
• Ensuring that relevant versions of applicable documents are available at
points of use
• Ensuring that documents remain legible and readily identifiable
• Ensuring that documents of external origin are identified and their
distribution controlled, and
• Preventing the unintended use of obsolete documents and to apply
suitable identification to them if they are retained for any purpose

4.2.4 Control of quality records


Quality records are maintained to provide evidence of conformity to requirements
and of the effective operation of the QMS. The records are maintained according to
the Control of Quality Records Procedure (AP-424). This procedure requires that
quality records remain legible, readily identifiable and retrievable. The procedure
defines the controls needed for identification, storage, protection, retrieval, retention
time and disposition of quality records.

Related Procedures
Document Control AP-423
Control of Quality Records AP-424

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The Quality Management System (QMS)

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Section 5

Management
Responsibility

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5.1 Management commitment


Top management has been actively involved in implementing the quality
management system (QMS). It has provided the vision and strategic direction for the
growth of the QMS, and established quality objectives and the quality policy.

To continue to provide leadership and show commitment to the improvement of the


QMS, management will do the following.
• Communicate the importance of meeting customer, statutory, and
regulatory requirements
• Establish quality objectives
• Establish the quality policy
• Conduct annual management reviews, and
• Ensure the availability of resources.

5.2 Customer focus


Our company strives to identify current and future customer needs, to meet customer
requirements and exceed customer expectations.

Top management ensures that customer requirements are understood and met, by
requiring compliance with documented customer communication procedures.
Customer requirements are determined, converted into internal requirements, and
communicated to the appropriate people in our organization (SP-720).

5.3 Quality policy


Top management ensures that the quality policy is communicated to all employees.
It is included in new employee training and training on the QMS. It is posted in
prominent places throughout the facility to maintain high standards within our
organization.
Management reviews the quality policy at each management review meeting to
determine the policy’s continuing suitability for our organization. The Quality Policy is
documented on A-500-001, Quality Policy.

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5.4 Planning
5.4.1 Quality objectives
Quality objectives are established to support our organization’s efforts in achieving
our quality policy and reviewed annually for suitability. Objectives have been
established for the following:

» Teamwork among CPN Electronics’ employees, customers and vendors to improve


overall satisfaction.

» Involvement of all CPN personnel through training, and communication, to achieve


continuous improvement in quality and delivery.

» Customer Satisfaction, through on time delivery of quality products.

» To detect and prevent any non-conformity during the sales and purchasing
processes, receiving and warehouse operations, through root cause and corrective
action thereby preventing reoccurrence.

Quality objectives are measurable, and reviewed against performance goals at each
management review meeting.

5.4.2 Quality management system planning


The quality system has been planned and implemented to meet our quality
objectives and the requirements of 4.1 of the ISO 9001 standard. Quality planning
takes place as changes that affect the quality system are planned and implemented.

5.5 Responsibility, authority and communication


5.5.1 Responsibility and authority
An organizational chart has been established to show the interrelation of personnel
in the organization. Job descriptions define the responsibilities and authorities of
each of the positions on the organizational chart. Job descriptions and the
organizational chart are reviewed and approved by top management for adequacy.
These documents are available throughout the organization to help employees

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understand responsibilities and authorities. An organizational chart is located on


page 5 of this manual.

5.5.2 Management representative


The Director of Quality has been appointed by top management as management
representative. As management representative, they have the following
responsibility and authority:
Ensure that processes needed for the quality management system are
established and implemented.
Report to top management on the performance of the quality management
system, and note needed improvements.
Promote awareness of customer requirements throughout the organization.
Act as a liaison with external parties such as customers or auditors on
matters relating to the QMS.

5.5.3 Internal communication


Processes are established for communication within the organization. Methods of
communicating the effectiveness of the QMS include department and management
meetings, management review, circulation of minutes of management review
meetings, Internal Audit Closing meetings, and other routine business
communication.

5.6 Management review


5.6.1 General
Top management reviews the QMS annually at management review meetings. This
review assesses the continuing QMS suitability, adequacy and effectiveness,
identifying opportunities for improvement and needed changes. Records are
maintained for each management review meeting.

5.6.2 Review input


Assessment of the QMS is based on a review of information inputs to management
review. These inputs include the following:
Results of audits
Customer feedback
Process performance and product conformity
Company level quality data
Status of preventive and corrective actions

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Follow-up actions from previous management reviews


Planned changes that could affect the quality management system
Recommendations for improvement

5.6.3 Review output


During these review meetings, management will identify appropriate actions to be
taken regarding the following issues:
Improvement of the effectiveness of the quality management system and its
processes
Improvement of product related to customer requirements
Resource needs
Responsibility for required actions are assigned to members of the management
review team. Any decisions made during the meeting, assigned actions, and their
due dates are recorded in the minutes of management review.

Related Procedures:
Customer Related Processes SP-720
Management Responsibility AP-500
Quality Planning MP-710

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Section 6

Resource Management

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6.1 Provision of resources


The company has implemented a Quality Management System that complies with
the ISO 9001:2000 standard. This implementation was achieved with management
commitment and with sufficient resources for the implementation. To effectively
maintain and continually improve the system, management determines and provides
necessary resources.

6.2 Human resources


6.2.1 General
To ensure competence of our personnel, job descriptions have been prepared
identifying the qualifications required for each position that affects product quality.
Qualifications include requirements for education, skills and experience. Appropriate
qualifications, along with required training, provide the competence required for each
position.

6.2.2 Competence, awareness and training


Qualifications are reviewed upon hire, when an employee changes positions or the
requirements for a position change. Human resources maintain records of employee
qualifications. If any differences between the employee’s qualifications and the
requirements for the job are found, training or other action is taken to provide the
employee with the necessary competence for the job. The results are then evaluated
to determine if they were effective. Training and evaluation are conducted according
to the Training procedure. (AP-662)
All employees are trained on the relevance and importance of their activities and how
they contribute to the achievement of the quality objectives.

6.3 Infrastructure
To meet quality objectives and product requirements CPN Electronics has
determined the infrastructure needed (EP-630). The infrastructure has been
provided, and includes buildings, workspace, utilities, process equipment and
supporting services. As new infrastructure requirements arise, they will be
documented in quality plans. Existing infrastructure is maintained to ensure product
conformity. Maintenance requirements are documented in:
Preventive maintenance plans
Sanitation plans
Building maintenance plans

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6.4 Work Environment


A work environment suitable for achieving product conformance is maintained.
Requirements are determined during quality planning and documented in the quality
plan. The work environment is managed for continuing suitability. Data from the
quality system is evaluated to determine if the work environment is sufficient for
achieving product conformance, or if preventive or corrective action related to the
work environment is required.

Related Documents
Competence, Awareness and Training AP-622
Infrastructure EP-630

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Section 7

Product Realization

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7.1 Planning of product realization


Quality planning is required before new products or processes are implemented. The
quality planning may take place as a design project, or according to the Planning of
Product Realization procedure (MP-710). During this planning, management or
assigned personnel identify:
The quality objectives and requirements for the product,
Processes, documentation and resources required
Verification, validation, monitoring, inspection and test requirements, and
Criteria for product acceptance
The output of quality planning includes documented quality plans, processes,
procedures and design outputs.

7.2 Customer-related processes


7.2.1 Determination of requirements related to the product
CPN Electronics determines customer requirements before acceptance of an order.
Customer requirements include those:

 Requested by the customer

 Required for delivery and post-delivery activities

 Not stated by the customer but necessary for specified use or known and
intended use

 Statutory and regulatory requirements related to the product

 Additional requirements determined by CPN Electronics


Customer requirements are determined according to the Customer Related
Processes Procedure. (SP-720)

7.2.2 Review of requirements related to the product


CPN Electronics has a process in place for the review of requirements related to the
product (SP-720). The review is conducted before the order is accepted. The
process ensures that:

 Product requirements are defined

 Contract or order requirements differing from those previously expressed are


resolved
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 CPN Electronics has the ability to meet the defined requirements

 Records are maintained showing the results of the review and any actions arising
from the review

 Where a customer does not provide a documented statement of requirement, the


customer requirements are confirmed before acceptance

 When product requirements are changed, CPN Electronics communicates


changes to relevant personnel and amends relevant documents

7.2.3 Customer communication


CPN Electronics has implemented an effective procedure (SP-720) for
communicating with customers in relation to:

 Product Information

 Enquiries, contracts and order handling, including amendments

 Customer Feedback, including customer complaints

7.3 Design and Development


7.3.1 Excluded

7.4 Purchasing
7.4.1 Purchasing process
A documented procedure (AP-740) is followed to ensure that purchased product
conforms to the specified purchase requirements. The procedure outlines the extent
of control required for suppliers. Suppliers are evaluated and selected based on their
ability to supply product in accordance with requirements as outlined in the
procedure. Criteria for selection, evaluation and re-evaluation are documented in the
procedure. Records of the evaluation and any necessary actions are maintained as
quality records.

7.4.2 Purchasing information


Purchasing information describes the product to be purchased, including where
appropriate:

 Requirements for approval of product, processes and equipment

 Requirements for qualification of personnel


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 Quality management system requirements


The purchasing documents are reviewed to ensure the adequacy of requirements
before orders are placed with the supplier.

7.4.3 Verification of purchased product


The Purchasing procedure (AP-740) describes the process used to verify that
purchased product meets specified purchase requirements. If CPN Electronics or the
customer will perform verification at the supplier’s premises, the verification
arrangements and method of product release are documented in the purchasing
information.

7.5 Production Provision


7.5.1 Control of production
CPN Electronics plans and carries out production provision under controlled
conditions according to documented procedure (MP-750). Controlled conditions
include, as applicable:

 The availability of information that describes the characteristics of the product

 The availability of work instructions

 The use of suitable equipment

 The availability and use of monitoring and measuring devices

 The implementation of monitoring and measurement

 The implementation of release and delivery activities

7.5.2 Validation of processes for production and service provision


CPN Electronics validates any processes for production and service provision where
the resulting output cannot be verified by subsequent monitoring or measurement.
This includes any processes where deficiencies become apparent only after the
product is in use or the service has been delivered. Validation demonstrates the
ability of these processes to achieve planned results.
CPN Electronics has documented the process for validation including:

 Defined criteria for review and approval of the processes

 Approval of equipment and qualification of personnel

 Use of specific methods and procedures


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 Requirements for records

 Revalidation

7.5.3 Identification and traceability


CPN Electronics identifies the product throughout product realization according to
the Identification and Traceability procedure (MP-753). Product is identified with
respect to monitoring and measurement requirements.
CPN Electronics controls and records the unique identification of the product where
ever traceability is a specified requirement.

7.5.4 Customer property


CPN Electronics exercises care with customer property while it is under the
organization's control or being used. A procedure (MP-754) outlines the
Identification, verification, protection and safeguarding of customer property provided
for use. If any customer property is lost, damaged or otherwise found to be
unsuitable for use, this is reported to the customer and records maintained.

7.5.5 Preservation of product


CPN Electronics preserves the conformity of product during internal processing and
delivery to the intended destination per procedure (MP-755). This preservation
includes identification, handling, packaging, storage and protection. Preservation
also applies to the constituent parts of a product.

7.6 Control of monitoring and measuring devices


CPN Electronics has determined the monitoring and measurement to be undertaken
and the monitoring and measuring devices needed to provide evidence of conformity
of product to determined requirements. A documented procedure (MP-760) outlines
the process used to ensure that monitoring and measurement to be carried out are
carried out in a manner that is consistent with the monitoring and measurement
requirements.
Where necessary to ensure valid results, measuring equipment is:

 Calibrated or verified at specified intervals, or prior to use, against measurement


standards traceable to international or national measurement standards

 Adjusted or re-adjusted as necessary;

 Identified to enable the calibration status to be determined;

 Safeguarded from adjustments that would invalidate the measurement result;

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 Protected from damage and deterioration during handling, maintenance and


storage.
In addition, Quality Control assesses and records the validity of the previous
measuring results when the equipment is found not to conform to requirements. CPN
Electronics takes appropriate action on the equipment and any product affected.
Records of the results of calibration and verification are maintained
When used in the monitoring and measurement of specified requirements, the ability
of computer software to satisfy the intended application is confirmed. This shall be
undertaken prior to initial use and reconfirmed as necessary.

Related Documents
Planning of Product Realization Processes MP-710
Customer Related Processes SP-720
Design and Development EP-730
Purchasing AP-740
Control of Production and Service Provision MP-750
Identification and Traceability MP-753
Preservation of Product MP-755
Control of Monitoring and Measuring Devices MP-760

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Section 8

Measurement, Analysis
and Improvement

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8.1 General
CPN Electronics plans and implements the monitoring, measurement, analysis and
improvement processes as needed

 To demonstrate conformity of the product,

 To ensure conformity of the quality management system, and

 To continually improve the effectiveness of the quality management system.


These processes are identified in documented procedures and include determination
of applicable methods, and the extent of their use.

8.2 Monitoring and Measurement


8.2.1 Customer Satisfaction
As one of the measurements of the performance of the quality management system,
CPN Electronics monitors information relating to customer perception as to whether
the organization has fulfilled customer requirements. The method for obtaining and
using this information is identified in the Customer Related Processes (SP-720) and
the Management Responsibility procedures (AP-500).

8.2.2 Internal Audit


CPN Electronics conducts internal audits at planned intervals to determine whether
the quality management system

 Conforms to the planned arrangements (see 7.1), to the requirements of this


International Standard and to the quality management system requirements
established by the organization

 Is effectively implemented and maintained.


An audit program has been designed and implemented and identifies an audit
schedule based on the importance of the areas to be audited, as well as the results
of previous audits. The audit criteria, scope, frequency, methods, responsibilities and
requirements for planning and conducting audits, and for reporting and maintaining
results, are defined and documented in the Internal Audit procedure (QP-822).
The management responsible for the area being audited is responsible for ensuring
that actions are taken without undue delay to eliminate detected nonconformities and
their causes. Follow-up activities include the verification of the actions taken and the
reporting of verification results.

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ISO 9001:2000 QUALITY SYSTEM MANUAL
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8.2.3 Monitoring and measurement of processes


CPN Electronics applies suitable methods for monitoring and, where applicable,
measurement of the quality management system processes. These methods
demonstrate the ability of the processes to achieve planned results. When planned
results are not achieved, correction and corrective action is taken, as appropriate, to
ensure conformity of the product. The process for identifying and carrying out the
required monitoring and measuring of processes is documented in the Monitoring,
Measuring and Analysis of Product Realization Processes (MP-824) and
Management Responsibility procedures (AP-500).

8.2.4 Monitoring and measurement of product


CPN Electronics monitors and measures the characteristics of the product to verify
that product requirements are fulfilled. This is carried out at appropriate stages of the
product realization process identified in Monitoring, Measuring and Analysis of
Product Realization Processes (MP-824).
Evidence of conformity with the acceptance criteria is maintained. Records indicate
the person authorizing release of product. Product release and service delivery does
not proceed until all the planned arrangements have been satisfactorily completed,
unless otherwise approved by a relevant authority, and where applicable by the
customer.

8.3 Control of Nonconforming Product


CPN Electronics ensures that product which does not conform to product
requirements is identified and controlled to prevent its unintended use or delivery.
The controls and related responsibilities and authorities for dealing with
nonconforming product are defined in the Control of Nonconforming Product
procedure (QP-830).

8.4 Analysis of Data


CPN Electronics determines, collects and analyses appropriate data to demonstrate
the suitability and effectiveness of the quality management system and to evaluate
where continual improvement of the quality management system can be made. The
process for determining, collecting and analyzing this data is defined in the
Management Responsibility procedure (AP-500). Appropriate data includes data
generated as a result of monitoring and measurement and from other relevant
sources.
The analysis of data provides information relating to

 Customer satisfaction

 Conformance to product requirements

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ISO 9001:2000 QUALITY SYSTEM MANUAL
QMS Rev.: 2 Originator: Quality Control Manager Page 31 of 32

 Characteristics and trends of processes and products including opportunities for


preventive action

 Suppliers

8.5 Improvement

8.5.1 Continual improvement


CPN Electronics continually improves the effectiveness of the quality management
system through the use of the quality policy, quality objectives, audit results, analysis
of data, corrective and preventive actions and management review.

8.5.2 Corrective action


CPN Electronics takes action to eliminate the cause of nonconformities in order to
prevent recurrence. Corrective actions are appropriate to the effects of the
nonconformities encountered.
A documented procedure (QP-852) defines requirements for

 Reviewing nonconformities (including customer complaints),

 Determining the causes of nonconformities,

 Evaluating the need for action to ensure that nonconformities do not recur,

 Determining and implementing action needed,

 Records of the results of action taken (see 4.2.4), and

 Reviewing corrective action taken.

8.5.3 Preventive action


CPN Electronics determines action to eliminate the causes of potential
nonconformities in order to prevent their occurrence. Preventive actions are
appropriate to the effects of the potential problems.
A documented procedure (QP-853) defines requirements for:

 Determining potential nonconformities and their causes

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ISO 9001:2000 QUALITY SYSTEM MANUAL
QMS Rev.: 2 Originator: Quality Control Manager Page 32 of 32

 Evaluating the need for action to prevent occurrence of nonconformities

 Determining and implementing action needed

 Records of results of action taken

 Reviewing preventive action taken

Related Documents
Management Responsibility AP-560
Customer Related Processes SP-720
Monitoring, Measuring and Analysis of Customer Satisfaction AP-821
Internal Audits QP-822
Monitoring and Measuring of Product and Realization Processes MP-824
Control of Nonconforming Product QP-830
Corrective Action QP-852
Preventive Action QP-853

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