ISO 9001 2008 Quality Manual

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Document Title: Quality Manual Document Type: Manual

Document No: Revision No: 00 Effective date: Page 1 of 38

Reviewed by

Approved by

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Table of contents

ISO 9001:2008 Clause

Manual Clause

Title Page

- - Front cover 1

- - Table of Contents 2

- - Organizational Profile 3

4.2.3 1.0 Revision history 4

4.2.2 2.0 Purpose 5

1.0 3.0 Scope 5

2.0 4.0 References 5

3.0 5.0 Terms and definitions 6

12.5 6.0 Responsibility 6

10.0 7.0 Records 7

4.1 8.0 Quality Management System 7

4.2.1 9.0 Documentation requirements 8

4.2.3 10.0 Control of documents 9

4.2.4 11.0 Control of records 10

5 12.0 Management responsibility 10

6 13.0 Resource management 16

7 14.0 Product realization 18

8 15.0 Measurement, analysis and improvement 32

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Organizational Profile

Describe your organization briefly for the benefit of readers of this manual, in terms of:

a. History

b. Products

c. Milestone achievements

d. Vision and mission

e. Etc.

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1.0 Revision History

Revision number DAF # Effective date Revision description

00 Initial issue

Legend: DAF # Document Approval Form Number

2.0 Purpose

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This manual describes the elements and processes of the quality management

system which is implemented as per the requirements of the ISO 9001:2008

international standard.

Relevant documents are referenced in the manual in order to provide users with

further guidance on the quality management system.

3.0 Scope and application

The quality management system demonstrates the organization’s ability to

consistently provide products that meet customer and applicable statutory and

regulatory requirements and to enhance customer satisfaction through the

effective application of the quality management system. .

The following clauses of the ISO 9001:2008 standard are excluded from the

quality management system due to their non-relevance to the organization’s

operations:

a. [Example: Clause 7.3]

State and justify which clauses of the ISO 9001:2008 that do not apply to your

quality management system. Exclusions are limited to sections within Clause 7

only.

Delete the sections of the manual that are excluded from the quality

management system. Example, if your organization does not design your

products, Clause 7.3 is not applicable. Therefore, delete Clause 7.3 from the

manual.

The scope of the quality management system applies to the following products

of the organization:

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a. List your products here.

b. List your products here.

4.0 References

These standards serve as references for the quality management system:

a. ISO 9001:2008 Quality management systems – Requirements

b. ISO 9000:2005 Quality management systems- Fundamentals and

vocabulary

c. ISO 19011:2002 Guidelines for quality and/or environmental

management systems auditing

d. ISO 9004:2000 Quality management systems – Guidelines for

performance improvements

[Note: You need to buy original versions of these documents at

http://www.iso.org/iso/store.htm]

5.0 Terms and definitions

For the purposes of this quality management system, the standard terms and

definitions given in the current version of the ISO 9000 standard apply.

Throughout the text of this manual, wherever the term "product" occurs, it

represents either the physical goods or intangible services of the organization.

Where appropriate, the specific product is expressly mentioned in order to

convey the actual intent of a particular requirement.

6.0 Responsibility

The Management Representative is responsible for the operation of the quality

management system and review of this document (see Clause 12.5.2)

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7.0 Records

Related records are maintained as per Clause 9.2.4.

8.0 Quality Management System

The organization documents, implements and maintains a quality management

system and continually improves upon its effectiveness in accordance with the

requirements of ISO 9001:2008, which is an international standard for quality

management systems published by the International Organization for

Standardization.

The organization ensures that

a. the criteria and methods needed to ensure that both the operation

and control of all processes within the quality management system

are effective;

b. necessary resources and information that are required to support

the operation of these processes are made available;

c. the monitoring, measurement, and where applicable, the analysis of

the processes are planned and implemented; and

d. necessary actions are taken to achieve planned results and

continually improve the quality management system.

The quality management system is made up of processes which relate to

a. Management responsibility (Clause 12.0),

b. Provision of resources (Clause 13.0),

c. Product realization (Clause 13.0), and

d. Measurement, analysis and improvement (Clause 14.0).

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The QMS Flowchart provides a pictorial representation of the interactions of

these elements.

9.0 Documentation requirements

The quality management system documentation is made up of documents and

records required by the ISO 9001:2008 international standard and the

organization.

The following documents are required by the ISO 9001:2008 standard:

a. Quality Manual, which describes the elements of the quality

management system,

b. Quality Policy, which states the organizational stance with regard to

product quality management,

c. Statements of quality objectives of the organization

d. Control of Documents procedure,

e. Control of Records procedure,

f. Internal Audit procedure,

g. Control of Product Nonconformity procedure,

h. Corrective Action procedure, and

i. Preventive Action procedure.

References to other documents which are required by the organization are

specified throughout this manual, where relevant.

All documents that are used within the quality management system are

recorded in the Registry of Documents.

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All records that are maintained within the quality management system are

recorded in the Registry of Records.

10.0 Control of documents

A Control of Documents procedure has been established to define the controls

needed to

a. approve documents for adequacy prior to issue,

b. review and update as necessary and re-approve documents,

c. ensure that the changes and the current revision status of documents are identified,

d. ensure that relevant versions of applicable documents are available at points of use,

e. ensure that documents of external origin are identified and their distribution controlled,

and

f. prevent the unintended use of obsolete documents, and to apply suitable identification to

them if they are retained for any purpose.

The Document Controller is responsible for the implementation of this process.

The following records are maintained for this process:

a. Registry of Documents

b. Document Approval Form

c. Document Approval Form Log

d. Document Distribution Form

11.0 Control of records

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In the operation of the quality management system, records are maintained to

provide evidence of conformity to requirements and of the effectiveness of the

quality management system.

A Control of Records procedure has been established to define the controls

needed for the identification, storage, protection, retrieval, retention, and

disposition of records.

Quality Representatives are responsible for maintaining records in their

respective departments to ensure that they remain legible and are readily

identifiable and retrievable.

The Document Controller is responsible for the implementation of this process.

The following records are maintained for this process:

a. Registry of Records

b. Records Disposal Form

12.0 Management responsibility

12.1 Management commitment

The top management of the organization is committed to continually improve

the quality management system and this is demonstrated by

a. communicating to the organization of the importance of meeting

customer as well as statutory and regulatory requirements,

b. establishing and documenting the Quality Policy,

c. ensuring that quality objectives are established (refer to Quality

Objectives Register),

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d. conducting management reviews, and

e. ensuring the availability of resources (see Clause 13.0).

12.2 Customer focus

Top management is focused towards the fulfillment of customer requirements

and the enhancement of customer satisfaction.

This is achieved by ensuring that customer requirements are determined (see

Clause 14.2.1) and customer satisfaction levels are monitored and measured

(see Clause 15.2.1).

12.3 Quality Policy

Top management has established a Quality Policy to direct the quality

management system.

The Quality Policy is appropriate to the purpose of the organization and

includes a commitment to comply with requirements and continually improve

the effectiveness of the quality management system, and provides a framework

for establishing and reviewing quality objectives.

Top management ensures that the quality policy is communicated and

understood within the organization, and is reviewed during management

reviews for continuing suitability.

12.4 Planning

12.4.1 Quality objectives

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Top management ensures that quality objectives, including those to meet

requirements for products, are established at relevant functions and levels

within the organization.

The quality objectives are measurable and consistent with the Quality Policy

and are reviewed during management review meetings.

Quality objectives are established to ensure good levels of customer

satisfaction, process and product conformities, and suppliers’ performance.

Quality objectives are maintained in the Quality Objectives Register.

12.4.2 Quality management system planning

Top management ensures that the planning of the quality management system

is carried out to meet all requirements as well as the quality objectives, and the

integrity of the quality management system is maintained when changes to the

quality management system are planned and implemented.

12.5 Responsibility, authority and communication

12.5.1 Responsibility and authority

Top management ensures that responsibilities and authorities are defined and

communicated within the organization.

Responsibilities and authorities are described within the QMS Organization

Chart and Job Descriptions.

12.5.2 Management Representative

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Top management has appointed a member of the organization's management to

be the Management Representative [refer to the QMS Organization Chart] who,

irrespective of other responsibilities, is responsible and has the authority in

a. ensuring that processes needed for the quality management system

are established, implemented and maintained,

b. reporting to top management on the performance of the quality

management system and any need for improvement, and

c. ensuring the promotion of awareness of customer requirements

throughout the organization.

The responsibility of the Management Representative also includes liaison with

external parties on matters relating to the quality management system.

12.5.3 The Management Representative is assisted at the departmental and process level

by Quality Representatives. These positions are assumed by the respective

managers and executives.

The Quality Representatives are responsible for the quality processes which are

applicable to their respective departments.

The Quality Representatives head their respective Quality Improvement Teams

which are established for the purpose of identifying opportunities for

improvements.

Members of the Quality Improvement Teams comprise of key personnel who

are appointed by the Quality Representatives.

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12.5.4 The Management Representative is also assisted by an appointed Document

Controller who is responsible for the effective implementation of the Control of

Documents and Control of Records procedures.

12.5.5 Collectively, the Management Representative, Quality Representatives and the

Document Controller make up the Quality Management System Committee.

This committee meets regularly to provide relevant inputs and resolutions for

the quality management system.

The structure of the Quality Management System Committee is defined in the

QMS Organization Chart.

12.5.6 Internal communication

Top management ensures that appropriate communication processes are

established within the organization.

The Quality Management System Committee and the Quality Improvement

Teams, respectively, meet regularly in order to ensure that communication

regarding the effectiveness of the quality management system takes place.

Pertinent information regarding the quality management system is posted by

the Management Representative on the Bulletin Board for the benefit of all

employees.

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Employees are encouraged to provide their inputs towards the quality

management system through suggestion boxes which are located at strategic

locations within the organization’s premises.

12.6 Management review

12.6.1 General

Top management reviews the quality management system at planned intervals

in order to ensure its continuing suitability, adequacy and effectiveness.

This review includes assessing opportunities for improvement and the need for

changes to the quality management system, including the quality policy and

quality objectives.

The management reviews are chaired by the [CEO/Managing Director] and

attended by the Management Representative, Document Controller and

members of the Quality Management System Committee.

12.6.2 Review input

The Management Representative provides the following inputs for the

management review:

a. Results of audit;

b. Customer feedback;

c. Process performance and product conformity;

d. Status of preventive and corrective actions;

e. Follow-up actions from previous management reviews;

f. Changes that could affect the quality management system;

g. Recommendations for improvement.

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12.6.3 Review output

The outputs from the management review include decisions and actions related

to the

a. improvement of the effectiveness of the quality management system

and its processes,

b. improvement of product related to customer requirements, and

c. resource needs.

Specific management directives are given to the Management Representative

on subsequent actions to be taken in consideration of the review outputs.

13.0 Resource management

13.1 Provision of resources

Resources are determined and made available in order to ensure the effective

operation, maintenance and continual improvement of the quality management

system and enhance customer satisfaction.

Resource requirements are determined and planned during management

reviews.

13.2 Human resources

The Human Resources Department ensures that all personnel performing work

within the quality management system are competent on the basis of

appropriate education, training, skills and experience.

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All Department Managers are required to conduct induction sessions for all

new employees and transfer personnel. These induction sessions involve

briefings, demonstrations and premise tours (where applicable), where

inductees are made aware of the relevance and importance of their activities

and how they contribute to the achievement of the quality objectives.

In order to ensure the competency of personnel within the quality management

system, the organization conducts regular competency assessments. This

process involves the following activities:

a. Determining the necessary competency requirements,

b. Providing training or taking other actions to achieve the necessary

competence, and

c. Evaluating the effectiveness of the actions taken.

The following records are maintained:

a. Employee Induction Form

b. Employee Competency Assessment

c. Training Request Form

d. Training Programs Planner

13.3 Infrastructure

The organization determines, provides and maintains infrastructures that are

necessary to support the processes of the quality management system and

ensure conformity to product requirements.

Describe your infrastructures here, such as:

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a. [Buildings/Work Areas]

b. [Process equipments]

c. [Transportation Vehicles]

d. [MIS/Software]

e. Etc.

Note 1: List any maintenance records.

Note 2: Please ensure that top management reviews resource requirements

during management reviews. Planning of resource management needs to be

captured in quality records. Implementation of resource management must be

recorded also. Subsequent reviews will serve as continual improvement efforts.

13.4 Work environment

The organization determines and manages its work environment under which

work is performed, in accordance with its product quality requirements.

Describe your work environment and controls that your organization

implements, such as the physical environment and other environmental aspects

like such as noise, temperature, humidity, lighting and weather, where

applicable.

Note 1: List any control records.

14.0 Product realization

14.1 Planning of product realization

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The organization plans and implements effective processes needed for the

creation of its products in order to meet customer requirements and enhance

customer satisfaction.

Product realization planning involves the considerations of:

a. Product requirements;

b. Quality objectives;

c. Resources specific to the product;

d. Processes specific to the product;

e. Required documentation;

f. Required verification, validation, monitoring, measurement,

inspection and test activities specific to the product and the criteria for product acceptance;

and

g. Records needed to provide evidence that the realization processes

and resulting product meet all specified requirements.

The following planning documents are maintained:

a. Product Quality Plan

14.2 Customer-related processes

14.2.1 Determination of requirements related to the product

Product requirements are effectively determined by the [Sales & Marketing

Department].

This process is controlled by the [Sales & Marketing Procedure]

Note: If you don’t have a procedure for your sales and marketing processes,

delete this section. In its place, you can briefly describe this process here.

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The organization considers these factors in determining the requirements

related to the product:

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 specified

or intended use, where known,

c. applicable statutory and regulatory requirements related to the

product, and

d. any additional requirements considered necessary by the

organization.

Details of product requirements are documented in the following documents:

a. [List your records by title here]

b. [List your records by title here]

14.2.2 Review of requirements related to the product

Requirements related to the product are reviewed prior to the organization's

commitment to supply any product to the customer.

These reviews ensure that

a. product requirements are defined,

b. contract or order requirements differing from those previously

expressed are resolved, and

c. the organization has the ability to meet the defined requirements.

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Where the customer provides no documented statement of requirements,

customer requirements are confirmed before acceptance.

Where product requirements are changed, the organization ensures that relevant

documents are amended and that relevant personnel are made aware of the

changed requirements.

14.2.3 Customer communication

The [Sales & Marketing Department] implements and maintains effective

arrangements for communicating with the organization’s customers, in relation

to product information, enquiries, order handling and customer feedback,

including product returns.


a. [Record title 1]

b. [Record title 2]

c. Quotations

d. Customer Complaints

e. Customer Satisfaction Surveys

f. Official Correspondences

14.3 Design and development [Note: If your organization does not design its

products, delete this section].

14.3.1 Design and development planning

In planning and controlling the design and development of a product, the

[Design & Development Department] determines

a. the design and development stages,

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b. the review, verification and validation that are appropriate to each

design and development stage, and

c. the responsibilities and authorities for design and development.

The following document controls this process:

a. [Example: Design and Development Procedure]

b. The following records are maintained:

c. [Product Design Record 1]

d. [Product Design Record 2]

14.3.2 Design and development inputs.

Inputs relating to product requirements are determined as follows:

a. functional and performance requirements,

b. applicable statutory and regulatory requirements,

c. information derived from previous similar designs, and

d. other requirements essential for design and development.

These inputs are reviewed for adequacy to ensure that they are complete,

unambiguous and not in conflict with each other.


a. [Example: Review of Design Inputs 1]

b. [Example: Review of Design Inputs 1]

14.3.3 Design and development outputs

Design and development outputs are ensured to meet the specified input

requirements and are approved by the Quality Representative prior to release.

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The design and development outputs include appropriate information for

a. purchasing requirements,

b. production and service provision and details for the preservation of

product,

c. product acceptance criteria, and

d. specifications of the characteristics of the product that is essential

for its safe and proper use.

The outputs are maintained in the following documents:

a. [Example: Purchasing Requirements]

b. [Example: Production and Service Provisions]

c. [Example: Product Acceptance Criteria]

d. [Example: Product Specifications]

14.3.4 Design and development review

Systematic reviews of design and development are performed in accordance

with planned arrangements at suitable stages.

These reviews are conducted for the purposes of evaluating the ability of the

results of design and development to meet requirements, and identifying any

problems and propose necessary actions.

Participants in such reviews include representatives of functions concerned

with the design and development stages being reviewed.

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The following records of the results of the reviews and necessary actions are

maintained:


b. [Design and development review 1]

c. [Design and development review 2]

14.3.5 Design and development verification

Verification is performed in accordance with planned arrangements to ensure

that the design and development outputs have met the design and development

input requirements.

The following records of the results of the verification and necessary actions

are maintained:


b. [Design and development verification 1]

c. [Design and development verification 2]

14.3.6 Design and development validation

Design and development validation ensures that the resulting product is capable

of meeting the requirements for the specified application or intended use.

This process is controlled by the [Example: Design and Development

Validation] procedure.

Wherever practicable, validations are completed prior to the delivery or

implementation of the product.

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The following records of the results of validations and necessary actions are

maintained:


b. [Design Validation Record 1]

c. [Design Validation Record 2]

14.3.7 Control of design and development changes

Design and development changes arising from the review, verification and

validation activities are identified, reviewed, verified and validated, as

appropriate, and approved before implementation.

The review of design and development changes includes evaluation of the

effect of changes on constituent parts and product already delivered.

Records of the review of design and development changes and any necessary

action are maintained via the following documents:



14.4 Purchasing

14.4.1 Purchasing process

The Purchasing Department ensures that purchased products conform to

specified requirements.

The type and extent of control applied to the suppliers and the purchased

products are dependent upon the effect of the purchased product on subsequent

product realization or the final products.

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The criteria for selection, evaluation and re-evaluation of suppliers are

maintained.

The organization evaluates and selects suppliers based on their ability to supply

product in accordance with the organization’s requirements.

Suppliers are included into the Approved Suppliers List only if their first three

deliveries do not involve any issues.

Approved suppliers are re-evaluated annually, based on both qualitative and

quantitative metrics, and they must achieve the minimum score standard to

remain in good standings.

Records of the results of evaluations and any necessary actions arising from the

evaluation are maintained in the following documents:

a. Approved Suppliers List

b. Supplier Selection Form

c. Supplier Performance Evaluation

14.4.2 Purchasing information

Purchasing information that is generated from the design and development

process describes the product to be purchased, including (where appropriate)

a. requirements for approval of product, procedures and equipment,

b. requirements for qualification of personnel, and

c. quality management system requirements.

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All purchasing information is approved prior to release by the Quality

Representative.

Records of purchasing information which is released to suppliers are

maintained via the following documents:

a. [Example: Purchase Order]

14.4.3 Verification of purchased product

The [Purchasing Department] inspects and tests all purchased products, where

appropriate, in order to ensure that they meet specified purchase requirements.

Where the organization or its customer intends to perform verification at the

supplier's premises, the organization states the intended verification

arrangements and method of product release in the purchasing information.

The following document is used to record all verification of purchased products

are maintained in the following documents:

a. [Example: Purchasing Inspection Form] Note: Use your existing

format for this record.

All nonconforming products are controlled via the Control of Nonconforming

Product procedure (See Section 15.3)

14.5 Production and service operations [You may modify this title to suit your products]

14.5.1 General

The [Production Department] implements production and service provisions

under controlled conditions. Controlled conditions include

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a. the availability of information that describes the characteristics of

the product,

b. the availability of work instructions (as necessary),

c. the use of suitable equipments,

d. the availability and use of monitoring and measuring equipments,

e. the implementation of monitoring and measurement, and

f. the implementation of product release, delivery and post-delivery

activities.

The following documents support and control the production and service

processes:

a. [List all documentation related to this section by title]

b. [Production procedures]

c. [Work instructions]

d. [Flowcharts]

e. [Drawings]

14.5.2 Validation of processes for production and service provision [If this section is not

applicable to your organization, delete it]

The organization validates processes for production and service provision

where the resulting output cannot be verified by subsequent monitoring or

measurement and, as a consequence, deficiencies become apparent only after

the product is use or the service has been delivered.

Validation demonstrates the ability of these processes to achieve planned

results. Where applicable, the validation process includes

a. defined criteria for review and approval of the processes,

b. approval of equipment and qualification of personnel,

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c. use of specific methods and procedures,

d. requirements for records, and

e. re-validation.

The following processes are validated:

a. [List the process here]

b. [List the process here]

The following documents record the methods of validation and their results:



14.4.3 Identification and traceability [If this section is not applicable to your organization,

delete it]

Product status is identified throughout product realization with respect to

monitoring and measurement requirements.

This process is defined in the following document:

a. Work Instruction (Document Title)

Where traceability is a requirement, the organization controls and records the

unique identification of the product and maintains appropriate records as

follow:



14.4.4 Customer property [If this section is not applicable to your organization, delete it]

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The organization reports any customer property that is lost, damaged, or

otherwise found to be unsuitable for use, to the customer.

Customer properties may include intellectual property and personal data.

This process is defined in the following document:


14.4.5 Preservation of product [If this section is not applicable to your organization, delete

it]

All products including their constituents are preserved during internal

processing and delivery to the intended destination in order to maintain

conformity to requirements.

Preservation activities include identification, handling, packaging, storage and

protection.

Storage requirements are defined in the following document:


Transportation and delivery requirements are defined in the following

document:


14.5 Control of monitoring and measuring equipment [If this section is not applicable to

your organization, delete it]

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The organization determines the necessary monitoring and measurement that

are to be undertaken and the required equipments needed in order to provide

evidence of conformity to product requirements.

The Equipments Calibration Register records the equipments that require

calibration, including the calibration methods, references, frequencies and

responsibilities.

In order to ensure valid results, measuring equipments are

a. calibrated or verified, or both, at specified interval, or prior to use,

against measurement standards traceable to international or national

measurement standards; where no such standards exist, the basis

used for calibration or verification are recorded;

b. adjusted or re-adjusted as necessary;

c. identified in order to determine its calibration status;

d. safeguarded from adjustment that would invalidate the measurement

result; and

e. protected from damage and deterioration during handling,

maintenance and storage.

Records of the previous measuring results are assessed to ensure validity when

the equipment is found not to conform to requirements and appropriate actions

shall be taken on the equipment and any product affected.

Individual records of calibration and verification of each equipment are

maintained:

a. Equipment Calibration Log

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15.0 Measurement, analysis and improvement

15.1 General

The organization plans and implements necessary monitoring, measurement,

analysis and improvement processes needed in order to

a. demonstrate conformity to product requirements,

b. ensure conformity of the quality management system, and

c. continually improve the effectiveness of the quality management

system.

These processes include determination of applicable methods, including

statistical techniques, and the extent of their use.

15.2 Monitoring and measurement

15.2.1 Customer satisfaction

Information relating to customer perception is monitored and measured in order

to quantify customer satisfaction levels.

Customer Satisfaction Surveys are conducted by the [Sales & Marketing

Department] to extract specific customer input towards specific aspects of the

organization’s products (goods and services).

Questionnaires are established by the Quality Management System Committee

and are reviewed and improved when necessary.

15.2.2 Internal audit

Internal audits are conducted at planned intervals as per the Internal Audit

procedure in order to determine whether the quality management system

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a. conforms to planned arrangements,

b. conforms to the requirements of the ISO 9001:2008 International

Standard, and

c. is effectively implemented and maintained.

The Internal Audit procedure defines the responsibilities and requirements for

planning and conducting audits, establishing records and reporting of results.

The audit programme is planned accordingly, taking into consideration the

status and importance of the processes and areas to be audited, as well as the

results of previous audits.

The audit criteria, scope, frequency and methods are defined.

Auditors are ensured to be objective, impartial and independent of the area

being audited.

The Quality Representatives who are responsible for the area being audited

ensures that any necessary corrections and corrective 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.

15.2.3 Monitoring and measurement of processes

Suitable methods for monitoring and, where applicable, measurement of the

quality management system processes are applied in order to demonstrate the

ability of the processes to achieve planned results.

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When determining suitable methods, the organization considers the type and

extent of monitoring or measurement appropriate to each of the processes in

relation to their impact on the conformity to product requirements and on the

effectiveness of the quality management system.

Relevant processes are monitored and measured by the respective Quality

Representatives in terms of their

a. Quality objectives ; and

b. Conformity to planned arrangements.

When planned results are not achieved, correction and corrective action are

taken, as appropriate.

Monitoring and measurement data which have been collected are analyzed for

continual improvements as per Section 15.4.

15.2.4 Monitoring and measurement of product

Product characteristics are monitored and measured in order to verify that

requirements have been met.

Products are monitored and measured at the following stages:

a. Verification and inspection of purchased products (Clause 14.4.3);

b. Verification and inspection of in-process products and finished

products (Clause 14.5.1);

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The release of product and delivery of service to the customer does not proceed

until the planned arrangements for the product have been satisfactorily

completed, unless otherwise approved by a relevant authority and, where

applicable, by the customer.

The following records that indicate evidence of conformity with the acceptance

criteria and person(s) authorizing release of product are maintained:

a. [List your inspection records by title]

15.3 Control of nonconforming product

The organization ensures that products which do not conform to product

requirements are identified and controlled to prevent unintended use or

delivery.

Quality Representatives are responsible for the implementation of this process

at the relevant stages of control.

A Control of Nonconforming Product procedure is established to define the

controls and related responsibilities and authorities for dealing with

nonconforming product.

Where applicable, the organization deals with nonconforming product by the

following ways:

a. taking action to eliminate the detected nonconformity;

b. authorizing its use, release or acceptance under concession by a

relevant authority and, where applicable, by the customer;

c. taking action to preclude its original intended use or application;

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d. taking actions which are appropriate to the effects, or potential

effects, of the nonconformity when nonconforming product is

detected after delivery or use has started.

When nonconforming product is corrected, it is subjected to re-verification to

demonstrate conformity to requirements.

The nature of nonconformities and any subsequent actions taken, including

concessions obtained, are recorded through the Nonconforming Product Form.

15.4 Analysis of data

Types of data for monitoring and measurement activities are maintained in the

Data Analysis Register.

These data are analyzed by the Quality Management System Committee at

specified intervals.

The analysis of data is conducted to demonstrate the suitability and

effectiveness of the quality management system and evaluate where continual

improvement of the effectiveness of the quality management system can be

made. These data include data generated as a result of monitoring and

measurement and from other relevant sources, as applicable.

The analysis of data provides information relating to

a. customer satisfaction,

b. conformity to product requirements,

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c. characteristics and trends of processes and products, including

opportunities for preventive action, and

d. suppliers.

15.5 Improvement

15.5.1 Continual improvement

The organization is committed to continually improve the effectiveness of the

quality manage system through the use of the quality policy, quality objectives,

audit results, analysis of data, corrective and preventive actions and

management review.

15.5.2 Corrective action

The organization takes appropriate action to eliminate the causes of

nonconformities in order to prevent recurrence.

The organization ensures that the corrective actions are appropriate to the

effects of the nonconformities encountered.

The Corrective Action procedure is established to define requirements for

a. reviewing nonconformities including customer complaints,

b. determining the causes of nonconformities,

c. evaluating the need for action to ensure that nonconformities do not

recur,

d. determining and implementing action needed,

e. records of the results of action taken, and

f. reviewing the effectiveness of the corrective action taken.

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15.5.3 Preventive action

The organization determines action to eliminate the causes of potential

nonconformities in order to prevent their occurrence.

The organization ensures that preventive actions are appropriate to the effects

of the potential problems.

A Preventive Action procedure is established to define requirements for

a. determining potential nonconformities and their causes,

b. evaluating the need for action to prevent occurrence of

nonconformities,

c. determining and implementing action needed,

d. records of results of action taken, and

e. reviewing the effectiveness of the preventive action taken.