13612990 iso 90012008 quality management system manual

Document originator Management Representative Page number 1 of 30

Document titleQuality Management System Manual

Effective date

Document number QMS-M-001-00 Revision number 00

Prepared byName Title Signature

Management Representative

Reviewed and approved by

Name Title Signature

REVISION HISTORY

Revision number DCF # DCF date Revision description

00 Initial issue

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Document title Quality Management System Manual Effective date


Table of contents

ISO 9001:2008

Clause

Manual Clause

Title Page

- - Front cover 1

- - Table of Contents 2

1 1 Scope 3

2 2 References 4

3 3 Terms and definitions 5

4 4 Quality Management System 6

5 5 Management responsibility 10

6 6 Resource management 14

7 7 Product realization 16

8 8 Measurement, analysis and improvement 25








Clause 1 Scope

1.1 This manual describes the organization’s quality management system in terms

of its policies, objectives and processes.

1.2 The purpose of the quality management system is to

1.2.1 demonstrate its ability to consistently provide product that meets

customer and applicable statutory and regulatory requirements, and

1.2.2 enhance customer satisfaction through the effective application of the

system, including processes for continual improvement of the system

and the assurance of conformity to customer and applicable statutory

and regulatory requirements.

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

organization:

1.3.1 Describe your products here.

1.3.2 Attach or insert your product’s process map here and describe it

textually.

1.4 Exclusions

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

quality management system.

1.4.2 Exclusions are limited to sections within Clause 7 only.

1.4.3 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.









Clause 2 References

2.1 These documents serve as references in the quality management system:

2.1.1 ISO 9001:2008 Quality management systems – Requirements (Document

ID #QMS-XX-XX-XX)

2.1.2 ISO 9000:2005 Quality management systems- Fundamentals and

vocabulary (Document ID #QMS-XX-XX-XX)

2.1.3 ISO 19011:2002 Guidelines for quality and/or environmental management

systems auditing (Document ID #QMS-XX-XX-XX)









Clause 3 Terms and definitions

3.1 For the purposes of this quality management system, the terms and definitions

given in ISO 9000 apply.

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

means "service".

3.3 Local terms that are unique to the organization and are used within this manual:

3.3.1 List unique acronyms, titles, references which are used within your

QMS.









Clause 4 Quality Management System

4.1 General requirements

4.1.1 This quality management system has been established and documented in

accordance with the requirements of ISO 9001:2008, which is an

international standard for a quality management system.

4.1.2 The quality management system is made up of the processes for

4.1.2.1 Management activities (reference Clause 5),

4.1.2.2 Provision of resources(reference Clause 6),

4.1.2.3 Product realization (reference Clause 7),, and

4.1.2.4 Measurement, analysis and improvement (reference Clause 8).

4.1.3 The Quality Management System Flow Diagram (Figure 1) describes the

sequence and interaction of these processes.

4.1.4 The quality management system defines the

4.1.4.1 criteria and methods needed to ensure that both the operation and

control of processes are effective;

4.1.4.2 necessary resources that are required in order to support

the operation of the quality management system; and

4.1.4.3 monitoring, measurement (where applicable) and analysis of the

processes..

4.1.5 In operating the quality management system, the organization is committed

to continually improve its effectiveness in meeting its objectives.

4.2 Documentation requirements

4.2.1 General

4.2.1.1 The quality management system documentation is made up of

4.2.1.1.1 statements of policies and objectives,






4.2.1.1.2 a quality manual,

4.2.1.1.3 documented procedures and records required by the ISO

9001:2008, and

4.2.1.1.4 other documents, including records, which are necessary to

ensure the effective planning, operation and control of the

quality management system’s processes.

4.2.2 Quality Manual (Document ID #QMS-M-001-00)

4.2.2.1 This quality management system manual

4.2.2.1.1 describes the scope of the quality management system, including

details of and justification for any exclusions,

4.2.2.1.2 includes references to the documented procedures established

for the quality management system, and

4.2.2.1.3 describes the interactions of the process of the quality

management system.

4.2.3 Control of documents (Document ID #QMS-XX-XX-XX)

4.2.3.1 A documented procedure has been established to define the controls

needed to

4.2.3.1.1 approve documents for adequacy prior to issue,

4.2.3.1.2 review and update as necessary and re-approve documents,

4.2.3.1.3 ensure that the changes and the current revision status of

documents are identified,

4.2.3.1.4 ensure that relevant versions of applicable documents are

available at points of use,

4.2.3.1.5 ensure that documents of external origin are identified and their

distribution controlled, and

4.2.3.1.6 prevent 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 records (Document ID #QMS-XX-XX-XX)

4.2.4.1 Records are established to provide evidence of conformity to

requirements and of the effective operation of the quality management

system.

4.2.4.2 A documented procedure has been established to define the controls

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

disposition of records.

4.2.4.3 Records are maintained in order to ensure that they remain legible and

are readily identifiable and retrievable.









Figure 1: Quality Management System Flow Diagram

(Note: You may need to expand this flow diagram to reflect the actual processes of

your organization. And to facilitate better document change management, you can

create this flow diagram as a separate document and as an attachment to the QMS

Manual.)









Clause 5 Management responsibility

5.1 Management commitment

5.1.1 The top management of the organization is committed to continually

improve the quality management system and this is demonstrated by

5.1.1.1 communicating to the organization of the importance of meeting

customer as well as statutory and regulatory requirements,

5.1.1.2 establishing the quality policy,

5.1.1.3 ensuring that quality objectives are established,

5.1.1.4 conducting management reviews, and

5.1.1.5 ensuring the availability of resources.

5.2 Customer focus

5.2.1 Top management ensures that customer requirements are determined and are

met with the aim of enhancing customer satisfaction.

5.3 Quality Policy (Document ID #QMS-XX-XX-XX)

5.3.1 Top management has established a quality policy that states the

organization’s position with regard to product quality.

5.3.2 It 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.

5.3.3 The quality policy also provides a framework for establishing and reviewing

quality objectives.

5.3.4 Top management ensures that the quality policy is communicated and

understood within the organization, and is reviewed for continuing

suitability.

5.4 Planning

5.4.1 Quality objectives (Document ID #QMS-XX-XX-XX)







5.4.1.1 Quality objectives, including those to meet requirements for

products, are established at relevant functions and levels within the

organization.

5.4.1.2 The quality objectives are measurable and consistent with the

quality policy.

5.4.1.3 Quality objectives are used as the primary tool of controlling a

given process in terms of its performance and effectiveness.

5.4.2 Quality management system planning

5.4.2.1 Top management ensures that the planning of the quality

management system is carried out in order 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.

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority (Document ID #QMS-XX-XX-XX)

5.5.1.1 Top management ensures that responsibilities and authorities are

defined and communicated within the organization.

5.5.2 Management Representative

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

management who, irrespective of other responsibilities, is

responsible and has the authority in

5.5.2.1.1 ensuring that processes needed for the quality

management system are established, implemented and

maintained,

5.5.2.1.2 reporting to top management on the performance of the

quality management system and any need for

improvement, and






5.5.2.1.3 ensuring the promotion of awareness of customer

requirements throughout the organization.

5.5.2.2 The responsibility of the Management Representative also includes

liaison with external parties on matters relating to the quality

management system.

5.5.2.3 The Management Representative is assisted at the departmental

level by Quality Representatives.

5.5.2.3.1 This position is assumed by the Department Manager.

5.5.2.3.2 The Quality Representative is responsible for the quality

processes which are applicable to his/her department.

5.5.2.3.3 The Quality Representative heads the Quality

Improvement Team which is established for the purpose

of identifying opportunities for improvements within

each department.

5.5.2.4 Collectively, the Management Representative and the Quality

Representatives represent the Quality Management System

Committee. This committee meets regularly to ensure that

communications and subsequent resolutions about the effectiveness

of the quality management system take place.

5.5.3 Internal communication

5.5.3.1 Top management ensures that appropriate communication processes

are established within the organization.

5.5.3.2 The Quality Management System Committee and the Quality

Improvement Teams meet regularly in order to ensure that

communication regarding the effectiveness of the quality

management system takes place.

5.5.3.3 Meeting minutes are maintained in order to ensure the effectiveness

of the communications.






5.6 Management review

5.6.1 General

5.6.1.1 Top management reviews the quality management system at

planned intervals in order to ensure its continuing suitability,

adequacy and effectiveness.

5.6.1.2 This review includes assessing opportunities for improvement and

the need for changes to the quality management system, including

the quality policy and quality objectives.

5.6.1.3 Records such as meeting minutes and supplemental documents from

management reviews are maintained.

5.6.2 Review input

5.6.2.1 The inputs to a management review include information on

5.6.2.1.1 results of audit,

5.6.2.1.2 customer feedback,

5.6.2.1.3 process performance and product conformity,

5.6.2.1.4 status of preventive and corrective actions,

5.6.2.1.5 follow-up actions from previous management reviews,

5.6.2.1.6 changes that could affect the quality management system,

and

5.6.2.1.7 recommendations for improvement.

5.6.2 Review output

5.6.2.1 The outputs from the management review include decisions and

actions related to the

5.6.2.1.1 improvement of the effectiveness of the quality

management system and its processes,

5.6.2.1.2 improvement of product related to customer requirements,

and

5.6.2.1.3 resource needs.







Clause 6 Resource management

6.1 Provision of resources

6.1.1 The organization is committed to continually improve the effectiveness of

the quality management system in order to meet customer requirements

and to enhance customer satisfaction. To achieve this, required resources

are determined and provided for as necessary.

6.1.2 Records of resource planning are maintained. (Document ID #QMS-XX-

XX-XX)

6.1.3 Human resources

6.1.3.1 General

6.1.3.2 The organization ensures that personnel performing work

affecting conformity to product quality requirements are

competent on the basis of appropriate education, training, skills

and experience.

6.1.3.3 Competence, training and awareness (Document ID #QMS-XX-

XX-XX)

6.1.3.3.1 The Employee Induction program ensures that all

personnel are made aware of the relevance and

importance of their activities and how they contribute

to the achievement of the quality objectives.

6.1.3.3.2 In order to ensure the competency of personnel

within the quality management system, the

organization

6.1.3.3.2.1 determines the necessary competency

requirements,

6.1.3.3.2.2 provides training or take other actions to

achieve the necessary competence, and






6.1.3.3.2.3 evaluates the effectiveness of the actions

taken.

6.1.3.3.3 Appropriate records of education, training, skills and

experience are maintained.

6.2 Infrastructure

6.2.1 Requirements for necessary infrastructure such as buildings, workspace and

associated utilities, process equipment (both hardware and software), and

supporting services such as transport, or communication, or information

systems are determined, provided for and maintained in order to ensure

conformity to product requirements.

6.3 Work environment

6.3.1 A conducive working environment which relates to conditions under which

work is performed including physical, environmental, and other factors such

as noise, temperature, humidity, lighting, or weather is maintained and

improved upon in order to ensure conformity to product requirements







Clause 7 Product realization

7.1 General

7.1.1 The organization defines the processes needed for product realization in

order to ensure that all customer and applicable legal requirements are met

and complied with.

7.1.2 The product quality planning includes:

7.1.2.1 Determination of quality objectives and requirements for the

product;

7.1.2.2 Description of the necessary processes,

7.1.2.3 Required documentation,

7.1.2.4 Provision of resources specific to the product;

7.1.2.5 Required verification, validation, monitoring, measurement,

inspection and test activities specific to the product and the criteria

for product acceptance; and

7.1.2.6 Records needed to provide evidence that the realization processes

and resulting product meet all specified requirements.

7.2 Customer-related processes

7.2.1 Determination of requirements related to the product (Document ID

#QMS-XX-XX-XX)

7.2.1.1 In determining the requirements related to the product, these

requirements are considered:

7.2.1.1.1 requirements specified by the customer, including the

requirements for delivery and post-delivery activities,

7.2.1.1.2 requirements not stated by the customer but necessary

for specified or intended use, where known,

7.2.1.1.3 applicable statutory and regulatory requirements related

to the product, and

7.2.1.1.4






7.2.1.1.5 additional requirements considered necessary by the

organization.

7.2.2 Review of requirements related to the product (DOCUMENT ID # QMS-

XX-XX-XX)

7.2.2.1 The organization conducts reviews of the requirements related to

the product prior to the organization's commitment to supply any

product to the customer. These reviews ensure that

7.2.2.1.1 product requirements are defined,

7.2.2.1.2 contract or order requirements differing from those

previously expressed are resolved, and

7.2.2.1.3 the organization has the ability to meet the defined

requirements.

7.2.2.2 Where the customer provides no documented statement of

requirement, the customer requirements are confirmed by the

organization before acceptance.

7.2.2.3 Where product requirements are changed, the organization ensures

that relevant documents are amended and that relevant personnel

are made aware of the changed requirements.

7.2.2.4 Records of the results of the review and actions arising from the

review are maintained.

7.2.3 Customer communication

7.2.3.1 The organization implements effective arrangements for

communicating with customers in relation to product information,

enquiries, contracts or order handling, including amendments, and

customer feedback, including customer complaints.

7.3 Design and development (Document ID # QMS –XX-XX-XX)

7.3.1 Design and development planning

7.3.1.1







7.3.1.2 In planning and controlling the design and development of a

product, the organization determines the

7.3.1.2.1 design and development stages,

7.3.1.2.2 review, verification and validation that are

appropriate to each design and development stage,

and

7.3.1.2.3 responsibilities and authorities for design and

development.

7.3.1.3 Design and development review, verification and validation are

conducted and recorded separately or in any combination, as

suitable for the product and the organization.

7.3.1.4 The interfaces between different groups involved in design and

development are controlled appropriately in order to ensure

effective communication and clear assignment of responsibility

and the planning output are updated, as appropriate, as the design

and development progresses.

7.3.2 Design and development inputs.

7.3.2.1 Inputs relating to product requirements are determined and

records maintained. The inputs include

7.3.2.1.1 functional and performance requirements,

7.3.2.1.2 applicable statutory and regulatory requirements,

7.3.2.1.3 where applicable, information derived from previous

similar designs, and

7.3.2.1.4 other requirements essential for design and

development.

7.3.2.2 These inputs are reviewed for adequacy to ensure that they are

complete, unambiguous and not in conflict with each other.

7.3.3 Design and development outputs






7.3.3.1 The outputs of design and development enable suitable

verification to be performed against the design and development

inputs and are approved prior to release.

7.3.3.2 The organization ensures that all design and development outputs

7.3.3.2.1 meet the input requirements for design and

development,

7.3.3.2.2 provide appropriate information for purchasing,

production, service provision and details for the

preservation of product.

7.3.3.2.3 contain or reference product acceptance criteria, and

7.3.3.2.4 specify the characteristics of the product that are

essential for its safe and proper use.

7.3.4 Design and development review

7.3.4.1 Systematic reviews of design and development are performed in

accordance with planned arrangements at suitable stages.

7.3.4.2 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.

7.3.4.3 Participants in such reviews include representatives of functions

concerned with the design and development stages being

reviewed.

7.3.4.4 Records of the results of the reviews and any necessary actions

are maintained.

7.3.5 Design and development verification

7.3.5.1 Verification is performed in accordance with planned

arrangements to ensure that the design and development outputs

have met the design and development input requirements.







7.3.5.2 Records of the result of the verification and any necessary

actions are maintained.

7.3.6 Design and development validation

7.3.6.1 Design and development validation is performed in accordance

with planned arrangements to ensure that the resulting product is

capable of meeting the requirements for the specified

application or intended use, when known. Wherever

practicable, validation shall be completed prior to the delivery or

implementation of the product.

7.3.6.2 Records of the results of validations and any necessary actions

are maintained.

7.3.7 Control of design and development changes

7.3.7.1 Design and development changes are identified and records

maintained. The changes are reviewed, verified and validated,

as appropriate, and approved before implementation.

7.3.7.2 The review of design and development changes includes

evaluation of the effect of changes on constituent parts and

product already delivered.

7.3.7.3 Records of the results of the review of changes and any

necessary actions are maintained.

7.4 Purchasing (Document ID # QMS –XX-XX-XX)

7.4.1 General

7.4.1.1 The organization 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.

7.4.1.2 The criteria for selection, evaluation and re-evaluation of

suppliers are maintained.





7.4.1.3 The organization evaluates and selects suppliers based on their

ability to supply product in accordance with the organization’s

requirements.

7.4.1.4 Records of the results of evaluations and any necessary actions

arising from the evaluation are maintained.

7.4.2 Purchasing information

7.4.2.1 Purchasing information that is generated from the design and

development process describes the product to be purchased,

including where appropriate

7.4.2.1.1 requirements for approval of product, procedures and

equipment,

7.4.2.1.2 requirements for qualification of personnel, and

7.4.2.1.3 quality management system requirements.

7.4.2.2 The organization ensures the adequacy of purchase requirements

prior to their communication to the suppliers.

7.4.3 Verification of purchased product

7.4.3.1 The organization inspects and tests all purchased products,

where appropriate, in order to ensure that they meet specified

purchase requirements.

7.4.3.2 Where the organization or its customer intends to perform

verification at the supplier's premises, the organization shall

state the intended verification arrangements and method of

product release in the purchasing information.

7.5 Production and service operations (Document ID # QMS –XX-XX-XX)

7.5.1 General

7.5.1.1 The organization plans and carries out production and service

provisions under controlled conditions. Controlled conditions

include





7.5.1.1.1 the availability of information that describes the

characteristics of the product,

7.5.1.1.2 the availability of work instructions, as necessary,

7.5.1.1.3 the use of suitable equipments,

7.5.1.1.4 the availability and use of monitoring and measuring

equipments,

7.5.1.1.5 the implementation of monitoring and measurement, and

7.5.1.1.6 the implementation of product release, delivery and post-

delivery activities.

7.5.2 Validation of processes for production and service provision

7.5.2.1 The organization validates any 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.

7.5.2.2 Where applicable, the validation process includes

7.5.2.2.1 defined criteria for review and approval of the

processes,

7.5.2.2.2 approval of equipment and qualification of

personnel,

7.5.2.2.3 use of specific methods and procedures,

7.5.2.2.4 requirements for records, and

7.5.2.2.5 re-validation.

7.5.3 Identification and traceability

7.5.3.1 All product status is identified throughout product

realization with respect to monitoring and measurement

requirements.





7.5.3.2 Where traceability is a requirement, the organization

controls and records the unique identification of the

product and maintains appropriate records.

7.5.4 Customer property

7.5.4.1 The organization reports any customer property that is

lost, damaged, or otherwise found to be unsuitable for use,

to the customer and maintains appropriate records. These

customer properties may include intellectual property and

personal data.

7.5.5 Preservation of product

7.5.5.1 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.

7.6 Control of monitoring and measuring equipment (DOCUMENT ID #

QMS-XX-XX-XX)

7.6.1 The organization maintains necessary monitoring and measurement

processes that are to be undertaken in order to provide evidence of

conformity of product requirements.

7.6.2 In order to ensure valid results, measuring equipments are

7.6.2.1 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;

7.6.2.2 adjusted or re-adjusted as necessary;

7.6.2.3 identified in order to determine its calibration status;





7.6.2.4 safeguarded from adjustment that would invalidate the

measurement result; and

7.6.2.5 protected from damage and deterioration during handling,

maintenance and storage.

7.6.3 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.

7.6.4 Records of the results of calibration and verification are maintained.








Clause 8 Measurement, analysis and improvement

8.1 General

8.1.1 The organization plans and implements necessary monitoring,

measurement, analysis and improvement processes needed in order to

8.1.1.1 demonstrate conformity to product requirements,

8.1.1.2 ensure conformity of the quality management system, and

8.1.1.3 continually improve the effectiveness of the quality management

system.

8.1.2 These processes include determination of applicable methods, including

statistical techniques, and the extent of their use.

8.2 Monitoring and measurement

8.2.1 Customer satisfaction (DOCUMENT ID # QMS-XX-XX-XX)

8.2.1.1 Information relating to customer perception is monitored and

measured in order to quantify customer satisfaction levels.

8.2.1.2 Monitoring customer perception may include obtaining input from

sources such as

8.2.1.2.1 customer satisfaction surveys,

8.2.1.2.2 user opinion surveys,

8.2.1.2.3 lost business analysis,

8.2.1.2.4 compliments,

8.2.1.2.5 warranty claims, etc.

8.2.2 Internal audit (DOCUMENT ID # QMS-XX-XX-XX)

8.2.2.1 Internal audits are conducted at planned interval to determine

whether the quality management system

8.2.2.1.1 conforms to the quality management system

requirements,






8.2.2.1.2 conforms to the requirements of the ISO 9001:2008

International Standard, and

8.2.2.1.3 is effectively implemented and maintained.

8.2.2.2 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.

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

8.2.2.4 Auditors are ensured to be objective, impartial and independent of

the area being audited.

8.2.2.5 A documented procedure is established to define the

responsibilities and requirements for planning and conducting

audits, establishing records and reporting results.

8.2.2.6 Records of the audits and their results are maintained.

8.2.2.7 The management 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.

8.2.2.8 Follow-up activities include the verification of the actions taken

and the reporting of verification results.

8.2.3 Monitoring and measurement of processes (DOCUMENT ID # QMS-

XX-XX-XX)

8.2.3.1 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.

8.2.3.2 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.

8.2.3.3 When planned results are not achieved, correction and corrective

action are taken, as appropriate.

8.2.4 Monitoring and measurement of product

8.2.4.1 Product characteristics are monitored and measured in order to

verify that requirements have been met. This is carried out at

appropriate stages of the product realization process in accordance

with the planned arrangements for the product.

8.2.4.2 Evidence of conformity with the acceptance criteria are maintained

and appropriate records indicate the person(s) authorizing release

of product for delivery to the customer.

8.2.4.3 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.

8.3 Control of nonconforming product (DOCUMENT ID # QMS-XX-XXX-XX)

8.3.1 The organization ensures that products which do not conform to product

requirements are identified and controlled to prevent unintended use or

delivery.

8.3.2 A documented procedure is established to define the controls and related

responsibilities and authorities for dealing with nonconforming product.

8.3.3 Where applicable, the organization deals with nonconforming product by

one of the following ways:

8.3.3.1 taking action to eliminate the detected nonconformity;

8.3.3.2 authorizing its use, release or acceptance under concession by a

relevant authority and, where applicable, by the customer;

8.3.3.3 taking action to preclude its original intended use or application;







8.3.3.4 taking action appropriate to the effects, or potential effects, of the

nonconformity when nonconforming product is detected after

delivery or use has started.

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

to demonstrate conformity to requirements.

8.3.5 Records of the nature of nonconformities and any subsequent actions taken,

including concessions obtained, are maintained.

8.4 Analysis of data (DOCUMENT ID # QMS-XX-XX-XX)

8.4.1 Data from monitoring and measurement activities are collected and analyzed

in order 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.

8.4.2 The analysis of data provides information relating to

8.4.2.1 customer satisfaction,

8.4.2.2 conformity to product requirements,

8.4.2.3 characteristics and trends of processes and products, including

opportunities for preventive action, and

8.4.2.4 suppliers.

8.4.3 A table has been drawn up to define the analysis process. The table defines

the

8.4.3.1 Data to be analyzed;

8.4.3.2 Methods of analysis;

8.4.3.3 Intervals between the analyses; and

8.4.3.4 Allocation of responsibilities.

8.5 Improvement

8.5.1 Continual improvement







8.5.1.1 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.

8.5.1.2 Improvement efforts are carried out by the Quality Management

System Committee at the quality management system level while at

the process level, the Quality Improvement Teams meet regularly to

identify ways and means to enhance the effectiveness of their

respective processes.

8.5.2 The organization takes appropriate action to eliminate the causes of

nonconformities in order to prevent recurrence. (DOCUMENT ID # QMS-

XX-XX-XX)

8.5.2.1 The organization ensures that the corrective actions are appropriate

to the effects of the nonconformities encountered.

8.5.2.2 A documented procedure is established to define requirements for

8.5.2.2.1 reviewing nonconformities including customer

complaints,

8.5.2.2.2 determining the causes of nonconformities,

8.5.2.2.3 evaluating the need for action to ensure that

nonconformities do not recur,

8.5.2.2.4 determining and implementing action needed,

8.5.2.2.5 records of the results of action taken, and

8.5.2.2.6 reviewing the effectiveness of the corrective action taken.

8.5.3 Preventive action (DOCUMENT ID # QMS-XX-XX-XX)

8.5.3.1 The organization determines action to eliminate the causes of

potential nonconformities in order to prevent their occurrence.

8.5.3.2 The organization ensures that preventive actions are appropriate to

the effects of the potential problems.

8.5.3.3 A documented procedure is established to define requirements for





8.5.3.3.1 determining potential nonconformities and their causes,

8.5.3.3.2 evaluating the need foe action to prevent occurrence of

nonconformities,

8.5.3.3.3 determining and implementing action needed,

8.5.3.3.4 records of results of action taken, and

8.5.3.3.5 reviewing the effectiveness of the preventive action

taken.





13612990 iso 90012008 quality management system manual

Documents

manual clause

requirements of iso

vocabulary document

title page

table of contents iso

improvement reference

effective application

regulatory requirements