ISO 90012008 Quality Management System Manual

Document originator Management Representative Page number 1 of 30
Quality Management System

Document title Effective date
Manual
Document number QMS-M-001-00 Revision number 00
Name Title Signature

Prepared by Management
Representative
Reviewed and approved Name Title Signature

by
REVISION HISTORY
Revision number DCF # DCF date Revision description
00 Initial issue
More ISO 9001:2008 documents at http://www.iso9001documents.blogspot.com
Distribution control status Master copy

Document title Quality Management System Manual Effective date
Table of contents
ISO Manual Title Page

9001:200 Clause
8 Clause
- - 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.
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ISO 90012008 Quality Management System Manual

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Document originator Management Representative Page number 1 of 30

Quality Management System

Name Title Signature

Reviewed and approved Name Title Signature

Revision number DCF # DCF date Revision description

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ISO Manual Title Page

3 3 Terms and definitions 5

4 4 Quality Management System 6

8 8 Measurement, analysis and improvement 25

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

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Clause 3 Terms and definitions

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Clause 4 Quality Management System

4.1 General requirements

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4.2.1.1.2 a quality manual,

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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

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Figure 1: Quality Management System Flow Diagram

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Clause 5 Management responsibility

5.1 Management commitment

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5.4.1.1 Quality objectives, including those to meet requirements for

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5.5.2.1.3 ensuring the promotion of awareness of

5.5.2.2 The responsibility of the Management Representative also includes

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5.5.3.3 Meeting minutes are maintained in order to ensure the effectiveness

5.6 Management review

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5.6.2.1.2 improvement of product related to customer requirements,

Clause 6 Resource management

6.1 Provision of resources

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6.1.3.3.2.2 provides training or take other actions to

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Clause 7 Product realization

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7.2.1.1.3 applicable statutory and regulatory

7.2.1.1.5 additional requirements considered necessary