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144 views30 pagesIso 9001-2008 PDF
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© © All Rights Reserved
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ISASO 9001 : 2008
Indian Standard
QUALITY MANAGEMENT SYSTEMS —
REQUIREMENTS
( Third Revision )
ICS 03.120.10
© BIS 2008
BUREAU OF INDIAN STANDARDS
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI 110002
December 2008 Price Group 10 Isso 9001 :
Contents Page
1 Scope
1.1 General
1.2. Application
2 Normative references
3 Terms and definitions
4 Quality management system
4.1 General requirements
42, Documentation requirements ..
5 Management responsibility ..
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management reviow ...
6 Resource management ..
6.1 Provision of resources
62 Human resources
6.3 Infrastructure
6.4 Work environment
7 Product realization
7. Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing 9
7.5. Produetion and service ProviSION wenn 10
7.8 Control of monitoring and measuring equipment .. 1"
8 Measurement, analysis and improvement 2
8.1 Gen 12
82. Monitoring and measurement ..
8.3. Control of nonconforming product
8.4 Analysis of da
85. Improvement
‘Annex A (informative) Correspondence between ISO 9001:2008 and ISO 14001:2004 16
‘Annex B (informative) Changes between ISO 9001:2000 and ISO 9001:2008 . 20
26
Bibliography .. ISASO 9001 : 2008
Introduction
0.4 General
‘The adoption of a quality management system should be a strategic decision of an organization. The design
{and implementation of an erganization's quality management system fs inuenced by
a) ‘ts organizational envionment, changes in that environment, and the risks associated with that
environment, :
b) its varying needs,
©) its particular objectives,
4) the products it provides,
€) the processes it employs,
4) its size and organizational structure,
It is not the intent of this International Standard to imply uniformity in the structure of quality management
systems or uniformity of documentation.
‘The quality management system requirements specified in this International Standard are complementary to
requirements for products. Information marked “NOTE” Is for guidance In understanding or clarifying the
associated requirement.
This International Standard can be used by internal and extemal parties, including certification bodies, to
assess the organization's abilty to meet customer, statutory and regulatory requirements applicable to the
product, and the organization's own requirements
“The quality management principles stated in ISO 9000 and 1SO 9004 have been taken into consideration during
the development of this International Standard.
0.2 Process approach
‘This International Standard promotes the adoption of a process approach when developing, implementing and
Improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting
customer requirements.
For an organization to function effectively, it has to determine and manage numerous linked activites. An
activity or set of activities using resources, and managed in order to enable the transformation of inputs into
outputs, can be considered as a process. Otten the output from one process directly forms the input tothe next
‘The application ofa system of protesses within an organization, together withthe identification and interactions
of these processes, and their management to produce the desired outcome, can be referred to as the “process
approach’.
‘An advantage of the process approach is the ongoing control that it provides over the linkage between the
individual processes within the system of processes, as well as over their combination and interaction.
‘When used within a quality management system, such an approach emphasizes the importance of
“ a) understanding and meeting requirements,
) the need to consider processes in terms of added value, ISASO 9001 : 2008
©) obtaining results of process performance and effectiveness, and
4) continual improvement of processes based on objective measurement,
‘The model of a process-based quality management system shown in Figure 1 illustrates the process linkages
presented in Clauses 4 to 8. This ilustration shows that customers play a significant role in defining
‘equirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to
‘customer perception as to whether the organization has met the customer requirements. The model shown in
Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed
level
NOTE. In addition, the methodology known as “Plan-Do-Check-Act" (POCA) can be applied to all processes. PDCA can be
bret, desorbed as flows.
Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and ihe
‘organization's pokcies.
Do: implement the processes.
Check: monitor and measure processes and product against policies, objectives and requirements for the product and
report the resus.
‘Act: take actions to continually improve process performance.
Continual improvement of
the quality management system
Customers,
TET
> Value-accng actives
= formation fow
Figure 1 — Model of a process-based quality management system ISSO 9001 : 2008
0.3 Relationship with ISO 9004
180 9001 and ISO 9004 are quality management system standards which have been designed to complement
‘each other, but can also be used independently.
180 9001 specifies requirements for a quality management system that can be used for internal application by
‘organizations, or for certification, of for contractual purposes. It focuses on the effectiveness of the quality
‘management system in meeting customer requirements.
{At the time of publication of tis Intemational Standard, 1S0 9004 is under revision. The revised edlion of
180.8004 wil provide guidance to management for actieving sustained success for any organization in a
complex, demanding, and ever changing, environment: 180 9004 provides a wider focus on qual
‘management than 180 8001; it addresses the needs and expectations of al interested parties and theif
satisfaction, bythe systematic and continual improvement ofthe organization’ performance. However, iis not
intended for certification, regulatory or contractual use.
0.4 Compatibility with other management systems
During the development of this Intemational Standard, due consideration was given to the provisions of
ISO 14001:2004 to enhance the compatiblity of the two standards for the benefit of the user community.
‘Annex A shows the correspondence between ISO 9001:2008 and ISO 14001:2004.
This International Standard does not include requirements specific to other management systems, such as
those particular to environmental management, occupational health and safely management, financial
‘management or risk management, However, this International Standard enables an organization to align or
Integrate its own quality management system with related management system requirements. It is possible for
an organization to adapt its existing management system(s) in order to establish a quality management system
that complies with the requirements of this International Standard. ISASO 9001 : 2008
Indian Standard
QUALITY MANAGEMENT SYSTEMS —
REQUIREMENTS
( Third Revision )
11 Gor
This Intemational Standard specifies requirements for a quality management system where an organization
2) needs to demonstrate its abilty to consistently provide product that meets customer and applicable
statutory and regulatory requirements, and
') alms to enhance customer satistaction 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.
NOTE 1 Inthis International Standard, the term “product” only applies 10
8) product intended fr, or required by, a customer,
1). any intended output resting from the product realization processes.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements
1.2 Application
[All requitements of this International Standard are generic and are intended to be applicable to all
‘organizations, regardiess of type, size and product provides.
Where any requirement{s) ofthis International Standard cannot be applied due to the nature of an organization
and its product, this can be considered for exclusion
Where exclusions are made, claims of conformity to this Internationa! Standard are not acceptable unless these
‘exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's.
ability, or responsibilty, to provide product that meets customer and applicable statutory and regulatory
requirements.
2. Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenzed document
(including any amendments) applies.
180 9000:2005, Quality management systems — Fundamentals and vocabulary
3. Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 apply.
‘Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean
“service” Isaso 9001
4 Quality management system
4.1, General requirements
‘The organization shall establish, document, implement and maintain a quality management system and
continually improve its effectiveness in accordance with the requirements ofthis Intemational Standard.
‘The organization shall
a) determine the processes needed for the quality management system and their application throughout the
organization (see 1.2),
'b) determine the sequence and interaction ofthese processes, :
©) determine criteria and methods needed to ensure that both the operation and contro! of these processes.
re effective,
4) ensure the availabilty of resources and information necessary to Support the operation and monitoring of
these processes,
2), monitor, measure where applicable, and analyse these processes, and
4) implement actions necessary to achieve planned results and continual improvement of these processes.
‘These processes shall be managed by the organization in accordance with the requirements of this
International Standard,
Where an organization chooses to outsource any process that affects product conformity to requirements, the
cxganization shall ensure control over such processes. The type and extent of contol to be applied to thase
‘outsourced processes shall be defined within the quality management system.
NOTE 1 Processes needed for the qualty management system refered to above include processes for management
actives, provision of resources, product realization, measurement, analysis and improvement.
NOTE 2_ An “outsourced provees" is process thal the organization needs for
the organization chooses to have performed by an external party.
ualty management system and which
|NOTE Ensuring control ever outsourced processes does not absolve the organization of the responsibilty of conformity
to all customer, stalviory and regulatory requirements, The type and extent of control to be applied to the outsourced
process can be influenced by factors such as.
4) the potential impact of the outsourced process on the organization's capably to provide product that conforms to
requirements,
1) the degree to which the contro forthe process is shared,
)_ the capabiy of achieving the necessary control through the application of 7.4
4.2, Documentation requirements
42.1 Generel
‘The quality management system decumerttion shall incls 12
2) documented statements ofa qualiy policy and quality objectives,
») 2 quality manual,
) documented procedures and records required by this International Standard, and
4) documents, including records, determined by the organization to be necessary to ensure the eifective
planning, operation and control of its processes. 1SASO 9001 : 2008
NOTE 1 Whore the tim ‘documented procedure" appears within this Intemational Standard, this means that the
procedure is established, documented, implemented and maintained. single document may address the requirements for
‘one or more procedures. A requirement fora documented procedure may be covered by more than one document.
NOTE 2 The extont of the quality management system documentation can differ rom one organization to another due to
4) the size of organization and type of activites,
) the complexity of processes and their interactions, and,
©) the competence of personnel
NOTE The documentation can be in any orm or type of medium,
422 Quality manual
“The organization shall establish and maintain a quality manual that includes
St oe coe come career eau Geen ol ne ecient cha]
(see 12),
the documented procedures established forthe qualty management system, or reference to them, and
€)_ a description ofthe interaction between the processes ofthe quality management system.
4.23 Control of documents
Documents required by the quality management system shall be controled. Records are a special type of
‘document and shall be controlled according tothe requirements given in 4.2.4,
‘A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
») to review and update as necessary and re-approve documents,
(©) to ensure that changes and the current revision status of documents are identified,
4) to ensure that relevant versions of applicable documents are cvailable at points of use,
) to ensure that documents remain legible and readily identifiable,
4) to ensure that documents of external origin detormined by the organization to be necessary forthe planning
and operation ofthe quality management system are identified and their distribution controlled, and
49) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are
retained for any purpose.
424 Control of records
Racords established to provide evidence of conformity to raquirements and of the effective operation of the
‘quality management system shall be controlled.
‘The organization shall establish a documented procedure to define the controls needed for the identification,
‘storage, protection, retrieval, retention and disposition of records.
Records shall remain iegbe, readily identifiable and retrievable.
5 Management responsibility
5.1, Management commitment
‘Top management shall provide evidence of its commitment to the development and implementation of the
‘quality management system and continually improving its effectiveness by Isso 9001 : 2008
8} communicating tothe organization the importance of meeting customer as well as statutory and regulatory
requirements,
) estabishing the quality policy,
)_ ensuring that quality objectives are established,
) conducting management reviews, and
©) ensuring the availabilty of resources.
5.2 Customer focus
Top management shall ensure that customer requirements are determined and are met with the aim of
enhancing customer satisfaction (see 7.2.1 and 82.1). és
53 Quality policy
“op management shal ensue that the quality policy
2) is appropriate tothe purpose of he organization,
») includes a commitment to comply with requirements and continually improve the effectiveness of the quality
management system,
©). provides a framework for establishing and reviewing quality objectives,
4) is communicated and understood within the organization, and
@) is reviewed for continuing suitability
5.4 Planning
5.4.1 Quality objectives
“Top management shall ensure that quality objectives, including those needed to meet requirements for product
{see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall
bbe measurablerand consistent wit the quality policy.
5.4.2 Quality management system planning
‘Top management shall ensure that
€)_ the planning of the quality management system is cartied out in order to meet the requirements given in 4.1,
as well as.the quality objectives, and
) the integrity of the quality management eystem is maintained when changes to the quality management
system are planned and implemented.
5.5 Responsibility, authority and communication
55.1 Responsibility and authority
‘Top management shall ensure that responsibilies and authorties are defined and communicated within the
organization Isso 9001 : 2008
55.2 Management representative
‘Top management shall appoint a member of the organization's management who, irespective of other
‘responsibilities, shail have responsibility and authority that includes
4) ensuring that processes needed for the quality management system are established, implemented and
maintained,
') reporting to top management on the performance of the quality management system and any need for
improvement, and
) ensuring the promotion of awareness of customer requirements throughout the organization,
NOTE he maposbity of management represen cn nc len wih eternal pares on mates eng o
the quality management system.
5.8.3 Internal communication
Top management shall ensure that appropriate communication processes are established within the
‘organization and that communication takes place regarding the effectiveness of the quality management
system,
5.6 Management review
5.6.1 General
‘Top management shall review the organization's quality management system. at planned intervals, to ensure its
continuing suitability, adequacy and effectiveness. This review shall inciude assessing opportunities for
improvement and the need for changes to the quality management system, including the quality policy and
quality objectives.
Records from management reviews shall be maintained (see 4.2.4)
5.62 Review input
‘The input to management review shall include information on
4) results of audits,
) customer feedback,
©) process performance and product conformity,
4) status of preventive and corrective actions,
©) follow-up actions from previous management reviews,
4) changes that could atfect the quality management system, and
‘9)_ recommendations for improvement.
5.6.3. Review output
The output from the management review shall include any decisions and actions related to
2) improvement ofthe etfectiveness of the quality management system and its processes,
) improvement of product related to customer requirements, and
€) resource needs. ISSO 9001 : 2008
6 Resource management
6.1. Provision of resources
‘The organization shall determine and provide the resources needed
42) toimplement and maintain the quality management system and continually improve its effectiveness, and
b) to-enhance customer satisfaction by meeting customer requirements.
6.2 Human resources
621 General
Personnel performing work affecting conformity to product requirements shall be competent on the basis of
appropriate education, traning, skils and experience,
NOTE Conformity to product requirements can be affected directly or indrecty by personnel performing any task within the
‘quality management system.
6.2.2 Competence, training and awareness,
‘The organization shall
1a) determine the necessary competence for personnel performing work affecting conformity to product
requirements,
-b)_ where applicable, provide training or take other actions to achieve the necessary competence,
©) evaluate the effectiveness of the actions taken,
4) ensure that its personnel are aware of the relevance and importance of their activities and how they
contribute to the achievement of the quality objectives, and
.e)_ maintain appropriate records of education, traning, skils and experience (see 4.2.4).
6.3 Infrastructure
‘The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to
product requirements Infrastructure includes, as applicable,
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
(©) supporting services (such as transport, communication or information systems).
6.4 Work environment
‘The organizai-on shall determine and manage the work environment needed to achieve conformity to product
requirements
NOTE The tem “work envionment” relates to those conditions under which work is performed including physical,
environment! sn ther factors (Such as noise, temperature, humid, ighting or weather) Isso 9001 : 2008
7 Product realization
7.1 Planning of product realization
‘The organization shall plan and develop the processes needed for product realization. Planning of product
realization shall be consistent withthe requirements of the other processes of the quality management system
(see 4.1).
In planning product realization, the organization shall determine the following, as appropriate:
2) quality objectives and requirements for the product;
the need to establish processes and documents, and to provide resources specific to the product;
€) required verification, validation, monitoring, measurement, inspection and test activities specific to the
product and the eta for product acceptance;
4) records needed to provide evidence that the realization processes and resulting product meet requirements
(se0 4.2.4).
“The output of this planning shall be in a form suitable forthe organization's method of operations.
NOTE 1 A document speciying the processes of the qualty management system (Including the product realization
‘rocesses) andthe resources to be applied toa spectic produc, projector contract can be referred to asa quality plan.
NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization
processes
7.2 Customer-related processes
7.21 Determination of requirements related to the product
‘The organization shall determine
12) requirements specified by the customer, including the requirements for delivery and post-delivery activites,
') requirements not stated by the customer but necessary for specified or intended use, where known,
©). statutory and reguiatory requirements applicable to the product, and
4) any additional requirements considered necessary by the organization
NOTE Postdeinery activites includ, for example, actions under warranty provisions, contractual obligations such as
maintenance services, and supplementary services such as recyeing or tna disposal
7.2.2. Review of requirements related to the product
‘The organization shall review the requirements related to the product. This review shall be conducted prior to
the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of
‘eontracts or orders, acceptance of changes to contracts or orders) and shall ensure that
a) product requirements are defined,
') contract or order requirements difering from those previously expressed are resolved, and
)_ the organization has the ability to meet the defined requirements.
Recons ofthe results ofthe review and actions arising from the review shall be maintained (see 4.2.4).
Where the customer provides no documented statement of requirement, the customer requirements shall be
onfirmed by the organization before acceptance. ISSO 9001 : 2008
Where product requirements,are changed, the organization shall ensure that relevant documents are amended
and that relevant personnel are made aware of the changed requirements.
NOTE In some stations, such as internet sales, a formal review i impractical or each order. Instead the review can cover
relevant prodvct information such as catalogues or advertising materia
7.23 Customer communication
‘The organization shall determine and implement elfective arrangements for communicating with customers in
relation to
a) product information,
) enquiries, contracts or order handling, including amendments, and
©) customer feedback, including customer complaints,
7.3. Design and development
7.3.1 Design and development planning
‘The organization shall plan and control the design and development of product.
During the design and development planning, the organization shall determine
1) the design and development stages,
) the review, verification and validation that are appropriate to each design and development stage, and.
©). the responsibilities and authorities for design and development.
‘The organization shall manage the interfaces between different groups involved in design and development to
ensure etfective communication and clear assignment of responsibilty.
Planning output shall be updated, as appropriate, as the design and development progresses.
NOTE Design and development review, verification and validation have distinct purposes. They can be conducted and
‘recorded separately or in any combination, as sultabe forthe product andthe organization.
73.2. Design and development inputs
Inputs relating to product requirements shall be determined and records maintained (see 42.4). These inputs
shall include
‘functional and performance requirements,
applicable statutory and regulatory requirements,
(©) where applicable, information derived from previous similar designs, and
{) other requirements essential for design and development.
‘The inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict
with each other.
7.3.3. Design and development outputs
‘outputs of design and development shall be in a form suitable for verification against the design and
“lopment input ar shall be approved priorto release IsMSO 9001 : 2008
Design and development ouput shal
2) met he Input requirements or design and developer
©) provide appropriate formation fr purchasing; production and src rovion,
©) contin or eterene reduc acceptance cite, and
6) sect the charactrsts ofthe produ hat ae essental forts safe and proper use.
[NOTE Information for production and sevice provision can include detals forthe preservation of product,
7.34 Design and development review
At sutable stages, systematic reviews of design and development shall be performed in accordance with
planned arrangements (see 7.3.1)
a) to evaluate the ability of the results of design and development to meet requirements, and
) to identity any problems and propose necessary actions.
Participants in such reviews shall include representatives of functions concerned with the design and
development stage(s) being reviewed. Records ofthe results of the reviews and any necessary actions shall be
maintained (see 4.2.4).
7.3.5 Design and development verification
é
Veriton shale performed in accordance wih planned arrangements (60 7.3.1) 9 ensure thatthe design
and development outputs have met the design and development input requirements. Records of the results of
the vertcaton and any necessary atone shal be maintained (eee 42),
7.38 Design and development validation
Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to
fencure that the resulting product is capable of meeting the requirements for the specified application or
intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or
implementation of the product. Records of the results of validation and any necessary actions shall be
‘maintained (see 4.2.4)
7.3.7 Control of design and development changes
Design and development changes shall be identified and records maintained. The changes shall be reviewed,
verified and validated, as appropriate, and approved before implementation. The review of design and
‘development changes shall include evaluation of the effect of the changes on constituent parts and product
already delivered. Records of the results of the review of changes and any necessary actions shall be
maintained (see 4.2.4)
7.4 Purchasing
7.41 Purchasing process
‘The organization shall ensure that purchased product conforms to specified purchase requirements. The type
land extent of control applied to the supplier and the purchased product shall be dependent upon the effect of
the purchased product on subsequent product realization or the final product. ISASO 9001 : 2008
‘The organization sal evaluate and select suppliers based ont abit to suply product in accordance wih
the onantatons requramertaCrtera fr selection, evlusbon on rerrahiion hal be eeabiched
Records of he reeufa ot vahiatons and any necessary actors aning Wom te evaluat shallbe maintained
(ceo a2).
7.42 Purchasing information
Purchasing information shall describe the product to be purchased, including, where appropriate,
4) requirements for approval of product, procedures, processes and equipment,
) requirements for qualification of personnel, and
©) qualty management system requirements.
‘The organization shall ensure the adequacy of specified purchase requirements prior to their communication to
the supplier. a
7.4.3 Verification of purchased product
‘The organization shall establish and implement the inspection or other activities necessary for ensuring that
purchased product meets specified purchase requirements.
‘Where the organization or its customer intends to perform verification at the suppliers premises, the
‘organization shall state the intended verification arrangements and method of product release in the purchasing
information.
7.5. Production and service provision
7.5. Control of production and service provision
&
“The organization shall plan anc camry out production and service provision under controled conditions.
Controlled conditions shal inlucc, as applicable,
2) the availabilty of informatior. that describes the characteristics ofthe product,
) the avaablty of work instructions, as necessary,
©) the use of suitable equipment.
4) the availabilty and use of monitoring and measuring equipment,
©) the implementation of monitoring anc measurement, and
4) the implementation of product release, delivery and post-deivery activites,
‘7.5.2 Validation of processes for production and service provision
The organization shall validate any processes for production and service provision where the resulting output
cannot be verted by subsequent monitoring or measurement and, as a consequence, deficiencies become
apparent only after the product is in use or the service has been delivered.
Validation shall demonstrate the ability of these processes to achieve planned results.
‘The organization shall establish arrangements for these processes including, as applicable,
{defined criteria for review and approval ofthe processes,
) approval of equipment and qualification of personnel,
©) use of specific methods and procedures,
10 ISSO 9001 : 2008
1) requirements for records (see 4.2.4), and
) revalidation,
7.83. Identification and traceability
Where appropriate, the organization shall identity the product by suitable means throughout product realization,
‘The organization shall identify the product status with respect to monitoring and measurement requirements
throughout product reaiizaton.
Were traceabity isa requirement, the organization shal conto the unique identification of the product and
maintain records (see 42.4).
NOTE In some industry sectors, configuration management is a means by which Identification and traceabity are
maintained,
7.54 Customer property
‘The organization shall exercise care with customer property while itis under the organization's control or being
used by the organization. The organization shall identity, verity, protect and safeguard customer property
provided for use or incorporation into the product. I any customer property is lost, damaged cr otherwise found
to be unsuitable for use, the organization shall report ths tothe customer and maintain records (see 4.2.4)
[NOTE Customer property can include intellectual property and personal data.
7.8 Preservation of product
“The organization shall preserve the product during intemal processing and delivery to the intended destination
in order to maintain conformity to requirements. As applicable, preservation shall include identification,
‘handing, packaging, storage and protection. Preservation shall also apply tothe constituent parts ofa product.
7.8 Control of monitoring and measuring equipment
‘The organization shall determine the monitoring and measurement to be undertaken and the monitoring and.
‘measuring equipment needed to provide evidence of conformity of product to determined requirements.
‘The organization shall establish processes to ensure that monitoring and measurement can be carried out and,
are carried out in a manner that is consistent withthe monitoring and measurement requirements,
‘Where necessary to ensure valid resuts, measuring equipment shall
2, be calibrated or veiled, or both, at specified intervals, or prior to use, against measurement standards
‘raceable to international or national measurement standards; where no such standards exist, the basis
Used for calibration or verification shall be recorded (see 4.2.4)
bbe adjusted or re-adjusted as necessary;
©) have identification in order to determine its calibration status;
)__be saleguarded from adjustments that would invalidate the measurement result;
€@) be protected from damage and deterioration during handling, maintenance and storage.
In addition, the organization shall assess and record the validity of the previous measuring results when the
‘equipment is found not to conform to requirements. The organization shall take appropriate action on the
‘equipment and any product affected.
Records ofthe results of calibration and verfcation shall be maintained (see 4.2.4).
" ISSO 9001 : 2008
When used in the monitoring and measurement of specitied requirements, the ability of computer software to
satisfy the intended application shall be confirmed, This shall be undertaken prior to initial use and reconfirmed
as necessary. ¥
NOTE Confirmation of the abity of computer software to salisty the intended application would typically include its
vetiication and configuration management to maintain its suitably fr use.
8 Measurement, analysis and improvement
8.1 General
‘The organization shall plan and implement the monitoring, measurement, analysis and improvement processes
needed = ig
4) to demonstrate conformity to product requirements,
») to ensure conformity ofthe qualty management system, and
€) to continually improve the etfectiveness of the quality management system.
This shail include determination of applicable methods, including statistical techniques, and the extent oftheir
use,
8.2. Monitoring and measurement
8.2.1 Customer satisfaction
‘As one of the measurements of the performance of the quality management system, the organization shall,
‘monitor information relating to customer perception as to whether the organization has met customer
requirements. The methods for obtaining and using this information shall be determined,
NOTE Monitoring customer perception can include obtaining input from sources such as customer satistaction surveys,
‘customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, waranty claims and
dealer repors.
8.2.2 Internal audit
‘The organization shall conduct internal audits at planned intervals to determine whether the quality
management system
2). conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to
the quality management system requirements established by the organization, and,
b) is effectively implemented and maintained,
‘An audit programme shall be planned, 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
shall be defined. The selection of auditors and conduct of aucits shall ensure objectivity and impartiality ofthe
‘audit process. Auditors shall not audit their own work
‘A documented procedure shall be established to define the responsibilities and requirements for planning and
Conducting audits, establishing records and reporting results.
Records of the audits and their results shall be maintained (see 4.2.4)
‘The management. responsible for the area being audited shall ensure that any necessary corrections and
corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.
12 Isso 9001 : 2008
Follow-up activities shall include the verification of the actions taken and the reporting of verification results
(see 852).
NOTE Soe ISO 19011 for guidance.
8.2.3 Monitoring and measurement of processes
‘The organization shall apply suitable methods for monitoring and, where applicable, measurement ofthe quality
management system processes. These methods shall demonstrate the abilly of the processes to achieve
planned results. When planned results are not achieved, correction and corrective action shall be taken, as
appropriate. ib
[NOTE When determining sultable methods, itis advisable thatthe organization consider the type and extent of monitoring
‘or measurement appropriate o each offs processes in relation to their impact onthe conformity to product requireme’ts
‘and onthe effectiveness ofthe quality management system
8.2.4 Monitoring and measurement of product
‘The organization shall_monitor and measure the characteristics of the product to verily that product
requirements have been met. This shall be carried out at appropriate stages of the product realization process
in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance eriteria
‘shall be maintained,
Records sh
‘The release of product and delivery of service tothe customer shall not proceed until the planned arrangements
(see 7.1) have been satistactorly completed, unless otherwise approved by a relevant authority and, where
applicable, by the customer.
indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4)
8.3. Control of nonconforming product
‘The organization shal ensure that product which does not conform to product requirements is identified and
controled to prevent ts unintended use or delivery. A documented procedure shall be established io deine the
Controls and related responsibilties and authorities for dealing with nonconforming product.
\Where applicabl; tie organization shall deal with nonconforming product by one or more of the following ways
‘) by taking action to eliminate the detected nonconformity:
b) by authorizing its use, release or acceptance under concession by a relevant authority and, where
applicable by the customer,
©) by taking action to preclude its original intended use or application;
4). by taking action 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 shall be subject to re-verification to demonstrate conformity to the
requirements. =
Records ofthe nature of nonconformities and any subsequent actions taken, including concessions obtained,
shall be maintained (see 4.2.4).
8.4 Analysis of data
‘The organization shall determine, collect and analyse appropriate data to demonstrate the suitabilily and
effectiveness of the qually management system and to evaluate where continual improvement of the
effectiveness of the quality management system can be made. This shall include data generated as a result of
‘monitoring and measurement and from other relevant sources.
¥
13 ISSO 9001 : 2008
‘The analysis of data shall provide information relating to
a) customer satistaction (see 8.2.1),
1b) conformity to product requirements (see 8.2.4),
©) characteristics and trends of processes and products, including opportunities for preventive action
(see 82.3 and 8.2.4), and
4) suppliers (see 7.4).
85. Improvement
85.1. Continual improvement
‘The organization shall continually improve the effectiveness of the quality manager-ent system through ‘he use
of the quality policy, quality objectives, audit resuts, analysis of data, corrective and preventive actions and
‘management review. a
852 Corrective action
‘The organization shall ake action to eliminate the causes of noncontormities in order to prevent recurrence.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
‘A documented procedure shall be established to define requirements for
a) reviewing nonconformities (including customer complaints),
) determining the causes of nonconformities,
)_ evaluating the need for action to ensure that nonconformities do not recur,
4d) determining and implementing action needed,
‘e) records of the results of action taken (see 4.2.4), and
4) reviewing the effectiveness of the corrective action taker.
5.3. Preventive action
2
‘The organization shall determine action to eliminate the causes o potential noncorformities in order to prevent
their occurrence. Preventive actions shall be appropriate to the effects of the potential problems,
Ra arene en cee)
aaa
oe
een
eee eee
€) reviewing the elfectiveness of the preventive action taken.
“4 Annex A
(informative)
Correspondence between ISO 9001:2008 and ISO 14001:2004
‘Table A.1 — Correspondence between ISO 9001:2008 and ISO 14001:2004
150 9007:2008 150 14001:2008
nvoaucion (te onby irvegicton
oneal os
Process approach lo2 :
Retaionsip wih iS0 9008 los
Compatbity wih cher management systoms [0
Scope cite ont) + [|S
General ha
Aplication h2
Normative references iz ornate references
Fes and datnons 3 arms and defor
[Quay management syste ie ony) g Exon marapenan stan arenes
[Generarrequrerers fat__[a1 | Genera requirements
[Documentation requremeris (ie ori) 2
Gener js2t [aaa |Dacimeniaton
uaiy manvat a
Consort documents faz [aes |Ganvol of documents
oniot of ecords jaa [asa [Convol of records
Management responsiiy ite ony) is
Manogement commitment Is [42 |Emronmenta poty
14.1 [Resouces roles, responsbity and authoty
[Cusiomertoeus [52 [431 [Environmental aspects
1432 |Lega! and eter requements
J46 _ [Management review
[Quaity poly 2 [53_[42 _|Emvronmental policy
[Planing ite on) [54 [43 [tanning ite ony)
[Quay objectives 54:1 [433 | Objectives, trgets and programma)
[Quaity management sytem panning 542 [433 _|Objecves, targets and programme()
spre, autoryanacenmnesion es
on
Respanabity and aubory [551 [47 |General vequremenis
[41 |Resoures, roles, esponsibity and authority
Management representative [552_[44:1_ [Resources roles, responsibly and auborty
irierntconmonicaton [55a [443 [Communication
Management review (ie oni) [58 [46 [Management review
[Gener [567 [46 [Management review
Review npat [562 [x6 | Managomert review
Review ouput [563 [46 |Managoment review
15 ISSO 9001 : 2008
Table A.1 — Correspondence between ISO 9001:2008 and ISO 14001:2004 (continued)
750.9007:2008 150 14001-2008
[Resource management (ile oni) ie
Provision of resources le [44.1 |Resources, roles, responsibilty and authori
[Human resources (tite oni) lez.
[General [62.1 [442 |Compotonco,vaining and awareness
[Competence raining and awareness [522 [442 [Competence raining and awareness
ntrastructure [53 [441 |Resources, roles, responsibilty and authority
Work environment lea
Product reatzaton (ile ony) [7&4 |ieplementation and operation (tle ony)
Pianning of product realization [71 [448 [Operational contol 5
[Customer-elated processes (ile ony) ra.
[Determination of requirements elatedto the _|7.2.1 [481 _|Endronmental aspecis
pane [4.32 |Legal and other requirements:
[4.46 |Operational control
Review of requirements elated tothe product [722 [4.31 [Environmental aspects
[446 |Operational contol
[Customer communication [723 [443 [Communication
Design and development ite ony) 3.
Design and development planning [7.3:1_|4.46 [Operational control
Design and development inputs [7.32 _|4.46 [Operational control
Design and development outputs [7.93 [4.46 [Operational control
Design and development review [7.34 [4.46 [Operational control
Design and development verification [735 [446 [Operational control
[Design and development validation [736 [4.46 _|Operational control
[Cont of design and development changes {7.8.7 _|446 [Operational control
Purchasing (ite oni) ra
Purchasing process [7.4:1_|&46 _|Operational control
Purchasing information [7.42 _|446 [Operational control
[Verication of purchased product [743 [446 [Operational conto!
Production and service provision (ile only) ig
[Control of production and service provision [75:1 [4.46 |Operational contro!
|Vaidaion of processes for production and service |7.52 [44.6 [Operational control
Jrovision
identification and waceabity rsa
[Customer propery 75a
Preservation of product [755 [448 [Operational control
[Control of monitoring andmeasuring equipment [7.6 [45.1 [Monitoring and measurement
[Measurement analysis and improvement (ile oni|[8 [45 [Checking (ite only)
[General Ja [45.1 [Monitoring and measurement
Monitoring and measurement (ie only) a2
[Customer satisfaction leat
internal avait la22 [455 |inemal avai
Monitoring and measurement of processes l823 [451 [Monitoring and measurement
1452 [Evaluation of compliance
16 ISASO 9001 : 2008
Table A.1 — Correspondence between ISO 9001:2008 and ISO 14001:2004 (continued)
150 9007-2008 150 14001-2008
[Monitoring and measurement of product [824 ]&5:1 | Montoring end measurement
[452_|Evauaton of compliance
[Cont ot nonconforming product JS [447 [Emergency preparedness and response
[453 |Nencntormty, coecive acton and preven
[Analysis of data [84 [45.1_|Montoring and measurement
improvement ile only) es,
[Continual improvement 851 42 [Environmental policy
[433 | objectives targets and programme(s)
l46 [Management reviow
[Comecive action E2653. [Nercntomiy, conocive cian and prong
Preventive action lass [asa
|Nonconformiy, corrective action and preventve|
lection
7 ISASO 9001 : 2008
‘Table A.2 — Correspondence between ISO 14001:2004 and ISO 9001:2008
Bo ToT IO" 15 9003008
faveaaion Taran ie nny
ox foener
oa frees approach
os |ratatonaip wen 160 9004
ou _[canpateaty win oer management syste
Spe Ji |B nin
1 leone
12 _|aoteaon
erate wrces pla — nerve rtrncne
ems ard defntons fsa [rome and deine :
Eneeoer reapsnoayion ames || |Biaymaacoer an oo
e
Sonera eairomane lai at [enero
55. ess, aut an onmanatn
s.1_[responstiy and ator
Eonar aay bea Iaageran continent
|Quality policy
conta! rrovement
Pianning ile ont) [3 [Planing (ite ont) |
Emwronmental specs fear fomiomer one
1221 Josteminaion of reqiremens raed 10 ta
pros
7.22 [reve of reqirarans odo he product
Cet and car aquremens 1aaa [ea —louiomer ass
721 Jonrminaton of requremans relates 10 te
edit
[oes ape nd pregame) naa eat [ony copcies
542 [oxaty managamentaytom aming
25.1 |Connua provenont
limplementation and operation (title only) 44 7 | Product realization (title only)
estes rcs responsty end auhoriy [4418.7] Wanaget ommament
5.5.1 |Responatary an autoey
552 |Maragenentepesenaive
1 [Peon of ecueas
a _fsasicie
[Competence, training and awareness ~ |4.42 [621 |(Human resources) General
2.2 |canoetoce, ining and varnees
[Communication 14.4.3 |8.5.3 [intemal communication
72._|cusoner conuicaten
[4.44 [42.1 |(Documentation requirements) General
— eas [az [eanre ot docu
18 ISASO 9001 : 2008
‘Table A.2— Correspondence between ISO 14001:2004 and ISO 9001:2008 (continued)
lass
180 14007-2008 150 9007:2008
[Operational contra) Jaa6 [7-1 [Planning of product realization
l72 | customer-elaed processes (tile only)
172.1 |Determination of requirements related to. the|
product
}7.22 |Review of requirements related tothe product
17.3.1 |Design and development planning
[7.32 [Design and development inputs
1733 |Design and development outputs
[7.3.4 [Design and development review
1735. |Design and development verification
[7.3.8 [Design and development validation
17.7. |Contra of design and development changes
1.4: |Purchasing process
17.42. |Purchasing information
17.43. |ertication of purchased product
175 | Production and service provision ttle only)
175.1. |Conto o production and service provision
1752. | validation of processes for production and servico|
provision
1755 | Preservation of product
[Emergency preparedness and response [447 [8.3 | Control of nonconforming product
[checking (ttle ony) [45 |e [Measurement analysis and improvement (ile ony)
[Mentoring and measurement [451 [7.6 [Control of monitoring and measuring equipment
8.1 | Measurement, analysis and improvement) General
18.23 |montoring and measurement of processes
J8.24 | ontoring and measurement of product,
Jb |analysis ot data
Evaluation of compliance |452 [825 |Montoring and measurement of processes
[8.24 | Monitoring and measurement of product
Nonconformiy, corecve action and preventive [4.3 [8.3 _|Contol of nonconforming product
ection la4 [Analysis of data
la52 |corective action
|a53 [Preventive action
[Control of records lesa [424 [Control of records :
internal aut [455 [022 [Internal avait
Management review [a6 _|&1 [Management commitment
156 | wanagement review ttle ony)
ls61 |General
l5.62 [Review input
[563 |Review output
|Continual improvement ISASO 9001 : 2008
Annex B
(informative)
Changes between ISO 9001:2000 and ISO 9991:2008
‘Table B.1 — Changes between ISO 9001:2000 and ISO 9401:2008,
so s00:200| "gre | taror
‘Clause No.'| Table! | Deletion ——
ote | o)
[Fowword |Parm® [0+ A” meratonal Standards ae raed n accordance win te rales Gven nro SORE Drecbes
|por Pac2
fFoword [Pama (A | Ihamainasi of echnical commiieas io aoa Inenalonal Sada
[Sentence 1
JFoword [Pama [D+A |Atonton w awn 10 the possbily thal some of ho comnts of tis iomatenar Sanaa
Sontesce 1 [acamact maybe the sbjet of pater gts
[Foword [Pas [0 | momatonol-Standard 150 8001 wat prepared by Tociical Commies ISO/TC 178, Guay]
management and quay assurance, Subcornmitee SC 2, Qualty systems
[Focwond [Paae [0 | hin urd nion 1160 600% oanoolo and opaaps te ssoond olen (50.0001 064 opr
wen 150-2002 104-and160 0003-1004 t-oonule otoohnieaoveion o tose dooumens |
"ihoe-orgaatatone which have-wod 450 00084054 ond 160 0000-1004 the gastmay ve
ne iiocnatono Standart by asl aor onucomontsnaooordanen wth v2
[A [Tictuch tion cancels and renlaces the til edion (S0800%-2000)afich has ben|
meade in cian pits nthe est and in eohance compat wh SO 14001-2004.
[Foward [Paa? [0 ftw to 0160 600%-hon boon rovond in fue edion and no longer nolodes tho orm ay
cptinent tin ena engi nnn tanner
Fa pe
[occomoreataction-
[Foewod [Pane |0 [Annexes Aand/Sal te ilomainal Sundand arlornlormoton an
[Fooword _[Newpaa7 |A Dell fib ctangaa bein ite tic aian andi uh edtion aa oben n Annan
low Pam 1, 0 ¥e-doign ara taporantaton aban arparianon quay managomont-ajstar i lvondod
Sonerce2 \brsaryng nome partonae stjoion the pots prow the poconsor employed ae
[ezeand dvvoure-t he erganeton,
[A | Mestesion andinsienentaton oan amaniaions ally management sysemainfuancid
bw
J) ts aganizatonalenvinoment change ia hal envicnment. and ie sks associated win]
faLendonment
lb) usarina needs:
J) nadie obioctins:
lo) epost ides:
fo) tre pocasses ema:
|). tasiznand oganizatonalsiucie,
[Sentences TNowa [i not the nt of tis Iniornationa) Standard wo Frey wnorrity the etre of quay]
now para |managerent systems or untormty of documentation.
ox JPaas [A | his irrational Standard can be usd by ieral and ecernal patos, nding corean|
leodes, to ass0s5 the organzaton's ably to moot customer, salon and regain
|equemontsanoicable oi adc. ance organizavor's own requrements.
oz JPam2 [D+ [Foren crantzation to incon fect, has tc Menaly dtarmina and mancge numerous
lrwoa aves. An acvty ase. acic using recouees and managed in orer to enable
|e tanetormation of inputs no ouput, car be considered as «process ISASO 9001 : 2008
‘Table 8.1 — Changes between 1S0 9001:2000 and ISO 9001:2008 (continued)
Paragraph | Adio |
ts0 s00t:2000) “Figure! | A) or a
‘Cuuse No. | Tabla | Dotton | ——
Wot | (o)
oz Paes |A |The aplicaion ols syst of pocesies win an rpaizaion ogator wit to encao]
land interactons of he prcesses, andthe management ig pixavoa ne desi ausoms |
oan be rere o asta “process approach”
los JPaat [0+A | eeprsantetions F150 9001 and 50 0004 have boon devoted ava oonalons para ao
|aaity maragemorteytom standards whch hav boon detzred to complomnt each other
lot canals bo used Independent, Athough-to-to-Ioratona Sinderde hav-orn
los JPaas [Dea
low fea) 8 Eee hlaascne Signor Ras boon ap ES HAM EEE cor pa |
a Jexteray |x Ja)_noeds to demonstrates ably to consisonty provide product hat meets custome and |
|apescablestanuaey and reguatory requirements, and \
joutet) |x lo) aims to enhance customer sasstaction trough te elacive application ofthe sysiom. |
inctucing process for cotnual improvement oh system andthe assurance of contami to
|cstomer and appa stay and requtory reqroments
|
Nowe —_|>_—_| No FE Antic nomationa! Standart tho tom produ appoe ont the prod tondod or
New Note2 [A ——_|NOTE2 Santor and raul sulemans can he exnssad as ecalreuicemants,
ne Faas [A _|Whavo exausane ao made, caine of concmity to tie Inomatonal Standard avo ht
accopiablo unless thaso excusions are ited te requremenis win Clause7. and suc
excisions donot fect the erganizaton’s ably, or responsi, fo provide product hat mee |
evstomer and applcabe salary and regio requirements. |
le [Part [D +A [Fre tokonng normale dooumont contains provision whieh _Bwowgh taorance Re
loa [IS0-se00aosea00s, Guay management systems— Fundamentals ad vocabuiary | tSASO 9001 : 2008
‘Table B.1 — Changes between ISO $001:2000 and ISO 8001:2008 (continued)
aa
‘aor
Amended ext
GC
Ie [Parat [0 +A |For te purposos of tis documact taematenal iondard the Tora and daiilons Gren
150 9000 apo.
q [Paras2,3 [| he tome torn sod h dis olin oF 160.0001 -o derbe the supply Sean have bon]
nif
poten troughout te organization 6001.2),
far JBatere) [A |e) mentor, measore wher anlcabl, and anaes these processes, and
|
| fer stray [OA |) wen aaemioa be proceies andes re Gay manager sem ardor
| far [Pama [0 +A [Where an orantzaton choses to odscuree any process that ales product contri wi a
i | requements, the ogarizaton shal ersure anal ovr such process. Ina yma and xia |
| onuol ine opted a these ousoued processes shale defined wii te ly
i management system,
|) ler INciot [D +A |NOTE Processes ranted Io the qually manapomen aya rolerod t above shows
|nciude processes for management actwties, proven of resources, product realzaon, and]
i |moasuremert, analysis and kneraamos.
ler New | _ (MONE An “nusoutced emoess” i a orcas thal the organization needs forts quali
Notes 28.3 management sysem and which ie oranzaton chooses i have permed by an axtacal
i
| faaw [Butore) [A _|@)doeurmerted procedwres and mca oqured by is eration Slandar and
laa lButoray [A+0 |e) cocumers, nusing receda, needed deerined by he organization Ibe naceasaay'©
[ensure te eetve paring. operation and con olt procaatas and
e)-1eoor sed ype ematonar indent (ece4aep
| fazs Naw [A NOTE + where the term "docomeniod prea” appear witin tis ireratonl Sundar
|
|
ts rears atte proce estaba, courant, pend ad areas 4
[aaa [Bator [A to ensure hat documents of terval orn
‘re ied and ol
\dsioubon contoted and
[aaa [Pari [0 >A |Resards oxtib ectabiahed and mainanod io provide ovdonce of conor to roquronent|
land o ho etecive operaton ofthe quay management sysom shal bu carl. Record]
snot somasnionbi ead dante ancvaiovbia.
i [tne erganaaten shal eslatish a documentod procedure chal-be-esstshed to define te]
conte needed otha artical, srape protectin, retieval, rotor ire and depoisn|
[Beco shall emai lege saci entible and tigate.
Past [A [Topmanagonen shal appania mare ol he agangalna Panagement who, irespocive
ctr responses, sha have responsbity and aunty at nudes
Pat |AvD [Personal pevorning won afecing conirmib_io product qvaty caaummenis chal be
[compote on ie bass of appropiate education, vahing sls and experienc.
New Note }A (NOTE Conformity to oroct remutements canbe atosid cect or ndvecly by earonna
[pedorming any asa the gully management sien.
I 22 ISASO 9001 : 2008
‘Table B.1 — Changes between ISO 9001:2000 and ISO 9001:2008 (continued)
Paragrapi | Adin |
!s0 s001:2000| “Figures | (A) or aa
‘Clause No.'| Table! | Deletion | peta
ote | (0)
saz [Gauss ie [A+ 0 |Conpetonc, kang and awareness anasranng
saa feutos favo
las)
[as jouer a
lea [New Now [a
Fa [eure [avo
ra [Baer [A _|0) required vorication valdaion, morionng, RSBRAAA inspection andes aces
sbectc ote product andthe cera for product acceptane
Za JBaiers) [DA |e) statory and regulatory requirements elated anslabla othe product and
levers, |o+a |@) ary adtonaroquroment doteminod considered nacasary bythe oganzaton
INewnoe 4 (NOTE Paskteeeny actos Incude. foc examola.actona_undec_waracty_srvsicos |
conmcual ogaions such as-malniacance seccesand supplemariary sana Such 2
recsing cal ciscasal
ras INewNoe [A OE Desion and dvelcomentsvaw.atiicton and alain hava disioct ourposes They
san be conducted and recoiied seoaraiey rin ay combinaloa ax suai rine nd an
Ine ocganizaten.
irae JPaa2 |D+A |Fhoco Tha inputs chal be rovawed tr adequacy Raquremonis shall be conics
lunamtiguous and notin confit wit each othe.
aa [Part [D+A |The cupsta of dasgn and davlopmant shall be provdoa is orm thar enables ina for
uate fr verfeaton against he dengn and developmant nut and sas be approved ri
‘eoase
Za [Buterb) [2 [01 provide appropriation for purchasing, prodsctn and ler sence provaon
a3 Now Waie |X
raz [Pas 182 [Nowa |Dasign and dsvlopman! changes shal be lend and records malnained: The changos shal
Jenange._ [be reviewed, verified and validated, as appropiate, and approved bere implemeriaton. The|
[Pars |rovaw of design and dovlopmort changes shal icuds evaluation ofthe affect of he change
Jnow [on consituort pats and product already dlvere. Records ofthe results of the revo of
merged [changes and any necessary acon shallbemaiaied (se0 42.4)
rsa JButera)_[D+A [ay te aalabity and use of montomng and measuring avewssaubmaat
rsa Jaator [A |? theimplonontaion of pal retease,dalvery and postaetvery actives
ree Para |D+A |The orparizaton shall vada any processes for production and earvice provision where tel
resuting ouput cannot vriied by subsequent montoning or measurement Fveineudor |
|noraceeeswhore and asa consaquanca, defences become apparent oly afer bm pros
In use ortho sorvce has boon devred.
rss [Paez [A |The onganizaton shal deny the product stave wih expec fo montoring nd measurement
requiremectstnouchout roc elation
rsa JPaas [D+A |Wrore vaceabiy & roquroment, the oianizaon shal con and-fecord the unique
entiation of he prosuct and masta rca (see 42.)
lrsa [Part [D+A _ |Wtany custome proper is bs, damaged or oherwise found io be unstable or se, woe
Semance 3 \neroporie t-te ovstonor-and-ovorde maitained ine organization shall aba ins la ta
|austomerand mainain ean 808 42.)
Note |A__|NOTE Customer propery can inchudeirteletual propery and prsonal a, | IsnSo 9001 : 2008
| ‘Table B.1 — Changes between ISO 9001:2000 and ISO 9001:2008 (continued)
Paregraph | Adin
| ts0 91200] "Faure | “aber
| ‘Caw, | ot | onto omraetid
Hts | he | oO
AI [rss [Pat [DA | Theorpnaton sa pesove fo endbndof puedo rere proonangand coon]
to he irtended destnation naar in mantan cafe to requirements, ve A ancl |
! ‘shal indie Idenifcaion, handing, packaging. slorage and protcton.
| | [Preservation shal iso appl the constituent parts of a product
| rs [Tie [D +A _|Canvol ot mentoring and measuring evooe anak
re [Part [DA |The orparizaon sal doternine the monioing ard measurement to bo underakan and te
) lmontonng and measuing soveos eaugmnl needed to provide evidence of conormiy a
iI pret o determined requomorts (ooo? 2) i
Fe [Butoray [A |a)_ be calratod verted, achat specie ies, or prio uso, agains massuromont|
| a ee a eet
HH | es ee ee ee eee
hil | bs nate) [0A | bonaiode eae ne oases sah be- amined
HW | [he kntton sat ama ncaa a
ba ua [taw row [Ross ih sus clan advan sabe mana 0 424)
Senate [pan
| ene
cme
Fe aia |B +A WORE Gan 60 00a anasto gaan
av Butera) [OA |a) to domonsite onlomly othe produce nadia mmuamanis,
lear NewNote |A [NOTE Montonoa customer narcanion can induge- chaning inna soues suchas
aa Ts fo igen a et a Sy
HM | a
| ozawa [A enn cn a sana ee anual
Hh scat a aac
| a7 [Ras for empoatain-oo-epir or pry nd my aE OT
para + |rocheand maintaining root feos 42-3} shal b-dohnes ine domsmonlod proved”
+A |Racontsot the suits anda sus shal be malnsned sea 42.4).
jazz
laze
leza Pat [A |The orpartznon shal montor and measure te chaaciodsica ofthe produc fo very tal
WW] Jreauc rquroments have boon met’ Ths shal bo card out at appropat sages of o|
precuctralzaton process aocordance wih he planned arangemerts (se 71). Evance al
I |coniomty wih he accertance cia shall be mained.
H | [Parez [D+ A _| evidence
