Vous êtes sur la page 1sur 10

Publication of new ISO 9001:2008 standard and the changes incorporated

1. Publication & Applicability –ISO 9001:2008


 Published on 15-11-2008, as fourth edition
 Accredited certification to the ISO 9001:2008 shall be granted after 15-11-2008.
 Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issued after a routine
surveillance or re-certification audit against ISO 9001:2008.
 One year after publication of ISO 9001:2008 all accredited certifications issued (new certifications or re-
certifications) shall be to ISO 9001:2008 – mandatory change over to the new standard (no fresh certification
against 9001:2000 after 15-11-2009)
 Twenty-four months after publication by ISO of ISO 9001:2008, any existing certification issued to ISO
9001:2000 shall not be valid. ( the certification against ISO 9001: 200 becomes invalid after 15-11-2010)

2. Salient changes in the new Standard (ISO 9001:2008)

 No new requirements
 Requirements of certain clauses re-clarified by additional notes
 Ambiguity in certain statements of the earlier standard removed by restating the requirements in a clear
manner
 Old references in standard replaced by new references
 Better consistency with ISO14001: 2004

3 SWISO’s plan for change over to new standard –ISO 9001:2008


 All new certification and re-certification after 01-01-2009 verified against ISO 9001:2008 for compliance.
 All the existing clients certified to ISO 9001:2000 shall complete transition to ISO 9001:2008 before 31-03-
2010 after verification through routine surveillance starting from April 2009. All the existing clients having their
routine surveillance due from April 09 onwards need to prepare themselves to confirm compliance against ISO
9001:2008.For clients having their surveillance due between now and march 09, they may also opt for
verification against ISO 9001:2008if they are prepared, but otherwise they have to complete the transition
before March 2010.

Page 1 of 10
Changes in ISO 9001: 2008
Clause Title / subject Existing – ISO 9001:2000 Changes - ISO 9001:2008 Implication (to client’s QMS
no (Changes underlined) and auditing)
0.1 Introduction ------(1) The design and the application ------(1) The design and the application of an For guidance and the changes
of an organization’s quality organization’s quality management system is may be noted
management system is influenced by influenced by
varying needs, particular objective, the (a) Its organizational environment, changes in
products produced, the processes that environment, and the risks associated
employed and the size and the with that environment
structure of the organization (b) Its varying needs,
(c) Its particular objective,
-------(2.) This international standard (d) The products it provides,
can be used by internal and external (e) The processes it employs,
parties, including certification bodies, to (f) Its size and the structure of the
assess the organization’s ability to meet organization
customer, regulatory and the
organization’s own requirements -------(2.) This international standard can be used by
internal and external parties, including certification
bodies, to assess the organization’s ability to meet
customer, statutory and regulatory requirements
applicable to the product, and the organization’s own
requirements
0.2 Process approach ------(1). for an organization to function ------(1). For an organization to function effectively, it For guidance and the changes
effectively, it has to identify and has to determine and manage numerous linked may be noted
manage numerous linked activities. An activities. An activity or a set of activities using
activity using resources, and managed resources, and managed in order to enable the
in order to enable the transformation of transformation of inputs into outputs, can be
inputs into outputs, can be considered considered as a process. Often the output from one
as a process. Often the output from one process directly forms the input to the next.
process directly forms the input to the
next. (2). The application of a system of processes within
(2). The application of a system of an organization, together with the identification and
processes within an organization, interactions of these processes, and their
together with the identification and management to produce the desired outcome, can
interactions of these processes, and be referred to as the “process approach”
their management, can be referred to
as the “process approach”

0.3 Relation ship with (1) The present editions of ISO (1) ISO 9001 and 9004 are quality management For guidance and the changes
ISO 9004 9901and ISO 9004 have been system standards which have been designed to may be noted

Page 2 of 10
Changes in ISO 9001: 2008
Clause Title / subject Existing – ISO 9001:2000 Changes - ISO 9001:2008 Implication (to client’s QMS
no (Changes underlined) and auditing)
developed as a consistent pair of complement each other, but can be used
quality management system standard independently
which have been designed to
complement each other, but can be (2). At the time of publication of this international
used independently. Although the two standard, ISO9004 is under revision. The revised
international standards have different edition of ISO 9004 will provide guidance to
scopes, they focuses on the management for achieving sustained success for any
collectiveness of the quality organization in a complex, demanding, and ever
management system in meeting changing, environment .ISO 9004 provides a wider
customer requirements (replaced) focus on quality management system than ISO9001;
(2) Last Para replaced it addresses the needs and expectations of all
interested parties and their satisfaction, by the
systematic and continual improvement of the
organization’s performance. However it is not
intended for certification, regulatory or contractual
use
0.4 Compatibility with First Para replaced During the development of this international For guidance and the changes
other management standard, due consideration was given to the may be noted
system provisions of ISO 14001:2004 to enhance the
compatibility of the two standards for the benefit of
the user community. Annex a shows the
correspondence between ISO 9001: 2008 and ISO
14001:2004
1.0 Scope / 1.1 general Note: in this international standard the Note.1: in this international standard, the term” For guidance and the changes
term “product ”applies only to the product” only applies to may be noted
product intended for or required by a (a) Product intended for or required by a
customer customer
(b) Any intended output resulting from the
product realization process
2.0 . Normative Existing statement deleted and The following reference documents are For guidance and the changes
references replaced indispensable for the application of this document. may be noted
For dated references, only the edition cited applies.
For undated references the latest edition of the
referenced document (including any amendment)
applies.
ISO 9000:2005, quality management systems-
fundamentals and vocabulary
3.0 3. Terms & Existing statement deleted and For the purpose of this document the terms and All terms & definitions in QMS
definitions replaced definitions given in ISO 9000 apply. shall be based on ISO 9000:2005,
Throughout the text of this international standard applicable to client and auditing
whenever the term “ product” occurs, it can also

Page 3 of 10
Changes in ISO 9001: 2008
Clause Title / subject Existing – ISO 9001:2000 Changes - ISO 9001:2008 Implication (to client’s QMS
no (Changes underlined) and auditing)
mean “service”
4.1 General 4.1(a). Identify the processes needed 4.1(a). Determine the processes needed for the Nil for client and auditing
requirements for the quality management system and quality management system and their application
their application through out the through out the organization (see1.2)
organization (see 1.2)
4.1 Outsourcing Where an organization chooses to Where an organization chooses to outsource any Applicable to client having its
outsource any process that affect process that affect product conformity with processes outsourced and the
product conformity with requirements, requirements, the organization shall ensure control client shall address in QMS at
the organization shall ensure control over such processes. The type and the extent of least the following
over such processes. Control of such Control to be applied to these outsource processes (a) Processes outsourced
outsourced processes shall be shall be defined within the quality management (b) Assumes responsibility to
identified within the quality system ensure conformity to all
management system Note 1:processes needed for the quality customer & statutory &
Note 1:processes needed for the quality management system referred to above should regulatory requirements
management system referred to above include processes for management activities, (c) The type and the extent
should include processes for provision of resources, product realization of control, a quality plan
management activities, provision of measurement, analysis and improvement for outsourced activity
resources, product realization and Note.2: an outsourced process is a process that the covering both process
measurement organization needs for its quality management and the product
system and which the organization chooses to have (d) Contract with the
performed by an external party outsource body defining
Note.3: ensuring control over outsourced processes controls required on both
does not absolve the organization of the sides to be covered
responsibility of conformity to all customers, statutory through application of 7.4
regulatory requirements. The type and extent of
control to be applied to the outsourced processes All the above to be verified and
can be influenced by factors such as confirmed during the audit
(a) The potential impact of the outsource
process on the organization’s capability to
provide product that conforms to
requirements
(b) The degree to which the control for the
process is shared
(c) The capability of achieving the necessary
control through the application of 7.4
4.2 4.2.1 general 4.2.1(d) &(e) Both combined into 4.2.1(d) as “documents including (1) Records have wider application
Note1: where the term” documented records determined by the organization to be and pertain to activities related to
procedure” appears within this necessary to ensure the effective planning, operation effective planning, operation and
international standard, this means the and control of its processes (record reference to control of its processes and not
procedure is established, documented, 4.2.4 removed giving wider scope) necessarily referenced by 4.2.4
implemented and maintained Note1: where the term” documented procedure” alone. Client to include all the

Page 4 of 10
Changes in ISO 9001: 2008
Clause Title / subject Existing – ISO 9001:2000 Changes - ISO 9001:2008 Implication (to client’s QMS
no (Changes underlined) and auditing)
appears within this international standard, this means documents and records in QMS
the procedure is established, documented, and the same verified during audit.
implemented and maintained .A single document
may address the requirements for one or more (2) Client can have one document
procedures. A requirement for documented describing more than one
procedure may be covered by more than one procedure e.g. for procedures on
document corrective and preventive actions
one document can address both
Note 2 & 3 retained as such these procedures and there should
be at least two documents
covering all mandatory procedures
4.2.3 4.2.3(f)-External To ensure that documents of external To ensure that documents of external origin More clarity as what type of
documents origin are identified and their determined by the organization to be necessary for external documents are necessary
distribution controlled the planning and operation of the quality to be identified and their
management system are identified and their distribution controlled
distribution controlled
4.2.4 Control of records Records shall be established and (The requirements re-stated with more clarity) No change.
maintained to provide evidence of Records established to provide evidence of More emphasis on identifying
conformity to requirements and of the conformity to requirements and of the effective records correctly and controlling
effective operation of the quality operation of the quality management system shall be them. The procedure to define the
management system. Records shall controlled. controls needed for the
remain legible, readily identifiable and identification, storage, protection,
retrievable. A documented procedure . The organization shall establish a documented retrieval, retention and the
shall be established to define the procedure to define the controls needed for the disposition of records
controls needed for the identification, identification, storage, protection, retrieval, retention
storage, protection, retrieval, retention and the disposition of records
time and the disposition of records
Records shall remain legible, readily identifiable and
retrievable
6.2. 6.2.1 general Personnel performing work effecting (Replaced by, as under) Client shall ensure that all the
product quality shall be competent on Personnel performing work effecting conformity to personnel performing work within
the basis of appropriate education, product requirements shall be competent on the the QMS are competent, not
training, skills 7 experience basis of appropriate education, training, skills & personnel pertaining to product
experience quality alone.
Note: conformity to product requirements can be
affected directly or indirectly by personnel performing
any task within the quality management system

6.2.2 (a) and (a) Determine the necessary (c) Determine the necessary competence for Better clarity of expression.
6.2.2(b) competence for personnel personnel performing work affecting ■ product quality replaced by
performing work affecting conformity to product requirements conformity to product requirements

Page 5 of 10
Changes in ISO 9001: 2008
Clause Title / subject Existing – ISO 9001:2000 Changes - ISO 9001:2008 Implication (to client’s QMS
no (Changes underlined) and auditing)
product quality (d) Where applicable provide training or take i.e. wider applicability.
(b) Provide training or take other other actions to achieve the necessary Competence need to be defined
actions to satisfy these needs competence for all the personnel within the
QMS
■ objective of training is to make
personnel competent and not for
satisfying need. Need arises from
the gap between desired (defined)
competence and the competence
currently possessed by the
personnel

6.3 6.3© / infrastructure ©Supporting services (such as ©Supporting services (such as transport, Information system also included
transport or communication communication or information system) in the infrastructure .The client to
identify these if found applicable.
6.4 Environment - Note added:
Note ‘the term “work environment” related to those More clarity now as to what to
conditions under which work is performed including include in work environment. Client
physical, environmental and other factors (such as has to address how various
noises, temperature, humidity, lighting or weather) requirements are being managed
and the same demonstrated during
audit for compliance
7.2 Customer related © Statutory and regulatory © Statutory and regulatory requirements ■ Post delivery activities clearly
process -7.2© and requirements Applicable to the product, and identified and the client shall
(d) Related to the product, and (d) Any additional requirements considered accordingly address and
(d) Any additional requirements necessary implement them if applicable.
determined By the organization ■ More specific statements about
By the organization requirements for easy
Note: post –delivery activities include, for example, understanding and
actions under warranty provisions, contractual implementation, (Otherwise no
obligation such as maintenance services and basic change in requirements)
supplementary services such as re-cycling or final
disposal
7.3 7.3.1.Design and - Note added
development Note; design and development review, verification Organization to have more focus
planning and validation have distinct purposes. They can be on review, verification and
conducted and recorded separately or in any validation especially and
combination, as suitable for the product and the accordingly maintain appropriate
organization records for demonstrating
compliance during audit.
7.3.3.design and The outputs of design and development The outputs of design and development shall be in a Client shall include requirements

Page 6 of 10
Changes in ISO 9001: 2008
Clause Title / subject Existing – ISO 9001:2000 Changes - ISO 9001:2008 Implication (to client’s QMS
no (Changes underlined) and auditing)
development output shall be provided in a form suitable that form suitable for verification against the design and for the preservation of product in
enables verification against the design development input and shall be approved prior to the output and communicated to
and development input and shall be release production and service provision.
approved prior to release ■organization to ensure
Note: information for production and service compliance and the auditor to
provision can include details for the preservation of verify
product
7.5 Control of (d) The availability and the use of (d) The availability and the use of monitoring and Nil for client and auditing
production-7.5.1 (d) monitoring and measuring devices measuring equipment
7.5.2 Validation of The organization shall validate any The organization shall validate any processes for Nil for client and auditing
processes processes for production and service production and service provision where the resulting
provision where the resulting output output cannot be verified by subsequent monitoring
cannot be verified by subsequent or measurement and as a consequence deficiencies
monitoring or measurement. This become apparent only after the product is in use or
includes any processes where the service has been delivered
deficiencies become apparent only after
the product is in use or the service has
been delivered
7.5.4 Customer property -------. If any customer property is lost, -------. If any customer property is lost, damaged or Personal data also included in the
damaged or otherwise found to be otherwise found to be suitable for use, organization customer property. Client shall
suitable for use, this shall be reported shall report this to the customer and maintain records also include personal data if any in
to the customer and records maintained the customer property. Same
Note: customer property can include intellectual verified during audit
Note: customer property can include property and the personal data
intellectual property
7.5.5 Preservation of The organization shall preserve the The organization shall preserve the product during Nil for client and auditing except
product conformity of product during internal internal processing and delivery to the intended better clarity in expression
processing and delivery to the intended destination in order to maintain conformity to
destination. This preservation shall requirements. As applicable preservation shall
include identification, handling, include identification, handling, packaging, storage
packaging, storage and protection. and protection. Preservation shall also apply to
Preservation shall also apply to constituent parts of a product
constituent parts of a product
7.6 Control of monitoring (1) The term “devices” appearing in all (1) The term “devices” appearing in the old standard ■ Better clarity in requirements.
and measuring the text changed. has been replaced by” equipment” in all places ■ where no calibration standard
equipment, 7.6. (a) & (2) 7.6. (a). Be calibrated or verified, at including in the title exist the basis used for calibration
(C) specified intervals or prior to use (2) 7.6. (a). Be calibrated or verified or both, at or verification need to be recorded
against measurement standards specified intervals or prior to use against mandatory now (4.2.4)
traceable to international or national measurement standards traceable to international or ■ no need to have calibration
measurement standards; where no national measurement standards; where no such status on the equipment except for
such standard exist, the basis used for standard sexist the basis used for calibration or identification number

Page 7 of 10
Changes in ISO 9001: 2008
Clause Title / subject Existing – ISO 9001:2000 Changes - ISO 9001:2008 Implication (to client’s QMS
no (Changes underlined) and auditing)
calibration or verification shall be verification shall be recorded (4.2.4) ■ confirmation of the ability of
recorded (4.2.4. computer software now clarified
(3) 7.6©. . Be identified to enable the (3) 7.6©. Have identification in order to determine and records need to be
calibration status to be determined calibration status accordingly maintained, emphasis
(4) Note: see ISO 10012-1 and ISO (4). Note: confirmation of the ability of computer on verification and configuration
10012-2 for guidance software to satisfy the indented application would management
typically include its verification and configuration
management to maintain its suitability for use
8.1 General 8.1(a). To demonstrate conformity of 8.1(a). To demonstrate conformity to product Nil for client and auditing except
the product requirements better clarity in expression
8.2.1 Customer - Note: monitoring customer perception can include Customer perception now clarified
satisfaction obtaining input from sources such as customer in terms of different inputs. The
satisfaction surveys, customer data on delivered client shall use a combination of
product quality, user opinion surveys, lost business these inputs to assess the
analysis, compliments, warranty claims and dealer customer satisfaction. Client to
reports establish or modify the existing the
system on these lines and these
will be verified during audit.
8.2.2 Internal audit (1)------- the responsibilities and the (1)-------(replaced by) a documented procedure shall ■ better clarity in requirements
requirements for planning and be established to define the responsibilities and the ■ clients shall now have to record
conducting audit, and for reporting requirements for planning and conducting audit, corrections and root cause & the
results and maintaining records (see establishing records and reporting results corrective actions for all the non-
4.2.4) shall be defined in a documented conformances. The format for
procedure . Records of the audits and their results shall be reporting NCs and corrective
maintained (see 4.2.4) action shall be modified
accordingly. Will be verified during
(2). The management responsible for (2). The management responsible for the area being audit
the area being audited shall ensure that audited shall ensure that any necessary correction
actions are taken with out undue delay and corrective actions are taken with out undue delay
to eliminate detected non conformities to eliminate detected non conformities and their uses
and their uses

8.2.3 Monitoring & - Note: when determining suitable methods, it is Further clarification through
measurement of advisable that the organization consider the type and additional note. Client shall identify
processes the extent of the monitoring or measurement the monitoring and measurement
appropriate to each of its processes in relation to criteria appropriate to each
their impact on the conformity to product process. Will be confirmed during
requirements and on the effectiveness of the quality audit
management system
8.2.4 Monitoring & -------. Records shall indicate the -------. Records shall indicate the persons authorizing ■ Client to define the authority for
measurement of persons authorizing the release of the release of product for delivery to the customer release of product for delivery to

Page 8 of 10
Changes in ISO 9001: 2008
Clause Title / subject Existing – ISO 9001:2000 Changes - ISO 9001:2008 Implication (to client’s QMS
no (Changes underlined) and auditing)
product product (see 4.2.4) (see 4.2.4) the customer
■ Only products and delivery of
Product release and service delivery service meeting the requirements
shall not proceed until planned The release of product and delivery of service to the shall only be released by the
arrangements (see 7.1) have been customer shall not proceed until planned defined authority
satisfactorily completed, unless arrangements (see 7.1) have been satisfactorily
otherwise approved by a relevant completed, unless otherwise approved by a relevant Compliance to be verified during
authority and where applicable by the authority and where applicable by the customer. audit
customer.
8.3 Control of non ------. (1) The controls and the related ------. (1) A documented procedure shall be ■ Better way of expressing the
conforming product responsibilities and authorities for established to define the controls and the related intent
dealing with non conforming product responsibilities and authorities for dealing with non
shall be defined in documented conforming product Clients shall accordingly address
procedure the ways of dealing with the non
(2) Organization shall deal with non (2) Where applicable organization shall deal with non conformities as applicable and the
conforming product by one or more of conforming product by one or more of the following same shall be verified during audit
the following ways ways .
(3) When non conforming product is (3) This included as 8.3(d). By taking action
detected after delivery or use has appropriate to the effects or potential effects of the
stared, the organization shall take non conformity when non conforming product is
action appropriate to the effects or detected after delivery or the use has started
potential effects of the non conformity
8.4 Analysis of data (1) 8.4(b). Conformity to product (1) 8.4(b). Conformity to product requirements (see Clarification with respect to the
requirements (see 7.2.1) 8.2.4) type of data required to be used
for analysis. Clients shall
(2) 8.4©. Charecteristsics and trends of (2) 8.4©. Charecteristsics and trends of processes accordingly utilize this information
processes and products, including and products, including opportunities for preventive in their analysis of data including
opportunities for preventive action, and action, (8.2.3 & 8.2.4) and process and product
measurements .
(3) 8.4(d). Suppliers (3) 8.4(d). Suppliers (7.4)

8.5.2 Corrective action 8.5.2(f). Reviewing corrective actions 8.5.2(f). Reviewing effectiveness of corrective actions An ambiguity removed. Important
taken taken to review the effectiveness of
corrective actions taken
8.5.3 Preventive action 8.5.3(e). Reviewing preventive actions 8.5.3(e). Reviewing effectiveness of preventive An ambiguity removed. Important
taken actions taken to review the effectiveness of
preventive actions taken

Page 9 of 10
Changes in ISO 9001: 2008
Clause Title / subject Existing – ISO 9001:2000 Changes - ISO 9001:2008 Implication (to client’s QMS
no (Changes underlined) and auditing)
Note (1) Only changes in the old document( ISO 9001:2000) high lighted
(2) For the remaining part of the old document,, same have been retained in the new document ( ISO 9001:2008)
(3) The clients need to make changes in the QMS in light of the new clarifications in ISO 9001:2008 and implement the same as per SWISO plan .
(4)The changes will be verified during certification, re-certification or routine surveillance as per SWISO plan and new certificate of compliance to ISO 9001:2008
issued .

Page 10 of 10