ISO Changes

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BM TRADA Certification Ltd January 2009 1 of 13

Guide to ISO 9001:2008 Changes

Objective:

This document identifies the changes between 9001:2000 and 9001:2008. In essence, there are no new requirements or major changes. Amendmentshave been made to bring more clarity to the clauses.

Words in italicsand highlighted in yellow are the changes in ISO 9001:2008.

Red&bold text in the Remarks column identify changes that need a little more attention.

Disclaimer: Whilst this document endeavours to identify and describe all the changes definitive reference should always be made to the Standard ISO 9001:2008.

ClauseNumber

ISO 9001:2000 ISO 9001:2008 Remarks

Foreword Details of the changes between the third edition and thisfourth edition are given in Annex B

This statement has been mentioned in thelast line of the foreword on page iv. Annex

B is very useful in quickly identifying thechanges.

0.1 General The design andimplementation of anorganizations qualitymanagement system isinfluenced by varying needs,particular objectives, the

products provided, theprocesses employed and thesize and structure of theorganization.

The design and implementation of an organizations qualitymanagement system is influenced by

a. Its organizational environment, changes in thatenvironment, or risks associated with thatenvironment,

b. Its varying needs,

c. particular objectives,d. the products it provides,e. the processes it employs,f. its size and organizational structure

The standard now identifies organizationalenvironment & changes therein along withrisks associated as a key factorinfluencing the design of a QMS.

0.1 General ..... meet customer, regulatoryand the organizations ownrequirements.

......meet customer, statutory andregulatory requirementsapplicable to the product, and the organizations ownrequirements.

The word statutory has been added torequirements that are applicable to theproduct.


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Guide to ISO 9001: 2008 Changes


ClauseNumber

ISO 9001:2000 ISO 9001:2008 Remarks

0.2 Processapproach

For an organization to functioneffectively, it has to identifyand manage numerous linkedactivities. An activity usingresources, and managed inorder to enable......

For an organization to function effectively, it has todetermineand manage numerous linked activities. Anactivity or set of activitiesusing resources, and managedin order to enable the transformation of inputs into outputs,can be considered as a process.

The word identify has been replaced withthe word determine.

Further clarity has been provided to thedefinition of the word process asprocess might have more than one

activity.0.2 Processapproach

And their management, can bereferred to as the processapproach.

......and their management to produce the desiredoutcome, can be referred to as the process approach.

Further clarity on the process approachhas been provided.

0.3Relationshipwith ISO 9004

Note At the time of publication of this InternationalStandard, ISO 9004 is under revision.

ISO 9004 is planned to be published in2009.

0.4Compatibility

with othermanagementsystems

This International Standardhas been aligned with ISO

14001:1996............

..........................., due consideration was given toprovisions of ISO 14001:2004 to enhance the

compatibility.....................

ISO 9001:2008 has been written to make itmore compatible with ISO 14001:2004.

1 Scope1.1 General

This International Standardspecifies requirements for aquality management systemwhere an organization

a. needs to demonstrateits ability to

consistently provideproduct that meetscustomer andregulatoryrequirements .

This International Standard specifies requirements for aquality management system where an organization

a. needs to demonstrate its ability to consistentlyprovide product that meets customer andapplicable statutoryand regulatory requirements.

Wherever the term applicableregulatory requirements appears, wordstatutory has been added to read andapplicable statutory and regulatoryrequirements.


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ClauseNumber

ISO 9001:2000 ISO 9001:2008 Remarks

4.1 GeneralrequirementsNOTE 3

NOTE 3Ensuring control over outsourced processes doesnot absolve the organization of the responsibility ofconformity to all customer, statutory and regulatoryrequirements. The type and extent of control to be appliedto the outsourced process can be influenced by factorssuch as

a) the potential impact of the outsourced process onthe organizations capability to provide product thatconforms to requirements,

b) the degree to which the control for the process isshared,

c) the capability of achieving the necessary controlthrough the application of 7.4.

d)

This NOTE has been added to clarify themeaning.

It also identifies factors that may influencethe type and extent of control overoutsourced processes.

4.2.1Documentationrequirementsc) and d)

Note 1

c) documented proceduresrequired by this InternationalStandard,d) documents needed by theorganization to ensure theeffective planning, operationand control of its processes,ande) records required by this

International Standard (see4.2.4).

c) documented procedures and recordsrequired by thisInternational Standard,d) documents, including records, determinedby theorganization to be necessaryto ensure the effectiveplanning, operation and control of its processes.

e) is now included in c)

4.2.1DocumentationrequirementsNOTE 1

A single document may address the requirements for oneor more procedures. A requirement for a documentedprocedure may be covered by more than one document.

Each procedure does not necessarilyhave to be written on a separatedocument. Organizations candocument procedures as they choose,as long as they are clearly understoodand meet the standard requirements.


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ClauseNumber

ISO 9001:2000 ISO 9001:2008 Remarks

4.2.3 Controlof documentsf)

To ensure that documents ofexternal origin are identifiedand their distributioncontrolled, and...

to ensure that documents of external origin determined bythe organization to be necessary for the planning andoperation of the quality management systemare identifiedand their distribution controlled,

Clarity has been provided on whichexternal documents organizations need tocontrol.

4.2.4 Control

of records

Records shall be established

and maintained to provideevidence of conformity torequirements and ......

Records established to provide evidence of conformity to

requirements and of the effective operation of the qualitymanagement system shall be controlled.The organization shall establish a documented procedureto define the controls needed for the identification, storage,protection, retrieval, retention and disposition of records.Records shall remain legible, readily identifiable andretrievable.

This clause has been re-worded to clarify

the meaning.

5.5.2Management

representative

Top management shallappoint a member of

management who, irrespectiveof other responsibilities, shallhave responsibility andauthority that includes....

Top management shall appoint a member of theorganizationsmanagement who, irrespective of other

responsibilities, shall have responsibility and authority thatincludes....

The Management Representative mustbe a part of the organizations

management. The organization may notoutsource this responsibility. Howeverthis does not prevent the delegation ofday to day responsibilities to otherindividuals (including sub contractors)reporting to the ManagementRepresentative.

6.2.1 General Personnel performing work

affecting product quality shallbe competent on the basis ofappropriate education,training, skills and experience

Personnel performing work affecting conformity to product

requirementsshall be competent on the basis ofappropriate education, training, skills and experience.

ISO 9001:2008 emphasises conformity

to overall product requirements anddoes not limit it to product quality only.


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ClauseNumber

ISO 9001:2000 ISO 9001:2008 Remarks

6.2.1 GeneralNOTE

NOTE Conformity to product requirements may beaffected directly or indirectly by personnel performing anytask within the quality management system.

A new note has been added to furtherexplain that personnel performing anytask which may directly (e.g. inproduction) or indirectly (e.g.processing relevant information) affectconformity to product requirements

shall be competent.

6.2.2Competencetraining andawareness

a) determine the necessarycompetence for personnelperforming work affectingproduct quality,

The organization shalla) determine the necessary competence for personnelperforming work affecting conformity to productrequirements,

This clause is linked to clause 6.2.1(Please refer to NOTE in 6.2.1).The Organization shall determine thenecessary competence for allpersonnel working within themanagement system who may directlyor indirectly affect conformity to

product requirements.6.2.2Competencetraining andawareness

b) provide training or takeother actions to satisfy theseneeds,

The organization shallb) where applicable, provide training or take other actionsto achieve necessary competence,

The phrase where applicable allowsorganizations to determine their ownapproach.

6.3Infrastructure

c) supporting services (suchas transport orcommunication)

c) supporting services (such as transport, communicationor information systems).

Information systems have been added tothe list of supporting services that areneeded to be determined and maintainedby organizations.

6.4 WorkEnvironment

NOTE The term work environment relates to thoseconditions under which work is performedincludingphysical, environmental and other factors (such as noise,temperature, humidity, lightning, or weather).

A NOTE has been added to clarify themeaning.

7.1 Planning ofproductrealization c)

c) required verification,validation, monitoring,inspection and test activitiesspecific to the product and thecriteria for product

c) required verification, validation, monitoring,measurement, inspection and test activities specific to theproduct and the criteria for product acceptance;

The word measurement has been addedto the previous statement.


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acceptance;ClauseNumber

ISO 9001:2000 ISO 9001:2008 Remarks

7.2 Customer-relatedprocesses7.2.1Determinationof

requirementsrelated to theproduct

c) Statutory and regulatoryrequirements related to theproduct, andd) any additional requirementsdetermined by theorganization.

c) Statutory and regulatory requirements applicableto theproduct, andd) any additional requirements considered necessarybythe organization.

This clause has been re-worded to clarifythe meaning

7.2 Customer-relatedprocesses7.2.1Determinationof

requirementsrelated to theproduct

NOTE Post-delivery activities include, for example, actionsunder warranty provisions, contractual obligations such asmaintenance services, and supplementary services suchas recycling or final disposal.

This NOTE gives examples of postdelivery activities.

7.3.1 Designanddevelopmentplanning

NOTE Design and development review, verification andvalidation have distinct purposes. They can be conductedand recorded separately or in any combination, as suitablefor the product and the organization.

This NOTE assists with understanding anduse of this design clause as a whole.

7.3.3 Designand

developmentoutputs

The outputs of design anddevelopment shall be provided

in a form that enablesverification against the designand development ....

The outputs of design and development shall be in a formsuitable forverification against the design and

development input and shall be approved prior to release.

This clause has been re-worded to clarifythe meaning.


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ClauseNumber

ISO 9001:2000 ISO 9001:2008 Remarks

7.3.3 Designanddevelopmentoutputs

NOTE Information for production and service provision caninclude details for the preservation of product.

This NOTE gives an example as to howthe clause could be used.

7.5.1 Controlof productionand serviceprovision

d) the availability and use ofmonitoring and measuringdevices,

d) the availability and use of monitoring and measuringequipment,


7.5.1 Controlof productionand serviceprovision

f) the implementation ofrelease, delivery and postdelivery activities.

f) the implementation of productrelease, delivery and postdelivery activities.


7.5.2Validation ofprocesses forproduction andserviceprovision

The organization shall validateany processes for productionand service provision wherethe resulting output cannot beverified by subsequentmonitoring or measurement.This includes any processeswhere deficiencies becomeapparent only after the product

is in use or the service hasbeen delivered.

The organization shall validate any processes forproduction and service provision where the resultingoutput cannot be verified by subsequent monitoring ormeasurement and, as a consequence, deficienciesbecome apparent only after the product is in use or theservice has been delivered.


7.5.3Identificationand traceability

The organization shall identifythe product status with respectto monitoring andmeasurement requirements.

The organization shall identify the product status withrespect to monitoring and measurement requirementsthroughout the product realization.

Clarification has been provided that theproduct status shall be identifiedthroughout the whole productrealization process.


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ClauseNumber

ISO 9001:2000 ISO 9001:2008 Remarks

7.5.3Identificationand traceability

Where traceability is arequirement, the organizationshall control and record theunique identification of theproduct (see 4.2.4).

Where traceability is a requirement, the organization shallcontrol the unique identification of the product andmaintain records(see 4.2.4).

This clause has been re-worded toemphasise maintenance of records relatedto identification and traceability of product.

7.5.4

Customerproperty

.....otherwise found to be

unsuitable for use, this shallbe reported to the customerand records maintained (see4.2.4).

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

organization shall report this to the customer and maintainrecords(see 4.2.4).


the meaning.

7.5.4Customerproperty

NOTE Customer property caninclude intellectual property.

NOTE Customer property can include intellectual propertyand personal data.

Personal data has been added to theNOTE.

7.5.5Preservation ofproduct

The organization shallpreserve the conformity ofproduct during internalprocessing and delivery to theintended destination. Thispreservation shall includeidentification, handling.

The organization shall preserve the productduring internalprocessing and delivery to the intended destination inorder to maintain conformity to requirements. Asapplicable, preservation shall include identification,handling....


7.6 Control ofmonitoring and

measuringequipment

The organization shalldetermine the monitoring and

measurement to beundertaken and the monitoringand measuring devicesneeded to provide evidence ofconformity of product todetermined requirements (see7.2.1).

The organization shall determine the monitoring andmeasurement to be undertaken and the monitoring and

measuring equipmentneeded to provide evidence ofconformity of product to determined requirements.

The word device has been substitutedwith the word equipment.


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ClauseNumber

ISO 9001:2000 ISO 9001:2008 Remarks

7.6 Control ofmonitoring andmeasuringequipment

a) Be calibrated or verified atspecified intervals, or.....

a) Be calibrated or verified or both, at specified intervals,or.....

This amendment has the option to useboth methods.

7.6 Control ofmonitoring and

measuringequipment

c) be identified to enable thecalibration status to be

determined;

c) have identification in order to determine its calibrationstatus;

This has been re-worded to clarify themeaning.

7.6 Control ofmonitoring andmeasuringequipment

NOTE See ISO 10012-1 andISO 10012-2 for guidance.

NOTE Confirmation of the ability of computer software tosatisfy the intended application would typically includeitsverification and configuration management to maintain itssuitability for use.

NOTE from ISO 9001:2000 has beenremoved and a new NOTE introduced togive an indication of how computersoftware is fit to meet its intendedapplication.

8.1 General a) to demonstrate conformity

of the product,

a) to demonstrate conformity to product requirements, This clause has been re-worded to clarify

the meaning.

8.2.1Customersatisfaction

NOTE Monitoring customer perception can includeobtaining input from sources such as customer satisfactionsurveys, customer data on delivered product quality, useropinion surveys, lost business analysis, compliments,warranty claims and dealer reports.

A NOTE introduced which should helporganizations to understand the differentways in which customer perception couldbe captured.

8.2.2 Internal

audit

The responsibilities and

requirements for planning andconducting audits, and forreporting results andmaintaining records (see4.2.4) shall be defined in adocumented procedure.

A documented procedure shall be established to define the

responsibilities and requirements for planning andconducting audits, establishing records and reportingresults.

Records of theaudits andtheirresults shall be maintained(see 4.2.4).


the meaning.

The requirement for audit records andtheir results has been separated out toemphasise their importance.


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ClauseNumber

ISO 9001:2000 ISO 9001:2008 Remarks

8.2.2 Internalaudit

The management responsiblefor the area being auditedshall ensure that actions aretaken without undue delay toeliminate detected nonconformities and their causes.

The management responsible for the area being auditedshall ensure that any necessary corrections and correctiveactionsare taken without undue delay to eliminatedetected non conformities and their causes.


8.2.2 Internalaudit

NOTE See ISO 10011-1, ISO10011-1 and ISO 10011-3 forguidance.

NOTE See ISO 19011 for guidance. Please refer to ISO 19011 Guidelines forquality and environmental managementsystems auditing

8.2.3Monitoring andmeasurementof processes

When planned results are notachieved, correction andcorrective action shall betaken, as appropriate, to

ensure conformity of theproduct.

When planned results are not achieved, correction andcorrective action shall be taken, as appropriate.

NOTE When determining suitable methods, it is advisable

that the organization should consider the type and extentof monitoring ormeasurement appropriate to each of itsprocesses in relation to their impact on the conformity toproduct requirements and on the management system.

A new NOTE has been introducedexplaining the factors that should beconsidered when determining suitablemethods for monitoring and measurement.

8.2.4Monitoring andmeasurementof product

This shall be carried out atappropriate stages of theproduct realization process inaccordance with the plannedarrangements (see 7.1).

Evidence of conformity withthe acceptance criteria shallbe maintained. Records shallindicate the person(s)authorising release of product(see 4.2.4).

This shall be carried out at appropriate stages of theproduct realization process in accordance with the plannedarrangements (see 7.1). Evidence of conformity with theacceptance criteria shall be maintained.

Records shall indicate the person(s) authorizing release ofproduct for delivery to the customer (see 4.2.4).

Paragraphs have been re-arranged to giveseparate emphasis to:

evidence of conformity

record requirement


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ClauseNumber

ISO 9001:2000 ISO 9001:2008 Remarks

8.2.4Monitoring andmeasurementof product

Product release and servicedelivery shall not proceed untilthe planned arrangements(see 7.1)....

The releaseof product and deliveryof service to thecustomershall not proceed until the planned arrangements(see 7.1)..


8.3 Control of

nonconformingproduct

The controls and related

responsibilities and authoritiesfor dealing with nonconformingproduct shall be defined in adocumented procedure.

A documented procedure shall be established to define the

controls and related responsibilities and authorities fordealing with nonconforming product.


the meaning.

8.3 Control ofnonconformingproduct

When nonconforming productis detected after delivery oruse has started, theorganization shall take action

appropriate to the effects, orpotential effects, of thenonconformity.

Where applicable,the organization shall deal withnonconforming product by one or more of the followingways:

e) by taking action appropriate to the effects, orpotential effects, of nonconformity whennonconforming product is detected after delivery oruse has started.

f)

The words where applicable have beenadded.

This clauses has been re-worded and re-

numbered. The intent remains the same.

8.4 Analysis ofdata

Analysis of data shall provideinformation relating toa) customer satisfaction (see8.2.1),

b) conformity to productrequirements (see 7.2.1),c) characteristics and trends ofprocesses and productsincluding opportunities forpreventive action, andd) suppliers.

a) customer satisfaction (see 8.2.1),b) conformity to product requirements (see 8.2.4),c) characteristics and trends of processes and productsincluding opportunities for preventive action (see 8.2.3 and

8.2.4), andd) suppliers (see 7.4).

The clause numbers now provide clearreference with respect to the kind of datato be analysed.


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ClauseNumber

ISO 9001:2000 ISO 9001:2008 Remarks

8.5.2Correctiveaction

The organization shall takeaction to eliminate the causeof nonconformities in order toprevent recurrence.Corrective actions shall beappropriate to the effects of

the nonconformitiesencountered.

The organization shall take action to eliminate the causesof nonconformities in order to prevent recurrence.Corrective actions shall be appropriate to the effects of thenonconformities encountered.

ISO 9001:2008 now refers to causesrather than cause since there could bemore than one cause of noncomformity.

8.5.2Correctiveaction

f) reviewing corrective actiontaken.

f) reviewing the effectiveness ofcorrective action taken. The word effectiveness has beenadded. This strengthens this clauseand clarifies the intent. Organizationsneed to review that the action taken hasbeen effective.

8.5.3Preventiveaction

e) reviewing preventive actiontaken.

e) reviewing the effectiveness ofpreventive action taken. The word effectiveness has beenadded. This strengthens this clauseand clarifies the intent. Organizationsneed to review that the action taken hasbeen effective.

Annex A Annex A has been updated to reflect ISO9001:2008 v ISO 14001:2004.

Annex B Annex B has been updated to reflectchanges between ISO 9001:2000 v ISO9001:2008.

Bibliography As applicable Includes new and amended references.

Documents

ISO Changes