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7/24/2019 ISO Documents

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ISO 9001:2000 Cross Reference MapISO 9001:2000

Clauses

Description Related ITD Procedure

1. Scope Scope of the QMS, areas covered and any exclusions identified Quality Manual

2. NormativeReference

The normative reference IS !"""#2""" $fundamentals%voca&ulary' must &e used incon(unction )ith the standard itself

Quality Manual

*. Terms +

efinitions

The terms and definitions -iven in IS !""" apply. Quality Manual

.1 /eneralRe0uirements.1 a'.1 &'.1 c'

.1 d'.1 e'

.1 f'

This clause covers the re0uirement of the or-anisation to actually set up a 0uality mana-ementsystem, and &roadly sets out the activities associated )ith this. The or-anisation shalldocument, implement and maintain a 0uality mana-ement system $QMS' and continuallyimprove its effectiveness in accordance )ith the re0uirements of the standard.

Quality Manual $Section 1.2 + 'Quality Manual $Section 'ach procedure under

ffectiveness Revie) sectionQuality Manual $Section 'Quality Manual $Section 3' and

Mana-ement Revie)IT 4orrective + 5reventive6ction 5rocedure and

Mana-ement Revie)

.2 ocumentationRe0uirements

The important issue here is that people must have the information they need to do their (o&.The QMS must include 0uality policy, 0uality o&(ectives, 0uality manual, documentedprocedures, documents to ensure the effective plannin-, operation and control of its processes,and records. 6ll documents are re0uired to &e controlled. 6lso re0uired is the control ofrecords, i.e. identification, stora-e, protection, retrieval, retention time and disposition ofrecords.

ocument 4ontrol5rocedure

3. Mana-ementResponsi&ility

Specifically identifies the responsi&ility of top mana-ement and the need for effectiveleadership

Quality Manual $Section *'

3.1 Mana-ement4ommitment

Top mana-ement shall provide evidence of its commitment to the development andimplementation of the QMS and continually improvin- its effectiveness

Quality 5olicy

3.2 4ustomer 7ocus Top mana-ement shall ensure that customer re0uirements are determined and are met )iththe aim of enhancin- customer satisfaction

Quality 5olicy

3.* Quality 5olicy 6 Quality 5olicy esta&lishes a commitment to 0uality, a commitment to continuousimprovement, the context for 0uality o&(ectives and ho) the o&(ectives relate to customerre0uirements

Quality 5olicy

3. 5lannin- Top mana-ement shall ensure that the plannin- of the QMS is carried out in order to meet there0uirements of the standard as )ell as the 0uality o&(ectives. The inte-rity of the QMS ismaintained )hen chan-es to the QMS are planned and implemented.

Quality Manual $Sections*.1 + '

3.3 Responsi&ility,6uthority +

Top mana-ement shall ensure that responsi&ility and authorities are defined andcommunicated )ithin the or-anisation. very&ody should 8no) )hat they are expected to do


IS !""1#2""" 4ross Reference Map Revision ate# 1 9uly :"35a-e 1 of


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ISO 9001:2000

Clauses





Quality Manual

4ommunication $responsi&ilities' and )hat they are allo)ed to do $authorities'. They should understand ho)these responsi&ilities and authorities relate to each other. 6 Mana-ement representative needs

to &e appointed )ho has responsi&ility for the QMS. 6ppropriate communication processesneed to &e esta&lished, and the effectiveness of the QMS must &e communicated to theor-anisation.

3. Mana-ementRevie)

The QMS must &e revie)ed at planned intervals, to ensure its continuin- suita&ility, ade0uacyand effectiveness. Records from the revie) must &e maintained. The revie) inputs and outputsmust &e clearly stated.


ISO 9001:2000

Clauses


. ResourceMana-ement

To ensure that the resources needed to &oth maintain and improve the QMS are availa&le, andalso to carry out the )or8 re0uired in a manner that )ill satisfy customer re0uirements.

Quality Manual $Section '

.1 5rovision ofResources

The or-anisation shall determine and provide resources needed to implement and maintain theQMS and continually improve its effectiveness, and to enhance customer satisfaction &ymeetin- customer re0uirements

Quality Manual $Section*.1, *. + '

.2 ;umanResources

5ersonnel performin- )or8 affectin- 0uality of service, shall &e competent on the &asis ofappropriate education, trainin-, s8ill and experience. The or-anisation must determine thenecessary competence and provide trainin- to satisfy these. They must evaluate theeffectiveness of the trainin- and maintain appropriate records. They must also ensure that itspersonnel are a)are of the relevance and importance of their activities and ho) they contri&uteto the achievement of the 0uality o&(ectives

Quality Manual $Section '+ Trainin- 5rocedure.

.* Infrastructure The or-anisation shall determine, provide and maintain the infrastructure needed to perform)or8. Infrastructure includes &uildin-s, )or8space, utilities, e0uipment and supportin- services.This means determinin- and providin- for current infrastructure re0uirements and plannin- forexpected future needs.


.


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ISO 9001:2000

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Quality Manual

maintained. This clause focuses mainly on the service provided, &ut can cover additionalfactors such as re-ulatory or le-al re0uirements, and unspecified customer expectations.

5ro(ect Mana-ement +System evelopment

5rocedure=.* esi-n +

evelopment

The or-anisation shall plan and control the desi-n and development of its service. Thisre0uires determinin- the desi-n and development sta-es, the revie), verification and validationof each sta-e, and the responsi&ilities and authorities for desi-n and development. This clausere0uires you to have controls for the desi-n processes and to esta&lish a disciplined approachto the desi-n process. The desi-n process should include inputs, outputs, revie), verificationand validation. esi-n and development chan-es also need to &e identified and recordsmaintained.

IT 5ro(ect Mana-ement +System evelopment5rocedure

ISO 9001:2000

Clauses


=. 5urchasin- The or-anisation shall ensure that purchased product conforms to specified purchasere0uirements. The or-anisation shall evaluate and select suppliers &ased on their a&ility tosupply product in accordance )ith these re0uirements. 4riteria for selection, evaluation and re?evaluation shall &e esta&lished. Records of results of evaluation shall &e maintained. Theor-anisation shall also esta&lish and implement the inspection or other activities necessary$verification' for ensurin- that purchased product meets specified re0uirements.

5urchasin- 5rocedure

=.3.1 4ontrol ofproduction +service provision

This clause descri&es the various types of controls that you mi-ht need to have in place for thedelivery of service. These include the availa&ility of information that descri&es the service, theavaila&ility of )or8 instructions, the use of suita&le e0uipment, the availa&ility of monitorin- andmeasurin- devices and the implementation of monitorin- and measurement.

Quality Manual $Section 'and related procedures

=.3.2 @alidation ofprocesses forproduction andservice provision

IT do not have any processes )here the resultin- outputs cannot &e verified &y su&se0uentmonitorin- and measurin-, therefore this clause is excluded

xcluded

=.3.* Identification +

Tracea&ility


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ISO 9001:2000

Clauses





Quality Manual

5roduct and delivery to the intended destination. This preservation shall include identification, handlin-,pac8a-in-, stora-e and protection.

5rocedure> 5rint Room5rocedure and 5ost Room

5rocedure=. 4ontrol of

monitorin- +measurin-devices

This means havin- confidence in the e0uipment used to chec8 your )or8. This clause appliesto or-anisations )here monitorin- devices and measurin- e0uipment are used to verify that)hat you are providin- meets your customer re0uirements. Monitorin- implies o&servation andsupervision activities. Measurement considers the determination of a 0uantity, ma-nitude ordimension.


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ISO 9001:2000

Clauses


A.1 Measurement6nalysis +Improvement

This clause covers the )ider monitorin-, measurement, analysis and improvement of the0uality mana-ement system. The or-anisation shall plan and implement the monitorin-,measurement, analysis and improvement processes needed to demonstrate conformity of theproduct%service, to ensure conformity of the QMS and to continually improve the effectivenessof the QMS. This shall include determination of applica&le methods, includin- statisticaltechni0ues, and the extent of their use.

Quality Manual $Section 3'

A.2.1 4ustomerSatisfaction

The or-anisation shall monitor information relatin- to customer perception as to )hether theyhave met customer re0uirements. The methods for o&tainin- and usin- this information shall&e determined. Monitorin- of customer satisfaction should &e performed on an on-oin- &asis,as customersB perceptions of performance chan-e over time. The results of the customersatisfaction monitorin- should &e addressed in the mana-ement revie) and continualimprovement activities, to identify and implement those chan-es )hich )ill improve therelationship )ith customers. Note# Satisfaction is not the opposite of dissatisfaction.Satisfaction can produce a neutral response )hereas dissatisfaction can produce a stron-ne-ative responseC

Quality Manual $Section 2'

A.2.2 Internal 6udit The or-anisation shall conduct internal audits at planned intervals to determine )hether theQMS conforms to the standard and to the QMS re0uirements esta&lished &y the or-anisation,

and is effectively implemented and maintained. The responsi&ilities and re0uirements forplannin- and conductin- audits, and for reportin- results and maintainin- records shall &edefined in a documented procedure. Mana-ement must ensure that actions are ta8en )ithoutundue delay to eliminate detected nonconformities and their causes. 7ollo)?up activities shallinclude the verification of the actions ta8en and the reportin- of verification results.

Internal 6udit 5rocedure

A.2.* Monitorin- +Measurement of5rocesses

The or-anisation shall apply suita&le methods for monitorin- and measurin- the QMSprocesses. These methods shall demonstrate the a&ility of the processes to achieve plannedresults.


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ISO 9001:2000

Clauses


A. 6nalysis of ata 6nalysin- data is an essential activity for any possi&le improvement in the 0uality mana-ementsystem, in the processes and in the product%service. The or-anisation shall determine, collectand analyse appropriate data to demonstrate the suita&ility and effectiveness of the QMS andto evaluate )here continual improvement of the effectiveness of the QMS can &e made. Thisshall include data -enerated as a result of monitorin- and measurement and from otherrelevant sources. The analysis of data shall provide information on customer satisfaction>conformity of product%service re0uirements> characteristics and trends of processes andproducts includin- opportunities for preventive action> and suppliers.


A.3.1 4ontinualImprovement

4ontinual improvement is the process of ta8in- actions on a recurrin- &asis to implementa-reed solutions that should &rin- positive &enefits. The or-anisation shall continually improvethe effectiveness of the QMS throu-h the use of the 0uality policy, 0uality o&(ectives, auditresults, analysis of data, corrective and preventive actions and mana-ement revie).

Quality Manual, Quality5olicy, Quality &(ectives,Mana-ement Revie) and4orrective + 5reventive

6ction 5rocedure

A.3.2 4orrective 6ction 4orrective action is an important improvement activity. 4orrective action identifies measuresneeded to correct identified pro&lems. It see8s to eliminate permanently the causes andconse0uent effects of pro&lems that could have a ne-ative impact on &usiness results> theor-anisationBs products%services, processes and QMS> and the satisfaction of customers.

4orrective action involves findin- the cause of a particular pro&lem and then puttin- in placethe necessary actions to prevent it from recurrin-.

4orrective + 5reventive6ction 5rocedure

A.3.* 5reventive6ction

5reventive action see8s to prevent the occurrence of potential pro&lems that could have ane-ative effect on &usiness results, products%services, processes, QMS or customersatisfaction. 6 documented procedure shall define re0uirements for determinin- potentialnonconformities and their causes> evaluatin- the need for action to prevent occurrence ofnonconformities> determinin- and implementin- action needed> records of the results of actionta8en> and revie)in- preventive action ta8en.

4orrective + 5reventive6ction 5rocedure

IS !""1#2""" 4ross Reference Map Revision ate# 1 9uly :"35a-e of