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Brief Introduction for RCCNZ

ISO 9001:2000

Gulf Consulting Limited 2004

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Rewriting ISO 9001

ISO Rule that all standards are re-written every fiveyears

T echnical Committee ( T C) 176 is responsible for theISO family of standardsIn 1990 T C 176 took a 2 stage process to amendingISO 9001

1994 amendments were cosmetic and in preparationfor the full overhaulSecond revision began in 1996 with the global survey

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C 176 SU RVEY RE SULTSTC 176 SU RVEY RE SULTS

ISO14000 Compatibility

Process ModelTailoring (ISO 9001 only)Continuous ImprovementEasy to UnderstandSuitable for All

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Objectives Objectives T wo of the most important objectives in the revision of

the ISO 9000 series of standards have been:

a) to develop a simplified set of standards thatwill be equally applicable to small as well as mediumand large organizations, and

b) for the amount and detail of documentationrequired to be more relevant to the desired results of the organizations process activities.

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The Twenty Clauses (1994)M anagement ResponsibilityQ uality SystemContract ReviewD esignD ocument ControlP urchasingCustomer Supplied P roduct

Identification andT raceabilityP rocess ControlInspection and T est

Inspection, T est andM easuring EquipmentInspection and T est Status

N on-Conforming P roductCorrective and P reventive

ActionH andling Storage P ackagingand D eliveryQ

uality RecordsT rainingServicingStatistical T echniques

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TH E C HANG E S - G E NER ALTH E C HANG E S - G E NER ALISO9001:1994

20 elements ISO9001:2000

4. Q uality M anagement System

5. M anagement Responsibility

6. Resource M anagement

7. P roduct Realisation

8. M easurement, Analysis & Improvement

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QUALIT Y MANAG E ME NTP R INC IPL E S

QUALIT Y MANAG E ME NTP R INC IPL E S

Customer-Focused Organisation

LeadershipInvolvement of PeopleProcess ApproachSystem Approach by Management

Continual ImprovementFactual approach to decision makingMutually beneficial supplier relationships

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comprehensive and fundamental ruleor belief, for leading and operating an

organisation, aimed at continuallyimproving performance over the longterm by focusing on customers while

addressing the needs of all other

stakeholdersISO/TC176/WG15

Quality Management Principle

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ResourceManagement

ManagementResponsibility

Measurement,Analysis andImprovement

ProductRealisation Produc

tInput Output

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C ONTINUAL IMP R OVE ME NT OF TH E QUALIT Y MANAG E ME NTS YST E M

C ONTINUAL IMP R OVE ME NT OF TH E QUALIT Y MANAG E ME NTS YST E M

Customer

Requirements

Customer

Satisfaction

Value Adding ActivitiesInformation Flow

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Some definitions Some definitions

Process Approach processes are activities thatconvert inputs to outputsCustomer organisation or person who receives aproductQuality degree to which a set of inherentcharacteristics fulfils requirementsRequirement need or expectation that is stated,generally implied or obligatory

Quality Improvement increasing the ability tofulfil quality requirementsContinual Improvement recurring activity toincrease the ability to fulfil quality requirements

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E STABLISHING TH E S YST E ME STABLISHING TH E S YST E M

Identify processes needed

Sequence and interactionCriteria and methods for operation and control

Information available for operation and monitoring

Measure, monitor, and analyse

Implement action to achieve planned results andcontinual improvement

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The Process ApproachPROCEDURE*

(Specified way to carry out an activity or aprocess - may be documented or not)

PRODUCT(Result of a

process)

MONITORING ANDMEASUREMENT OPPORTUNITIES

(Before, during and after the process)

OutputInput PROCESS(Set of interrelated

or interacting activities)

EFFECTIVENESS

OF P ROCESS = Ability to achieve

desired results

(Focus of ISO9001:2000)

EFFECTIVENESS

OF P ROCESS = Ability to achieve

desired results(Focus of ISO

9001:2000)

EFFICIENCY OFP ROCESS =

Results achievedvs resources used

(Focus of ISO9004:2000)

EFFICIENCY OFP ROCESS =

Results achievedvs resources used

(Focus of ISO9004:2000)

(IncludesResources)

* Note This is the definition of procedure given in ISO 9000:2000.This does not necessarily mean one of the 6documented procedures required by ISO 9001:2000

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The P-D-C-A Cycle

PlanWhat to do?How to do it?

DoDo what wasplanned

CheckDid things happen

according to plan?

ActHow to improvenext time?

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The Process Approach- Identifying the processes necessary for the

effective implementation of the qualitymanagement system.

- Understanding the interactions between these processes.

- Documenting the processes to the extent necessary to assure their effective operation

and control .(It may be appropriate to document the processes using process maps.It is emphasized, however, that documented process maps are not a

requirement of ISO 9001:2000.)

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4 .1 QMS G E NER ALRE QUIRE ME NTS

4 .1 QMS G E NER ALRE QUIRE ME NTS

establish, document, implement, maintain a quality

management system

and

CONTINUALLY IMPROVE ITS

EFFECTIVENESS

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4 .2 DO C UME NTATION RE QUIRE ME NTS4 .2 DO C UME NTATION RE QUIRE ME NTS4.2.1 General

Quality PolicyQuality Objectives

Quality Manual

Documented Procedures required by the Standard (6)

Documents required by the OrganisationQuality Records

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Documents r equi r ed the o r nisation

Documents r equi r ed the o r anisation

Size of organisation and type of activities

Complexity and interaction of processes

Competence of personnel

documents are needed by the organization to ensurethe effective planning, operation and control of itsprocesses

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ISO Documen t a ti Gu i ance ISO Documen t a ti Gu i ance

Communication of information

Evidence of conformity

Knowledge sharing

Why procedures?

Some examples

Paper Electronic

Photograph

Sample

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How much documentation?

Analysis of the processes should be the

driving force for defining the amount of documentation needed for the qualitymanagement system, taking into accountthe requirements of ISO 9001:2000. It

should not be the documentation thatdrives the processes.

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Abou t documen t a tiAbou t documen t a ti

It is stressed that ISO 9001 requires (andalways has required) a Documented quality management system , and not a system of documents .

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Compl iance

V Confo

rm

an

ce ISO 9001 is a voluntary standard i.e. at the outsetyou are said to comform with the minimum level.Compliance usually means with regulations andlegislation.Conformance systems are normally built upon thecompliance systems as you shouldnt have onewithout the other.Conformance standards like ISO 9001 are minimalstandards, good companies use these systems to

adopt performance management systems.

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SUMMARY OF KEY CHANGESSUMMARY OF KEY CHANGES

Process ApproachContinual ImprovementCompetency and Awareness

Quality Objectives (at appropriate levels)Effective CommunicationsManual to define Scope, and ExclusionsUn-stated Product Requirements

Management review to include productconformance and process performanceProactive Customer Satisfaction MeasuresAudits to confirm compliance to ISO9001

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ISO 9001 CertificationISO 9001 Certification is recommendedwhen the auditor agrees with themanagement representative that thequality management system in placecomplies with the requirements of the

standard.