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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.