2. Quality is a customer determination, not aQuality is a customer determination, not a
producer’s or supplier,s determination.It isproducer’s or supplier,s determination.It is
based upon the customer’s actualbased upon the customer’s actual
experience with the product or serviceexperience with the product or service
measured against his or her requirements.measured against his or her requirements.
3. Standard is a document established byStandard is a document established by
consensus and approved by aconsensus and approved by a
recogonised body that provides forrecogonised body that provides for
common and repeated use, rules,common and repeated use, rules,
guidelines or characterstics of theirguidelines or characterstics of their
activities or their results aimed at theactivities or their results aimed at the
achievement of the optimum degree ofachievement of the optimum degree of
order in a given context.order in a given context.
4. Quality Management Systems organisesQuality Management Systems organises
the overall activities of the company inthe overall activities of the company in
such a way that the technical,such a way that the technical,
administrative and human factors affectingadministrative and human factors affecting
the quality of its products or services arethe quality of its products or services are
under control.under control.
All such controls are oriented towardsAll such controls are oriented towards
towards the reduction , elimination andtowards the reduction , elimination and
prevention of quality deficiencies.prevention of quality deficiencies.
5. Auditing : identifies the non-conformity ofAuditing : identifies the non-conformity of
the system and product, and follows upthe system and product, and follows up
the corrective actions.the corrective actions.
Quality audit : is a systematic,Quality audit : is a systematic,
independent and documented process ofindependent and documented process of
examining any activity of an organisationexamining any activity of an organisation
based on objective evidence to determinebased on objective evidence to determine
6. Extent to which quality activities andExtent to which quality activities and
related results comply with the plannedrelated results comply with the planned
arrangements.arrangements.
Extend to which these arrangements haveExtend to which these arrangements have
been implemented effectively.been implemented effectively.
Whether these arrangements are suitableWhether these arrangements are suitable
to achieve the quality objectives.to achieve the quality objectives.
7. Adequacy audit is the process ofAdequacy audit is the process of
comparing the QMS manual against thecomparing the QMS manual against the
requirements of ISO 9001: 2000 to ensurerequirements of ISO 9001: 2000 to ensure
that the manual has suitably andthat the manual has suitably and
sufficiently addressed all the requirementssufficiently addressed all the requirements
of the standards and meets each of theseof the standards and meets each of these
requirements in full.requirements in full.
8. Compliance audit on the other hand is theCompliance audit on the other hand is the
process of checking whether theprocess of checking whether the
organisation has implemented what theyorganisation has implemented what they
have stated and whether the people arehave stated and whether the people are
doing what the documents have askeddoing what the documents have asked
them to do.them to do.
9. First party audit/self – audit/ internal auditFirst party audit/self – audit/ internal audit
Carried out by people of the organisationCarried out by people of the organisation
or on behalf of the organisation itself toor on behalf of the organisation itself to
examine its own QMS.examine its own QMS.
Second party audit/audit bySecond party audit/audit by
customers/external auditcustomers/external audit
Carried out by the customers, or by theCarried out by the customers, or by the
organisation on the supplier’sorganisation on the supplier’s
10. Third party/ independent agency/externalThird party/ independent agency/external
audit.audit.
Carried by an external agency to assessCarried by an external agency to assess
compliance usually for the purpose ofcompliance usually for the purpose of
certificationcertification
11. Internal auditInternal audit
Primary goal – correction and improvementPrimary goal – correction and improvement
REQUIREMENT OF INTERNAL AUDITREQUIREMENT OF INTERNAL AUDIT
plan – area, departmentplan – area, department
FrequencyFrequency
Qulification of auditorsQulification of auditors
Procedure to be followedProcedure to be followed
Method of reporting.Method of reporting.
12. Timing – when people are busy.Timing – when people are busy.
ScheduleSchedule
Internal auditorsInternal auditors
Checklists – methodical way of ensuringChecklists – methodical way of ensuring
all necessary areas are audited and rightall necessary areas are audited and right
questions asked.questions asked.
13. Certification is the procedure action by aCertification is the procedure action by a
duly authorised body of determinig,duly authorised body of determinig,
verifying, and attesting in writing to theverifying, and attesting in writing to the
qualification of the personnel, process,qualification of the personnel, process,
procedures, systems or items inprocedures, systems or items in
accordance with applicable requirements.accordance with applicable requirements.
14. CertificationCertification
Based upon the findings of the auditorsBased upon the findings of the auditors
and their final reccomendations an ISOand their final reccomendations an ISO
9000 quality system certificate is issued by9000 quality system certificate is issued by
the certification agency.the certification agency.
Certificates are valid for specific periodCertificates are valid for specific period
During the valid period someDuring the valid period some
unannounced surveilance visits made.unannounced surveilance visits made.
15. Some official agenciesSome official agencies
Bureau of Indian Standards.Bureau of Indian Standards.
ABS quality evaluation in USA.ABS quality evaluation in USA.
Bureau Veritas in France.Bureau Veritas in France.
16. ReferenceReference
i)i) Implementing ISO 9001 : 2000.Implementing ISO 9001 : 2000.
Pradeep Kumar Mathur.Pradeep Kumar Mathur.
ii) Preparation, implementation & registrationii) Preparation, implementation & registration
of ISO 9000 QUALITY SYSTEM.of ISO 9000 QUALITY SYSTEM.
A N SINGH.A N SINGH.
