Post on 28-Dec-2015
AET9907C.PPT2004-03-13 1
AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
AUDITING AND CERTIFICATION OF AUDITING AND CERTIFICATION OF QUALITY MANAGEMENT SYSTEMSQUALITY MANAGEMENT SYSTEMS
bybyDr. Anwar El-TawilDr. Anwar El-Tawil
ISOISO
AET9907C.PPT2004-03-13 2
AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMSISO Standards for Auditing QMSISO Standards for Auditing QMS
Previously, three standards existed for auditing QMS:
ISO 10011/1, 2 and 3
A JWG between ISO/TC 176 and ISO/TC 207 has prepared a common auditing standard
ISO 19011
for auditing QMS and EMS
Common auditing standard does not mean that there must be one audit of QMS and EMS
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMSWhat is an Audit?What is an Audit?
Audit « a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are met »
(ISO 9000)(ISO 9000)
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMSObjectives of QMS AuditObjectives of QMS Audit
To determine conformity of QMS to requirements
To determine effectiveness of QMS
To identify areas for improvement
To permit certification/registration of organization
To meet legal requirements (e.-g. for manufacturers of medical devices)
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
Types of QMS AuditTypes of QMS Audit
Internal audits (first-party audits):
Audits conducted by, or on behalf of, the Organization itself for internal purposes
Internal audits can form the basis for an orgnization’s self-declaration of conformity
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
Types of QMS Audit (cont.)Types of QMS Audit (cont.)
External audits (second- and third party audits):
Second-party audits are conducted by parties interested in the Organization (e.g. customers)
Third-party audits are conducted by external, independent certifiers/registrars
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
Principles of Auditing (ISO 19011)Principles of Auditing (ISO 19011)
Principles relating to auditor character:
Ethical conduct - foundation of professionalism
Fair presentation - obligation to report truthfully and accurately
Due professional care - reasonable care in auditing
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
Principles of Auditing (ISO 19011) (cont.)Principles of Auditing (ISO 19011) (cont.)
Principles relating to audit process:
Independence - basis for impartiality and objectivity in conclusion
Evidence - rational basis for reaching conclusion
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMSParties involved in QMS AuditParties involved in QMS Audit
Provision of data/information
Provision of data/information
Determination of audit objectives
and criteria
Determination of audit objectives
and criteria
Audit ReportAudit Report
AuditeeAuditee
ClientClient
AuditorAuditor Determination of audit scope
Determination of audit scope
Conduct of the audit
Conduct of the audit
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
Audit ProcessAudit Process
Initiating the Audit
Document Review
Preparing for on-site audit activities
On-site Audit Activities
Reporting on Audit
Audit Follow-up
Audit completed
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMSInitiating the Audit Initiating the Audit
Determine audit objectives, scope, and criteria Objectives can be:
checking conformity to ISO 9001, checking capability to ensure compliance with
laws, regulations and/or contractual requirements,
identifying areas of potential improvement Scope is defined in terms of
location organizational units activities and processes
Establish audit feasibility
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMSInitiating the Audit (cont.) Initiating the Audit (cont.)
Establish audit team and appoint its leader based on:
audit objectives, scope, criteria, location and duration
overall competence of audit team by:
identifying knowledge and skills needed
selecting audit team with needed knowledge and, if necessary, including technical
experts acting under the direction of an auditor
language and cultural environment of audit
independence of audit team and avoidance of conflict of interest
Contact auditee
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
Document Review Document Review
Review QMS documents including records and previous audit reports
The review is done by the audit team leader or by one or more auditors
A preliminary on-site visit can be necessary to get an overview of available information
If the QMS documentation is found inadequate,the auditclient should be informed
No further resources should be spent on the audit until such concerns are resolved
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMSPreparing for On-site AuditPreparing for On-site Audit
An audit plan should be prepared including: Audit objectives, scope and criteria Dates and places of on-site audit Organizational and functional units to be audited Expected time and duration of audit including
meetings with auditee’s management and audit team meetings
Audit team work assignments taking into account auditor independence, competence and responsibilities of auditors,auditors-in-training and technical experts
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
Working Documents for On-site AuditWorking Documents for On-site Audit
Working documents used by audit team include: Audit procedures, checklists and audit sampling
plans; Forms for recording information, supporting
evidence, records of audit findings and meetings Work documents and records should be retained
at least until audit completion Work documents involving confidential information
should be safeguarded
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMSOn-site Audit Activities - Opening MeetingOn-site Audit Activities - Opening Meeting
Objectives To confirm audit plan To clarify how audit will be performed To establish communication with auditee
Participation Auditee’s management
Staff responsible for audited functions, if appropriate
Audit team whose leader should chair meeting
Main Issues Introduction of participants and their role Audit objectives, scope, criteria and timetable Audit methods, language, confidentiality and reporting
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
Collecting information:• document review• interviews• site visits
Collecting information:• document review• interviews• site visits
CriteriaCriteria
On-site Audit Activities - Collecting InformationOn-site Audit Activities - Collecting Information
Verification
Review
Audit conclusions
Information
Audit evidence
Audit findings
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMSPossible Sources of Information for the AuditPossible Sources of Information for the Audit
Interviews Observation of activities, work environment and conditions Documents, for example
Q Policy, Q objectives and Q plans Procedures, instructions, licences and permits, Specifications, drawings Contracts, orders
Records such as Inspection records, reports
Minutes, logbook of customer complaints, audit reports
Data summaries, analyses and performance indicators
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
On-site Audit Activities - Closing Meeting (I)On-site Audit Activities - Closing Meeting (I)
Preparation
Audit team should confer prior to the closing meeting to: Review audit findings Reach consensus on audit conclusions Agree on roles and tasks for closing meeting
Participation Auditee’s management and responsible staff
Audit team whose leader should chair the meeting
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
On-site Audit Activities - Closing Meeting (II)On-site Audit Activities - Closing Meeting (II)
Main Issues
Presentation of audit findings and conclusions
Acknowledgement by auditee and agreement on
corrective action plan
Resolving diverging opinions
If specified, presentation of recommendations for
improvement
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
Audit ReportAudit Report
Should contain audit conclusions on: Conformance of QMS to criteria Effective implementation and maintenance of QMS Effectiveness of management review process
Report should also identify
units audited audit client audit team
dates and places of audit audit criteria
audit findings
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
Audit Report (cont.)Audit Report (cont.) Audit report can also include:
Agreed audit objectives, scope and plan auditee’s key representatives summary of audit process including obstacles met statement regarding confidential nature of report any agreed follow-up actions any unresolved divergences between auditors and
auditee recommendations for improvement, if specified in
objectives Distribution
to recipients designated by audit client
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMSCompetence of QMS AuditorsCompetence of QMS Auditors
QMS auditors should have knowledge and skills in:
Audit procedures, tools and methods
Management systems and their standards
Organizational situations
Applicable laws
Quality techniques (terminology, principles and tools, for ex. statistical tools, FMEA)
Sector-specific products and processes
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMSQualifications of QMS AuditorsQualifications of QMS Auditors
Auditors should have ( minimum recommended)
sufficient education (secondary),
technical, managerial or professional work experience (5 y.)part of which is in QM (2 y.),
auditor training (40 hours),
audit experience (4 complete audits - 20 hours)
Auditor ’s personal attributes: observation, tenacity, independence, realism, ethics, diplomacy, cool under stress, oral and written expression
AET9907C.PPT2004-03-13 25
AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMSQMS Lead AuditorsQMS Lead Auditors
Lead auditors should demonstrate necessary knowledge and skills to lead and manage the audit:
planning organizing directing
performing reporting
Lead auditors should have performed additional audits (3 complete audits in 15 days) as lead auditor under supervision of a competent lead auditor
Lead auditors should be able to reach audit conclusions on overall capability of QMS
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMSCertification ProcessCertification Process
Pre-assessmentPre-assessmentPre-assessmentPre-assessment
Initial visitInitial visitInitial visitInitial visit
Audit preparationAudit preparationAudit preparationAudit preparation
The Audit(s)The Audit(s)The Audit(s)The Audit(s)
Corrective ActionsCorrective ActionsCorrective ActionsCorrective Actions
SurveillanceSurveillanceSurveillanceSurveillance
Certificate grantedCertificate grantedCertificate grantedCertificate granted
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
Some Certification IssuesSome Certification Issues
Interpretation of ISO 9000 – National Committees,
ISO/TC 176
Credibility of certifier (see slide 28)
Accreditation programmes (see slide 28)
Cross – border recognition (see slides 29-32)
Certification costs
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
• Accreditation Confidence in competencecompetence and impartialityimpartiality of certifier
• Accrediation is carried out to check conformance of QMS Certifiers with ISO Guide 62 (future ISO/IEC 17021)
• Accreditation Bodies should conform to ISO Guide 61 (future ISO/IEC 17011)
Accreditation of QMS CertifiersAccreditation of QMS Certifiers
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
Objective: One-Stop Assessment Accepted Worldwide
Possible Approaches
Mutual Recognition Agreements (MRAs) between two certifiers
Multilateral Recognition between certifiers
International Recognition between accreditors
Cross-border Acceptance of CertificatesCross-border Acceptance of Certificates
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
Country XCountry X Country YCountry Y
Certifier ACertifier A Certifier BCertifier BMRAMRA
Supplier 1Supplier 1 Supplier 2Supplier 2
DisadvantagesDisadvantages– Limited recognition– MRAs are time consuming and costly to establish
and maintain
Mutual Recognition Agreements (MRA)Mutual Recognition Agreements (MRA)
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
Examples: IQNet, IIOC, itqs, Regional
CQSCQS
DeltaDelta
TÜVTÜVBayernBayern
itqsitqsitqsitqs IQNetIQNetIQNetIQNet
QMIQMI
DQSDQS
APCERAPCERNSAINSAIAENORAENOR
FCAVFCAV KEMAKEMA
AFAQAFAQBSIBSI
bureaus of shippingbureaus of shippingand consultantsand consultants
Disavantage:Disavantage: Incomplete coverage of worldIncomplete coverage of world
IIOCIIOCIIOCIIOC
SQSSQS
ÖQSÖQS
Multilateral Recognition between CertifiersMultilateral Recognition between Certifiers
SGSDNV
BVQI
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
Mutual Recognition Mechanism(Peer Evaluation/Multilateral Agreement)
Mutual Recognition Mechanism(Peer Evaluation/Multilateral Agreement)
Country BCountry BCountry ACountry A Country CCountry C
AA AA
CCCC CC CC CC
SS SS SS SS SS SS SS SS SS
S:S: Supplier Supplier C:C: Certifier Certifier A:A: Accreditor Accreditor
International Recognition System (IAF)International Recognition System (IAF)
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
Traditionally, NSBs carried out Product Certification This involved the company quality system
(ISO System No 5)
With the advent of ISO 9000 then 14000 NSBs either started a certification/registration system, or
co-established such as system with other bodies
As Accreditation became widespread, some NSBs established an accreditation system
others co-established such systems with other bodies
Role of NSBs in Certification & AccreditationRole of NSBs in Certification & Accreditation
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AUDITING AND CERTIFICATIONS OF QMSAUDITING AND CERTIFICATIONS OF QMS
To ensure competencecompetence (technical and administrative) and impartialityimpartiality
To avoid conflict of interest Consultancy on Management Systems and
certification should not be combined
Certification and Accreditation should not be combined
Laboratory Accreditation and running a lab should not be combined
Conditions for NSBs to be engaged inConditions for NSBs to be engaged inCertification & AccreditationCertification & Accreditation