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8/8/2019 Credibility Certificacion Iso 9001 Rev2
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Nov 2006 (C) Nigel H Croft 2006 - All rights reserved 1
Credibility of ISO 9001
CertificationDr Nigel H CroftBrazilian Expert to ISO/TC176 since 1995
Convener ISO/TC176 Conformity AssessmentLiaison Group
Co-convener ISO 9000 Advisory Group
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DisclaimerThe views presented in this
seminar are my own!
(They do not necessarily reflect
official ISO or IAF opinions)
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ISO/TC176 Strategic Plan
HORIZON 2010 TC 176 is focused on:
Ensuring the market relevance of its products,
Enhancing the compatibility of managementsystem standards,
Actively managing liaison relationships, inActively managing liaison relationships, in
particular to ensure the continued credibilityparticular to ensure the continued credibility
of ISO/TC 176 products in their use forof ISO/TC 176 products in their use forconformity assessmentconformity assessment, and
Improving its own internal processes.
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ISO 9001:2000 Scope Clause 1.1 - Specifies quality management
system requirements for organization to: demonstrate ability to consistently providedemonstrate ability to consistently provide
product that meets customer and applicableproduct that meets customer and applicable
regulatory requirementsregulatory requirements
enhance customer satisfaction
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WHAT IS CERTIFICATION ALL
ABOUT? CONFIDENCE
Demonstrating that the organization does have amanagement system conforming to the relevantstandard
Providing CONFIDENCE to the organizationscustomers and other stakeholders that the systemis effective in achieving the desired outputs
Consistent conforming productsConsistent conforming products(ISO 9001)(ISO 9001) Prevention of pollution; regulatory compliance;Prevention of pollution; regulatory compliance;
continual improvementcontinual improvement(ISO 14001)(ISO 14001)
etcetc
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Who is The Customer? ISO 9000:2000 definition:
organization or person that receives a product
Who is the customer of the certification body?
Contractual customer = certified organization
Ultimate customer = those who purchase or receiveUltimate customer = those who purchase or receive
products from the certified organizationproducts from the certified organization
Trust in the ability of a certified organization toTrust in the ability of a certified organization toconsistently provide them with conforming productsconsistently provide them with conforming products
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HOW TO PROVIDE CONFIDENCE?
(ISO 9001 example)
Accreditation Body
IAF Recognition
Organization
Certification Body
Customers
Confidence
ISO 9001:2000
ISO/TC176
(Translation)
National Body
Confidence
Confidence
ConfidenceConfidence
Chain of confidence-promoting activities
(ISO/CASCO)ISO 17011
ISO 17021-1
ISO 17021-2ISO 17024
Confidence
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Ongoing confidence (The C
in the PDCA cycle) Focus on results
Did the productmeet customer requirements?(Customers rarely see the quality managementsystem!)
If YES, Confidence in certification INCREASES
If NO, customers lose confidence in certification,
and ISO 9000 credibility suffers
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Some personal
reflectionsStratification throughout the
supply chain
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Stratification
(BIMODAL DISTRIBUTION)
PARAMETERPARAMETER
FREQUE
NCY
FREQUE
NCY
GOOD GUYSBAD GUYS
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Stratification of organizations Qualityorganizations
Use ISO 9001:2000 as part of an overall qualityphilosophy. QMS is a managementtool
Driven by top management leadership
Results focused
Minimalistorganizations
Whats the minimum we have to do to get thecertificate??
Driven by fear, and customer pressure
May try to cut corners
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Stratification of consultants Value-adding
Knowledgeable Business focused Adaptable Offer several solutions
ETHICAL
Used car salesmen Superficial knowledge Sell documentation packages This is how it has to be done UNETHICAL
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Stratification of auditors Value-adding
Process-oriented Results-focused
Knowledge of Business and Quality Tools
Common sense approach Bureaucratic
Documentation-oriented
Records-focused Out of date concepts
Nit-picking approach
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Stratification of certification
bodies Good guys
Consider needs of client and clientand clients customerss customers Technically sound decision making
Able to add value (certification is usefuluseful)
Bad Guys Commercially driven
Aim is to maintain / increase market share Pro-forma (tick-the-boxes) approach to auditing
Low cost, low added value
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Stratification of accreditation
bodies Truly Independent
Protecting consumer interests Facilitating world trade
Rigorous, but fair
Working to ISO/CASCO rules and IAF Guidelines
Commercially driven
Not-for-profit in name only Rubber-stamp for certification bodies
Reluctant to impose sanctions (financial impact)
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Stratification of purchasers Intelligent
Purchase based on overall life cycle cost
Give credit for good quality / performance
Ignorant Purchase only based on cheapest price
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Permutations......
GOOD GUYS
CERT BODY
MINIMALISTBAD GUYS
QUALITY
ORGANIZATION CUSTOMER
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The challenges.. Downward spiral for QMS confidence (Japanese study)Downward spiral for QMS confidence (Japanese study)
Focus on certification, not quality
Certification becomes a commodity Pressure from direct customers
Prices (auditor days and day-rates) driven down
Difficulty to recruit competent auditors
More superficial audits Loss in confidence of CBs clients customers
The ultimate accreditation is from the clientsThe ultimate accreditation is from the clientscustomerscustomers
Risk of taking matters into their own hands
Auto industry (IATF)
Large purchasers returning to 2nd party audits
Possibility of government regulation
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LESSONS FROM
AUTOMOTIVE INDUSTRY.
Accreditation Body(Auto Industry)
IAF Recognition
Organization (Supplier)
Certification Body
Customers (Auto Industry)
Competent Auditors
AuditorRegistration(Auto Industry)
TS16949:2002
ISO/TC176
(Translation)
Chain of confidence-promoting activities
X
(Auto Industry)
Feedback
loop!!
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TELECOM INDUSTRY.
Accreditation Body
IAF Recognition
Organization (Supplier)
Certification Body
QuEST FORUM(TL 9000) QMS Requirements
MeasurementsMeasurements Auditor Competence Oversight
F
eedback
loop!!
Customers(Telecom Companies)
Consumers
Th d f lid d
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The need for a consolidated
approach.. We are all in this together:
Organizations ISO (TC176; CASCO)
National Standards bodies
Accreditation Bodies Certification Bodies
Consultants
Trainers
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ISO 9000 Advisory Group (IAG)
IAG
IAF CRB AssociationMembers
IAF Industry
Association Members
IAF Accreditation
Body Members
ISO/TC176 National
Standards Body members
ISO/TC176 Liaison
Members
IPC (ex-IATCA)
ISO/CASCO
Co-chairs:- Nigel Croft (TC176) + Randy Dougherty (IAF)Secretary :- Peter Dennehy (CASCO)
+ Participation from IAF President & Secretary; TC176 Chair & Secretary;
CASCO Chair & Secretary; IPC Chair; ISO Secretary-General
ISO/COPOLCO
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Objectives of Advisory Group Monitor the credibility of the ISO 9001 standard in its role for
certification, and provide feedback for each of the component
members of the group, as appropriate. Provide a forum for discussion of user satisfaction, and to action
component members of the group, as necessary, whencomplaints or indications of concern are identified.
Provide a catalyst for ISO Member Bodies and AccreditationBody members of IAF to stimulate similar shadow committeeson a local or regional basis
In simple language.
Make sure that all the various players know whats going on,and that nothing gets missed.
S t ti P bl l i
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Systematic Problem-solving
approach 2002 / 2003 What is the problem??
Multi-stakeholder involvement Brainstorming
Cause & effect diagrams
2003 / 2004 Promoting awareness(Problem? .. What Problem???)
2004 / 2005 Identifying possible solutions Focusing on critical issues
2006 / 2007 Implementing solutions
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Recent and future
developments..
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Promoting feedback. ISO 9001:2000 What does it mean in the
Supply Chain? Aims to educate purchasers about what they can
reasonably expect from ISO 9000-certified
suppliers
Explains about concepts of self-declaration,certification and accreditation
Encourages feedback
Available on ISO website www.iso.org
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Other IAG initiativesAuditing Practices Group (APG)
Aim is to promote consistent approach betweenauditors
Comprises experts from
ISO/TC176 (SC1, SC2 & SC3 + WG Interpretations)
IAF
IPC
Approx 30 guidance papers now availablewww.iso.org/tc176/ISO9001AuditingPracticesGroup
http://www.iso.org/tc176/ISO9001AuditingPracticesGrouphttp://www.iso.org/tc176/ISO9001AuditingPracticesGroup8/8/2019 Credibility Certificacion Iso 9001 Rev2
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Other IAG initiatives (cont) AccreditationAccreditationAudit Practice Group now
formed Guidance available on following topics:
Assessing the competence of CB auditors Witness audits
Process Approach for accreditation audits
Click on hyperlink from APG website
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Other IAG initiatives White Paper to ISO/IAF/ILAC highlighting
continuing concerns and recommendations Key topics:
Output matters Remember the clients customer
Need to separate the Bad guys from the Good
guys
ISO/TC176 Official interpretations
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ISO/TC176 Official interpretations
for ISO 9001:2000 ISO/TC176 Working Group on Interpretations
now fully operative Interpretations freely available on
www.tc176.org
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ISO/TC176 Initiatives Review and update of ISO 9001:2000
Work already underway Publications scheduled for 2009
Amendment No major changes of intent
Impact / benefit analysis for all proposedchanges
Incorporates review of ability of ISO 9001:2000 tosupport its stated objectives (consistent,conforming products)
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ISO/CASCO initiatives ISO 17021 Part 1 Requirements for
Certification Bodies Published very recently
Applies to both QMS and EMS
Addresses many current concerns such as
CB independence
Managing conflicts of interest Need for CB to have its own QMS
Need for 2-stage audits
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ISO/CASCO initiatives (cont) Future ISO 17021 Part 2 - Requirements for
Certification Body Auditors / Audits Work just started by ISO/CASCO
Recognizes need for:
Competent auditors
Competent useuseof competent auditors (team selection)
ResourcesResourcesto allow a competent audit teamteamto carryout a competent auditaudit(mainly time)
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IAF initiatives (cont) IAF Strategic Planning
Need to focus on the clients customer Are they satisfied with their suppliers performanceperformance?
Recognition that OUTPUT MATTERSOUTPUT MATTERS
Is the management system delivering on its promise?
Recognizes need for a more aggressive posturefrom Accreditation Bodies
To separate the Good Guys from the Bad Guys
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IAF initiatives (cont) IAF Cross-Frontier Accreditation Policy
Does not require local accreditation BUTBUTrecognizes that the local AB is best placed tomonitor certification activities in its own region
Requires closer collaboration between nationalABs and overseas ABs
Still not yet fully implemented
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Other initiatives New IAF Guidance published for:
CAAT Computer Assisted Auditing Techniques ASRP Advanced Surveillance and
Reassessment Procedures
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The challenge. To be sufficiently flexible and non-
prescriptive to satisfy the needs of industry Allow mature, responsible organizations and
their respective CBs to use ASRP and CAAT to
enhanceenhancethe conventional audit process
To ensure sufficient AB oversight
to avoid abuses, and/or excessive commercialpressures that could compromise integrity of thecertification process.
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Conclusions Concerns about credibility of certification
BUTBUT Theres a lot happening to address the
problem IAG initiatives (Supply chain; Audit Practices etc)
ISO/TC176 (Interpretations / update of ISO 9001)
ISO/CASCO (ISO 17021 Parts 1 & 2)
IAF Strategic Plan (Output matters!)
I am optimistic!I am optimistic!
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THANK YOU