Module 12
Oversight Assessment of Accreditation Bodies
Office and Witnessed Assessment
February 2015
IAQG OPMT OP Assessor Training
Module Summary
• In this module we will discover:
‒ How AB’s Work
‒ Requirements for AB’s
» All about ISO 17011
» AB Relationship with the IAF
» 9104-001 as applicable to AB’s (Section 5)
‒ How to conduct AB Oversight
» Office Assessment including Form J
» Witnessed Assessment including Form K
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Oversight of Accreditation Bodies
• Oversight of Accreditation Bodies (ABs) is described in 9104002 clause 7.11
• It requires oversight of ABs in two forms:
- Office Assessment
- Witnessed Assessment
• To conduct an effective assessment we need to understand
how a AB works
• Assessment of ABs will usually be an OP Assessor only
oversight
• Let’s start with the standard that the AB works to, and is peer
evaluated against - ISO 17011:2004
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Introducing ISO 17011:
• ISO 17011:2004, Conformity assessment — General
•
requirements for accreditation bodies accrediting conformity
assessment bodies
What’s it all about?
- Applicable to Accreditation Bodies (ABs) accrediting all types of
-
Conformity Assessment Bodies (CABs)
Contains requirements for assessing and accrediting CABs
Also used for the peer evaluation process for mutual recognition
arrangements between ABs
• References:
- ISO 17000:2004 Conformity Assessment – Vocabulary and general
principles
• Please refer to ISO 17011:2004 as we proceed:
– Note: 9104-002 Form J questions are referenced (Qxx)
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Accreditation Body (AB) Responsibilities
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Where does ISO 17011 fit?
CB Trade Associations
IAF
Industry Trade Associations
Regional Special Recognition Groups e.g.:
PAC – Pacific Accreditation Cooperation
EA - European – cooperation for Accreditation
IAAC – Inter American Accreditation Cooperation
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Accreditation Bodies
ISO/IEC 17011
Certification Bodies
ISO/IEC 17021
Certified Management Systems
e.g. ISO 9001
9100 series
Accredited Certification Framework
IAQG OPMT OP Assessor Training
ISO 17011 within an AB:
Accreditation Bodies
ISO/IEC 17011
Certification Bodies
EMAS Verifiers
Council Regulation
761/2001
ISO/IEC 17021
Eco-Management
and Audit Scheme
Environmental
Management
Systems
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ISO/IEC 17065
ISO/IEC 17021
ISO/IEC 17024
Products
Quality
Management
Systems
Persons
IAQG OPMT OP Assessor Training
ISO 17011 within an AB:
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Illustration of typical AB processes
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ISO 17011 Sections for Focus:
•
•
•
•
4.6
4.3
6
7
• 5
Accreditation Activity
Impartiality
Human resources
Accreditation process
-
7.2 Application
7.3 Resource review
7.5 Preparation for assessment
7.6 Documentation and record review
7.7 On-site assessment
7.8 Analysis of findings and assessment report
7.9 Decision-making and granting accreditation
7.11Reassessment and surveillance
Management including:
- 5.7 Internal audits
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Section 4.6 - Accreditation Activity:
• AB to describe its accreditation activities
• May adopt application or guidance documents and/or
participate in the development of them
- shall ensure that such documents have been formulated by
committees or persons possessing the necessary competence,
and
- with participation of interested parties (as appropriate)
- Where international application or guidance documents are
available, these should be used
• The AB shall establish procedures for extending its activities
and to react to demands of interested parties
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Section 4.3 – Impartiality:
• AB operated to safeguard objectivity and impartiality
• Non-discriminatory policies and procedures
• Structure for safeguarding impartiality and for developing and
maintaining the principles and major policies:
- To provide an opportunity for effective involvement by interested
parties
- With a balanced representation of interested parties with no single
party predominating
• ABs shall not offer or provide any service that affects its
impartiality, such as
- The conformity assessment services that CABs perform
- Consultancy
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Section 4.3 – Impartiality:
• AB to ensure that the activities of its related bodies do not
compromise the confidentiality, objectivity and impartiality
of its accreditations
• ABs to identify, analyse and document the relationships
with related bodies to determine the potential for conflict
of interest:
- Where identified, appropriate action to be taken
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Section 6 – Human Resources: (Q44)
• AB shall have a sufficient number of competent personnel for
the type, range and volume of work performed
• For each activity involved in the accreditation process the AB
describes (Q45)
- qualifications, experience and competence required
- initial and ongoing training required
• Procedures required for selecting, training and formally
approving assessors and experts
• AB to identify the specific scopes in which each assessor and
expert has demonstrated competence to assess
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Section 6 – Human Resources:
• AB ensure the satisfactory performance of the assessment and
the accreditation decision-making process
‒ by establishing procedures for monitoring the performance and
competence of the personnel
• AB to conduct monitoring to evaluate an assessor’s
•
•
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performance and to recommend appropriate follow-up actions
to improve performance
Each assessor shall be observed on-site regularly, normally
every three years, unless there is sufficient supporting
evidence that the assessor is continuing to perform
competently
Personnel records required to be kept
IAQG OPMT OP Assessor Training
Section 7 – Accreditation Process:
• General criteria for accreditation of CABs shall be those set out
in the relevant normative documents such as International
Standards and Guides for the operation of CABs
• AB to make information publicly available as per clause 7.1.2
• Application: (Q16)
- CABs to make formal application, and
- Provide information to the AB including copy of management
system
- AB to review for adequacy (Q17)
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Section 7.3 – Resource Review: (Q18)
• AB to review its ability to carry out the assessment of the
applicant CAB:
- in terms of its own policy
- its competence, and
- and the availability of suitable assessors and experts
• Also the ability of the AB to carry out the initial assessment in a
timely manner
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Section 7.5 – Preparation for Assessment:
• AB may conduct a preliminary visit:
- May identify deficiencies in the CAB management system or its
competencies
• AB appoint an assessment team consisting of a lead assessor
and assessors and/or experts:
- With appropriate knowledge of the specific scope(s)
- Understanding sufficient to make a reliable assessment of the
competence of the CAB to operate within its scope of accreditation
• Assessment team to act in an impartial and non-discriminatory
manner
• Procedures for sampling where the scope covers a variety of
specific conformity assessment services
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Section 7.5 – Preparation for Assessment:
• For initial assessments:
– Visit the main or head office
– All other premises of the CAB from which one or more key activities
are performed and which are covered by the scope
• For surveillance and reassessment
– And where the CAB works from various premises
– AB to use procedures for sampling all premises from which one or
more key activities are performed
– May identify deficiencies in the CAB management system or its
competencies
• AB and CB and assessment team to agree dates of assessment
to meet overall assessment plan
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Section 7.6 – Documents and Record Review:
• Review all relevant documents and records supplied by the CAB
to evaluate the CAB documented system
• May decide not to proceed with an on-site assessment
• Must document and report nonconformities to CAB if not
proceeding
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Section 7.7 – On-site Assessment:
–
-
Commence with an opening meeting including:
Purpose of the assessment
Accreditation criteria and scope for the assessment
Assessment schedule
• Assess:
- The conformity assessment services of the CAB
- At the premises of the CAB from which one or more key activities
are performed
- Perform witnessing at other selected locations where the CAB
operates,
- To gather objective evidence that the CAB is competent and
conforms to the relevant standard(s) and other requirements
- Witness the performance of staff of the CAB to provide assurance
of the competence of the CAB
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IAQG OPMT OP Assessor Training
Section 7.8:
• Analysis of findings:
- Analyse all relevant information and evidence gathered during the
assessment
- Analysis to be sufficient to allow the determination of the extent of
competence and conformity of the CAB
- May provide observations on areas for possible improvement but
not consultancy
• Assessment Report:
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A meeting shall take place prior to leaving the site
Provide a written and/or oral report on findings
Opportunity for the CAB to ask questions to be provided
A written report provided to the CAB promptly
Report shall contain comments on competence and conformity, and
shall identify any nonconformities
IAQG OPMT OP Assessor Training
Section 7.8:
• Assessment Report:
- CAB shall be invited to respond to the assessment report and to
describe the specific actions taken or planned to be taken, within a
defined time, to resolve any identified nonconformities
- Responses of the CAB to be reviewed to see if the actions appear
to be sufficient and effective.
- Evidence of effective implementation of actions or a follow-up
assessment may be carried out to verify effective implementation of
corrective action
- Information provided to the accreditation decision-maker(s) as per
clause 7.8.6 a) to k)
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Section 7.9 - Decision-Making: (Q28)
• AB shall, without undue delay, make the decision on whether to
grant or extend accreditation on the basis of an evaluation of all
information received and any other relevant information
• AB shall provide an accreditation certificate to the accredited
CAB containing information as per clauses 7.9.4 a) to g) and
7.9.5
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IAQG OPMT OP Assessor Training
Section 7.11 - Reassessment & Surveillance: (Q32)
• AB shall have procedures and plans for carrying out periodic
surveillance on-site assessments, other surveillance activities
and reassessments at sufficiently close intervals to monitor the
continued fulfilment of the requirements for accreditation by the
accredited CAB.
• Reassessment is similar to an initial assessment, except that
experience gained during previous assessments shall be taken
into account
• Surveillance on-site assessments are less comprehensive than
reassessments
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IAQG OPMT OP Assessor Training
Section 7.11 - Reassessment & Surveillance:
• AB to design its plan for reassessment and surveillance of each
•
CAB so that representative samples of the scope of accreditation
are assessed on a regular basis
AB to rely on either reassessment alone or a combination of
reassessment and surveillance:
- Reassessment alone at intervals not exceeding 2 years; or
- If reassessment and surveillance; then reassessment at least every
5 years;
- Interval between the surveillance on-site assessments should not
exceed 2 years
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IAQG OPMT OP Assessor Training
Section 7.11 - Reassessment & Surveillance:
• Where nonconformities are identified, the AB shall define strict
time limits for corrective actions to be implemented
• AB to confirm the continuation of accreditation, or decide on the
renewal of accreditation, based on the results of surveillance and
reassessments
• AB may conduct extraordinary assessments as a result of
complaints or changes
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Section 5 - Management:
• ABs required to establish, implement and maintain a
management system and continually improve its effectiveness in
accordance with ISO 17011 that addresses: (Q5)
- Policies and objectives including a quality policy
- Objectives should be measurable and shall be consistent with the
AB’s policies
- Management manual and associated documents to include:
» Document control (5.3) and records (5.4)
» Nonconformities and corrective actions (5.5)
» Preventive actions (5.6)
» Internal audits (5.7)
» Management reviews (5.8)
» Complaints (5.9) and Appeals (7.10) (Q8-9) (Q30)
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Section 5 - Management:
• Top management shall appoint a member of management who,
irrespective of other responsibilities, shall have responsibility and
authority that includes:
- ensuring that procedures needed for the management system are
established, and
- reporting to top management on the performance of the
management system and any need for improvement
• Note: Many of the management system requirements are similar
but not always the same as ISO 9001 requirements
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IAQG OPMT OP Assessor Training
Other Clauses:
• ISO 17011 also includes requirements for:
-
Legal responsibility (4.1) and structure (4.2)
Confidentiality (4.4) (Q48)
Liability and financing (4.5)
Subcontracting the assessment (7.4) (Q47)
Extending accreditation (7.12)
Suspending, withdrawing or reducing accreditation (7.13)
Records (7.14)
Proficiency testing and other comparisons for laboratories (7.15)
Responsibilities of the AB and the CAB (8)
• Take some time to read these requirements
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The IAF Multilateral Agreement (MLA):
• Multilateral Agreements (MLAs) create confidence in, and
acceptance of, accredited certifications, inspections and test
reports, eliminating the need for suppliers to be certified in each
country where they sell their products or services
• Each signatory is subject to routine rigorous evaluations by peer
evaluation teams in order to verify continuing conformance with
the international standard for accreditation bodies (ISO/IEC
17011)
• MLA Signatories and the accreditations they grant are
internationally recognised through the IAF (and ILAC for
Laboratories) and Regional Accreditation Groups
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IAQG OPMT OP Assessor Training
ICOP and the AB
• To participate in the ICOP process ABs must be signatories to
the IAF MLA for Quality Management Systems (Q1)
– The IAF MLA has 5 levels
– AB’s are required to be scope ISO 17021 Level 5 for ISO 9001
• MLA Signatories can be found on the IAF website at
http://www.iaf.nu/articles/IAF_Members__Signatories/4
• All current ABs in the ICOP process are MLA signatories
• MLA process includes peer evaluations of ABs
• Results of peer evaluations are available on request, during
oversight assessment of ABs
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IAQG OPMT OP Assessor Training
Cross Frontier (Q47)
• The IAF operates a facility where MLA signatory ABs can
subcontract assessments to each other called ‘Cross Frontier
Accreditation’
• Details can be found on the IAF website at http://www.iaf.nu/ by
following the link under the ‘Publications’ button looking for IAF
GD 3:2003 Guidance on Cross Frontier Accreditation
• ABs participating in ICOP may only subcontract ICOP
assessments to other ABs approved within the ICOP scheme
‒ Refer to 9104-001 clause 16 for detailed requirements
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Additional Requirements?
• There are no IAF Mandatory Documents applicable to AB’s
– Remember AB’s assess CB’s to the requirements of the MD’s
• ABs that are signatories of the MLA are required to observe
IAF/ILAC A5:04/2009 IAF/ILAC Multi-Lateral Mutual Recognition
Arrangements: Application of ISO/IEC 17011:2004
• It adds few additional requirements to ISO 17011
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IAQG OPMT OP Assessor Training
Questions
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IAQG OPMT OP Assessor Training
9104 Series Requirements for AB’s
• We will examine the following requirements in 9104-001
• Section 5:
- Titled “Requirements for Accreditation Bodies”,
- Comprises the majority of ICOP Scheme requirements for AB’s
• Additional requirements for AB’s are found in 9104-001 clauses
- 8.6.i) Relating to inappropriate use of marks and/or logos
- 15.3.a) Actions on suspension of an AB
- 16.3 & 16.4 AB Cross Frontier working
• All 9104-001 AB requirements constitute the basis for the 9104002 Forms J (Office) & K (Witness) check sheets.
• So more on 9104-001 section 5 ….
• Note: Form J questions will be referenced (Qxx)
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IAQG OPMT OP Assessor Training
9104-001
Section 5: Requirements for accreditation bodies:
• AB responsible for the accreditation of CBs to 9104-001 (Q4)
‒ including granting, maintaining, suspending, withdrawing
• AB’s agree to right of access and to oversight (Q6-7)
• Conformance to ISO 17011 and IAF ML 4 required (Q1)
• Requirement to have a person(s) with continuing direct and
relevant work experience in the AB’s structure for developing and
maintaining the principles and major policies of operation (Q3)
• Additions to the AB’s QMS for 9104-001 include ensuring: (Q4)
‒ CBs identify a single lead office with directly employed or contracted
staff to develop, implement and control ICOP scheme (Q24)
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IAQG OPMT OP Assessor Training
9104-001
Section 5: Requirements for accreditation bodies:
• Additions to the AB’s QMS for 9104-001 include ensuring:
‒ CBs use staff directly employed or contracted by the CB lead office
for all key ICOP activities (Q25)
‒ No CB outsourcing or deployment of activities to other offices
‒ Applicant CBs are not to ‘make promises’ to clients (Q19)
‒ No CB use of IAF defined critical locations allowed – no ICOP
recognition
‒ Process for CB Application, review and initial assessment, includes
(Q16-Q17)
» Review of documentation (QMS changes, competence development, etc.)
» CB Office Assessment
» Witnessed assessment to include a Stage 1 and a Stage 2 for the
complete AQMS
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IAQG OPMT OP Assessor Training
9104-001
Section 5: Requirements for accreditation bodies:
• Additions to the AB’s QMS for 9104-001 include ensuring:
‒ Scope of Accreditation for each CB by individual AQMS starting with
9100 and scope expansion requirements for other AQMS standards
(Q22) (Q27)
‒ During accreditation cycle witnessed assessments are to cover all
AQMS and each certification cycle audit stage (St 1, St 2, SV, RC) (Q36)
‒ Annual Surveillance and re-accreditation that includes: (Q33)
» A CB lead office assessment that includes file reviews per Table 1:
» Witnessed assessments per Table 1:
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IAQG OPMT OP Assessor Training
9104-001
Section 5: Requirements for accreditation bodies:
• Additions to the AB’s QMS for 9104-001 include ensuring:
‒ Optional reporting of AQMS Auditor competency issues to the relevant
Auditor Authentication Body (AAB) (Q39)
‒ Control of ABs marks and symbols
‒ Procedures for suspension and withdrawal that include action for: (Q10)
» Suspension for occurrence of specific conditions (see 5.3.7.c) (Q11)
» Action within 60 days if SMS (or CBMC) recommends suspension
(Q12)
» Conditions to be placed on the CB during suspension (Q13)
‒ Eligibility for transfer of CB clients on accreditation expiry/withdrawal
‒ Closure of nonconformity issued to CBs within 90 days of issue (Q41)
» Failure to close to result in CB suspension
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IAQG OPMT OP Assessor Training
9104-001
Section 5: Requirements for accreditation bodies:
• Additions to the AB’s QMS for 9104-001 include ensuring:
‒ ABs to reject CB applications for 12 months after suspension,
withdrawal, expiry of termination of an application (Q20) (Q31)
‒ Records to be held for 2 accreditation cycles (up to 10 years) (Q52)
‒ Operation of a complaint or issue resolution process including a
response within 30 days
‒ Requirements for AB personnel competence: (Q46)
» AB Assessment teams as per 5.4.1
» AB decision-making personnel as per 5.4.2 that includes knowledge of
aviation, space and defence
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IAQG OPMT OP Assessor Training
9104-001
Section 5: Requirements for accreditation bodies:
• Read 9104-001 Section 5
• Comments?
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IAQG OPMT OP Assessor Training
Exercise
Exercise AB Assessment
• Consider an AB conducting assessments on a CB and answer
the following:
a) For the initial accreditation of a CB to 9104-001 that includes 9100,
9110 and 9120 what assessment activity does the AB require to
carry out?
b) For the annual surveillance of a CB with accreditation for 9100 and
9110 with a total of 148 certified clients covering 175 sites (on
OASIS) with 50 of the clients being 9110 certified the remainder
9100, what assessment activity does the AB require to carry out?
c) If the AB cannot complete its annual assessment activity on the CB
what happens?
• Take 15 minutes to write down your answers
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IAQG OPMT OP Assessor Training
Exercise – Suggested Answers
Exercise Oversight
• A) Initial Accreditation to 9104-001 for 9100 9110 and 9120:
‒ Documentation review
‒ Office assessment at the CB lead office
‒ Witnessed Assessments (x4)
» for 9100 stage 1 and stage 2
» for 9110 stage 1 and stage 2
• B) Surveillance activity:
‒ From 9104-001 Table1 for 175 certificated sites
‒ 10 client file reviews
‒ 3 witnessed assessments (2 in 9100, 1 for 9110 – approx.
proportional)
‒ Remember need to cover all AQMS and all stages of the audit
cycle
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IAQG OPMT OP Assessor Training
Exercise – Suggested Answers
Exercise Oversight
• C) Annual assessment activity not complete:
‒ Special condition as per 9104-001 clause 5.3.7.d)
‒ Initiates the process to suspend the CB
‒ Note: that this is the decision process and does not necessarily
automatically result in CB suspension
‒ What else?
» AB is likely to raise a major nonconformity on the CB at the
same time
• Any Questions or Comments?
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IAQG OPMT OP Assessor Training
9104-001
Section 16: Cross Frontier Policy for Oversight:
• Enables AB operations and 9104-002 Oversight in countries or
sectors away from home country or sector
• ABs to follow IAF GD 3 (Guidance Document)
• ABs can sub-contract work to other ICOP approved ABs in other
countries or Sectors
– Accrediting AB retains responsibility for the work
• OP Assessors can also sub-contract work to OP Assessors in
other countries or sectors
– Subcontracting sector or CBMC retains responsibility
• Fees can be levied on CBs for Oversight outside SMS/CBMC
home region
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IAQG OPMT OP Assessor Training
Questions
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IAQG OPMT OP Assessor Training
9104 Series Requirements for AB’s: 9104-002
• 9104-002 also contains requirements for AB
– Focuses on additions for assessment of CB’s
• We will examine the following requirements in 9104-002
–
–
–
–
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5.1.3 relating to AB Assessor competency
7.14.2 regarding completed 9104-002 Forms
8.3.1 for the annual AB report to the SMS or CBMC
8.3.2 regarding the AB annual reporting of other oversight results
IAQG OPMT OP Assessor Training
9104-002
9104-002 Requirements for accreditation bodies:
• Clause 5.1.3
‒ AB Assessors to be competent and qualified as per 9104-001
‒ Adds requirement for AB assessors to be trained in roles and
responsibilities as documented in 9104-002
‒ Clause 7.14.2 for Joint Oversight
‒ OP Assessors 9104-002 forms to be provided to AB lead
‒ AB lead to incorporate 9104-002 Forms in AB report
‒ Report part of AB’s assessment records, to be maintained by AB
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IAQG OPMT OP Assessor Training
9104-002
9104-002 Requirements for accreditation bodies:
• Clause 8.3.1 (Q55)
‒ Requires an annual report from the AB to the SMS or CBMC for
each CB accredited
‒ Report to contain:
» a) Date of last CB assessment (office and witness) with number and
grading of nonconformities identified
» b) Any increase in AB assessments and CB performance information
(e.g. complaints, suspensions etc.)
‒ Clause 8.3.2 (Q56)
‒ AB to report annually results of other assessments to SMS or CBMC
» Includes items such as IAF Peer evaluations, IAQG member or regulator
authority 9104 series assessments of the AB
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IAQG OPMT OP Assessor Training
9104 Series Requirements for AB’s: 9104-003
• 9104-003 does NOT contain requirements for AB’s
– Focuses on additions for assessment of CB’s
– Some AB’s may require other formal qualification as a pre-requisite
to performing AQMS AB Assessor activities.
» e.g. AAB authentication to the AQMS Standards
» IAQG OPMT Resolution 102 contains applicability requirements for AB
Assessors that wish to become authenticated
– Competency of AB AQMS Assessors is the responsibility of the AB
however must include 9104-001 requirements.
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IAQG OPMT OP Assessor Training
Other Requirements for AB’s
• Don’t forget the additional requirements imposed by:
• IAQG ICOP OPMT Resolutions
– https://www.sae.org/iaqgdb/oasishelp/iaqgresolutionslog.pdf?02272014
• IAQG OPMT Supplemental Rules
– As may be applicable at the time of the assessment
– Located under “Help/Guidance” on the OASIS website
» http://www.sae.org/?PORTAL_CODE=IAQG
• IAQG OPMT Procedure 204
– Requirements for AB’s in the Complex Structure Oversight process.
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Questions?
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IAQG OPMT OP Assessor Training
Requirements Relationship for AB’s
• Approval of AB’s to perform accreditations of CB’s includes:
̶
ISO 17011:2004
̶
IAF membership
̶
Regional MLA signatory (where applicable)
• In addition the ICOP process adds:
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̶
IAF MLA signatory
̶
9104 series (9104-001, 9104-002 and 9104-003)
̶
IAQG OPMT Supplemental Rules
̶
ICOP Resolutions (IAQG and Sector)
IAQG OPMT OP Assessor Training
Oversight of ABs:
• Oversight of ABs is essentially the same processes that as when
assessing a CB
• AB Oversight is conducted by industry only OP Assessor
oversight
• 9104-002 requires that oversight of each AB each year
comprising a minimum of one each of :
- AB Office Assessment (7.11.2)
- AB Witness Assessment (7.11.3)
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IAQG OPMT OP Assessor Training
Oversight of ABs (9104-002):
• AB Office Assessment (7.11.2) includes:
- A review of AB management system and assessment activity to
assess conformance with 9104-001 and applicable industry
standards (ISO/IEC 17011)
- Verification that the AB is approved by the respective SMS or CBMC
- Review of the last AB oversight office assessment reports, including
actions taken
• AB Witness Assessment (7.11.3) assesses:
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Team competence
Conformity to established requirements
The effectiveness of the assessment program
Conformity of the assessment team with the AB procedures and
processes
IAQG OPMT OP Assessor Training
AB Assessment:
• OP Assessor Requires to:
- Prepare yourself for the assessment (refer to ISO 19011)
» Have you got your documentation?
» Have you got your standards and normative references?
- Review the Audit Plan
- Review any available AB documentation to gain knowledge and
understanding of the ABs processes
- Review appropriate parts of the standards and requirements to refresh your memory
• If witnessing the AB you may need up to 2 hours after the end of
the AB Audit for your assessment conclusions and closing meting
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IAQG OPMT OP Assessor Training
AB Assessment:
• OP Assessor Requires:
- 9104-002 Forms
» Form D – Oversight Nonconformity Record
» Form J - AB Office Assessment Checklist
» Form K - AB Witness Assessment Checklist
- Standards and Reference Documents:
» 9104 series (9104-001, 9104-002, 9104-003)
» ISO / IEC 17011 and ISO / IEC 17021
» IAF Mandatory Documents (1 to 5 inclusive, 10 and 12)
» IAQG Supplemental Rules (e.g. SR002)
» IAQG and Sector (where applicable) Resolutions Log
- Audit Plan
- Copy of previous assessment and oversight reports including
verification evidence for any nonconformities
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IAQG OPMT OP Assessor Training
AB Office Assessment:
• Conduct the assessment
- Gather objective evidence that the AB is structured and operated to
safeguard objectivity and impartiality and conforms to ISO 17011
and 9104 series requirements
- Follow your audit plan
- Use checklist for guidance
• Focus on key AB processes and procedures
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The accreditation process – through AB client file reviews
The AB competence process
Process for impartiality management
Don’t forget to review results of any recent IAF peer review –
usually every 4 years, conducted by the Regional Accreditation
Group
IAQG OPMT OP Assessor Training
9104-002 Form J Check Sheet:
• Review the check sheet now:
• Questions on content?
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IAQG OPMT OP Assessor Training
AB Client File Reviews:
• Follow the accreditation process (ISO 17011 clause 7)
- From application to accreditation
- Through surveillance
- And reassessment
• Examine competency of assessors and accreditation staff
associated with the accreditation process (ISO 17011 Clause 6)
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What are the competence criteria ? (Note: 9104-001 clause 5.4)
How are accreditation decision-makers competent?
How is the assessors scope competence approved?
How are assessors monitored on-site?
Don’t forget applicable 9104-001 requirements
IAQG OPMT OP Assessor Training
AB Client File Reviews:
• Reporting (ISO 17011 clause 7.8)
- What conclusions (including extent of competence and conformity)
were reached?
- What recommendations for accreditation were made?
- Were nonconformities correctly reported and graded in accordance
with 9104-002 clauses 3.11 and dispositioned according to 9104001 clause 5.3.8 timescales
- Remember that there are CB Office and Witness Assessment
reports to review each year
• Accreditation Decisions (ISO 17011 clause 7.9)
- Don’t forget competence of AB decision-makers (Note: 9104-001 clause
5.4.2)
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IAQG OPMT OP Assessor Training
AB Client File Reviews:
• Accreditation Certificates
- ISO 17011 clauses 7.9.4 and 7.9.5 and 9104-001 clause 5.3.f)
- Do they identify the CB Lead Office for the ICOP scheme?
- Do they refer to 9104-001 for certification of CB clients to the
appropriate AQMS standard?
- Check accreditation validity dates
• Surveillance and Reassessment
- ISO 17011 clause 7.11
• OASIS: 9104-001 clause
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5.3.g)
- AB status and details in OASIS correct?
- Correct entry of CB and AQMS standard accreditation details?
- CB Address refers to the Aerospace Lead Office?
IAQG OPMT OP Assessor Training
Other AB Office Assessment Activity:
• How approved by SMS (and CBMC where applicable)?
• Does the committee in ISO 17011 clause 4.3.2 and 9104-001
clause 5.2.c) have competence and continuing direct
involvement in aviation space and/or defence?
• Annual Report to SMS (or CBMC) - 9104-002 clause 8.3?
• Appeals and Complaints relating to ICOP
– ISO 17011 clauses 7.10 Appeals and 5.9 Complaints
• OASIS feedback reviewed and dispositioned?
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IAQG OPMT OP Assessor Training
AB Witness Assessment:
• 9104-002 Clause 7.11.6:
– AB witness assessments shall be performed while the AB is
conducting an office assessment of an accredited CB
• Discussion: If the AB’s assessment of the CB office is a joint
assessment as per 9104-002, how many OP Assessors are
required to conduct both oversights?
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IAQG OPMT OP Assessor Training
AB Witness Assessment:
• 9104-002 Clause 7.11.6:
– AB witness assessments shall be performed while the AB is
conducting an office assessment of an accredited CB
• Discussion: If the AB’s assessment of the CB office is a joint
assessment as per 9104-002, how many OP Assessors are
required to conduct both oversights?
• Answer: 9104-002 clause 7.11.4: The OP assessor shall not
influence the AB or joint assessment team; the role, when
witnessing, is one of observation only.
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IAQG OPMT OP Assessor Training
AB Witness Assessment:
• Remember - AB Assessment Team Leader performs the
Opening Meeting
• Conduct the assessment
-
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OP Assessor observes the assessment being undertaken
DO NOT INFLUENCE THE AUDIT!
Remember to control your body language and talking or comments
Do not interfere or conduct the assessment of the CB client yourself
Do not answer direct questions about the assessment, AB or CB
client
IAQG OPMT OP Assessor Training
9104-002 Form K Check Sheet:
• Review the check sheet now:
• Questions on content?
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IAQG OPMT OP Assessor Training
Witness Assessment Focus:
• You are assessing the effective deployment of the ABs
management system
- Are opening and closing meetings effective (ISO 19011)?
- Does the AB assessment team demonstrate appropriate
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competence for the assessment of the CB
Are the correct definitions of nonconformity, observation or
opportunity for improvement actually used?
Do you have confidence in this accreditation based on the
assessment witnessed?
Assess AB conformity to 17011 and 9104-001 requirements
Assess conformity of the AB assessment team with AB procedures
and processes
Assess effectiveness of the AB assessment program
IAQG OPMT OP Assessor Training
AB Office and Witness Assessment:
• Remember the assessments are linked with results from one
•
•
•
•
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affecting the other
It does not matter if the office or witness comes first
You may need to go back to the AB Office to close out NCRs
Do not carry out oversight of the AB and CB at the same time!
Enjoy the activity!
IAQG OPMT OP Assessor Training
Questions?
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IAQG OPMT OP Assessor Training