IAQG OPMT OP Assessor Training Module 12 Oversight Assessment of Accreditation Bodies Office and...

IAQG OPMT OP Assessor Training

Module 12

Oversight Assessment of Accreditation Bodies

Office and Witnessed Assessment

February 2015


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


Oversight of Accreditation Bodies

• Oversight of Accreditation Bodies (ABs) is described in 9104-002 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


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)


Accreditation Body (AB) Responsibilities


Where does ISO 17011 fit?

Accredited Certification Framework

Regional Special Recognition Groups e.g.:PAC – Pacific Accreditation Cooperation

EA - European – cooperation for AccreditationIAAC – Inter American Accreditation Cooperation

IAF

ISO/IEC 17011Accreditation Bodies

Certification Bodies ISO/IEC 17021

Certified Management Systemse.g. ISO 90019100 series

CB Trade Associations

Industry Trade Associations


ISO 17011 within an AB:

ISO/IEC 17011Accreditation Bodies

Certification Bodies

EMAS Verifiers Council Regulation

761/2001

Eco-Management and Audit Scheme

ISO/IEC 17021

Environmental Management

Systems

ISO/IEC 17021

Quality Management

Systems

ISO/IEC 17024

Persons

ISO/IEC 17065

Products


ISO 17011 within an AB:


Illustration of typical AB processes


ISO 17011 Sections for Focus:• 4.6 Accreditation Activity• 4.3 Impartiality• 6 Human resources • 7 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

• 5 Management including:- 5.7 Internal audits


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


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


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


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


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 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


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)


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


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


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


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


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


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:- 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


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)


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


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


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


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


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)


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


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


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


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

http://www.iaf.nu/articles/IAF_Members__Signatories/4


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

http://www.iaf.nu/

http://www.compad.com.au/cms/iaf/workstation/upFiles/443945.IAF-GD3-2003_Cross_Frontier_Accredn_Issue1v3_Pub.pdf


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

http://www.compad.com.au/cms/iaf/workstation/upFiles/557184.IAF-ILAC-A5_2009_Final.pdf







Questions


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 9104-002 Forms J (Office) & K (Witness) check sheets.

• So more on 9104-001 section 5 ….• Note: Form J questions will be referenced (Qxx)


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)

9104-001



• 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

9104-001



• 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:

9104-001




‒ 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

9104-001




‒ 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

9104-001



• Read 9104-001 Section 5

• Comments?

9104-001


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

Exercise


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

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?

Exercise – Suggested Answers


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

9104-001


Questions


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

– 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


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

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

9104-002


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.


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.

https://www.sae.org/iaqgdb/oasishelp/iaqgresolutionslog.pdf?02272014

http://www.sae.org/?PORTAL_CODE=IAQG


Questions?


Requirements Relationship for AB’s

• Approval of AB’s to perform accreditations of CB’s includes:

S ISO 17011:2004

S IAF membership

S Regional MLA signatory (where applicable)

• In addition the ICOP process adds:

S IAF MLA signatory

S 9104 series (9104-001, 9104-002 and 9104-003)

S IAQG OPMT Supplemental Rules

S ICOP Resolutions (IAQG and Sector)


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)


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:

- Team competence

- Conformity to established requirements

- The effectiveness of the assessment program

- Conformity of the assessment team with the AB procedures and processes


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 re-fresh 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


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


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

- 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


9104-002 Form J Check Sheet:

• Review the check sheet now:

• Questions on content?


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)

- 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



• 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 9104-001 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)



• 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 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?


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?


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?



• 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.



• Remember - AB Assessment Team Leader performs the Opening Meeting

• Conduct the assessment

- 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


9104-002 Form K Check Sheet:

• Review the check sheet now:

• Questions on content?


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 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


AB Office and Witness Assessment:

• Remember the assessments are linked with results from one 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!


Questions?

IAQG OPMT OP Assessor Training Module 12 Oversight Assessment of Accreditation Bodies Office and...

Documents

Transcript of IAQG OPMT OP Assessor Training Module 12 Oversight Assessment of Accreditation Bodies Office and...