L’ accr?©ditation
EME262 -28/02/2009
Beno?Æt Phuez
David Cohen-Solal
Vocabulaire
Certification
Proc?©dure par laquelle une tierce partie donne une assurance ?©crite qu’un produit, un processus ou un service est conforme aux exigences sp?©cifi?©es
R?©f?©rentiels d’ accr?©ditation
Le processus d’ accr?©ditation Cofrac
Le cycle d’ accr?©ditation
L’ accr?©ditation au laboratoire
Selon le r?©f?©rentiel
NF EN ISO/CEI 17025
R?©f?©rentiels
En France, l’ accr?©ditation des laboratoires est effectu?©e par le Cofrac (D?©cret n¬? 2008-1401 du 19 d?©cembre 2008)
selon les r?©f?©rentiels :
NF EN ISO/CEI 17025
Exigences manag?©riales (‚âà ISO 9001)
Exigences techniques
Lab ref 02
Normes techniques d’ analyse
Une vision globale
Exigences manag?©riales
Organisation et direction
Syst?®me qualit?©
Maitrise de la documentation
R?©clamations, non-conformit?©s et action correctives
Enregistrements
Revues de direction

Exigences de l’ ISO 9001
Exigences manag?©riales sp?©cifiques (1)
Le personnel d’ encadrement technique doit avoir l’ autorit?© et les ressources n?©cessaires pour accomplir ses fonctions et identifier les ?©carts ?©ventuels
Des dispositions sont prises pour assurer que la direction et le personnel ne subissent pas de pression commerciale
Le laboratoire assure la protection des donn?©es confidentielles et des droits de propri?©t?© des clients
Un organigramme pr?©sente la structure du laboratoire
Exigences manag?©riales sp?©cifiques (2)
Il faut un responsable qualit?© qui doit avoir (ind?©pendamment de ses autres fonctions) une autorit?© pour assurer que le syst?®me qualit?© est mis en ?-uvre et observ?© en tout temps. Il doit avoir acc?®s ?† la direction.
Il faut nommer des suppl?©ants pour le personnel d’ encadrement
Le personnel est conscient de l’ importance de ses activit?©s et de la fa?ßon dont il contribue ?† la r?©alisation des objectifs du laboratoire
Exigences techniques
Comp?©tence du personnel
Installations et conditions ambiantes
M?©thode d’ essai et d’ ?©talonnage
Comp?©tence du personnel
Qualifi?©
Etudes
Formations
Exp?©rience
Comp?©tences
Form?©
Politique de formation
Emploi d?©fini
Fiche de poste
Installations et conditions ambiantes
Surveillance et maitrise des conditions d’ environnement
S?©paration des activit?©s incompatibles
Acc?®s limit?©s / r?©glement?©s
M?©thodes d’ essais
M?©thodes s?©lectionn?©es issues
des normes
Internationales
R?©gionales
Nationales
Organisations scientifiques de renom
M?©thodes d?©velopp?©es et valid?©es par le laboratoire
M?©thodes sp?©cifi?©es par le client
Validation des m?©thodes d’ essais
Incertitude des m?©thodes d’ essais
Surveillance des m?©thodes d’ essais
Equipements
En ?©tat de fonctionnement
Mise en service
Raccordement m?©trologique
Etalonnages
Entretien, maintenances pr?©ventives
Adapt?© aux besoins
Utilis?© par un personnel comp?©tent et autoris?©
Tra?ßabilit?© du mesurage
D?©finition
Propri?©t?© d’ un mesurage ou d’ un ?©talon qui peut ?™tre raccord?© ?† des r?©f?©rences d?©termin?©es, g?©n?©ralement des ?©talons nationaux ou internationaux ?† travers une cha?Æne ininterrompue de comparaisons ayant toutes des incertitudes d?©clar?©es.
Accords multinationaux
Le Cofrac est signataire des accords
EA (European cooperation for Accreditation)
ILAC (International Laboratory Accreditation Co-operation)
IAF (International Accreditation Forum)
Exemple pratique
Technologie PCR

Monitoring en Temps R?©el des L?©gionelles

Utiliser la PCR?
Son fonctionnement
Validation COFRAC
Contexte international
Moteur: Gestion du risque sanitaire et Pression r?©glementaire

Clients: Gestionnaires, Traiteurs d’ eau, Industriels, H?¥pitaux, Autorit?©s publiques

France:
10% du march?© en PCR
Norme AFNOR Avril 2006
Nouvelle r?©glementation Monitoring L?©gionelles

UK: 3 laboratoires nationaux dont 1 UKAS

Espagne, Hollande, USA, Europe du Nord, Japon, Australie, Afrique du Sud, Moyen Orient.

Soci?©t?© fran?ßaise de biotechnologie fond?©e en 2000.
Fournisseur de solutions analytiques dans les domaines de l’ agroalimentaire, de l’ environnement, de l’ eau et de la sant?© humaine.
Pourquoi utiliser la PCR ?
Cartographie
Localiser les zones critiques du r?©seau

Alertes Sanitaires
Pr?©venir la prolif?©ration et le d?©passement de seuil
Adapter les actions de maintenance 3h
Red?©marrage de l’ installation

Monitoring
Gestion du risque SANITAIRE
D?©tection pr?©coce des foyers de prolif?©ration
Optimiser les actions de maintenance
Quels avantages ?† changer de m?©thode ?
Son fonctionnement
Amorce

Sonde avec 2 marqueurs
Ce que demande le COFRAC
Dossier de certification

Dossier de validation de sp?©cificit?© de l’ analyse
Validation des champs
Registre mat?©riel
Habilitation de ou des agents
Validation des rapports d’ essai

Dossier de certification
Dossier de validation de la m?©thode

Limite de d?©tection: R?©p?©tabilit?© (10) d’ une analyse sur une solution connue (5UG/l -Etalon ADN)

Limite de quantification: R?©p?©tabilit?© (5) sur une gamme de solution connue (25 UG/l -Etalon ADN)

V?©rification de la lin?©arit?© de la m?©thode: R?©p?©tabilit?© avec une gamme de cinq points (0 -250 000 UG/l -Etalon ADN)

Rendement: R?©p?©tabilit?© sur 2 niveaux ?† partir d’ une souche bact?©rienne connue sur une matrice connue
Carte de contr?¥le
Carte de contr?¥le
Essais interlaboratoires

Questions ?

Certification of Conformity

The purpose of certification is to assess whether adequate confidence can be justified that a duly identified subject (product, process, service or person) is in conformity with a specific standard or other normative document (this definition is consistent with the International Standard ISO 17024) .
A Certificate of Conformity is a document indicating that an independant and impartial third party, the Certification Body, has obtained this adequate confidence from an assessment of the certificated subject against the relevant standard.
Certification of Conformity is strictly regulated in European Standards. The following categories of certification are distinguished:
Certification of products, applicable standard: EN 45011.
Certification of processes/organisations (e.g. ISO 9002-certification), applicable standard: EN 45012.
Certification of competence (persons), applicable standard: EN 45013, to be replaced by the international standard ISO 17024.
The Certification Bodies are supervised frequently by an Accreditation Body to verify compliance with the standard indicated above.

Certification of Competence

There are three essential elements of professional competence:
Level of general education;
Professional education;
Professional skill/experience.

Specifically the latter two have a dynamic aspect: professional education may fade away or become outdated when not maintained and professional skill requires continuing professional experience. Therefore, different from a diploma, a certificate of professional competence has a limited validity period. After the validity period has expired, the certificate can only be renewed if sufficient proof can be given that the professional education is maintained and the profession skill is practiced with adequate frequency.
The requirements for initial certification cover all three elements mentioned. With respect to the professional education, the subjects and level to be covered by the scope of the training are specified in a `Programme of Requirements`. Furthermore the training course must have a robust staff and an adequate administrative organisation.

The standard EN 45013, as will ISO 17024, requires that every certification system is supervised by a Board of Experts, where the relevant parties, such as the professional societies and employer and employees associations, are evenly represented. The Board of Experts is independent from the Certification Body. One of the tasks of a Board of Experts is to see that the certification criteria for the relevant system, including the `Programme of Requirements`, are continuously updated.

Certification of Competence versus Certification of Professional Training

From the above it may be clear that there are significant differences between certification of competence and certification of training. Whereas the latter concentrates on the various educational aspects of a training course and the updating mechanisms as part of a quality system, certification of competence not only covers the initial educational aspects, but also the maintenance by the professional of his knowledge and skill. The updating mechanism for the training requirements for initial certification is through the `Programme of Requirements`.
With respect to the professional training, both certification of competence and certification of professional training have dynamic aspects, requiring updating as the profession develops. However, whereas for the latter any adequate updating mechanism may satisfy the certification requirements, for certification of competence this mechanism must be by implementation of the `rogramme of Requirements’.

Summary

Certification of Competence according to EN 45013/ISO 17024 ensures continuing conformity of both education and skill of the certificated person. Certification of Professional Training according to EN 45012 confirms conformity of quality, level and state-of-the-art of the certificated training course and the professional education of those who completed the course succesfully. If both certification programs are consistent, the latter contributes to the certification process of professional competence.

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Beroepsorganisatie Arboverpleegkunde
The Netherlands

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Stichting voor de Certificatie van Vakbekwaamheid

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Body Of Knowledge for OP Assessors
Will Tate Triumph Aerostructures

Body of Knowledge
Purpose of the training module:
Training on the criteria and processes that OP assessors will be implementing when performing oversight on behalf of the AAQG/RMC

Objective:
Provide OP assessors with knowledge and tools to perform effective oversight of ABs, CBs, AABs and TPABs.
Documents comprising BOK

AS9104-1 & AS9014
AQMS Standards AS9100/9110/9120
AS9104-2
AS9104-3
ISO 19011
ISO 17011
ISO 17021
ISO 17024
IAF Mandatory Documents

Additional relevant documents
Official ISO 9001 Interpretations
ISO 9001 Auditing Practices Group papers
Accreditation Auditing Practices Group papers
AB specific documents
IAQG Supplemental Rules Doc -SR001
IAQG Resolutions log

Where to obtain the documents
All AS documents and ISO standards are copyrighted

AS documents can be purchased from www.sae.org

ISO Standards can be purchased from several places, such as the ASQ website, ANSI webstore or www.iso.ch

The IAF Mandatory documents can be downloaded for free from www.iaf.nu

OP Assessors MUST bring the relevant documents to the assessments
Links to the available documents.
IAF Mandatory documents
IAQG Resolutions log
ANAB Accreditation Manual, MA 6000
ISO Auditing Practices Group
Accreditation Auditing Practices Group
Supplemental Rules Document SR001

Remember
It is the OEM’ s responsibility to gain access to these standards; standards are not provided by the AB or CB.¬†

OP Assessors must read and familiarize themselves with the applicable parts of the Standards prior to the oversight assessments.
Applicability
CB Office Assessment Body of Knowledge
CB Office Assessment
Gather objective evidence that the CB is competent and conforms to the relevant standard(s) and other requirements for accreditation.
ISO 17011 (7.7.2)

OP Assessor to Focus on AS specific elements as they relate to:
Impartiality – ISO 17021 (5.2)
Management – ISO 17021 (5, 6, 7)
Inclusion of AS in internal audits & management review- ISO 17021, AS9104
Review AS complaints – ISO 17021, AS9104
Effective closure of previously issued aerospace related findings
File Review

CB Office Assessment
Main activity by OP Assessor -File Review
Registration, surveillance, re-certification process – ISO 17021 (9)
Competency (qualifications) of audit team – AS9104 (7, 8.1), AS9104-3, ISO 17021 (7)
Citation of findings (by CB) -AS9104 (8.3), ISO 17021 (9)
Appropriate resolution of findings -AS9104 (8.3), ISO 17021 (9)
Reporting -AS9104 (8.4), ISO 17021 (9)
Certification decisions (including competency of reviewers) -AS9104 (8.6), ISO 17021 (7, 9)
OASIS -AS9104
Proper site structure determination (New AS9104-1)
CB Office Assessment
A critical aspect is the audit time
Correct audit duration -Supplemental Rule (SR 001: 7e, k) or AS9104-1: table 2/3 when published
Multi-site -AS9104 (8.2.3), IAF Guidance to Guide 62 (Annex 3)
AS9104-1 Table 3 -when published
Competency of staff -AS9104, ISO 17021 (7)
ASRP / CAAT Process(es) approved by AB if applicable (IAF MD 3/MD 4)
Max reduction of 30% from AS9104-1 table 2 values

OPMT assessors must understand IAF Mandatory Document 5 and the auditor-days estimation process.
Supplemental Rules SR 001, Section 7e, k
New AS9104-1 Tables 2 and 3,
Audit Time Determination process: AS91XX:2009
Additional time per AS9104
Audit Time Determination process: AS91XX:2009 (con’ t)
CB to determine any additional audit days required to assess to AS91XX:2009
CB must have documented justification for audit days
Justification for increasing/decreasing audit days
Complexity of product
Maturity of QMS
Complexity of business, etc.
AS9104-1 Tables 2/3 (when published)

Upgrade audits
Another critical issue -Multi-site
AS9104, paragraph 8.2.3
IAQG Resolution # 76
Changing with the rewrite of AS9104
Refer to table 3 in new AS9104-1 for audit frequency
CB Witness Assessment Body of Knowledge
CB Witness Assessment
Silently gather objective evidence that the CB is competent and conforms to the relevant standard(s) and other requirements for accreditation.
ISO 17011 (7.7.2)

CB Witness Assessment
Focus on:
Opening and closing meeting (and team caucuses)
ISO 17021 (9)

Audit days and audit efficiency, effectiveness
AS9104 (8.2), ISO 19011 (6.5), IAF Guidance to Guide 62, Annex 2

CB’ s audit team’ s competency to perform audit
Including knowledge of standards, industry, regulatory requirements and interpretations
Including CB’ s process for assigning audit team
AS9104 (7, 8), AS9104- 3, ISO 17021 (7)

Certificate accuracy
ISO 17021 (8)
CB Witness Assessment
KEY Focus:

Audit depth and trails to the AQMS Standard (e.g. AS9100)
AQMS (e.g. AS9100)
AS9104 (8), ISO 19011 (6.5), IAF Guidance to Guide 62
OP Assessor must complete all applicable AS9104-2 appendices (J, K, etc)

For AB, AAB & TPAB Oversight see Presentation Attached

Burning questions

Certification in the World of Translation and Interpreting (AKM 2012Apr11)

Part I (Big Picture)

A. Certification and Related Credentials

– certification of a translation service provider (TSP) (process oriented: see European EN 15038 and soon ISO 17100, the international replacement)
– certification of a translator (person oriented, even when an individual translator is acting as a TSP; TSP certification does not certify the translators of a TSP)
– licensure (credential granted by a government agency)
– diploma-granting (credential granted by a university or other institution of higher education)
– certificate-granting (sometimes receiving a certificate for a weekend course is confused with being certified)

B. Signals

All five credentials in (A) are examples of third-party “signals” to translation requesters who cannot directly evaluate the competence of a translator, as explained in detail in Andy Chan’s doctoral dissertation.

C. Minimal Requirements for a Translator Certification Body

There is an ISO standard for certification bodies that focus on persons rather than organizations such as TSPs: ISO 17024. The key requirements in ISO 17024 for any certification body to be considered acceptable are:

– validity
– reliability
– fairness
– involvement of all stakeholders in an advisory council
– documentation of certification processes, including the appeal and re-certification

Part II Certification News

A. There are at least three current at least three efforts to review existing or develop new translator certification systems:
(1) NAATI (Australia)
(2) TransCert (Europe)
(3) ATA (USA)

B. A special issue of a T&I journal (www.trans-int.org) will focus on certification of translator and interpreters (any FIT Council members willing to be reviewers?).

C. TISAC (www.tisac.org) will consider whether to work on establishing an international organization to accredit translator certification bodies.

Part III Background Information on Certification (see attached paper — TranslatorCertAnd17000-validityV1c)
Alan Melby

Body Of Knowledge for OP Assessors
Will S. Tate Triumph Group

Body of Knowledge
Purpose of the training module:
Training on the criteria and processes that OP assessors will be implementing when performing oversight on behalf of the AAQG/RMC

Objective:
Provide OP assessors with knowledge and tools to perform effective oversight of ABs, CBs, AABs and TPABs.
Documents comprising BOK

AS9104-1 & AS9014
AQMS Standards AS9100/9110/9120
AS9104-2
AS9104-3
ISO 19011
ISO 17011
ISO 17021
ISO 17024
IAF Mandatory Documents

Additional relevant documents
Official ISO 9001 Interpretations
ISO 9001 Auditing Practices Group papers
Accreditation Auditing Practices Group papers
AB specific documents
IAQG Supplemental Rules Doc -SR001/002
IAQG Resolutions log

Where to obtain the documents
All AS documents and ISO standards are copyrighted

AS documents can be purchased from www.sae.org

ISO Standards can be purchased from several places, such as the ASQ website, ANSI webstore or www.iso.ch

The IAF Mandatory documents can be downloaded for free from www.iaf.nu

OP Assessors MUST bring the relevant documents to the assessments
Links to the available documents.
IAF Mandatory documents
IAQG Resolutions log
ANAB Accreditation Manual, MA 6000
ISO Auditing Practices Group
Accreditation Auditing Practices Group
Supplemental Rules Document SR001
Supplemental Rules Document SR002
Certification Structure Guidance Materials

Remember
It is the OEM’ s responsibility to gain access to these documents; standards are not provided by the AB or CB.¬†

OP Assessors must read and familiarize themselves with the applicable parts of the Standards prior to the oversight assessments.
Applicability
CB Office Assessment Body of Knowledge
CB Office Assessment
Gather objective evidence that the CB is competent and conforms to the relevant standard(s) and other requirements for accreditation.
ISO 17011 (7.7.2)

OP Assessor to Focus on AS specific elements as they relate to:
Impartiality – ISO 17021 (5.2)
Management – ISO 17021 (5, 6, 7)
Inclusion of AS in internal audits & management review- ISO 17021, AS9104-1
Review AS complaints – ISO 17021, AS9104
Effective closure of previously issued aerospace related findings
File Review

CB Office Assessment
Main activity by OP Assessor -File Review
Registration, surveillance, re-certification process – ISO 17021 (9)
Competency (qualifications) of audit team – AS9104 (7, 8.1), AS9104-3, ISO 17021 (7)
Citation of findings (by CB) -AS9104 (8.3), ISO 17021 (9)
Appropriate resolution of findings -AS9104 (8.3), ISO 17021 (9)
Reporting -AS9104 (8.4), ISO 17021 (9)
Certification decisions (including competency of reviewers) -AS9104 (8.6), ISO 17021 (7, 9)
OASIS -AS9104
Proper site structure determination (AS9104-1)
CB Office Assessment
A critical aspect is the audit time
Correct audit duration -Supplemental Rule (SR 001: 7e, k) or AS9104-1: table 2/3
Multi-site -AS9104 (8.2.3), IAF Guidance to Guide 62 (Annex 3)
AS9104-1 Table 3
Competency of staff -AS9104, ISO 17021 (7)
ASRP / CAAT Process(es) approved by AB if applicable (IAF MD 3/MD 4)
Max reduction of 30% from AS9104-1 table 2 values

OPMT assessors must understand IAF Mandatory Document 5 and the auditor-days estimation process.
Supplemental Rules SR 001, Section 7e, k
AS9104-1 Tables 2 and 3
Audit Time Determination process: AS91XX:2009 For Audits performed in 2012
Additional time per AS9104
Audit Time Determination process: AS91XX:2009 (con’ t)
CB to determine any additional audit days required to assess to AS91XX:2009
CB must have documented justification for audit days
Justification for increasing/decreasing audit days
Complexity of product
Maturity of QMS
Complexity of business, etc.
AS9104-1 Tables 2/3 used in 2013 and forward
Upgrade audits
Another critical issue -Multi-site
AS9104, paragraph 8.2.3
IAQG Resolution # 76
Changed with new AS9104-1
Refer to table 3 in new AS9104-1 for audit frequency
Refer to appendix B (Matrix) for certification structure requirements
Complex site must be reviewed by Certification Structure Oversight Committee (CSOC)
CB Witness Assessment Body of Knowledge
CB Witness Assessment
Silently gather objective evidence that the CB is competent and conforms to the relevant standard(s) and other requirements for accreditation.
ISO 17011 (7.7.2)

CB Witness Assessment
Focus on:
Opening and closing meeting (and team caucuses)
ISO 17021 (9)

Audit days and audit efficiency, effectiveness
AS9104-1 (7.2), ISO 19011 (6.5),
CB’ s audit team’ s competency to perform audit
Including knowledge of standards, industry, regulatory requirements and interpretations
Including CB’ s process for assigning audit team
AS9104-1 (7.2), AS9104- 3, ISO 17021 (7)

Certificate accuracy
ISO 17021 (8)
CB Witness Assessment
KEY Focus:

Audit depth and trails to the AQMS Standard (e.g. AS9100)
AQMS (e.g. AS9100)
AS9104-1 (8), ISO 19011 (6.5),
OP Assessor must complete all applicable AS9104-2 forms

For AB, AAB & TPAB Oversight see Presentation Attached

Burning questions