Accreditation Process, IsO 17011

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ISO/IEC 17011: 2004ISO/IEC 17011: 2004

© Social Accountability Accreditation Services,

June 2010


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Social AccountabilityAccreditation Services

Mission:

SAAS supports social responsibility by ensuringthe implementation of credible social standardsdesigned to protect people and their communities.SAAS evaluates and accredits auditingorganizations to assure they are qualified to holdtheir clients accountable to such social standards.


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Accreditation

Accreditation is the process by which formal recognition ofcompetence is given to qualified organizations, known asCertification Bodies (CBs).

CBs are then granted the ability to perform certifications.

Certification of compliance to SA8000 and other verificationcodes within the SAAS scope of accreditation is availableonly through qualified CBs granted accreditation by SAAS.

Accreditation is necessary to assure stakeholders that theCBs are able to consistently, reliably and effectively performcertification audits and that these audits are carried out in aprofessional manner.

The accreditation process by SAAS includes documentationreview, site audits and observation of auditors in the field.


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Conformity assessment — Generalrequirements for accreditationbodies accrediting conformity

assessment bodies.

ISO/IEC 17011:2004ISO/IEC 17011:2004


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ISO/IEC 17011ISO/IEC 17011

A system to accredit CB conformity

assessment services should provideconfidence in the CBs competency and abilityto perform their tasks. Accreditation bodiesprovide impartial verification of that

competence – such verification is done byaccreditation bodies that are impartial inrelation to both the CBs and their clients.


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SAAS Normative Requirements

• SAAS maintains a set of Procedures and Policies,revised between 2007 and 2008, that it follows inconducting accreditation work:

SAAS Procedure 200 sets out the certification processrequirements for Certification Bodies (CBs) undertakingthe assessments of organizations against the SA8000standard.

SAAS Procedure 201 sets out the internal policies SAASmust follow in granting and maintaining accreditation of a

CB by SAAS. SAAS Procedure 203 contains the qualifications and

training requirements for accreditation auditors and SAASstaff.

SAAS has also developed a set of Work Instructions that

accreditation auditors must follow in undertaking documentreviews, on-site office and witness audits, and review ofcorrective actions.

These policies are all written and maintained within therequirements of ISO 17011:2004.


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SAAS Normative Requirements

• In addition, SAAS requires implementationof several ISO documents:

SAAS maintains procedures and policies incompliance with ISO/IEC 17011:2004, theinternational standard for accreditation bodiesaccrediting certification bodies.

SAAS requires implementation of ISO/IEC17021:2006 by all accredited CBs. 17021 is theinternational standard setting out requirements

for bodies providing audit and certification ofmanagement systems.


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ISO/IEC 17011ISO/IEC 17011

ISO 17011 specifies the general requirements

for accreditation bodies. Audit and evaluationmechanisms against ISO 17011 providesassurance that accreditation bodies areoperating in accordance with the standard.

SAAS conducts internal audits andmanagement review sessions, as well as

undertaking external verification audits toensure continued compliance with ISO 17011requirements.


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Accreditation and CertificationProcess


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What is ISO/IEC?

What ISO's name means

Because "International Organization forStandardization" would have differentabbreviations in different languages ("IOS" inEnglish, "OIN" in French for Organisation

internationale de normalisation ), it was decided atthe outset to use a word derived from the Greekisos, meaning "equal". Therefore, whatever thecountry, whatever the language, the short form ofthe organization's name is always ISO.


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What is ISO/IEC?

What IEC means

IEC = International Electrotechnical Commission

The International Electrotechnical Commission

(IEC) is the leading global organization thatprepares and publishes international standards forall electrical, electronic and related technologies.


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How is an ISO standarddeveloped?

ISO Standards are developed by internationaltechnical committees.

DIS = technical committee meets to discuss,debate and argue until they reach consensus on adraft agreement, it is circulated and ISO Membersvote

FDIS = If the voting is in favor, the document, with

modifications, is circulated to the ISO membersvote again

Standard = If that vote is positive, the document is

then published as an International Standard


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Accreditation HierarchyAccreditation Hierarchy

SAAS

Certification Body

ISO/IEC 17011 and

SAAS Procedure 201

ISO/IEC 17021 andSAAS Procedure 200

Standard

Requirement Documents

Client


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ISO/IEC 17011 StructureISO/IEC 17011 Structure

Eight Sections:

• 1 Scope

• 2 Normative references

• 3 Terms and definitions


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ISO/IEC 17011 StructureISO/IEC 17011 Structure

Eight Sections – 5 Normative:

•4 Accreditation Body

•5 Management

•6 Human Resources

•7 Accreditation Process

•8 Responsibilities of the AB and CB


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ISO/IEC 17011 ContentISO/IEC 17011 Content

Section 1 – Scope:•Specifies general requirements for ABs accrediting CBs.•CBs may be accredited for:

• Testing• Inspection services• Management system certification• Personnel certification

• Product certification• Calibration.


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Section 2 - Normative references:•ISO 9000:2000, Quality management systems — Fundamentals and vocabulary

•ISO/IEC 17000:2004, Conformity assessment — Vocabulary and general principles


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Section 3 - Terms and definitions : For the purposes ofthis document, the terms and definitions given in ISO/IEC17000 and the following apply.

• 3.1: accreditation – third party attestation relatedto a CB conveying formal demonstration ofcompetence.

•3.2: accreditation body – body that performsaccreditation.•3.3: logo – logo used by AB.•3.4: accred certificates – document stating

accreditation has been granted, within a scope.•3.5: accred symbol – symbol used to indicateaccred status.•3.6: appeal – request for reconsideration ofadverse decision.


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•3.7: assessment – process undertaken to assessthe competence of a CB based on a normativedocument.

•3.8: assessor – person assigned by the AB as partof the assessment team.•3.9: complaint – expression of dissatisfaction,other than an appeal, to an AB relating to the

activities of the AB or accredited CB.•3.10: conformity assessment body – body thatperforms conformity assessment services, can beobject of accreditation.


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2020



•3.11: consultancy – participation in activities of aCB subject to accreditation.•3.12: expert – person assigned by AB to provide

specific knowledge.•3.13: extending accreditation – enlarging thescope of accreditation.•3.14: interested parties – parties with direct or

indirect interest in accreditation.•3.15: lead assessor – overall responsibility forassessment activities.•3.16: reducing accreditation – cancelling partialscope of accreditation.


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•3.17: scope of accreditation – specific conformityassessment services for which accreditation issought.

•3.18: surveillance – set of activities to monitorcontinued fulfillment of requirements.•3.19: suspending accreditation – temporarilymaking accreditation invalid.

•3.20: withdrawing accreditation – cancellingaccreditation in full.•3.21: witnessing – observing CB carrying outassessment services.


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Section 4 – Accreditation Body:

Clause 4 describes the principles on which credibleaccreditation is based. These principles include thestructure, legal responsibility, confidentiality and liability

for accreditation activity.


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Section 4 – General:

Principles for inspiring confidence include4.1 legal responsibility,4.2 structure,4.3 impartiality4.4 confidentiality,4.5 liability and financing, and4.6 accreditation activity.


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4.1 Legal Responsibility4.1 Legal Responsibility

The accreditation body must be a registered legal

entity.


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4.2 Structure4.2 Structure

•The structure of the AB must give confidence in

its accreditations.

•The AB retains authority and responsibility foraccreditation decisions.

•The AB has to have a description of its legalstatus, names of owners, etc.

•The AB must have documentation of duties,

structure, responsibilities, authorities ofpersonnel and management.

•The AB shall have access to technical experts.


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4.3 Impartiality4.3 Impartiality

•The AB shall safeguard objectivity andimpartiality of its activities.

•AB policies must be non-discriminatory and beadministered in a non-discriminatory way.

•The AB services shall be accessible to allapplicants.

•All personnel and committees shall actobjectively and free from undue pressures.

•Decisions on accreditation shall be taken by

competent persons or committees different fromthe assessment team.

•The AB shall not provide consultancy or auditing

services that might affect impartiality.


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4.4 Confidentiality4.4 Confidentiality

•The AB must have adequate arrangements to

ensure confidentiality of the information obtainedthrough accreditation activities.

•This includes committees, external bodies,individuals acting on behalf of the AB, etc.

•Confidential information shall not be disclosed

without written consent of the CB.


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4.5 Liability and Financing4.5 Liability and Financing

•The AB shall have arrangements to cover

liabilities arising from its activities.•The AB shall have resources for operation of

activities and descriptions of sources of income.


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4.6 Accreditation activity4.6 Accreditation activity

•The AB shall describe its activities.

•The AB may adopt guidance documents andsuch documents must be formulated bycompetent committees/persons.

•The AB shall have procedures for extendingactivities and to meet the demands of interested

parties.


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Section 5 – Management:

Principles for inspiring confidence include5.1 General,5.2 Management System,5.3 Document Control,5.4 Records,5.5 Nonconformities,5.6 Preventive Actions,

5.7 Internal Audits,5.8 Management Reviews, and5.9 Complaints.


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5.0 Management of the AB5.0 Management of the AB

The AB shall establish and maintain an effectivemanagement system. Such procedures includesystems for:

•Policies and objectives, including a quality policy.

•Document control for approval, review, updating.

•Records maintenance including IDing, collecting, storingrecords.

•Identification of nonconformities and corrective actions,including rot cause analysis, action plans and review.

•Identification of opportunities for improvement.

•Conduct of annual internal audits.

•Establishment of management reviews for review of audits,activities, feedback, trends and CAs.

•Complaints management and response.


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Section 6 – Human Resources:

6.1 Personnel Associated with AB,6.2 Personnel involved in accreditation,6.3 Monitoring,6.4 Personnel Records


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6.0 Human Resources6.0 Human Resources

•The AB shall have a sufficient number of competentpersonnel to perform necessary work.

•These personnel must have appropriate education,training, technical knowledge, skills and experience.

•The AB must have access to sufficient assessors to

cover activities.•Personnel shall commit themselves by signature tocomply with the rules defined by AB.

•The AB shall set out required qualifications,experience, and training required.


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6.0 Human Resources6.0 Human Resources

•The AB shall ensure that assessors and experts:

• Are familiar with procedures, criteria and other

requirements.

• Have undergone training.

• Have knowledge of assessment methods.

• Are able to communicate effectively.

•The AB shall ensure satisfactory performance of theaccreditation process through procedures andmonitoring of personnel performance.

•The AB shall maintain records of qualifications,training and experience of personnel.


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Section 7 – Accreditation Process:

This section provides general information on theprocess of accreditation including the

application, audit, findings, and decision making.


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7.0 Accreditation Process7.0 Accreditation Process

•The AB shall use normative documents and

references throughout it process.

•The AB will make information publicly availabledescribing its accreditation process, fees, complaints

process, rights and obligations of CBs, rights andduties and information about its financial support.


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7.2 Application Process7.2 Application Process

•The CB must submit a formal application to the AB.

•The application must include:

• General features of the CB.

• General information about the CB.

• Requested scope of accreditation.• Agreement to fulfill the requirements.

• Description of services the CB undertakes.

• A copy of the CB quality manual.


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7.0 Resources and Subcontracting7.0 Resources and Subcontracting

•The AB shall review its ability to carry out theassessment of the applicant re: competence and

availability of assessors.•The AB may subcontract assessment activities butmust take full responsibility for all assessment anddecision-making.


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7.5 Preparation7.5 Preparation

•The AB shall formally appoint the assessment team.

•The team shall have appropriate knowledge to

conduct the audit.

•The AB shall ensure the team is impartial.

•The AB will notify the CB of the audit team and

provide sufficient time in case there is an objection.

•The initial assessment will include a visit to the CBhead office and others where key activities are

performed.•The audit team will have access to the appropriatecriteria and documents.

7 0 Document and On7 0 Document and On--SiteSite


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7.0 Document and On7.0 Document and On--SiteSiteAssessmentAssessment

•The assessment team shall review all relevantdocuments and records.

•The AB may decide not to proceed with the on-siteassessment if NCs are identified.

•The on-site assessment will have an opening

meeting where criteria are clearly defined.•The assessment will be conducted at the premisesof the CB where key activities are performed, togather objective evidence that the CB is competent.

•The assessment team will witness the performanceof CB staff to provide assurance of the competenceof the CB.


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7 8 A l i d R t7 8 A l i d R t


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7.8 Analysis and Report7.8 Analysis and Report

•Information provided to the decision makers shallinclude:

• ID of the CB

• Dates of the assessment

• Names of the assessors

• Proposed scope

• Assessment report

• Statement on the adequacy of the organization

• Information on resolution of NCs

7 9 D i i M ki7 9 D i i M ki


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7.9 Decision Making7.9 Decision Making

•The AB shall, without undue delay, make thedecision on accreditation on the basis of the

evaluation information.•The accreditation certificate to the CB shall identify:

• The ID and logo of the AB

• Unique ID of the CB

• Location of the key activities of the CB

• Effective and expiration date of the

accreditation

• Scope of accreditation

• Reference to normative document.

7.0 Appeals, Reassessment and7.0 Appeals, Reassessment and


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7.0 Appeals, Reassessment and7.0 Appeals, Reassessment andSurveillanceSurveillance

•The AB shall have procedures to address appeals.

•The AB shall have procedures for carrying out

surveillances and reassessments.

•Between surveillances and reassessments shallinclude representative samples of the scope of

accreditation.•The AB shall have strict time limits for NCs identifiedduring surveillances or reassessments.

•The AB shall develop procedures for suspension,withdrawal and reduction of scope

•The AB shall maintain records on CBs and ensuretheir confidentiality.



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Section 8 – Responsibilities and

Obligations of the AB and CB

8 0 Responsibilities and Obligations8 0 Responsibilities and Obligations


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8.0 Responsibilities and Obligations8.0 Responsibilities and Obligations

•The CB shall commit to fulfill the requirements setout.

•The CB shall afford accommodation and cooperationto enable fulfillment and monitoring by the AB.

•The CB shall notify the AB of significant changes

within its organization.•The AB shall make information publicly availableabout the status of its accreditations.

•The AB shall have a policy governing the use of itsaccreditation symbol and monitor its use.

Accreditation Process, IsO 17011

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