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Presentation to ITU Consultation on Conformity Assessment and
Presentation to ITU Consultation on Conformity Assessment and
ISO/CASCO structure
ISO/CASCO structure
ISO/CASCO structure
ISO/CASCO structure
Conformity Assessment Standards - Standards generation
Conformity Assessment Standards - Standards generation
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1Presentation to ITU Consultation on 1817005).
Conformity Assessment and Interoperability 19CASCO projects in progress. ISO/IEC
Testing Mr. Sean Mac Curtain Head, 17021 Part 2 (CASCO WG 21), Conformity
Conformity Assessment CASCO Secretary 20 assessment — Requirements for 3rd party
July 2009, Geneva. certification auditing of management
2Contents. What is conformity systems (DIS) ISO/IEC 17007 (CASCO WG 27),
Assessment CASCO structure Conformity Conformity assessment — Guidelines for
assessment standards and the CASCO toolbox drafting normative documents for use for
CASCO working groups Standards development conformity assessment (FDIS) ISO/IEC 17043
Conformity Assessment process Mutual (CASCO WG 28), Conformity assessment —
Recognition CASCO projects Conclusions. Requirements for proficiency testing
3What is conformity assessment? (FDIS) ISO/IEC 17065 (CASCO WG 29),
Conformity Assessment: The demonstration Conformity assessment — Requirements for
that specified requirements relating to a certification bodies certifying products
product, process, system, person or body (including services) and processes (CD)
are fulfilled. [Clause 2.1, ISO/IEC ISO/IEC 17020 (CASCO WG 31), Conformity
17000:2004(E): Conformity assessment — assessment — General criteria for the
Vocabulary and general principles]. operation of various types of bodies
4The 1-1-1 dream of Conformity performing inspection (WD) ISO/IEC 17024
Assessment. (CASCO WG 30), Conformity assessment —
5ISO/CASCO structure. 107 ISO members General requirements for bodies operating
are represented in CASCO (71 participating certification of persons (WD).
members and 36 observers). Fifteen 20CASCO Working Groups. ISO/CASCO P
international organizations are liaison Members nominate to the WG. A-Liaison
members of CASCO: BIPM, CEOC, CODEX members nominate to WG. D-Liaison can be
Alimentarius, EOQ, Eurolab, IAF, IFAN, established between an organization and a
IFIA, IIOC, ILAC, IPC, IQNet, ITU-T, OIML, WG. They are nominated as experts and
UILI. Both policy and technical work required to input as experts. WG group
Continual improvement cycle CASCO members act as independent experts not as
Secretary acts as Secretary for ISO 9000 national delegates. The WG develops a
Advisory Group (IAG). Working draft document (WD). It evolves
6CASCO Interpretation Panel. Need into a Committee Draft (CD) document. The
identified at CPC. Provide a uniform CD goes to member bodies who distribute to
consistent approach to interpretation and NMC (NMC) for CASCO. At this stage no
maintenance of existing standards and longer the experts but the national
guides. Request to NMB which will where consensus comments. Responsible for the
relevant be forwarded to CASCO. development of the document
Interpretation Panel within CPC will (Standard/Guide) (DIS and FDIS and
address all queries in a reasonable time. publication).
Possibility of “quick” response or 21Common Structure. Following a CASCO
detailed response. Response will be resolution (12/2002), CASCO Standards
available on Web page. should follow the same structure, wherever
7The ISO/CASCO toolbox. The CASCO possible. Informative Preliminary.
toolbox consists of 25 documents covering: Normative General. Normative Technical.
Vocabulary, principles and common elements Informative supplementary. Title page
of conformity assessment. Code of good Table of contents Foreword Introduction
practice. Product, system, and persons (including relationship to other
certification. Testing, calibration, standards). Title Scope Normative
inspection, marks of conformity. references. Terms and definitions
Supplier’s declaration of conformity, Principles Requirements Structural
accreditation, peer assessment, and mutual requirements Resource requirements
recognition arrangements. (including Human resources) Process
8Components of the CASCO toolbox (1). requirements (including operational
General standards and guides. Subject. functions) Management system requirements
Document. Publication date. Vocabulary. Normative annexes. Any further
17000. 2004. Code of good practice. Guide explanations that are not part of the
60. 2004. Mutual Recognition Arrangements normative process Informative annexes
(MRA’s). Guide 68. 2002. Peer assessment. Bibliography Indexes.
17040. 2005. Accreditation. 17011. 2004. 22Conformity Assessment Standards -
Marks of conformity. 17030. 2003. Standards generation. ISO Standard A
9Components of the CASCO toolbox (2). normative document, developed according to
Technical functions. Subject. Document. consensus procedures, which has been
Publication date. Suppliers declaration of approved by the ISO membership and
conformity. 17050. 2004. Testing & P-members of the responsible committee in
calibration laboratories Proficiency accordance with Part 1 of the ISO/IEC
Testing. 17025 Guide 43. 2005 1997. Directives as a draft International
Inspection. 17020. 1998. Product Standard and/or as a final draft
certification. Guide 23, 28 Guides 53, 65, International Standard and which has been
67. 2003, 2004 2005, 1996, 2004. System published by the ISO Central Secretariat
certification. 17021. 2006. Person ISO/PAS Publicly available specification A
certification. 17024. 2003. For a full normative document representing the
list of CASCO documents, visit www.iso.org consensus within a working group. ISO/TS
and follow this path: Conformity Technical specification A normative
Assessment > Publications and resources document representing the technical
> List of CASCO standards and guides. consensus within an ISO committee ISO/TR
10The “CASCO Toolbox” relationships… Technical report An informative document
Terms and definitions – ISO/IEC 17000 containing information of a different kind
(2001). Requirements for accreditation from that normally published in a
bodies –ISO/IEC 17011 (2004). Conformity normative document. International Workshop
assessments of suppliers ISO/IEC 17050-1 Agreement (IWA) An IWA is an ISO document
ISO/IEC 17050-2 (2004). Mutual Recognition produced through workshop meeting(s) and
ISO/IEC 17040 (2005). Requirements for not through the technical committee
Certification bodies. Persons ISO/IEC process. ISO Guide Guides provide guidance
17024 (2003). Requirements for testing to technical committees for the
& calibration laboratories ISO/IEC preparation of standards, often on broad
17025 (2005). Requirements for Inspection fields or topics.
bodies ISO/IEC 17020 (1998). Products 23Conformity Assessment (CASCO).
Revision Agreed ISO/IEC Guide 65 (2006). Objective of CASCO is to ensure that,
Management Systems Part 2 in preparations wherever Conformity Assessment is used by
ISO/IEC 17021 (2006). ISO TC’s, it is used and applied in a
11ISO/IEC 17011. Conformity assessment – consistent manner and the rules are the
General requirements for accreditation same. We saw the majority of “rules” are
bodies accrediting conformity assessment contained in ISO/IEC 17007. This rules
bodies (2004) Can also be used as a have been taken from the ISO/IEC
requirements document for the peer Directives clause 6.7 CASCO has
evaluation process for MRA between "rules" for when a Technical
accreditation bodies Competence based Committee needs to use Conformity
document Important for the purchaser, Assessment.
regulator and the public to know that CABs 24ISO/CASCO Rule 1: Neutrality.
are competent to perform their tasks. ISO/CASCO has a neutral policy with regard
Increasing the demand for their competence to the application of standards by 1st,
to be verified. This verification is done 2nd or 3rd parties (includes
by AB Also important to know that the AB’s accreditation). Standards must be written
globally operate competently and that this in a manner that they can be used through
too is verified though peer assessment to 1st party, 2nd party or 3rd party
this standard. conformity assessment activities. The
12ISO/IEC 17007. Principles and guidance application of 1st, 2nd or 3rd party
for drafting normative documents suitable should be decided on by the client ( or
for use for conformity assessment (FDIS) regulator) and not by the TC.
Intended for standards developers not 25ISO/CASCO Rule 2. Sector policy is not
applying the ISO/IEC Directives – industry to encourage the unnecessary proliferation
associations and consortia, purchasers, of sector scheme documents but to assist
regulators, consumers and non-government where there is a real need. Food, Motor,
groups, AB’s CAB’s scheme owners etc. Telecommunications, IT ISO 22000 is Food
13ISO/IEC 17007 continued. Contains 5 safety Management System and cannot
principles: 1) Separation of specified contain CA procedures but can develop
requirements for the object of CA from another document ISO/TS 22003 which is
specified requirements related to CA based on ISO/IEC 17021 and contains the
activities 2) Neutrality towards parties requirements for CB that certify to ISO
performing CA activities 3) Functional 22000. There are rules for when a sector
Approach to CA (selection, determination, wishes to develop its own scheme. Before a
review and attestation and surveillance) sector develops their own scheme,
4) Comparability of CA results 5) Good communication should be sought between the
practice in CA. sector and CASCO.
14ISO/IEC 17025. General requirements 26Mutual Recognition. International
for the competence of testing and Accreditation Forum (IAF) International
calibration laboratories (2005) Competence Laboratory Accreditation Cooperation
to carry out tests and/or calibrations (ILAC). Peer evaluation. National AB -
including sampling based Focused on Country A ISO/IEC 17011. National AB -
technical issues and quality management Country B ISO/IEC 17011. Mutual
Applicable to all test and calibration recognition. Recognition & acceptance.
laboratories (Generic) Guildelines for Laboratory ISO/IEC 17025. Laboratory
establishing applications for specific ISO/IEC 17025. CB ISO/IEC 17021 ISO/IEC
fields – should not add additional general 17065. CB ISO/IEC 17021 ISO/IEC 17065.
requirements Revision 2010. Recognition & acceptance. Recognition
15ISO/IEC 17021. Conformity assessment – & acceptance. Company A ISO
Requirements for bodies providing audit 9001/Product. Company B ISO 9001/Product.
and certification of management systems Test report for CB. Test report for CB.
Principles and requirements for the Recognition & acceptance.
competence, consistency and impartiality 27CASCO Priority Projects. IAF-ISO
of the audit and certification of action plan on monitoring the
management systems of ALL types and for effectiveness of accredited management
the bodies providing these activities system certification Management system
Management system – system to establish annual survey A liaisons and interaction
policy and objectives and to achieve those with sectors Changes to clause 6.7 of the
objectives. Directives Representation on CASCO WG’s
16ISO/IEC Guide 65 (ISO/IEC 17065). IAF mandatory documents versus CASCO
General requirements for bodies operating generated documents Interaction with
product certification systems (1996) ISO/TC’s Relationship with
Undergoing revision to ISO/IEC 17065 intergovernmental organizations Developing
Principles and requirements for the countries and CASCO and UNIDO/DEVCO/CASCO
competence, consistency and impartiality publications.
of the certification bodies evaluating and 28Conclusions on conformity assessment.
certifying products, processes and A global framework for conformity
services. Certification of products, assessment will increase consumer and
processes and services is a 3rd party CA regulator confidence by: Providing a
activity. Therefore bodies performing this common interpretation of test results;
activity are 3rd party conformity Providing a mechanism for acceptance of
assessment bodies called “certification certificates and reports Ensuring
bodies”. consistency and building confidence in
17ISO/IEC 17050 Parts 1 and 2. products and services Applying to the
Conformity assessment – Suppliers International Standards a principle of
declaration of conformity P1 – general neutrality; Defining good practices for
requirements Part 2 – Supporting market surveillance.
documentation (to substantiate a SDoC) 29My ISO Job – Guidance for delegates
Purpose is to give assurance of conformity and experts Joining in – Participating in
of the identified object to specified International Standardization ISO/IEC
requirements to which the declaration Directives Part 1 and 2 (mainly used by WG
refers and to identify who is responsible Convenors and Secretaries) ? all these
for that conformity and declaration. May documents are available on the TC Server.
be used alone or in conjunction with Useful reading.
another conformity assessment procedure 30Useful links. Very useful information
for regulatory or non-regulatory purposes. directly available on ISO Website: ISO
18Common elements. ISO/IEC International Standards development flowchart ISO
Standards and Guides on conformity Standards development process and much
assessment are written on an understanding more at:
of some basic common elements Impartiality http://www.iso.org/iso/standards_developme
(ISO/PAS 17001) Confidentiality (ISO/PAS t.htm.
17002) Complaints and appeals (ISO/PAS 31ISO. Contact maccurtain@iso.org
17003) Disclosure of information (ISO/PAS bleeker@iso.org marinkovic@iso.org
17004) Use of management systems (ISO/PAS emorine@iso.org Thank you www.iso.org.
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