Page 1

The Impact of ISO and CEN Standardization on EQAS by Prof. Dr. H. Reinauer D端sseldorf/Germany Bulgary, 2009

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1. What is ISO? ISO,

the

International

Organization

for

Standardization, was founded in 1946 by delegates from 25 countries and started operations in 1947. At the end of 2006, the number of national ISO members had risen to 158. The organization is a vast network of national standards bodies from all regions of the world, served and supported by a Central Secretariat in Geneva with approximately 150 staff. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

2


ISO’s declared mission is to be the leading value-adding platform and partner for the production of globally and market-relevant international specifications,

standards, services,

covering test

product methods,

conformity assessment, management and organizational practices. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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ISO, through its decentralized global system of standardization, produces voluntary consensus standards.

ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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ISO STRUCTURE

ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

5


The ISO system 157 national members 98% of world GDP 97% of world population

Collection > 17,000 ISO Standards

185 active TCs 3 000 technical bodies 50 000 experts ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

Central Secretariat in Geneva 155 staff 6


An increasing demand for consensus based international standards

• • • •

Globalization of trade in products and services

Deployment of new technologies and innovation

Delocalization of procurement and investment Deregulation of public services Public demand for consumer and environmental protection

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ISO Standardization Classes of Standards:

他 horizontal

standard:

standards

indicating

fundamental concepts, principles and requirements with regard to general aspects applicable to all kinds or a wide range of products and/or processes (e.g. ISO 17511:2003). All procedures are listed as options to the user. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

8


他 vertical

standard:

standards

indicating

necessary aspects of specific products and/or processes, processes making reference, as far as possible, to

horizontal

standards

and

semi-horizontal

standards. Specific procedures are prescribed (e.g. IVD instruments for self-testing). (GHTF, SG1/N044R4, 2002) ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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ISO´s project stages Stage name

Product name (document)

Acronym

Preliminary stage

Preliminary work item (project)

PWI

Proposal stage

New proposal for a work item

NP

Preparatory stage

Working draft(s)

WD

Committee stage

Committee draft(s)

CD

Enquiry stage

Draft International Standard

DIS

Approval stage

Final Draft International Standard

FDIS

Publication stage

International Standard

IS

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ISO Standards ISO has developed over 17500 International Standards on a variety of subjects and some 1100 new ISO standards are published every year. The full range of technical

fields

can

be

seen

from

the

listing

International Standards. Users can browse that listing to find bibliographic information on each standard and, in many cases, a brief abstract. The online ISO Standards listing integrates both the ISO Catalogue of published standards and the ISO Technical programme of standards under development. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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Definitions Standard (according to ISO): Document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context. N O T E: Standards should be based on the consolidated results of science, technology and experience, and aimed at the promotion of optimum community benefits. ISO/IEC Directives, Part 2:2001

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„

For information on the nature and elaboration of deliverables other than standards, i.e.

™ Technical Specifications (TS) ™ Technical Report (TR) ™ Publicly Available Specifications (PAS) ™ International Workshop Agreements (IWA) ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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ISO/TC 212 Scope of ISO/TC 212: Standardization and guidance in the field of laboratory medicine and in vitro diagnostic test system. This includes, for example, quality management, pre- and post-analytical procedures, analytical performance, laboratory safety, reference systems and quality assurance. Excluded:

他 generic quality management standards dealt with by ISO/TC 176; 他 quality management standards for medical devices dealt with by ISO/TC 210;

他 reference materials guidelines dealt with by the ISO Committee on Reference Materials (REMCO);

他 conformity assessment guidelines dealt with by the ISO Committee on Conformity Assessment (CASCO)

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„

ISO/TC 212:

- Technical Committee on Laboratory Medicine and in vitro diagnostic Systems

- participating countries: countries:

32 observer 16

- secretariat: CLSI (former NCCLS) on behalf of ANSI

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ISO/TC 212-Working Groups Working Group

Title

TC 212/WG 1

Quality and competence in the medical laboratory

TC 212/WG 2

Reference Systems

TC 212/WG 3

In vitro diagnostic product

TC 212/WG 4

Antimicrobial susceptibility testing

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ISO/TC 212 Standards for medical laboratories ISO 15189:2003 Medical laboratories – Particluar requirements for quality and competence ISO 15190:2003 Medical laboratories – Requirements for safety ISO/TR 22869:2005 Medical laboratories – Guidance on laboratory implementation of ISO 15189:2003 Project under consideration: Medical laboratories – Genetic testing – Specific requirements for quality and competence ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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Relevant Standards in ISO/TC 212 (1): ISO 15193:2002 In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Presentation of reference measurement procedures ISO 15194:2002 In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Description of reference materials ISO 15195:2003 Laboratory medicine – Requirements for reference measurement laboratories ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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Relevant Standards in ISO/TC 212 (2): ISO 17511:2003 In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values assigned to calibrators and control materials ISO 18153:2003 In vitro diagnostic medical devices – Measurement of quantities in biological origin – Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials

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ISO/PDTS 25680.8 Medical Laboratories Calculation and expression of measurement uncertainty

19


ISO/IEC FDIS 17043:2009 Conformity assessment - general requirements for proficiency testing

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ISO against EN Standard on EQAS: EN 14136:2004 ISO/IEC 17043:2009

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Cooperation with CEN (Vienna Agreement) The Agreement on technical cooperation between ISO and CEN (Vienna Agreement) is an agreement on technical cooperation between ISO and the European Committee for Standardization (CEN). Formally approved on 27 June 1991 in Vienna by the CEN Administrative Board following its approval by the ISO Executive Board at its meeting on 16 and 17 May 1991 in Geneva.

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Conflict “If you have failed with your standardisation project at CEN, then go to ISO� EXAMPLE:

EN 14136:2004

ISO/IEC 17043:2008

Use of external quality

General requirements

assessment schemes in

for proficiency testing

the assessment of the performance of in vitro diagnostic procedures. A ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

mandated

harmonized standard

and 23


European Committee for Standardization

European Committee for Electrotechnical Standardization

1050 Brussels, Belgium

1050 Brussels, Belgium

Phone: +32 2 550 0811 Fax: +32 2 550 0819

Phone: +32 2 519 6871 Fax: +32 2 550 6919

www.cen.eu

www.cenelec.eu

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DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998 on in vitro diagnostic medical devices

THE EUROPEAN PARLAMENT AND THE COUNCIL OF THE EUROPEAN UNION ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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Directive on in vitro Diagnostic Medical Devices 98/79/EC

Scope 1.

Conditions for placing in vitro diagnostic medical devices on the EU-market.

2.

Essential requirements in terms of reliability of the diagnostic medical devices

3.

Harmonization of the procedures (CE marking)

conformity

4.

Mechanisms procedures)

the

ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

to

monitor

market

assessment (vigilance

26


Article 11 Vigilance procedure 1. Member States shall take the necessary steps to ensure that any information brought to their knowledge, in accordance with the provisions of this Directive, regarding the incidents mentioned below involving devices bearing the CE marking is recorded and evaluated centrally: a) any malfunction, malfunction, failure deterioration in the a) any failure or or deterioration in the characteristics of of a device, as as wellwell as characteristicsand/or and/orperformance performance a device, any inadequacy in theinlabelling or the or instructions for use as any inadequacy the labelling the instructions which, indirectly,ormight lead to might or might have for usedirectly which,or directly indirectly, lead to led or to the death patient, or user other persons a might have of leda to the death ofora of patient, or userorortoof serious deterioration state of health; in their state other persons or to in a their serious deterioration of health;

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2. Where a Member State requires medical practitioners, the medical institutions or the organisers of external quality assessment schemes to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorised representative, is also informed of the incident. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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Incidents and Deteriorations 1. Incidents: - which lead to death (blood groups, HIV, hepatitis C) 2. Serious deterioration in the state of health: - life threatening illness - permanent impairment of body function - conditions necessitating medical interventions 3. Near incidents: which might have led to death ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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European Standard (EN) - the principal product of CEN. Developed by a Technical Committee, approved by the CEN Members and featuring a public commenting stage in its development, an adopted European Standard is published as an identical national standard by the National Standards Bodies.

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Production of a standard

Initiative (societies, industry) ”work item” National standardization organization CEN: Mandate CEN/TC 140 Technical Committee financial support Working group consisting of delegates from all interested national standardization organization Secretariat Convenor

} of the WG

Meetings over 1 – 3 years CEN/TC: Voting Translation in French, German ? ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

CEN decision Publication in the Official Journal of EC

32


European Regulations in Laboratory Medicine Article 11:

European Council and Parliament: In-vitro Medical Device Directive 98/79/EU

Vigilance German Act on Medical Products

EN 14136:2003 Use of external quality assessment schemes in the assessment of the performance of invitro diagnostics procedures

ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

Regulations on Use of Medical Products ยง 4a

Guideline of the Federal Medical Association of Germany on Quality Assurance in Medical Laboratories 2003

33


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CEN/TC 140 N

707

CEN/TC 140 In vitro diagnostic medical devices E-mail of Secretary: rainer.schmidt@din.de Secretariat: DIN

Mandat for EN 14136 Date of document Expected action

2008-07-28 Info

Background

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Standardization Mandate M 252 from 1997 to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices 35


II.

Standardization Mandate Having identified the needs and also taking into account the programme of work suggested by CEN and CENELEC, the Commission assigns to CEN/CENELEC the task of establishing standards EN in the following areas:

Level 1 standards 1. Performance evaluation plans and methods for IVD MDs including those for self-testing; 2. Description and validation of “special microbiological states� for IVD MDs; 3. Testing of stability of IVD MDs (with particular attention to accelerated stability testing); 4. Presentation of reference measurements procedures (including aspects related to interferences); ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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5. Description of reference materials; 6. Demonstration of traceability through reference measurement procedures and/or reference materials; 7. Sampling procedures used in the manufacture of IVD MDsStatistical and systematic considerations; 8. Elimination or reduction of risk of infection related to IVD MDs; 9. Symbols and colour codes to be used for IVD MDs; 10. External quality assessment schemes in relation to medical laboratories (EQAS). ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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EN 14136 : 2004 Mandate given on 12 September 1997 by the EC as Level 1 standard: No. 10: External quality assessment schemes in relation to medical laboratories Meeting and report to European Commission, Brussels, on 2 February 1984 Voting in CEN/TC 140 in Paris, 2003 Voting of the National Standardisation Organisations: 27 November 2003 Published in the Official Journal of the EU on 15 November 2006 ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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The Impact of Harmonized EN-Standards A harmonized standard is an European standard (EN), prepared under the mandate of the European Commission or the EFTA Secretariat with the purpose of supporting the essential requirements of a directive. Distinction should be made between the regulated area of the standard, which "supports" the requirements of the directive, and the voluntary area of the standard. This relation is explained in "Annex Z" to every mandated standard. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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CEN/TC 140 BS EN14136 Date: 2004

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

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In the following a description of the intended European Standard was formulated which is to be adopted into the business plan of CEN/TC 140: Title:

Use of external quality assessment schemes in the assessment of the performance of IVD procedures

Scope: This standard applies to EQAS the are intended to be used in the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including IVD MDs). It sets out the requirements relating to: survey samples and the regularity of their distribution identification of procedures (devices) reporting and evaluation of data that are necessary to enable EQAS to fulfil this function. With regard to the growing number of IVD MDs this standard will help to produce objective information to assist the selection and development of reliable IVD procedures. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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Minutes of a meeting between representatives of CEN/TC 140 and the European Commission held on 2 February 1998 in Brussels In agreement between Prof. Reinauer, Convenor of CEN/TC 140/WG, and Mr. Anselmann, European Commission, the above-mentioned meeting took place with the goal of stating more precisely the aim and scope of the mandated standards projects “External quality assessment schemes in relation to medical laboratories (EQAS)�, taking into account the concerns expressed by the European Commission prior to and at the plenary meeting of CEN/TC 140 held on 24 November 1997. The meeting was attended by Dr. Breitsameter, Dr. Jung and Prof. Reinauer for CEN/TC 140, Mr. Anselmann, Dr. Dirscherl and Mrs. Howes for the European Commission. Prof. Verwillghen represented the European Commission and CEN/TC 140. Prof. Moss took part on request of Mr. Anselmann. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

EN 14136:2004

This European Standard was approved by CEN on 2 March 2004.

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EN 14136:2004 This European Standard has been prepared by the Technical Committee CEN /TC 140, "In vitro diagnostic medical devices", the secretariat of which is held by DIN. This document has been approved by the majority of CEN member countries. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade

Association

and

supports

requirements

of

EC

Directive(s). For relationship with EC Directive(s), see informative annex ZA, which is an integral part of this standard. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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Essential of EN 14136:2004 1) The European Standard does not specify ways in which EQAS are organized, nor how the individual or collective performance of clinical laboratories is evaluated. 2) EQAS

are

able

to

contribute

to the post-marketing

monitoring of IVDMDs. 3) The general design requirements for EQAS are well defined and shall be followed. 4) The frequency of surveys shall be appropriate for the investigation, preferable at least 6 times per year. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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5) The target values are:

± reference measurement procedure ± value derived from known composition ± consensus value 6) Requirements for organizations conducting EQAS. The EQAS organization shall be free from any commercial, financial or other conflicting interests – whether internal or external – which might influence its independent judgement or adversely affect the quality of work. 7) The organization should be accredited by a national or European accreditation body and/or acknowledged by a national authority. 8) There is no European Regulation for internal quality control. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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EN 14136:2004

ISO/IEC WD 17043.3

Requirements for organisations conducting EQAS

5.1.5 The proficiency testing providers shall:

5.3 The EQAS organisation shall be free from any commercial, financial or other conflicting interests – whether internal or external – which might influence its independent judgement or adversely affect the quality work.

have arrangements to ensure that its management and personnel are free from any undue internal or external commercial, financial and other pressures that may adversely affect the quality of their work.

NOTE: National authorities may state additional requirements for the qualification of the EQAS organisation.

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ISO Standards

EN Standards

Standards are not legal documents Only voluntary

Mandated and

consensus-based

harmonized EN

documents. No

standards. They

legal basis except

support the Essential

when imposed by

Requirements of the

national acts.

EU-Directive.

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ILAC International Laboratory Accreditation Cooperation ILAC is an international cooperation of laboratory and inspection accreditation bodies, formed about 30 years ago (1977) to help remove technical barriers to trade. ILAC represents more than 70 economies and regional organizations. ILAC, CIPM, IFCC have a Cooperation for Traceability in Laboratory Medicine (JCTLM). ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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ILAC Section 2 : Management Requirements 2.1.5. The provider shall: b)

have

arrangements

management

and

to

personnel

ensure are

that free

its from

commercial, financial and other internal and external pressures that my adversely affect the quality of work

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Accreditation of EQAS organizers

EU

EN 14136:2004 ISO-Guide 43-1,43-2

International: ISO/IEC 17043.3 Special certification: ISO/IEC 17020

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ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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Summary 1) In Europe international standardization is realized at ISO and CEN. 2) ISO standards are voluntary standards, except the national government decides by law that a certain standard must be followed. 3) CEN produces voluntary and mandatory standards. 4) Mandated and harmonized standards have regulatory functions. 5) Problems around the EN 14136:2004 are presented. 6) The EU has better and more consistent regulations than countries outside of the EU. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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Summary 7) At ISO a new standard on “Proficiency testing” is in work.: This is ISO/IEC 17043:2008. 8) In EU the accreditation of EQAS organizers shall be performed according EN 14136:2004 and ISO-Guide 43-1, 43-2. 9) Though we have a Vienna Agreement between CEN and ISO some differences remain to be solved.

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Thank you for your attention

ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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Future When a national regulating body (ministry of health) or a national organization (Medical Association or Chamber) or on behalf of the national government decides on • frequency • analytes • acceptability criteria than any competent ISO or EN Standard many be mandatory. In the EU the mandated an harmonized standards have to be fallowed in the member countries of the EU. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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Harmonized standards, common technical specifications (1) If medical devices conform to harmonized standards or equivalent European Pharmacopoeia monographs or common technical specifications relating to the specific medical device, it shall be presumed in this respect that they conform to the provisions contained in the present Act. (2) As a rule, compliance with the common technical specifications is required. If, with sufficiently good reason, the manufacturer does not comply with these specifications, he/she must choose solutions of a level which is at least equivalent so that of the specifications. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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Harmonised EN-Standards and Directive 98/79/EC on in vitro diagnostic medical devices

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EN 14136 : 2004 • Mandate given on 12 September 1997 by the EC. as Level 1 standard: No. 10:

External quality assessment schemes in relation to medical laboratories.

• Meeting and report to European Commission, Brussels, on 2 February 1998. • Voting in CEN/TC 140 in 2003 • Voting of the National Standardization Organisations : 27 November 2003. • Published in the Official Journal of the EU on 15/11/2006. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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1. EQAS are performed in many countries see : EQALM 2. The program are different the evaluations also 3. Evaluation criteria in Europe Impression 4. Need for standardization at international level ISO CEN 5. 6. ISO 7. 8. 9. 10. 11. 12. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

CEN

62


13. Which standards are relevant for EQAS? •

ISO/TC 212

CASCO 17043

CEN/TC 140 EN 15193 EN 15194 EN 15195 EN 14136:2004 1. Which role influence have the standards on the EQAS? 2. ISO standards are recommendations 3. Mandated and harmonized have to be fallowed 4. Not mandated and harmonized CEN standards are recommendations

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Harmonized Standards A “Harmonized Standard” is a standard that is in support of one or more Directives, has been produced by CEN or CENELEC and when the reference has been published in the Official Journal of the EC (OJ) and at least one national standards body has published it, provides a presumption of conformity with the EHSRs (Essential Health and Safety Requirements) covered by the standard. These standards – produced under a mandate from Member States through the Commission – give the technical measures to meet the EHSRs. In other words the:

• Directives would state the legal objectives (EHSRs) to be met, and

• Harmonized Standards would identify the technical means

to

meet these legal objectives. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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EN 14136:2004 Mandate given on 12 September 1997 by the EC as Level 1 standard: No. 10: External quality assessment schemes in relation to medical laboratories Meeting an report to European Commission, Brussels, on 2 February 1984 Voting in CEN/TC 140 in Paris, 2003 Voting of the National Standardisation Organisations: 27 November 2003 Published in the Official Journal of the EU on 15 November 2006 ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

65


The Impact of Harmonized EN-Standards A harmonized standard is an European standard (EN), prepared under the mandate of the European Commission or the EFTA Secretariat with the purpose of supporting the essential requirements of a directive. Distinction should be made between the regulated area of the standard, which "supports" the requirements of the directive, and the voluntary area of the standard. This relation is explained in "Annex Z" to every mandated standard. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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When, in terms of the CEN/CENELEC rules, the result of formal voting is positive, the CEN Administrative Center will send to its members the text of the standard to be transposed into their national standards systems. At this point, the mandated standard is still a "candidate" for a harmonized standard. When the mandated standard is published in the Official Journal of the European Communities together with the indication of the directive in whose support the standard has been prepared. Through this act, a mandated European standard becomes a "Harmonized Standard". ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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Conflict If you have failed with your standardisation project at CEN, then go to ISO. EXAMPLE:

ISO/IEC 17043:2008

EN 14136:2004

General requirements

Use of external quality

for proficiency testing

assessment schemes in the assessment of the performance of in vitro diagnostic procedures

ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

68


EN 14136:2003

ISO/IEC WD 17043.3

Requirements for organisations conducting EQAS

5.1.5 The proficiency testing provider shall:

5.3 The EQAS organisation shall be free from any commercial, financial or other conflicting interests – whether internal or external – which might influence its independent judgement or adversely affect the quality work.

have arrangements to ensure that its management and personnel are free from any undue internal or external commercial, financial and other pressures that may adversely affect the quality of their work.

NOTE: National authorities may state additional requirements for the qualification of the EQAS organisation.

ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

69


Summary 1) In Europe international standardization is realized at ISO and CEN. 2) ISO standards are voluntary standards, except the national government decides that a certain standard shall be followed. 3) CEN produces voluntary and mandatory standards. 4) Mandated and harmonized standards have regulatory functions. 5) Problems around the EN 14136:2004 are presented. 6) The EU has better and consistent regulations than countries outside of the EU. 7) Though we have a Vienna Agreement between CEN and ISO some differences remain to be solved.

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4 Design requirements for EQAS 4.1 The EQAS organisation shall formulate the objectives of its surveys at its start. 4.2 The EQAS organisation shall provide survey samples composed in such a way that they simulate as closely as possible the relevant properties of the samples on which the examination procedures are intended to be used. NOTE 1 For assigning target values to survey samples see prEN ISO 17511. NOTE 2For some evaluations it may be appropriate to use a set of survey samples with different target values. NOTE 3 The responsibility of the EQAS organisation for providing survey samples with appropriate properties is set out in ISO/IEC Guide 43-1. NOTE 4 EQAS organisations should not select survey samples containing unphysiological additives which may disadvantage an individual IVD MD. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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5.4 The EQAS shall be organised in such a way that all parties involved maintain confidence in its independent judgement at all times. 5.5 The EQAS organisation shall establish and maintain a quality management system. NOTE 1

ISO/IEC

Guide

43-1

and

ILAC–G13:2000

give

examples for a quality management system.

*

NOTE 2

The organisation should be accredited by a national or

European accreditation body and/or acknowledged by a national authority.

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Justification: With regard to the growing number of IVD MDs this standard will help to produce objective information to assist the selection and development of reliable IVD procedures.

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The three levels of standards within this “Hierarchical” approach are: Level 1 basic standards Level 2 group or “family” standards Level 3 product standards ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

These “horizontal standards” cover common requirements for all or a wide range of medical devices The “semi-horizontal standards” cover requirements for a related “family” of medical devices, where such requirements are typical for a number of products

These standards cover requirements for a specific type of medical device

74


Harmonized standards, common technical specifications (1) If medical devices conform to harmonized standards or equivalent European Pharmacopoeia monographs or common technical specifications relating to the specific medical device, it shall be presumed in this respect that they conform to the provisions contained in the present Act. (2) As a rule, compliance with the common technical specifications is required. If, with sufficiently good reason, the manufacturer does not comply with these specifications, he/she must choose solutions of a level which is at least equivalent so that of the specifications. ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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II. Standardization Mandate Having identified the needs and also taking into account the programme of work suggested by CEN and CENELEC, the Commission assigns to CEN/CENELEC the task of establishing standards EN in the following areas: Level 1 standards 1. Performance evaluation plans and methods for IVD MDs including those for self-testing; 2. Description and validation of “special microbiological states� for IVD MDs; 3. Testing of stability of IVD MDs (with particular attention to accelerated stability testing); 4. Presentation of reference measurements procedures (including aspects related to interferences); ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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5. Description of reference materials; 6. Demonstration of traceability through reference measurement procedures and/or reference materials; 7. Sampling procedures used in the manufacture of IVD MDsStatistical and systematic considerations; 8. Elimination or reduction of risk of infection related to IVD MDs; 9. Symbols and colour codes to be used for IVD MDs; 10. External quality assessment schemes in relation to medical laboratories (EQAS). ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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Standards development processes and deliverables

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ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

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Objectives and structure of CASCO „

„

ISO/CASCO is ISO's policy development committee on conformity assessment, reporting to the ISO Council. CASCO, as it is commonly referred to, was established in 1970 to study means of conformity assessment, prepare documents concerning the practice and operation of conformity assessment, and to promote their use. CASCO membership is open to all ISO member bodies as participating (P) or observer (O) members, with both developing and industrialized countries well represented.

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80


他 Semi-horizontal

standard:

standards

indicating aspects applicable to families of similar products and/or processes making reference as far as possible to horizontal standards (e.g. ISO 18153:2003) and

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Summary list of titles and references of harmonised standards related to in vitro diagnostic medical devices

ESO (1)

CEN

ISO-/CEN-Standard. Bulgary 07.10.2009 14:25

Reference and title of the harmonised standard (and reference document)

First publication OJ (*)

Reference Date of of cessation of supersede presumption d standard of conformity of superseded standard Note 1

EN 14136:2004 15/11/2006 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedure 82

5c_01  
5c_01  
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