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ISO-/CEN-Standard.Bulgary

07.10.2009 14:25

The Impact of ISO and CEN

Standardization on EQASby

Prof. Dr. H. Reinauer

Düsseldorf/GermanyBulgary, 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.

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ISO’s declared mission is to be the leading

value-adding platform and partner for the

production of globally and market-relevant

international standards, covering product

specifications, services, test methods,

conformity assessment, management and

organizational practices.

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ISO, through its decentralized global

system of standardization, produces

voluntary consensus standards.

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ISO STRUCTUREISO STRUCTURE

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185 active TCs3 000 technicalbodies50 000 experts

CentralSecretariatin Geneva155 staff

157 national members98% of world GDP

97% of world population

The ISO system

Collection > 17,000 ISOStandards

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An increasing demand for consensus based international standards

•• GlobalizationGlobalization of trade in products and services

•• DelocalizationDelocalization of procurement and investment

•• DeregulationDeregulation of public services

• Public demand for consumer and environmentalconsumer and environmentalprotectionprotection

• Deployment of new technologies and innovationnew technologies and innovation

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ISO StandardizationClasses of Standards:

horizontal standard:horizontal standard: standards indicating

fundamental concepts, principles and requirements

with regard to general aspects applicable to all kinds general aspects applicable to all kinds

or a wide range of products and/or processesor a wide range of products and/or processes (e.g.

ISO 17511:2003). All procedures are listed as options

to the user.

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vertical standard:vertical standard: standards indicating

necessary aspects of specific products and/or specific products and/or

processesprocesses, 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)

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ISOISO´́s project stagess project stagesStage nameStage name Product name (document)Product name (document) AcronymAcronym

Preliminary stagePreliminary stage Preliminary work item (project)Preliminary work item (project) PWIPWI

Proposal stageProposal stage New proposal for a work itemNew proposal for a work item NPNP

Preparatory stagePreparatory stage Working draft(s)Working draft(s) WDWD

Committee stageCommittee stage Committee draft(s)Committee draft(s) CDCD

Enquiry stageEnquiry stage Draft International StandardDraft International Standard DISDIS

Approval stageApproval stage Final Draft International Final Draft International StandardStandard FDISFDIS

Publication stagePublication stage International StandardInternational Standard ISIS

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ISO StandardsISO 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.

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DefinitionsStandard (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:N O T E:

Standards should be based on the consolidated results of Standards should be based on the consolidated results of science, technology and experience, and aimed at the science, technology and experience, and aimed at the promotion of optimum community benefits.promotion of optimum community benefits.

ISO/IEC Directives, Part 2:2001

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

Technical Specifications (TS)Technical Specifications (TS)

Technical Report (TR)Technical Report (TR)

Publicly Available Specifications (PAS)Publicly Available Specifications (PAS)

International Workshop Agreements (IWA)International Workshop Agreements (IWA)

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ISO/TC 212ISO/TC 212Scope 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:

generic quality management standards dealt with by ISO/TC 176;

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

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

conformity assessment guidelines dealt with by the ISO Committeeon Conformity Assessment (CASCO)

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ISO/TC 212:ISO/TC 212:

-- Technical Committee on Laboratory Medicine Technical Committee on Laboratory Medicine and and in vitro diagnosticin vitro diagnostic SystemsSystems

-- participating countries: participating countries: 3232-- observer observer

countries:countries: 1616

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

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Working Working GroupGroup TitleTitle

TC 212/WG 1TC 212/WG 1 Quality and competence in the Quality and competence in the medical laboratorymedical laboratory

TC 212/WG 2TC 212/WG 2 Reference SystemsReference Systems

TC 212/WG 3TC 212/WG 3 In vitro diagnostic productIn vitro diagnostic product

TC 212/WG 4TC 212/WG 4 Antimicrobial susceptibility Antimicrobial susceptibility testingtesting

ISO/TC 212-Working Groups

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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

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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 15195:2003 Laboratory medicine –Requirements for reference measurement laboratories

ISO 15194:2002 In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Description of reference materials

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

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/IEC FDIS 17043:2009

Conformity assessment - general requirements

for proficiency testing

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ISO against ENISO against EN

Standard on EQAS: Standard on EQAS:

EN 14136:2004EN 14136:2004

ISO/IEC 17043:2009ISO/IEC 17043:2009

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Cooperation with CEN (Vienna Agreement) 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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ConflictConflict“If you have failed with your standardisation project at

CEN, then go to ISO”

ISO/IEC 17043:2008EN 14136:2004

General requirements for proficiency testing

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

A mandated and harmonized standard

EXAMPLE:EXAMPLE:

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European Committee for Standardization

1050 Brussels, Belgium

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

www.cen.eu

European Committee for Electrotechnical Standardization

1050 Brussels, Belgium

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

www.cenelec.eu

http://www.cenelec.eu/Cenelec/

http://www.cen.eu/cenorm/index.htm

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DIRECTIVE 98/79/EC OF THEDIRECTIVE 98/79/EC OF THE

EUROPEAN PARLIAMENTEUROPEAN PARLIAMENT

AND OF THE COUNCILAND OF THE COUNCIL

of 27 October 1998of 27 October 1998

on on in vitroin vitro diagnostic medical devicesdiagnostic medical devices

THE EUROPEAN PARLAMENT AND THE COUNCIL OF THE EUROPEAN UNION

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Scope

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

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

2. Essential requirements in terms of reliability of the diagnostic medical devices

3. Harmonization of the conformity assessment procedures (CE marking)

4. Mechanisms to monitor the market (vigilance procedures)

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1. Member States shall take the necessary steps to ensure thatany 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:

Article 11Article 11Vigilance procedureVigilance procedure

a) any malfunction, failure or deterioration in thecharacteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health;

a) any malfunction, failure or deterioration in thecharacteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state 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.

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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

Incidents and DeteriorationsIncidents and Deteriorations

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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 Production of a of a

standardstandard

Initiative Initiative (societies, industry)(societies, industry)

National standardization organization

CEN: Mandate

CEN/TC 140 Technical Committee

Working group consisting of delegates from all interested national standardization

organization

SecretariatConvenor

Meetings over 1 – 3 years

CEN/TC: Voting

CEN decision

Publication in the Official Journal of EC

} of the WG

”work item”

Translation in French, German ?

financial support

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European Regulations in Laboratory European Regulations in Laboratory MedicineMedicine

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

German Act on Medical Products

Regulations on Use ofMedical Products § 4a

Guideline of the Federal Medical Association of Germanyon Quality Assurance in Medical Laboratories 2003

Vigilance

Article 11:

Use of externalquality assessment

schemes in theassessment of theperformance of in-vitro diagnostics

procedures

EN 14136:2003

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CEN/TC 140 N 707

CEN/TC 140In vitro diagnostic medical devicesE-mail of Secretary: [email protected]: DIN

Mandat for EN 14136Date of document 2008-07-28Expected action Info

BackgroundStandardization Mandate M 252 from 1997 to CEN/CENELECconcerning the development of European standards relating to invitro diagnostic medical devices

mailto:[email protected]

http://www.cen.eu/cenorm/index.htm

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II. Standardization MandateHaving 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);

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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 MDs-

Statistical 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).

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EN 14136 : 2004Mandate 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

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The Impact of Harmonized ENThe Impact of Harmonized EN--StandardsStandards

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.

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Use of external quality assessment Use of external quality assessment

schemes in the assessment of the schemes in the assessment of the

performance of in vitro diagnostic performance of in vitro diagnostic

examination proceduresexamination procedures

CEN/TC 140BS EN14136Date: 2004

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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 theassessment 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.

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Minutesof 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 plenarymeeting 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.

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Use of external quality assessment schemesUse of external quality assessment schemes

in the in the assessmentassessment of the performanceof the performance

of in vitro diagnostic examination proceduresof in vitro diagnostic examination procedures

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

EN 14136:2004

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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.

EN 14136:2004EN 14136:2004

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Essential of EN 14136:2004Essential 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.

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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.

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EN 14136:2004

Requirements for organisations conducting EQAS

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.

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

ISO/IEC WD 17043.3

5.1.5 The proficiency testing providers shall:

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.

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ISO Standards EN Standards

Only voluntary consensus-based documents. No

legal basis except when imposed by

national acts.

Mandated and harmonized EN standards. They

support the Essential Requirements of the

EU-Directive.

Standards are not legal documents

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ILACInternational 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).

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Section 2 : Management Requirements

2.1.5. The provider shall:

b) have arrangements to ensure that its

management and personnel are free from

commercial, financial and other internal and

external pressures that my adversely affect the

quality of work

ILAC

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Accreditation of EQAS organizers

EN 14136:2004

ISO-Guide 43-1,43-2EU

International: ISO/IEC 17043.3

Special certification: ISO/IEC 17020

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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.

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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 attentionThank you for your attention

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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.

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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.

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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.

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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 levelISOCEN

5.6.7.8.

9.10.11.12.

ISO

CEN

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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 StandardsHarmonized StandardsA “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 ofthe 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.

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EN 14136:2004Mandate 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

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The Impact of Harmonized ENThe Impact of Harmonized EN--StandardsStandards

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.

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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".

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ConflictConflictIf you have failed with your standardisation project at CEN,

then go to ISO.

ISO/IEC 17043:2008 EN 14136:2004

General requirements for proficiency testing

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

EXAMPLE:EXAMPLE:

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EN 14136:2003

Requirements for organisations conducting EQAS

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.

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

ISO/IEC WD 17043.3

5.1.5 The proficiency testing provider shall:

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.

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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.

Summary

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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 surveysamples 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.

4 Design requirements for EQAS4 Design requirements for EQAS

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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

NOTE 2

ISO/IEC Guide 43-1 and ILAC–G13:2000 give

examples for a quality management system.

The organisation should be accredited by a national or

European accreditation body and/or acknowledged by a national

authority.

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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.

Justification:

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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

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

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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.

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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);

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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 MDs-

Statistical 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).

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Standards development processes and deliverables

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Objectives and structure of CASCOObjectives and structure of CASCOISO/CASCO is ISO's policy development ISO/CASCO is ISO's policy development

committee on conformity assessmentcommittee on conformity assessment, reporting , reporting to the ISO Council. to the ISO Council. CASCO, as it is commonly CASCO, as it is commonly referred to, was established in 1970 to study referred to, was established in 1970 to study means of conformity assessmentmeans of conformity assessment, prepare , prepare documents concerning the practice and documents concerning the practice and operation of conformity assessment, and to operation of conformity assessment, and to promote their use. promote their use.

CASCO membership is open to all ISO is open to all ISO member bodies as participating (P) or observer member bodies as participating (P) or observer (O) members, with both developing and (O) members, with both developing and industrialized countries well represented. industrialized countries well represented.

http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee_participation.htm?commid=54998

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SemiSemi--horizontal standard:horizontal standard: standards

indicating aspects applicable to families of families of

similar products and/or processessimilar 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

ESOESO(1)(1)

Reference and title of the Reference and title of the harmonised standard harmonised standard

(and reference document)(and reference document)

First First publication publication

OJOJ(*)(*)

Reference Reference of of

supersedesuperseded standardd standard

Date of Date of cessation of cessation of presumption presumption

of of conformity conformity

of of superseded superseded standardstandardNote 1Note 1

CENCEN EN 14136:2004EN 14136:2004Use of external quality Use of external quality

assessment schemes in the assessment schemes in the assessment of the assessment of the

performance of in vitro performance of in vitro diagnostic examination diagnostic examination

procedure procedure

15/11/200615/11/2006

5c_01

Documents

vertical standard

impact of iso

number of national iso

semihorizontal standards

voluntary consensus

international organization

specific procedures

work itemnew proposal