General requirements for the competence of reference material producers (ISO 17034:2016)

ISO 17034:2016 specifies general requirements for the competence and consistent operation of reference material producers.
ISO 17034:2016 sets out the requirements in accordance with which reference materials are produced. It is intended to be used as part of the general quality assurance procedures of the reference material producer.
ISO 17034:2016 covers the production of all reference materials, including certified reference materials.

Allgemeine Anforderungen an die Kompetenz von Referenzmaterialherstellern

Diese Internationale Norm legt allgemeine Anforderungen an die Kompetenz und die konsistente Arbeitsweise von Referenzmaterialherstellern fest.
Diese Internationale Norm legt die Anforderungen fest, nach denen Referenzmaterialien hergestellt werden. Sie ist dazu vorgesehen, als Teil der allgemeinen Qualitätssicherungsverfahren der Referenzmaterial¬hersteller angewendet zu werden.
Diese Internationale Norm deckt die Herstellung sämtlicher Referenzmaterialien, einschließlich zertifizierter Referenzmaterialien ab.
ANMERKUNG   Referenzmaterialhersteller, Regulierungsbehörden, Organisationen und Programme, die eine Begut-achtung unter Gleichrangigen anwenden sowie Akkreditierungsstellen und andere können diese Internationale Norm ebenfalls zur Bestätigung oder Anerkennung der Kompetenz von Referenzmaterialherstellern einsetzen.

Exigences générales pour la compétence des producteurs de matériaux de référence (ISO 17034:2016)

ISO 17034:2016 spécifie les exigences générales pour la compétence et le fonctionnement cohérent des producteurs de matériaux de référence.
ISO 17034:2016 spécifie les exigences par rapport auxquelles les matériaux de référence sont produits. Elle est destinée à être utilisée dans le cadre des procédures générales d'assurance qualité d'un producteur de matériaux de référence.
ISO 17034:2016 couvre la production de tous les matériaux de référence, y compris les matériaux de référence certifiés.

Ugotavljanje skladnosti - Splošne zahteve za usposobljenost proizvajalcev referenčnih materialov (ISO 17034:2016)

Ta mednarodni standard določa splošne zahteve, v skladu s katerimi mora proizvajalec referenčnih materialov dokazano delovati, da je priznan kot usposobljen za proizvajanje referenčnih materialov. Ta mednarodni standard uporabljajo proizvajalci referenčnih materialov pri razvoju in izvajanju svojega sistema za upravljanje postopkov v zvezi z zagotavljanjem kakovosti ter upravnih in tehničnih postopkov. Stranke ter zakonodajni in akreditacijski organi, ki uporabljajo referenčni material, lahko ta standard uporabljajo tudi pri potrjevanju in priznavanju usposobljenosti proizvajalcev referenčnega materiala. Ta mednarodni standard določa zahteve, v skladu s katerimi je treba proizvajati referenčne materiale. Namenjen je za uporabo kot del splošnih postopkov zagotavljanja kakovosti (QA) proizvajalca referenčnega materiala. Ta mednarodni standard zajema proizvodnjo vseh referenčnih materialov. Proizvodne zahteve za certificirane referenčne materiale so strožje kot za druge referenčne materiale.

General Information

Status
Published
Publication Date
29-Nov-2016
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
30-Nov-2016
Completion Date
30-Nov-2016

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SLOVENSKI STANDARD
SIST EN ISO 17034:2017
01-februar-2017
8JRWDYOMDQMHVNODGQRVWL6SORãQH]DKWHYH]DXVSRVREOMHQRVWSURL]YDMDOFHY
UHIHUHQþQLKPDWHULDORY ,62

Conformity assessment - General requirements for the competence of reference material

producers (ISO 17034:2016)
Konformitätsbewertung - Allgemeine Anforderungen an die Kompetenz von
Referenzmaterialherstellern (ISO 17034:2016)
Exigences générales pour la compétence des producteurs de matériaux de référence
(ISO 17034:2016)
Ta slovenski standard je istoveten z: EN ISO 17034:2016
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
SIST EN ISO 17034:2017 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 17034:2017
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SIST EN ISO 17034:2017
EUROPEAN STANDARD
EN ISO 17034
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2016
ICS 03.120.20
English version
General requirements for the competence of reference
material producers (ISO 17034:2016)

Exigences générales pour la compétence des Konformitätsbewertung - Allgemeine Anforderungen

producteurs de matériaux de référence (ISO an die Kompetenz von Referenzmaterialherstellern

17034:2016) (ISO 17034:2016)
This European Standard was approved by CEN on 26 October 2016.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for

giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical

references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to

any CEN and CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC

Management Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,

Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany,

Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,

Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Avenue Marnix 17, B-1000 Brussels

© 2016 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 17034:2016 E

reserved worldwide for CEN national Members and for
CENELEC Members.
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SIST EN ISO 17034:2017
EN ISO 17034:2016 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 17034:2017
EN ISO 17034:2016 (E)
European foreword

This document (EN ISO 17034:2016) has been prepared by Technical Committee ISO/CASCO

"Committee on conformity assessment" in collaboration with Technical Committee CEN/CLC/TC 1

“Criteria for conformity assessment bodies” the secretariat of which is held by BSI.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by May 2017, and conflicting national standards shall be

withdrawn at the latest by May 2017.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent

rights.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,

Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,

Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,

Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 17034:2016 has been approved by CEN as EN ISO 17034:2016 without any modification.

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SIST EN ISO 17034:2017
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SIST EN ISO 17034:2017
INTERNATIONAL ISO
STANDARD 17034
First edition
2016-11-01
General requirements for the
competence of reference material
producers
Exigences générales pour la compétence des producteurs de
matériaux de référence
Reference number
ISO 17034:2016(E)
ISO 2016
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SIST EN ISO 17034:2017
ISO 17034:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 17034:2017
ISO 17034:2016(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 General requirements ..................................................................................................................................................................................... 3

4.1 Contractual matters ............................................................................................................................................................................ 3

4.2 Impartiality ................................................................................................................................................................................................ 3

4.3 Confidentiality ......................................................................................................................................................................................... 4

5 Structural requirements .............................................................................................................................................................................. 4

6 Resource requirements ................................................................................................................................................................................. 5

6.1 Personnel ..................................................................................................................................................................................................... 5

6.2 Subcontracting ........................................................................................................................................................................................ 5

6.3 Provision of equipment, services and supplies ........................................................................................................... 6

6.4 Facilities and environmental conditions .......................................................................................................................... 7

7 Technical and production requirements ..................................................................................................................................... 7

7.1 General requirements ....................................................................................................................................................................... 7

7.2 Production planning ........................................................................................................................................................................... 7

7.3 Production control ............................................................................................................................................................................... 8

7.4 Material handling and storage ................................................................................................................................................... 8

7.5 Material processing ............................................................................................................................................................................. 9

7.6 Measurement procedures.............................................................................................................................................................. 9

7.7 Measuring equipment ....................................................................................................................................................................10

7.8 Data integrity and evaluation ..................................................................................................................................................10

7.9 Metrological traceability of certified values ...............................................................................................................10

7.10 Assessment of homogeneity .....................................................................................................................................................11

7.11 Assessment and monitoring of stability.........................................................................................................................11

7.12 Characterization .................................................................................................................................................................................12

7.13 Assignment of property values and their uncertainties ...................................................................................13

7.14 RM documents and labels ...........................................................................................................................................................14

7.15 Distribution service .........................................................................................................................................................................15

7.16 Control of quality and technical records ........................................................................................................................16

7.17 Management of non-conforming work ...........................................................................................................................16

7.18 Complaints ...............................................................................................................................................................................................17

8 Management system requirements ...............................................................................................................................................18

8.1 Options ........................................................................................................................................................................................................18

8.1.1 General...................................................................................................................................................................................18

8.1.2 Option A ................................................................................................................................................................................18

8.1.3 Option B ................................................................................................................................................................................18

8.2 Quality policy (Option A) ............................................................................................................................................................18

8.3 General management system documentation (Option A) ..............................................................................19

8.4 Control of management system documents (Option A) ...................................................................................19

8.5 Control of records (Option A)..................................................................................................................................................19

8.6 Management review (Option A) ............................................................................................................................................20

8.7 Internal audit (Option A) ............................................................................................................................................................20

8.8 Actions to address risks and opportunities (Option A) ....................................................................................21

8.9 Corrective actions (Option A) ..................................................................................................................................................21

8.9.1 General...................................................................................................................................................................................21

8.9.2 Cause analysis .................................................................................................................................................................21

8.9.3 Selection and implementation of corrective actions .....................................................................21

8.9.4 Monitoring of corrective actions .....................................................................................................................22

© ISO 2016 – All rights reserved iii
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SIST EN ISO 17034:2017
ISO 17034:2016(E)

8.9.5 Additional audits...........................................................................................................................................................22

8.10 Improvement (Option A) .............................................................................................................................................................22

8.11 Feedback from customers (Option A) ..............................................................................................................................22

Annex A (informative) Summary of production requirements for RMs and CRMs ...........................................23

Bibliography .............................................................................................................................................................................................................................24

iv © ISO 2016 – All rights reserved
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SIST EN ISO 17034:2017
ISO 17034:2016(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,

as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the

Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.

ISO 17034 was prepared by the ISO Committee on Conformity Assessment (CASCO), in collaboration with

the ISO Committee on Reference Materials (REMCO).

This first edition of ISO 17034 cancels and replaces ISO Guide 34:2009, which has been technically

revised.
The following major changes have been made compared with ISO Guide 34:2009:

— inclusion of requirements for production of all types of reference materials, and additional specified

requirements for certified reference materials;
— harmonization with the revisions of ISO Guide 31 and ISO Guide 35;
— inclusion of more details on required reference material documentation;
— inclusion of risks and opportunities;

— restructuring based on the common structure adopted by other International Standards on

conformity assessment developed by CASCO;
— incorporation of modifications based on ISO/CASCO PROC 33.
© ISO 2016 – All rights reserved v
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SIST EN ISO 17034:2017
ISO 17034:2016(E)
Introduction

Reference materials (RMs) are used in all stages of the measurement process, including for method

validation, calibration and quality control. They are also used in interlaboratory comparisons for

method validation and for assessing laboratory proficiency.

The demonstration of the scientific and technical competence of reference material producers (RMPs)

is a basic requirement for ensuring the quality of RMs. The demand for new RMs of higher quality

is increasing as a consequence of both the improved precision of measuring equipment and the

requirement for more accurate and reliable data in the scientific and technological disciplines. It is not

only necessary for RMPs to provide information about their materials in the form of RM documents, but

also to demonstrate their competence in producing RMs of appropriate quality.

This International Standard outlines the general requirements for the producers of RMs, including

certified reference materials (CRMs). It supersedes ISO Guide 34:2009 and is aligned with the relevant

requirements of ISO/IEC 17025. Further guidance (e.g. concerning the content of certificates and

the design of characterization, homogeneity and stability studies) is provided in ISO Guide 31 and

ISO Guide 35. While the approaches outlined in ISO Guide 31 and ISO Guide 35 meet the relevant

requirements of this International Standard, there might be alternative ways to achieve compliance to

this International Standard.

RMPs that comply with this International Standard will also operate generally in accordance with the

principles of ISO 9001. For tests performed in the medical field, ISO 15189 can be used as the reference

instead of ISO/IEC 17025.

In this International Standard, the term “certification” refers to the certification of RMs.

In this International Standard, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Further details can be found in the ISO/IEC Directives, Part 2.

For the purposes of research, users are encouraged to share their views on this document and their

priorities for changes to future editions. Click on the link below to take part in the online survey:

https://www.surveymonkey.com/r/CDZZWYH
vi © ISO 2016 – All rights reserved
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SIST EN ISO 17034:2017
INTERNATIONAL STANDARD ISO 17034:2016(E)
General requirements for the competence of reference
material producers
1 Scope

This International Standard specifies general requirements for the competence and consistent

operation of reference material producers.

This International Standard sets out the requirements in accordance with which reference materials

are produced. It is intended to be used as part of the general quality assurance procedures of the

reference material producer.

This International Standard covers the production of all reference materials, including certified

reference materials.

NOTE Reference material producers, regulatory authorities, organizations and schemes using peer

assessment, accreditation bodies and others can also use this International Standard in confirming or recognizing

the competence of reference material producers.
2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO/IEC 17000, ISO Guide 30,

ISO/IEC Guide 99, ISO 9000 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at http://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1
reference material producer
RMP

body (organization or company, public or private) that is fully responsible for project planning and

management; assignment of, and decision on property values and relevant uncertainties; authorization

of property values; and issuance of a reference material certificate or other statements for the reference

materials it produces
[SOURCE: ISO Guide 30:2015, 2.3.5]

1) The definitions in ISO Guide 30 take precedence where more than one definition for the same term related to

reference materials exist.
© ISO 2016 – All rights reserved 1
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SIST EN ISO 17034:2017
ISO 17034:2016(E)
3.2
certified reference material
CRM

reference material characterized by a metrologically valid procedure for one or more specified

properties, accompanied by a reference material certificate that provides the value of the specified

property, its associated uncertainty, and a statement of metrological traceability

Note 1 to entry: The concept of value includes a nominal property or a qualitative attribute such as identity or

sequence. Uncertainties for such attributes may be expressed as probabilities or levels of confidence.

Note 2 to entry: Metrologically valid procedures for the production and certification of reference materials are

given in, among others, ISO Guide 35.

Note 3 to entry: ISO Guide 31 gives guidance on the contents of reference material certificates.

Note 4 to entry: ISO/IEC Guide 99:2007 has an analogous definition.

[SOURCE: ISO Guide 30:2015, 2.1.2, modified — Reference to ISO Guide 34 has been removed from Note

2 to entry]
3.3
reference material

material, sufficiently homogeneous and stable with respect to one or more specified properties, which

has been established to be fit for its intended use in a measurement process
Note 1 to entry: Reference material is a generic term.

Note 2 to entry: Properties can be quantitative or qualitative, e.g. identity of substances or species.

Note 3 to entry: Uses may include the calibration of a measurement system, assessment of a measurement

procedure, assigning values to other materials, and quality control.

Note 4 to entry: ISO/IEC Guide 99:2007 has an analogous definition, but restricts the term “measurement” to

apply to quantitative values. However, Note 3 of the definition in ISO/IEC Guide 99:2007 specifically includes

qualitative properties, called “nominal properties”.

[SOURCE: ISO Guide 30:2015, 2.1.1, modified — Second sentence of Note 4 to entry has been modified.]

3.4
certified value

value, assigned to a property of a reference material that is accompanied by an uncertainty statement

and a statement of metrological traceability, identified as such in the reference material certificate

[SOURCE: ISO Guide 30:2015, 2.2.3]
3.5
impartiality
presence of objectivity

Note 1 to entry: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely

influence the activities of the reference material producer.

Note 2 to entry: Other terms that are useful in conveying the element of impartiality include “independence”,

“freedom from conflict of interests”, “freedom from bias”, “lack of prejudice”, “neutrality”, “fairness”, “open-

mindedness”, “even-handedness”, “detachment”, “balance”.

[SOURCE: ISO/IEC 17021-1:2015, 3.2, modified — In Note 1 to entry, “certification body” has been

replaced by “reference material producer”.]
2 © ISO 2016 – All rights reserved
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SIST EN ISO 17034:2017
ISO 17034:2016(E)
3.6
reference material document
RM document

document containing all the information that is essential for using any reference material

Note 1 to entry: The reference material document covers both the product information sheet and reference

material certificate.

[SOURCE: ISO Guide 31:2015, 3.5, modified — The second preferred term “reference material document”

has been added.]
3.7
operationally defined measurand

measurand that is defined by reference to a documented and widely accepted measurement procedure

to which only results obtained by the same procedure can be compared

Note 1 to entry: Examples include crude fibre in foods, impact toughness, enzyme activities and extractable lead

in soils.
4 General requirements
4.1 Contractual matters

4.1.1 Any request, tender or contract concerning the production of an RM shall be reviewed, following

documented policies and procedures established by the RMP, to ensure that:

a) the requirements for RMs and their production are adequately defined, documented and

understood;
b) the RMP has the capability and resources to meet the requirements.

NOTE 1 Capability means that the RMP has access to, for example, the necessary equipment, knowledge and

information resources and that its personnel have the skills and expertise necessary for the production of those

RMs in question. The review of capability can include an assessment of previous RM production and/or the

organization of interlaboratory characterization programmes using samples of similar composition to the RMs

to be produced.
NOTE 2 A contract can be any written or verbal agreement.
NOTE 3 A request to prepare a specific RM can originate from the RMP.

4.1.2 The review shall include any work that needs to be subcontracted by the RMP.

4.1.3 The RMP shall maintain records of these reviews, including any changes, records of pertinent

discussions with the customer relating to the customer’s requirements, and subcontracted work.

4.2 Impartiality
4.2.1 The RMP shall be structured and managed so as to safeguard impartiality.

NOTE Impartiality implies that decisions are based on objective criteria and not on the basis of bias,

prejudice, or preferring the benefit of one person over another for improper reasons.

4.2.2 The RMP shall:

a) have arrangements to ensure that its management and personnel are free from any undue internal

and external commercial, financial and other pressures and influences that may adversely affect

the quality of their work;
© ISO 2016 – All rights reserved 3
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