EN ISO 17034:2016
(Main)General requirements for the competence of reference material producers (ISO 17034:2016)
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
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2017
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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
ISO 17034:2016(E)
© ISO 2016, Published in Switzerland
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ii © ISO 2016 – All rights reserved
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) .
...
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