ДСТУ EN ISO 17034:2022 Загальні вимоги до компетентності виробників референтних матеріалів (EN ISO 17034:2016, IDT; ISO 17034:2016, IDT)



ДСТУ EN ISO 17034:2022
(EN ISO 17034:2016, IDT; ISO 17034:2016, IDT)

Загальні вимоги до компетентності виробників референтних матеріалів

 
   
 
Не є офіційним виданням.
Офіційне видання розповсюджує національний орган стандартизації
(ДП «УкрНДНЦ» http://uas.gov.ua)

Contents

Foreword

Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 General requirements

4.1 Contractual matters

4.2 Impartiality

4.3 Confidentiality

5 Structural requirements

6 Resource requirements

6.1 Personnel

6.2 Subcontracting

6.3 Provision of equipment, services and supplies

6.4 Facilities and environmental conditions

7 Technical and production requirements

7.1 General requirements

7.2 Production planning

7.3 Production control

7.4 Material handling and storage

7.5 Material processing

7.6 Measurement procedures

7.7 Measuring equipment

7.8 Data integrity and evaluation

7.9 Metrological traceability of certified values

7.10 Assessment of homogeneity

7.11 Assessment and monitoring of stability

7.12 Characterization

7.13 Assignment of property values and their uncertainties

7.14 RM documents and labels

7.15 Distribution service

7.16 Control of quality and technical records

7.17 Management of non-conforming work

7.18 Complaints

7.18 Management system requirements

8 Management system requirements

8.1 Options

8.2 Quality policy (Option A)

8.3 General management system documentation (Option A)

8.4 management system documents (Option A)

8.5 Control of records (Option A)

8.6 Management review (Option A)

8.7 Internal audit (Option A)

8.8 Actions to address risks and opportunities (Option A)

8.9 Corrective actions (Option A)

8.10 Improvement (Option A)

8.11 Feedback from customers (Option A)

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

Bibliography