ДСТУ EN ISO 20387:2022 Биотехнология. Биотоника. Общие требования к биобанкингу (EN ISO 20387:2020, IDT; ISO 20387:2018, IDT)

ДСТУ EN ISO 20387:2022
(EN ISO 20387:2020, IDT; ISO 20387:2018, IDT)

Біотехнологія. Біотаніка. Загальні вимоги до біобанкінгу

 
     
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 General

4.2 Impartiality

4.3 Confidentiality

5 Structural requirements

6 Resource requirements

6.1 General

6.2 Personnel

6.3 Facilities/dedicated areas and environmental conditions

6.4 Externally provided processes, products and services

6.5 Equipment

7 Process requirements

7.1 General

7.2 Collection of biological material and associated data

7.3 Reception and distribution of biological material and associated data

7.4 Transport of biological material and associated data

7.5 Traceability of biological material and associated data

7.6 Preparation and preservation of biological material

7.7 Storage of biological material

7.8 Quality control of biological material and associated data

7.9 Validation and verification of methods

7.10 Management of information and data

7.11 Nonconforming output

7.12 Report requirements

7.13 Complaints

8 Quality management system requirements

8.1 Options

8.2 Documented information for the quality management system (Option A)

8.3 Control of quality management system documents (Option A)

8.4 Control of records (Option A)

8.5 Actions to address risksand opportunities (Option A)

8.6 Improvement (Option A)

8.7 Corrective action for nonconforming output (Option A)

8.8 Internal audits (Option A)

8.9 Quality management reviews (Option A)

Annex A (normative) Documentation requirements

Annex В (informative) Implementation guidance for Annex A

Annex C (informative) Quality management system options

Bibliography