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17/30349163 DC : 0

NA

NA

Status of Standard is Unknown

BS ISO 20387 - BIOTECHNOLOGY - BIOBANKING - GENERAL REQUIREMENTS FOR BIOBANKING

Available format(s)

Hardcopy , PDF

Language(s)

English

£20.00
Excluding VAT

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Structural requirements
6 Resource requirements
7 Process requirements
8 Management requirements
Annex A (normative) - Documentation requirements
Annex B (informative) - Implementation guidance for Annex A
Bibliography

BS ISO 20387.

Committee
BTI/1
DocumentType
Draft
Pages
39
PublisherName
British Standards Institution
Status
NA

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO/IEC 17000:2004 Conformity assessment — Vocabulary and general principles
ISO 17034:2016 General requirements for the competence of reference material producers
ISO 19011:2011 Guidelines for auditing management systems
ISO 15189:2012 Medical laboratories — Requirements for quality and competence
ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
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 8601:2004 Data elements and interchange formats — Information interchange — Representation of dates and times
ISO/IEC 17020:2012 Conformity assessment — Requirements for the operation of various types of bodies performing inspection
ISO/IEC 17043:2010 Conformity assessment — General requirements for proficiency testing
ISO Guide 30:2015 Reference materials — Selected terms and definitions
ISO 8459:2009 Information and documentation — Bibliographic data element directory for use in data exchange and enquiry
ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
NFS 96 900 : 2011 QUALITY OF BIOLOGICAL RESOURCE CENTRES (BRCS) - MANAGEMENT SYSTEM OF A BRC AND QUALITY OF BIOLOGICAL RESOURCES
ISO 9001:2015 Quality management systems — Requirements
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 17364:2013 Supply chain applications of RFID — Returnable transport items (RTIs) and returnable packaging items (RPIs)
ISO 17100:2015 Translation services — Requirements for translation services
ISO 27799:2016 Health informatics — Information security management in health using ISO/IEC 27002
ISO/IEC 17021-1:2015 Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1: Requirements

£20.00
Excluding VAT