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  • 17/30349163 DC : 0

    NA Status of Standard is Unknown

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

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    General Product Information - (Show below) - (Hide below)

    Comment Closes On
    Committee BTI/1
    Document Type Draft
    Publisher British Standards Institution
    Status NA

    Standards Referencing This Book - (Show below) - (Hide below)

    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
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