17/30349163 DC : 0
NA
Status of Standard is Unknown
BS ISO 20387 - BIOTECHNOLOGY - BIOBANKING - GENERAL REQUIREMENTS FOR BIOBANKING
Hardcopy , PDF
English
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.