ISO 13485 - PRACTICAL GUIDE : 2016
Current
Current
The latest, up-to-date edition.
ISO 13485:2016 - MEDICAL DEVICES - A PRACTICAL GUIDE
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English
Published date
01-01-2016
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
5 Management responsibility
6 Resource management
7 Product realization
8 Measurement, analysis and improvement
Annex A - Guidance for small organizations
Bibliography
This International Standard specifies requirements for a quality management
system where an organization needs to demonstrate its ability toprovidemedical devicesandrelatedservicesthatconsistny meetcustomerand applicable regulatory requirements.
| Committee |
TC 210
|
| DocumentType |
Guide
|
| ISBN |
978-92-67-10774-5
|
| Pages |
0
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| SA HB 13485:2020 | Identical |
| NSAI-ISO Guide to ISO 13485:2016 | Identical |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 19011:2011 | Guidelines for auditing management systems |
| ISO 14006:2011 | Environmental management systems Guidelines for incorporating ecodesign |
| ISO 10015:1999 | Quality management Guidelines for training |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO/IEC 27001:2013 | Information technology — Security techniques — Information security management systems — Requirements |
| ISO 14160:2011 | Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
| ISO/TR 10017:2003 | Guidance on statistical techniques for ISO 9001:2000 |
| IEC/ISO 31010:2009 | Risk management - Risk assessment techniques |
| ISO 31000:2009 | Risk management Principles and guidelines |
| IEC 61160:2005 | Design review |
| ISO 10019:2005 | Guidelines for the selection of quality management system consultants and use of their services |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
| ISO 10005:2005 | Quality management systems Guidelines for quality plans |
| ISO 10008:2013 | Quality management — Customer satisfaction — Guidelines for business-to-consumer electronic commerce transactions |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 10006:2003 | Quality management systems Guidelines for quality management in projects |
| ISO 10018:2012 | Quality management Guidelines on people involvement and competence |
| ISO 9004:2009 | Managing for the sustained success of an organization A quality management approach |
| ISO 20857:2010 | Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO/TR 10013:2001 | Guidelines for quality management system documentation |
| IEC 60300-1:2014 | Dependability management - Part 1: Guidance for management and application |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO 14001:2015 | Environmental management systems — Requirements with guidance for use |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling |
| ISO 37500:2014 | Guidance on outsourcing |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO/IEC 90003:2014 | Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
| ISO 10007:2017 | Quality management — Guidelines for configuration management |
| ISO 14040:2006 | Environmental management Life cycle assessment Principles and framework |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO/TR 80002-2:2017 | Medical device software — Part 2: Validation of software for medical device quality systems |
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