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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

Preview

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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