Implementing an ISO 13485 Quality Management System for Medical Devices

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BIP 0115:2014

Implementing an ISO 13485 Quality Management System for Medical Devices

Status : Current   Published : April 2014



This book is based on the previous editions of BS EN ISO 13485 (2012 and 2003).

Implementing an ISO 13485 Quality Management System for Medical Devices

This book provides you with the appropriate background information and all the practically-based guidance you need to confidently tackle an implementation of ISO 13485. It also reviews projects against the requirements of the medical device quality management system requirements.  The book is written by  Ann Goodall, IVD Product Specialist who gives you her considerable experience of assessing hundreds of medical device manufacturer processes.
Reasons to buy your copy:

  • Identify how to specifically address all the challenges in implementing ISO 13485 e.g. whether to outsource, documenting environmental conditions or controlling change
  • Be introduced to the core processes and the enhancements that are required in order to successfully implement ISO 13485 to the degree whereby a notified body, regulator or customer are satisfied that the system fulfils requirements
  • Use the examples to keep up with best practice

About the author
Ann Goodall is currently working for BSI Healthcare as an IVD Technical Specialist in the IVD team as well as a Lead Assessor for ISO 9001/13485.  She also delivers training on ISO 13485 Quality Management Systems. Before joining BSI, she worked for over 30 years in the In Vitro Diagnostic industry after completing her Ph.D at St Mary’s Hospital, London. This has included a variety of roles in small and large diagnostic companies including R&D, Quality Assurance and more recently 5 years in Supplier Quality Management working with international suppliers of finished products, to ensure appropriate product quality and quality system interface. Ann was a member of the EDMA Member of Standardisation Quality and Risk Management Working Party for more than 15 years.

Who should buy it?
This book is for anyone needing affordable guidance on the implementation of ISO 13485.

Medical device manufacturers and their supply chains, medical organisations involved with biomedical engineering.

  • Quality Directors / VP’s responsible for implementation or system review projects
  • Quality Engineers and Assurance personnel
  • Regulatory Affairs Managers
  • Design and Development staff
  • Industry Regulators gaining an understanding of typical approaches to specific medical device processes.
  • Open University Delegates interested in Quality modules
  • Biomedical Engineering Students


Chapter 1 – Introduction
Chapter 2 - ISO 13485
Chapter 3 - Getting started
Chapter 4 - Quality management system: meeting the requirements of Clauses 1,2,3 and 4 of ISO 13485
Chapter 5 - Management responsibility: meeting the requirements of Clause 5 of ISO 13485
Chapter 6 -Resource management: meeting the requirements of Clause 6 of ISO 13485
Chapter 7 - Product realization; meeting the requirements of Clause 7 of ISO 13485
Chapter 8 - Measurement, analysis and improvement: meeting the requirements of Clause 8 of ISO 13485
Chapter 9 - Achieving and continuing to maintain ISO 13485 certification
Appendix - Background and origins of ISO 13485:2003

You may also be interested in:
Guide to European Medical Device Trials, by Duncan Fatz

Standard NumberBIP 0115:2014
TitleImplementing an ISO 13485 Quality Management System for Medical Devices
Publication Date04 April 2014
DescriptorsMedical equipment, Medical instruments, Medical technology, Quality management, Quality assurance systems, Acceptance (approval), Management Quality and Management
ISBN978 0 580 68595 8
File Size1.416 MB

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