ISO 13485 Medical Device Quality          Management Guide
ISO 13485 2016 is a global quality management standard for medical devices. 
Use it to establish a quality management system that is oriented towards the design,
development, production, and installation of medical devices and related services.
Use it to become certified (registered) and to demonstrate your ability to supply
medical devices and related services that meet customer requirements.


Introduction to ISO 13485 2016

Outline of ISO 13485 2016 Standard

Overview of ISO 13485 2016 Standard

ISO 13485 2016 versus ISO 13485 2003

Plain English ISO 13485 2016 Definitions

ISO 13485 2016 Translated into Plain English

ISO 13485 2016 Quality Management Checklist

Plain English ISO 13485 2016 Gap Analysis Tool

ISO 13485 2016 Quality Management Audit Program

Skills and Knowledge Internal Auditors Should Have

ISO 14971 is a risk management standard for medical devices. It defines
a set of risk management requirements. The purpose of ISO 14971 is to help
manufacturers to establish a medical device risk management process that
they can use to identify hazards, to estimate and evaluate risks, and to
implement and monitor the effectiveness of risk control measures.

ISO 14971 2007 GUIDE

Introduction to ISO 14971 Risk Management

Overview of Medical Device Risk Management Standard

Medical Device Risk Management Standard in Plain English

Plain English Medical Device Risk Management Definitions


ISO 13485 2003 ARCHIVE

Introduction to ISO 13485 2003 Standard

ISO 13485 2003 Quality Management Definitions

Outline of ISO 13485 2003 Medical Device Standard

ISO 13485 2003 Standard Translated into Plain English

MORE MANAGEMENT GUIDES

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ISO 31000 2009 Risk Management Guide

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ISO 19011 Management System Auditing Guide

ISO 90003 Software Quality Management Guide

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OHSAS 18001 Occupational Health & Safety Guide

ISO 27000 Information Security Management Guide

ISO 22301 Business Continuity Management Guide

ISO 28000 Supply Chain Security Management Guide

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Updated on August 24, 2017. On the Web since May 25, 1997.

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