CSA ISO 13485 : 2016

Current

Current The latest, up-to-date edition.

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES

Publisher: Canadian Standards Association

Published: 01-01-2016

Available Formats: PDF - French, Hardcopy - French, PDF - English, Hardcopy - English
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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 (informative) - Comparison of content between         ISO 13485:2003 and ISO 13485:2016 Annex B (informative) - Correspondence between         ISO 13485:2016 and ISO 9001:2015 Bibliography

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Defines requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

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Published
Document Type	Standard
Status	Current
Publisher	Canadian Standards Association
Pages
ISBN
Supersedes	CSA ISO 13488 : 0

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
ISO 13485 : 2016(R2020)	Identical
ISO 13485 : 2016(R2020)	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

CSA ISO 8319-1 : 0	ORTHOPAEDIC INSTRUMENTS - DRIVE CONNECTIONS - PART 1: KEYS FOR USE WITH SCREWS WITH HEXAGON SOCKET HEADS
CSA ISO 5832-4 : 0	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 4: COBALT-CHROMIUM-MOLYBDENUM CASTING ALLOY
CSA Z14161 : 2011 : R2015	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
CSA ISO 5833 : 0	IMPLANTS FOR SURGERY - ACRYLIC RESIN CEMENTS
CSA ISO 5835 : 0	IMPLANTS FOR SURGERY - METAL BONE SCREWS WITH HEXAGONAL DRIVE CONNECTION, SPHERICAL UNDER-SURFACE OF HEAD, ASYMMETRICAL THREAD-DIMENSIONS
CSA Z1416: 2011	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
CSA ISO 5832-3 : 0	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 3: WROUGHT TITANIUM 6-ALUMINIUM 4-VANDIUM ALLOY
CSA Z14161 : 2011 : FR	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
CSA Z14161 : 2011	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
CSA ISO 5832-5 : 0	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 5: WROUGHT COBALT-CHROMIUM-TUNGSTEN-NICKEL ALLOY
CSA ISO 5832-2 : 0	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 2: UNALLOYED TITANIUM
CSA ISO 8319-2 : 0	ORTHOPAEDIC INSTRUMENTS - DRIVE CONNECTIONS - PART 2: SCREWDRIVERS FOR SINGLE SLOT HEAD SCREWS, SCREWS WITH CRUCIATE SLOT AND CROSS-RECESSED HEAD SCREWS
CSA Z7396.1 : 2017	MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINES FOR MEDICAL GASES, MEDICAL VACUUM, MEDICAL SUPPORT GASES, AND ANAESTHETIC GAS SCAVENGING SYSTEMS
CSA Z314.0 : 2013	MEDICAL DEVICE REPROCESSING - GENERAL REQUIREMENTS
CSA ISO 7206-2 : 0	IMPLANTS FOR SURGERY - PARTIAL AND TOTAL HIP JOINT PROSTHESES - PART 2: ARTICULATING SURFACES MADE OF METALLIC, CERAMIC AND PLASTICS MATERIALS
CSA ISO 7207-1 : 0	IMPLANTS FOR SURGERY - FERMORAL AND TIBIAL COMPONENTS FOR PARTIAL AND TOTAL KNEE JOINT PROSTHESES - PART 1: CLASSIFICATION, DEFINITIONS AND DESIGNATION OF DIMENSIONS
CSA ISO 5832-6 : 0	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 6: WROUGHT COBALT-NICKEL-CHROMIUM-MOLYBDENUM ALLOY

Standards Referencing This Book - (Show below) - (Hide below)

ISO 19011 : 2011	GUIDELINES FOR AUDITING MANAGEMENT SYSTEMS
ISO 11607-2 : 2006(R 2015)	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
IEC 62366-1 : 2015 COR 1 2016	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
ISO 10012 : 2003(R2015)	MEASUREMENT MANAGEMENT SYSTEMS - REQUIREMENTS FOR MEASUREMENT PROCESSES AND MEASURING EQUIPMENT
ISO 9001:2015	QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS
ISO 9000 : 2015	QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY
ISO 14971 : 2007(R2010)	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

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CSA ISO 13485 : 2016

Table of Contents - (Show below) - (Hide below)

Abstract - (Show below) - (Hide below)

General Product Information - (Show below) - (Hide below)

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Standards Referenced By This Book - (Show below) - (Hide below)

Standards Referencing This Book - (Show below) - (Hide below)

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