CAN/CSA-ISO 13485:16
Current
The latest, up-to-date edition.
Medical devices - Quality management systems - Requirements for regulatory purposes (Adopted ISO 13485:2016, third edition, 2016-03-01)
Hardcopy , PDF
English, French
01-01-2016
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
This International Standard specifies 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.
DevelopmentNote |
Supersedes CSA ISO 13488. (05/2008)
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DocumentType |
Standard
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ISBN |
978-1-4883-0704-1
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Pages |
0
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PublisherName |
Canadian Standards Association
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Status |
Current
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Supersedes |
Preface This is the third edition of CAN/CSA-ISO 13485, Medical devices - Quality management systems - Requirements for regulatory purposes, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 13485 (third edition, 2016-03-01). It supersedes the previous edition published in 2003 as CAN/CSA-ISO 13485 (adopted ISO 13485:2003).? Scope This International Standard specifies 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. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.? Requirements of this International Standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.? The processes required by this International Standard that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.? If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to this International Standard reflect any exclusion of design and development controls.? If any requirement in Clauses 6, 7 or 8 of this International Standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.
Standards | Relationship |
ISO 13485:2016 | Identical |
CSA Z1416: 2011 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
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 8319-1 : 0 | ORTHOPAEDIC INSTRUMENTS - DRIVE CONNECTIONS - PART 1: KEYS FOR USE WITH SCREWS WITH HEXAGON SOCKET HEADS |
CSA Z14161 : 2011 : R2015 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
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 |
Z7396.1-17 | Medical gas pipeline systems - Part 1: Pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems |
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 ISO 5832-2 : 0 | IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 2: UNALLOYED TITANIUM |
CSA ISO 5832-4 : 0 | IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 4: COBALT-CHROMIUM-MOLYBDENUM CASTING ALLOY |
CSA ISO 5832-3 : 0 | IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 3: WROUGHT TITANIUM 6-ALUMINIUM 4-VANDIUM ALLOY |
CSA ISO 5832-5 : 0 | IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 5: WROUGHT COBALT-CHROMIUM-TUNGSTEN-NICKEL ALLOY |
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 5832-6 : 0 | IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 6: WROUGHT COBALT-NICKEL-CHROMIUM-MOLYBDENUM ALLOY |
ISO 19011:2011 | Guidelines for auditing management systems |
ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
ISO 10012:2003 | 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 | 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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