This International Standard specifies requirements for a quality management system when an organization is required to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and applicable regulatory requirements. Such organizations may be involved in one or more stages of the life cycle of a medical device, including development, production, storage and distribution, installation or maintenance of a medical device and development or provision of related activities (e.g. technical support). This International Standard may also be applied by suppliers or external parties who provide products, 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, unless otherwise specified. Where requirements are determined to apply to medical devices, the requirements apply equally to related services provided by the organization. The processes required by this International Standard that are applicable to the organization but not carried out by the organization are the responsibility of the organization and are taken into account in the organization's quality management system by monitoring, maintaining and controlling the processes. If applicable regulatory requirements allow exclusions from development controls, this can be used as justification for their exclusion from the quality management system. These regulatory requirements may provide alternative approaches to be taken into account in the quality management system. It is the responsibility of the organization to ensure that any exclusion from development controls is reflected in the claims for conformity with this International Standard. If, due to the activities carried out by the organization or due to the type of medical device to which the quality management system is applied, one or more requirements in clauses 6, 7 or 8 of this International Standard are not applicable, the organization does not need such a requirement include in your quality management system. For each section determined to be inapplicable, the organization shall record the justification in accordance with 4.2.2.
EN ISO 13485:2016 Referenced Document
ISO 10012:2003 Measurement management systems - Requirements for measurement processes and measuring equipment
ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
ISO 14644-2:2015 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
ISO 14644-3:2005 Cleanrooms and associated controlled environments - Part 3: Test methods
ISO 14644-4:2001 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
ISO 14644-5:2004 Cleanrooms and associated controlled environments - Part 5: Operations
ISO 14644-7:2004 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
ISO 14644-8:2013 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
ISO 9000:2015 Quality management systems - Fundamentals and vocabulary
ISO 9001:2015 Quality management systems - Requirements
EN ISO 13485:2016 history
2021EN ISO 13485:2016/A11:2021 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
2018EN ISO 13485:2016/AC:2018 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
2016EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
2012EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (Incorporating corrigendum July 2012)
2003EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes Incorporating corrigendum June 2007 [Superseded: CEN EN 46003, CEN EN ISO 13488]
2000EN ISO 13485:2000 Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9001 Revision of EN 46001:1996; Identical to ISO 13485:1996