ISO 13485:2016 Transition
16 March 2016
The requirements for quality management systems have been going through a year of changes, led by the 2015 revision of the hugely successful ISO 9001:2015 Quality Management Systems (QMS) requirements.
This update will require the whole family of ISO 9001 QMS-based quality standards to update, including the automotive, aerospace, environmental and occupational health standards, all of which were based on the older ISO 9001:2008 Standard.
It may also include peripheral design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including QMS-related services to such organizations.
Requirements of ISO 13485:2016 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 ISO 13485:2016 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 QMS by monitoring, maintaining, and controlling the processes.
If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 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 not be applicable, the organization records the justification as described in 4.2.2.
Further, these tools will also be utilized by our auditors to assess and successfully transition both our registered and future clients, providing what we consider the most effective and seamless update.
THE NEW MEDICAL DEVICES STANDARD
The new ISO 13485:2016 standard specifies the requirements for a QMS 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, distribution, installation, and servicing of a medical device.It may also include peripheral design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including QMS-related services to such organizations.
Requirements of ISO 13485:2016 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 ISO 13485:2016 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 QMS by monitoring, maintaining, and controlling the processes.
ISO 13485 REQUIREMENTS AND EXCLUSIONS
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 ISO 13485:2016 reflect any exclusion of design and development controls.If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 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 not be applicable, the organization records the justification as described in 4.2.2.
IMPACT ON CERTIFICATION
There will be some fall out as the industry embraces the older 9001:2008 management system requirements, as many organizations will hold joint ISO 9001:2008 and ISO 13485:2003 certification maintained by a single visit. With only 60-70% of the 9001:2015 requirements aligned with the revised ISO 13485:2016 standard, organization requiring both standards should expect additional audit day duration and more costly registrations.TRANSITION SUPPORT
There is good news. NQA has developed easy to use and free to download transition tools focused at organizations transitioning, with or without the help of external consultants, and needing to separate or combine their ISO 9001:2015 and ISO 13485:2016 systems.Further, these tools will also be utilized by our auditors to assess and successfully transition both our registered and future clients, providing what we consider the most effective and seamless update.