Proposed Changes to the ISO 13485
17 June 2015
The internet is awash with information regarding ISO 13485. Some content is excellent, and most provides good sources of reference, but we also see that some information regarding the proposed changes to the ISO 13485 requirements seems more personal in nature than practical.
The internet is awash with information regarding ISO 13485. Some content is excellent, and most provides good sources of reference, but we also see that some information regarding the proposed changes to the ISO 13485 requirements seems more personal in nature than practical.
What seems to have been missed from these internet discussions and some of the biggest news on this planned revision is the separation of the ISO 9001:2015 and ISO 13485 requirements. This may cause some changes for organizations that use the convenience of a single visit to maintain both their ISO 13485 and 9001 certification, as with the planned revisions for 9001 to adopt a new format, and the older 9001:2008 structure remaining as the base for 13485, there is likely to be more time added to audits in the future to cover both standards.
Historically, the family of management system standards changes or evolves every six to eight years and 9001 is a prime example with ISO 9001:2008 being revised later this year to ISO 9001:2015. Looking at the ISO 13485:2003 standard, it is clearly past the time for change, but it has and continues to service the medical device industry with a good, basic platform for quality assurance in the medical device supply chain, and regularly is used in conjunction with supplemental or additional customer requirements and/or regulatory requirements to meet contractual needs.
Last year the first draft of the ISO 13485 standard (ISO/DIS 13485.1) was issued for comment and voting. Unfortunately it was rejected outright. Change in the industry by nature is conservative! This rejection was followed by a second draft (ISO/DIS 13485.2) issued early in 2015, and was based on the structure and requirements of 9001:2008. It was much more traditional and ready to meet the medical devices hunger for constancy, systems and records.
In May 2015 the DIS 13485.2 was given a positive vote, which confirmed the industries approval of the core document, but with over 800 comments ranging from simple grammatical errors to core revision and clarification, the working group will be busy over the next few months turning all inputs into a Final Draft International Standard (FDIS) 13485 which is expected to be released by the middle to the end of 2015. With this program in mind we could expect a revised ISO 13485:2016 standard to be released early in 2016.
Once this FDIS has been issued, we can start to prepare for the transition to the new requirements, but customers, accreditation bodies, registrars and auditors will need to learn and interpret what the new requirements will mean to certified organizations. Using the 9001:2015 revision as an example, we have been working for more than a year now on training and developing auditors skills and their knowledge base, working with consultants and organizations alike, using public training events and web based information to educate and build a knowledge base of expectations before we start.
In short, if you have a combined ISO 9001:2008 and ISO 13485 system you will have up to three years to convert your system to the 9001:2015 revisions and separate your 13485:2016 system (based on the current information). If you have a standalone ISO 13485 registration that does not include ISO 9001, we expect a transition completion deadline by 2019.
If you have a combined system, you may wonder how to proceed. We are working on an adaptor/interface tool for duel registered organizations, which when used should allow combined visits. However, organizations should expect that additional audit time may be required as standards will be against two sets of requirements. More information from the industry is expected to become available over the next few months.
Keep an eye on the NQA blog and newsletters for more on this topic as it becomes available.
In the meantime, my advice is: Keep Calm and Carry on as Normal.
Authored by: Stephen Upton, NQA-USA
What seems to have been missed from these internet discussions and some of the biggest news on this planned revision is the separation of the ISO 9001:2015 and ISO 13485 requirements. This may cause some changes for organizations that use the convenience of a single visit to maintain both their ISO 13485 and 9001 certification, as with the planned revisions for 9001 to adopt a new format, and the older 9001:2008 structure remaining as the base for 13485, there is likely to be more time added to audits in the future to cover both standards.
Historically, the family of management system standards changes or evolves every six to eight years and 9001 is a prime example with ISO 9001:2008 being revised later this year to ISO 9001:2015. Looking at the ISO 13485:2003 standard, it is clearly past the time for change, but it has and continues to service the medical device industry with a good, basic platform for quality assurance in the medical device supply chain, and regularly is used in conjunction with supplemental or additional customer requirements and/or regulatory requirements to meet contractual needs.
Last year the first draft of the ISO 13485 standard (ISO/DIS 13485.1) was issued for comment and voting. Unfortunately it was rejected outright. Change in the industry by nature is conservative! This rejection was followed by a second draft (ISO/DIS 13485.2) issued early in 2015, and was based on the structure and requirements of 9001:2008. It was much more traditional and ready to meet the medical devices hunger for constancy, systems and records.
In May 2015 the DIS 13485.2 was given a positive vote, which confirmed the industries approval of the core document, but with over 800 comments ranging from simple grammatical errors to core revision and clarification, the working group will be busy over the next few months turning all inputs into a Final Draft International Standard (FDIS) 13485 which is expected to be released by the middle to the end of 2015. With this program in mind we could expect a revised ISO 13485:2016 standard to be released early in 2016.
Once this FDIS has been issued, we can start to prepare for the transition to the new requirements, but customers, accreditation bodies, registrars and auditors will need to learn and interpret what the new requirements will mean to certified organizations. Using the 9001:2015 revision as an example, we have been working for more than a year now on training and developing auditors skills and their knowledge base, working with consultants and organizations alike, using public training events and web based information to educate and build a knowledge base of expectations before we start.
In short, if you have a combined ISO 9001:2008 and ISO 13485 system you will have up to three years to convert your system to the 9001:2015 revisions and separate your 13485:2016 system (based on the current information). If you have a standalone ISO 13485 registration that does not include ISO 9001, we expect a transition completion deadline by 2019.
If you have a combined system, you may wonder how to proceed. We are working on an adaptor/interface tool for duel registered organizations, which when used should allow combined visits. However, organizations should expect that additional audit time may be required as standards will be against two sets of requirements. More information from the industry is expected to become available over the next few months.
Keep an eye on the NQA blog and newsletters for more on this topic as it becomes available.
In the meantime, my advice is: Keep Calm and Carry on as Normal.
Authored by: Stephen Upton, NQA-USA