New BSI Policy: All ISO 13485 Assessments to be performed to ISO 13485:2016 from 1 September 2017.

From 1 September 2017, you will only have 18 months until the end of the three-year transition period for ISO 13485:2016. To date, across the industry, there has been a very slow uptake on transitioning to ISO 13485:2016.

Due to this, BSI believe that many of our clients face the possibility of not completing transition in time and therefore are placing themselves at real risk of not holding a valid ISO 13485 certificate as of 1st March 2019.

In the transition assessments we have conducted, our experience has been that many organisations are closer than they may think to meeting the additional requirements of ISO 13485:2016.

Therefore ALL BSI assessments for organisations holding existing ISO 13485 certification and applying for certification to ISO13485 will be conducted to ISO 13485:2016 from 1 September 2017.

Why is BSI making this change?

The objective and reasons behind this is to:

1. Ensure you have proactively prepared to check your readiness against the new ISO 13485:2016 requirements at your next audit.
2. Provide a safety margin and avoid last minute panic to gain your certification.
3. Make certain your organisation remains in business by ensuring you have a valid ISO 13485:2016 certificate before the 1^st March 2019 deadline. This will then support your CE mark and license to operate and access all relevant markets.
4. Demonstrate to your customers and stakeholders that you are prepared and ready: eliminating concerns and ensuring trust and confidence in your ability to continue your supply of products/services.

Please be assured that BSI will not issue any Major non-conformities against the NEW requirement of the ISO 13485:2016 revision, but rather list these as minor non-conformities, so it will not impact your certification but give you time to respond. Any non-conformities against ISO 13485:2003/EN ISO 13485:2012 requirements will be raised as normal.

How will this change affect me?

• If you have already booked your transition visit, no further changes are required and the assessment will proceed as planned.
• If you have not yet booked your transition and your next assessment is after 1 September 2017, we will commence your transition at this visit. Many of the changes to ISO 13485:2016 are not vast and by working in this way, you will find out where you are conforming to the requirements and what you still need to do to meet the new obligations. This change will not threaten your current certification status. Transition assessment will then continue (if needed) at your next visit in 2018 or at an additional visit. We may still need to add extra time to the assessment (confirmed in advance) to ensure an effective transition is completed.
• If your next visit is a recertification assessment then all clauses of the 2016 standard will be covered at this one visit. We may still need to add extra time to the assessment (confirmed in advance) to ensure an effective transition is completed. If you have any type of surveillance visit booked in 2018, then you will have to transition at that single visit. Additional time may be added to cover the transition depending on remaining clauses or scope processes to be assessed to the 2016 standard.

What will happen at the assessment?

Your assessor will conduct the assessment to ISO 13485:2016 and raise minor non-conformities, as necessary, to the requirements of ISO 13485:2016. If there are areas that would constitute a major non-conformity against only the NEW requirements, we will identify these as areas that need further assessment.

It is important to understand that BSI will not raise major non-conformities against the new requirements as part of transition assessments. If there are major non-conformities against ISO 13485:2003 / EN ISO 13485:2012 requirements these will be raised as normal.

Possible outcome from an ISO 13485:2016 assessment

• If there are minor non-conformities, a corrective action plan will be requested and transition will be recommended subject to a suitable corrective action plan being received and accepted.
• If there are a number of minor non-conformities associated with the same requirement or issue that could demonstrate a systematic failure or major gaps against ISO 13485:2016 these will NOT be raised as major non-conformities. However, you will not be recommended for transition and a list of the areas that will require further assessment will be provided. Assessment of these areas will then be undertaken during your next visit in 2018.

Final steps following a recommendation for certification to ISO 13485:2016

• Once you have been successfully audited to ISO 13485:2016 and a recommendation for certification to ISO 13485:2016 has been made in the assessment report (subject to a satisfactory corrective action plan if applicable), the documents are collated and following successful BSI internal review the current certificate will be re-issued to ISO 13485:2016.
• If this is following a recertification assessment then the reissued certificate will have a three year expiry date.
• If this is following a continuing assessment visit, i.e. you are mid assessment- cycle then the new certificate expiry date will be three years from the last recertification issue.

What do I need to do now?

We very strongly recommend you now plan your transition with urgency and prepare to receive your BSI assessments from 1 September 2017 to the requirements of the new standard.

If you have questions or concerns further information can be provided via your BSI Client Manager or BSI Scheme Manager.