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ISO 13485:2016 Transition Guidance for Clients

The new standard ISO13485:2016 - Medical device quality management system was published on March 1, 2016. Compared with ISO 13485:2003, the requirements have changed significantly and organizations with ISO 13485:2003 certification are now in a transition period.

In accordance with the IAF, all accredited certificates to ISO 13485:2003 and ISO 13485:2012 have until March 31, 2019 to successfully transition to ISO 13485:2016. This is 3 years after the publication of the 2016 standard.

Transition period 3 years from the publication date of ISO 13485:2016.

The expiry of the certificates to ISO 13485:2003 and BS EN ISO 13485:2012 is March 31, 2019.
From March 31, 2019 all accredited certifications to ISO13485:2003 and BS EN ISO13485:2012 will cease to be valid. Clients who fail to complete the transition by this point will have their certificate withdrawn. If clients feel the need to continue certification they will require a full initial audit.

The IAF has also stated that from March 1, 2018 (2 years after the publication of ISO 13485:2016) all new certification and re-certification certificates issued must be to ISO13485:2016. We will, therefore, not issue any ISO 13485:2003 or BS EN ISO 13485:2012 certifications from 1 March 2018.

Step 1: Transition guidelines - ISO 13485:2016

1. Clients should prepare for the transition as early as possible in order to ensure that they have sufficient time. Preparation should include as a minimum:

  • Standard training
  • Understanding the changes and the requirements of the new standard including the technical requirements
  • Recognizing the difference between the requirements of the current standard and new standard
  • Conducting a gap analysis of the management system between the old standard and the new standard.

2. Create a transition plan to ensure compliance by March 31, 2019. Clients should conduct comprehensive and effective training on the new standard for all relevant persons within the organization. Internal Auditor training is also recommended for the organizations internal auditors.

3. Update the existing management system according to the new standards. This should include revising and improving the management system processes and policies, and then implementing them. Please ensure that all of the specific requirements of the new standard have been fully and demonstrably implemented.

4. Conduct an internal audit and management review to  assess whether the management system meets the requirements of the new standard ISO 13485:2016 and is ready for an ISO 1348:2016 transition audit. Clients should take corrective and preventive measures if they do not meet the requirements.

5. Until the transition is complete, the organization’s Management System must maintain compliance with the old standards. Where a lack of conformity is identified, a non-conformance will be raised and must be addressed per the current corrective action process.

6. If your organization’s current certificate expires before you are able to fully transition to the 2016 standard, you may be re-registered to the previous version (subject to a cut-off period to allow for subsequent transition). The expiration date of this new certificate will be the three year anniversary of the release of the 2016 version, as mentioned above.

7. A new certificate to the 2016 version will be issued when it can be satisfactorily shown that your organization has fully met the requirements of the new standard.  As is the current practice, all major non-conformities must be formally closed out and corrective actions for any minor non-conformances must be received and accepted by NQA, prior to issuance of a certificate.

Contact NQA as early as possible to discuss your transition plans.

Step 2: Your transition process

Based on the three-year transition timeline, we have developed the three options below to support your implementation approach. Each option has different implications for timing and cost of transition.

OPTION 1 - Re-Certification Transition Recommended and Default Option

  • Full transition conducted at the time of re-certification audit. NQA recommends that you use this opportunity to undertake your transition audit as it will minimize the amount of additional audit time needed over a three year audit cycle.

  • If you wish to bring forward your next re-certification visit you must contact NQA in advance, if successful, allowing NQA to issue a new certificate. This will reset the three year certification cycle and the certificate valid until date. 

  • If your re-certification visit is between September 2015 and September 2016 and you are not ready to transition NQA recommend you consider option 2 or 3. 

OPTION 2 - Surveillance Transition

  • Full transition will be conducted at the time of your existing surveillance audit.

  • Additional time will be added to the audit activity to allow time to complete a full assessment against the new standard. This additional time will equate, as a minimum, to the duration of a re-certification audit.

  • If successful NQA will issue a new certificate and will reset the three year certification cycle and the certificate valid until date. 

OPTION 3 - Special/Any-time Visit Transition

  • Special Visit conducted as a stand-alone visit (out of the annual sequence at your request) or where the current certificate has expired prior to a transition audit being conducted. 

  • This will be additional to your existing certification activities and will therefore incur additional costs.

  • If successful NQA will issue a new certificate and will reset the three year certification cycle and the certificate valid until date.

Please note: At the point of scheduling your transition audit you will be informed of the additional days required and therefore the audit duration and cost. This will be determined by NQA and applies to all of the options above.

Step 3: Inform NQA

We need to know if you do not wish to transition at your next RE-CERTIFICATION audit. If you are planning on transitioning at re-certification you do not need to do anything.

Please help us to plan your forthcoming transition audit by informing us of your decision.