Two weeks ago, we successfully passed our "ISO 13485:2016 certification upgrade" audit by a renowned ISO registrar and Notified Body (TüV SüD Product Service of Munich, Germany).
Our company is in a comparable situation as yours : a medium size company (around 65 staff) entirely focusing on medical device design and development with manufacturing done by commercialization partners or contract manufacturers.
Our QMS was first certified in 1995 (to MDD - Annex II, ISO 9001 + EN 46001, remember ?) and well maintained throughout the years (including compliance to 21 CFR 820) and strengthening processes like risk management, software life cycle management, and usability engineering over time, as these subjects became more important to us as well as to the regulators.
We prepared early on for the 2016 revision of ISO 13485 by studying publicly available draft versions of the standard, (free) white papers available from standards organizations or consulting organizations, attending (free) webinars by the same organizations, and some paid training for our quality staff. We did all the work ourselves at little additional effort as part of the regular review and maintenance of our QMS.
Based thereupon, and as stated by Dr Lim, your upgrade should be relatively smooth and straightforward.
Our recommendation to you would be to use outside consultants only for those parts of your QMS update where you feel somewhat uncomfortable with requirements that are new in the standard or for which you internally lack adequate expertise or resources. Yet, where updating to the revised standard consists of expanding or brushing up your existing SOPs, Work Instructions, or Forms, we recommend that you do this yourself. It will likely take you less time for a result that is better adapted to your needs and operational context than supervising these same efforts done by an outside consultant.
Finally, and as applicable to your company, ensure that the update of your QMS to the revised ISO 13485 standard will facilitate the next really big step for your QMS : compliance with the newly published European regulations known as MDR and IVDR.
With kindest regards and wishing you the best of luck !
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Ary Saaman
Director, Regulatory Affairs
Debiotech S.A.
Lausanne
Switzerland
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Original Message:
Sent: 19-Sep-2017 19:23
From: Anonymous Member
Subject: Cost of ISO 13485:2016 transition
This message was posted by a user wishing to remain anonymous
Hi RAPS community,
Based on your experience, how long/how many hours would you say it normally takes for a consultant/group of consultants to conduct an ISO 13485:2016 transition project for a small medical device manufacturer, which subcontracts manufacturing to a third-party, and also considering that this small medical device manufacturer recently had an FDA inspection and ISO 13485 audit with no findings (i.e., considering that there's already a relatively robust QMS in place)?
Does anyone know a consultant/company that does ISO 13485:2016 transition for a flat rate/fixed fee (rather than per the hour)? If so, what would you say is the usual/average cost for a small medical device manufacturer's QMS transition to ISO 13485:2016?
Thank you very much in advance for your inputs.