This post will help you understand some of the steps you should start taking immediately to implement your new ISO 13485:2016 QMS. Updated with additional info on 29 February 2016 and 5 April 2016 (Update is italicized)
Are you ready for the 3 year transition that just started to get your Medical Device Quality System upgraded to meet ISO 13485:2016 and EN ISO 13485:2016?
The sooner you can start on your transition planning the better.
Step 1 – Purchase the standard. The ISO 13485:2016 and the BSI EN ISO 13485:2016 versions are already available for purchase.
Step 2 – Get up to speed on the standard(s) (ISO 13485 versions that apply and ISO 9001 or other QMS standards that apply to your situation) – Train your auditors, management (upper and working managers) and your employees that impact quality.
- A good starting point is to hear directly from someone that was on the committee for the standard about the changes. Mark Swanson did a webinar on the changes to the standard with greenlight.guru, a strategic partner of ours.
- greenlight.guru also has another webinar that can help “How To Prepare Your Organization for the Transition to ISO 13485:2016“
- Some additional resources for learning about this standard include: We have a group of experts within our ranks at Eisner Safety Consultants that can help you train, audit and plan your new QMS. Also, you can learn from other experts such as from:
- A podcast on the changes to the standard by Mark Swanson,
- review BSI’s white paper titled “ISO 13485 – The proposed changes and what they mean to you”, and
- multiple blog posts by Robert Packard of Medical Device Academy – like Management Review Revisions for ISO 13485:2016 or do a search on ISO 13485 on Rob’s site you will find a wealth of information.
- Another resource I have been following for many years is Sam Lazzara. His recent post is titled “(EN) ISO 13485:2016 Medical Device QMS Standard” and he compares the numbering and titles for the requirements clauses between ISO 13485:2003 and ISO 13485:2016 (& also the EN version of the standard). Additional Sam wrote a post related to ISO 9001:2015 that may be of interest as the terms in that Standard are also in the ISO 13485:2016 (At least a portion of them). The post is titled “Words Matter – ISO 9000:2015 Quality Management System Vocabulary.”
- TÜV SÜD America will be having a webinar on an “Update on the New CE Marking Rules in Europe” on May 3, 2016 which will discuss among several topics the new revision of ISO 13485. After the webinar is run their will be a recording available.
- LNE-GMed March 2016 newsletter has a paper explaining parts of the new ISO 13485:2016.
There are a lot of other resources out there just be careful that you are using a reliable resource (expert) that knows and understands the implications well otherwise you could set your company back instead of moving forward. So, please make sure to vet any resources.
- As ISO 13485:2016 and ISO 9001:2015 structures are not aligned anymore you will need to consider this if you decide to comply with both. BSI did a presentation on this subject.
- Part of this training effort may include a focus on Risk Management as ISO 13485:2016 references ISO 14971 so you will want to make sure your workforce is up on this standard as it will impact more people than in the past.
Step 3 – Start planning your transition. Do you also need to consider ISO 9001 & other QMS standards?
In broad strokes you will need to do at least the following:
- Write Quality Plan
- Determine what changes will impact your QMS
- Update your QMS Manual
- Update your QMS procedures
- Train appropriate staff on the new QMS (Manual, Procedures, Processes)
- Implement QMS
- Run your Management Reviews under the new QMS more often til at least kinks worked out
- Audit new QMS
- Keep at it as Quality is a Continuous Loop System – there is always a way to improve the process and system
Step 4 – Open discussions with your QMS certifier and Notified Body so you stay on track and you get scheduled for your audit before they book up. With both ISO 13485 & 9001 just being published recently and with the EU New Medical Device Regulation scheduled to be published sometime this year your Notified Bodies and QMS certifiers are going to be busy and book up. So, plan this out well in advance of when you want your audit scheduled to upgrade to the new QMS standard.
Step 5 – Keep on working thru your Quality Plan to make sure the system is implemented well and continues to work for your company.
A footnote: The EN version of the standard each EU country’s standards development organization needs to issue a national version of the standard. They have til September 30, 2016 to issue their version of EN ISO 13485:2016. This information comes from the CENELEC & CEN websites on the draft’s of EN ISO 13485:2016.
If you need help with your implementation of ISO 13485:2016 or you are interested in our new Eisner Safety Consultants Standards Reconnaissance Database please email Leo Eisner directly at , or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants.