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 Leo@EisnerSafety.com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants.

We strive at Eisner Safety Consultants (ESC) to provide the best services for our clients and we have found one that is ideal for many of our small to mid size medical device companies we work with.  greenlight.guru produces an electronic Quality Management System (eQMS) solution built exclusively for medical device companies that is:

• Simple to use,
• integrated product development activities with quality processes,
• is hosted in a secure cloud environment,
• is easy to deploy,
• your team can be spread out all over the world & be able to work on the same documents without any lapse or issues of communication,
• provides easy to use project management tools,
• consolidates your documents into one system,
• helps coordinate your design process into a visual based system that is easy to follow,
• helps fulfill the requirements of ISO 13485, 21 CFR Part 820, and ISO 14971 (& EN 14971),
• has an easy to use document control process,
• and so much more,

This solution will help you ensure compliance, reduce risk and improve team collaboration from the idea stage all the way through post market commercialization. With greenlight.guru’s powerful, easy to use eQMS solution, and Eisner Safety Consultants expertise we will help medical device companies navigate the ever shifting regulatory, quality systems, and product safety environments, enabling them to bring higher quality life changing devices to market, faster – which, after all, is our mission.

To find out more about greenlight.guru please contact Leo Eisner at Leo@EisnerSafety.com or call us at 503-244-6151 or go to our Partners page. We would be happy to discuss the product with you and set you up for a demonstration of the greenlight.guru eQMS solution so you can test drive it to see if it is the right fit for your company.

This posts discusses BSI’s article on the status of the draft ISO 13485:201X standard.  

Recently BSI published an e-newsletter and in it was an excellent article explaining the status of the next draft revision of ISO 13485 and some of the details of the draft standard. The development of this standard project is being managed under the ISO Technical Committee 210, Working Group 1.  The Committee Draft (CD) received over 500 comments and from that the committee published the Draft International Standard (DIS) on 20 Feb 2014.  So, now we are within the required 5 month voting period for comments with the period closing on 20 July 2014.  Note, that some National Committees may ask for feedback up to a couple weeks or more earlier than the 20 July 2014 deadline so get your comments in fast to your National Committee wherever in the world you are.  For most National Committees you or your company have to be members of that committee to submit comments. Note, that since this is at the DIS stage of the process these comments, unless really minor typos, typically will not have an impact on the 3rd revision of the standard but will probably have to wait til the next revision cycle of the standard as at DIS you can’t make any technical changes to the standard. This stage is fairly late in the process and so you aren’t typically allowed to make these types of changes based on how the process is structured in the ISO and IEC standards development process.

When is it anticipated this standard will be released?

The article goes on to say if things run smoothly you may be able to see the actual published standard by late 1st quarter 2015 or early 2nd quarter 2015.  It is expected that there would be some type of transition period established for this standard and this may be impacted by things like the publication of ISO 9001 which this standard relies on, supporting the existing European Medical device Directives and the upcoming Medical Devices Regulations.

The article mentions that you can view a copy of the draft on the BSI National Standards Body website or you can buy a copy as noted in the article. 

If you need additional support in the standards development process for a standard email Leo Eisner at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151 as he is a Convener for an IEC/ISO, EN and ANSI/AAMI standard for IEC/ISO 80601-2-58 on Lens Removal and Vitrectomy Equipment. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

• Essential Principles of Safety & Performance of Medical Devices GHTF/SG1/N68:2012 supersedes GHTF/SG1/N41:2005
• Principles of Conformity Assessment for Medical Devices GHTF/SG1/N78:2012 supersedes GHTF/SG1/N40:2006
• Principles of Medical Devices Classification GHTF/SG1/N77:2012 supersedes GHTF/SG1/N15:2006
• Quality Management System – Medical Devices – Nonconformity Grading System for Regulatory Purposes & Information Exchange GHTF/SG3/N19:2012
• Clinical Evidence for IVD Medical Devices – Clinical Performance Studies for In Vitro Diagnostic Medical Devices GHTF/SG5/N8:2012
• Clinical Evidence for IVD Medical Devices – Scientific Validity Determination & Performance GHTF/SG5/N7:2012
• Clinical Evidence for IVD Medical Devices – Key Definitions & Concepts GHTF/SG5/N6:2012