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).

Joe Hage (www.medicalmarcom.com) will be offering a free webinar, taught by Rob Packard and Brigid Glass, on the “Best Practices in Medical Device Auditing”. If you want to be part of this I suggest you click http://medgroup.biz/best-audits right now to register, because 1,000 seats is the maximum available and 250 people signed up in the first 24 hours, about a day ago.

The free webinar, scheduled for Wednesday, February 13^th, 3 – 4pm (PST) or 6 – 7pm (EST), will include 10 minutes on the topic of Turtle Diagrams, a 15 minute video by Brigid Glass about audit program planning, and Rob will close with about 15 minutes explaining how the topics Brigid mentioned can be applied to planning an audit. The 10 minutes Rob will spend on the topic of Turtle Diagrams is not really long enough to cover the use of the process approach in detail.  

Rob mentioned to me that he is also teaching a 1-hour audio seminar through FX Conferences on Tuesday, February 19th, 8:30am to 9:30am (PST) or 11:30am to 12:30pm (EST). That audio seminar will be specific to the topic of Turtle Diagrams and the Process Approach. http://www.fxconferences.com/Adding-Value-to-Audits-Using-the-Process-Approach-P1170.aspx

Also, check out http://MedicalDeviceAcademy.com. Rob and Brigid will be teaching a live, two-day course on Best Audit Practices in April. Only 60 seats (20 per city: San Diego, Orlando, Las Vegas).

Enjoy the news postings!

“The purpose of this questionnaire is to determine the need for modification or updating of the ISO 13485:2003 requirements standard and the ISO/TR 14969:2004 guidance document.”

From what the full text on LinkedIn says ISO 13485 will be getting an update either way but this way you can provide feedback, to the authors of the standard, as to what you think and maybe that can have some impact on the development of the next edition of the standard.  If you are a medical device company and interested in responding to this survey you can access it by clicking here.  It asks some really good questions and hopefully your feedback will help the development  of the standard.

Thx Marcelo for posting this survey.