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Big Changes in ISO 13485:2015?

Big changes expected from ISO 13485: 2015? The short answer is, no. But, you need to familiarize yourself with the changes. This article summarizes the 113 page draft to 3 pages.

On February 5, 2015, a second draft of ISO 13485 was released to the world for comment. The expectation is that there will be very few comments of significance for this second draft. If the comments can be resolved quickly, the technical committee is expected to release the final version of ISO 13485:2015 this fall prior to the release of ISO 9001:2015.

I read through the 113 pages of the draft and was surprised to see fewer significant changes than I expected. The draft’s first four pages are a forward and table of contents. The Standard itself actually begins on page five and ends on page 36. I understand that the technical committee is not convinced that there is a need for a guidance document for this new revision (i.e., there is no need for ISO 14969 to be updated). I agree that the changes are minor and there is little advantage to creating a new guidance document. At most, I would make minor revisions to the existing ISO 14969 guidance, but I seriously doubt that the committee will take the time to do this.

Organization of the Draft Standard
Originally I planned to perform a side-by-side comparison of the two versions, but this draft already includes a side-by-side comparison of every clause in pages 37-90 of the draft. Pages 91-111 are harmonization annexes (Annex ZA-ZC), which explain how the Standard is harmonized with the three medical device directives in Europe. I suspect that these Annexes will need to be completely re-written when the new European Medical Device Regulations are released in 2016. Page 112 is a bibliography, and page 113 is blank.

What's New with ISO 13485:2015 DIS2
The following section of the article is divided into the Clauses of the Standard.

Clause 0
Clause 0.1 identified seven expectations of your quality system, and Clause 0.2 has four new goals for your quality system. These two subsections should be specifically addressed in your revised quality manual.

Clause 1
The most significant change here is that Clause 1.2 now expands the possible clauses for non-applicability from just Clause 7 to now include Clauses 6 and 8. I always felt that this was needed—especially for service organizations that do not have physical products that are manufactured. However, the changes made to clause 6 and 8 necessitate this change.

Clause 2
The only change associated with this clause is specific to referencing the updated version of standards (e.g., ISO 9000:2005).

OMTEC transparent 2016

Mr. Greg Howard will provide an update on ISO 13485 and how companies can implement changes at OMTEC 2016. 

Get a jump start on the revised risk management standards, the scope of the revisions, and more during Mr. Howard's session, "How to Implement ISO 13485 Updates".

     Clause 3
     There were a number of definitions that were added to this draft. How exciting.

     Clause 4
     There are very few changes to this Clause, but the three most significant changes are:
             •   Clause 4.1.5 includes a specific requirement for controls of outsourced
                 processes to be risk-based and to have written agreements with suppliers,
             •   Clause requires creating and maintaining technical files, and
             •   Clause 4.2.4 requires defining methods for maintaining confidential
                 patient records.

     Clause 5
     The changes to this clause are quite minor. The changes are primarily isolated to
     management review requirements. Specifically, rationale for the frequency of
     management reviews must now be documented. The management review inputs must
     now include more information related to complaint handling to reflect the addition of

Finally, the management review output must now include changes needed to the quality system in order to address new and revised regulatory requirements. Most companies already do this, but now it is a specific requirement to be documented in the meeting outputs.