Regulatory Open Forum

ISO published ISO 13485:2016 on March 1, 2016. I had understood that ISO TC210 would publish a handbook by the end of 2016 to explain some of the changes, offer implementation strategies, etc.

I checked to ISO website for 13485 and did not see the handbook as either published or under development. (There is a 12 page document that doesn’t provide implementation details.)

I check the TC 210 website for their work program and did not see the handbook as either published or under development.

Have I misunderstood the plan to publish a handbook? If not, can somebody provide a status and expected publication date?

ISO published ISO 13485:2016 on March 1, 2016. I had understood that ISO TC210 would publish a handbook by the end of 2016 to explain some of the changes, offer implementation strategies, etc.

I checked to ISO website for 13485 and did not see the handbook as either published or under development. (There is a 12 page document that doesn’t provide implementation details.)

I check the TC 210 website for their work program and did not see the handbook as either published or under development.

Have I misunderstood the plan to publish a handbook? If not, can somebody provide a status and expected publication date?

ISO published ISO 13485:2016 on March 1, 2016. I had understood that ISO TC210 would publish a handbook by the end of 2016 to explain some of the changes, offer implementation strategies, etc.

I checked to ISO website for 13485 and did not see the handbook as either published or under development. (There is a 12 page document that doesn’t provide implementation details.)

I check the TC 210 website for their work program and did not see the handbook as either published or under development.

Have I misunderstood the plan to publish a handbook? If not, can somebody provide a status and expected publication date?

Thank you for the update on the handbook.

Andreas said, “The issue is that new ISO Version will have to be revised after the new medical device regulations in Europe coming into force mid this year.” I’m confused by that. The EU has published a version, through annexes, that shows the differences between the international version and the directives. For example, EN ISO 13485:2016 has a series of annexes that explain the differences between the quality requirements in the conformity assessment paths and the international version, ISO 13485:2016.

Has TC 210 adopted the position that it will change the international QMS standard for changes in national and regional regulations?

ISO published ISO 13485:2016 on March 1, 2016. I had understood that ISO TC210 would publish a handbook by the end of 2016 to explain some of the changes, offer implementation strategies, etc.

I checked to ISO website for 13485 and did not see the handbook as either published or under development. (There is a 12 page document that doesn’t provide implementation details.)

I check the TC 210 website for their work program and did not see the handbook as either published or under development.

Have I misunderstood the plan to publish a handbook? If not, can somebody provide a status and expected publication date?

ISO published ISO 13485:2016 on March 1, 2016. I had understood that ISO TC210 would publish a handbook by the end of 2016 to explain some of the changes, offer implementation strategies, etc.

I checked to ISO website for 13485 and did not see the handbook as either published or under development. (There is a 12 page document that doesn’t provide implementation details.)

I check the TC 210 website for their work program and did not see the handbook as either published or under development.

Have I misunderstood the plan to publish a handbook? If not, can somebody provide a status and expected publication date?

ISO published ISO 13485:2016 on March 1, 2016. I had understood that ISO TC210 would publish a handbook by the end of 2016 to explain some of the changes, offer implementation strategies, etc.

I checked to ISO website for 13485 and did not see the handbook as either published or under development. (There is a 12 page document that doesn’t provide implementation details.)

I check the TC 210 website for their work program and did not see the handbook as either published or under development.

Have I misunderstood the plan to publish a handbook? If not, can somebody provide a status and expected publication date?

ISO published ISO 13485:2016 on March 1, 2016. I had understood that ISO TC210 would publish a handbook by the end of 2016 to explain some of the changes, offer implementation strategies, etc.

I checked to ISO website for 13485 and did not see the handbook as either published or under development. (There is a 12 page document that doesn’t provide implementation details.)

I check the TC 210 website for their work program and did not see the handbook as either published or under development.

Have I misunderstood the plan to publish a handbook? If not, can somebody provide a status and expected publication date?

ISO published ISO 13485:2016 on March 1, 2016. I had understood that ISO TC210 would publish a handbook by the end of 2016 to explain some of the changes, offer implementation strategies, etc.

I checked to ISO website for 13485 and did not see the handbook as either published or under development. (There is a 12 page document that doesn’t provide implementation details.)

I check the TC 210 website for their work program and did not see the handbook as either published or under development.

Have I misunderstood the plan to publish a handbook? If not, can somebody provide a status and expected publication date?