ISO 14971:2019改定点(その2)

前回に引き続きISO 14971:2019の改定について筆者の分析を紹介したい。

【経営者の責任】
注記に「リスクマネジメントプロセスの適合性レビュ」が追加された。
トップマネジメントは、リスクマネジメントプロセスの継続的な有効性を保証するために、あらかじめ計画された間隔でリスクマネジメントプロセスの適合性をレビュし、あらゆる決定および講じた措置を文書化しなければならない。

注)ISO 14971はQMSの構築を要求していない。もし製造業者がQMSを構築していれば、QMSのレビュの一環として実施しても良い。

【リスク分析】
リスク分析における「4.2 意図する医療機器(付属品を含む)の使用特質の明確化」が「5.2 意図された使用と合理的に予見可能な誤使用」と「5.3 安全性に関する特性の特定」に細分化された。
”合理的に予見可能な誤使用”が追加されたことが大きい。

【リスクコントロール】
リスクコントロールに「製造」「トレーニング」が追記された。
a)本質的に安全な設計と製造
b)医療機器自体または製造プロセスにおける保護対策
c)安全性に関する情報、および必要に応じてユーザーへのトレーニング

【リスクマネジメントファイル】
リスクマネジメントファイル(RMF)にトレーサビリティ要件が追記され、具体的になった。
RMFにおいては、各ハザードについて、次の活動に対してのトレーサビリティをもたなければならない。
・リスク分析
・リスク評価
・リスクコントロール手段の実施と検証
・残留リスクの評価の結果

Related post

Comment

  1. You actually make it appear really easy with your presentation however I find this topic to be actually something that I feel I’d never understand. It sort of feels too complicated and extremely large for me. I’m having a look forward for your next post, I will attempt to get the grasp of it!

  2. Hello just wanted to give you a quick heads up and let you know a few of the pictures aren’t loading properly. I’m not sure why but I think its a linking issue. I’ve tried it in two different internet browsers and both show the same results.

  3. You really make it seem so easy along with your presentation but I in finding this topic to be actually one thing which I think I’d never understand. It sort of feels too complex and very broad for me. I am taking a look ahead for your subsequent submit, I will try to get the dangle of it!

  4. Utterly indited articles, Really enjoyed looking through.

  5. FitSpresso is a natural weight loss supplement that will help you maintain healthy body weight without having to deprive your body of your favorite food or take up exhausting workout routines.

  6. I got what you intend, thankyou for posting.Woh I am thankful to find this website through google.

  7. I must show my gratitude for your kind-heartedness giving support to those who should have assistance with in this area. Your special commitment to passing the message all through turned out to be certainly practical and has frequently permitted individuals much like me to arrive at their dreams. Your entire insightful report means so much a person like me and further more to my office workers. Best wishes; from all of us.

  8. Very interesting topic, regards for posting.

  9. After going over a handful of the articles on your web site, I seriously appreciate your way of writing a blog.
    I book marked it to my bookmark website list and will be checking back soon. Please check out my website as well and tell me how
    you feel.

  10. I got good info from your blog

  11. I believe you have remarked some very interesting details, thanks for the post.

  12. I do consider all the ideas you’ve offered on your post. They are very convincing and will certainly work. Still, the posts are too quick for novices. May you please prolong them a little from next time? Thanks for the post.

  13. I got what you intend,saved to fav, very decent internet site.

  14. Rattling informative and good complex body part of content, now that’s user friendly (:.

  15. What i don’t realize is in truth how you’re now not actually much more well-preferred than you may be right now. You are so intelligent. You realize therefore considerably relating to this matter, made me personally consider it from numerous numerous angles. Its like women and men don’t seem to be involved except it is something to accomplish with Lady gaga! Your individual stuffs great. All the time deal with it up!

  16. I am extremely impressed with your writing skills and also with the layout on your blog. Is this a paid theme or did you customize it yourself? Either way keep up the excellent quality writing, it’s rare to see a great blog like this one nowadays..

  17. It is appropriate time to make a few plans for the longer term and it’s time to be happy. I’ve learn this publish and if I may I want to recommend you few fascinating things or advice. Perhaps you can write next articles relating to this article. I desire to read more issues approximately it!

  18. I?¦ve recently started a site, the info you provide on this website has helped me tremendously. Thank you for all of your time & work.

TOP