QMS省令とは
「医療機器及び体外診断用医薬品の製造管理及び品質管理の基準に関する省令」(QMS省令)
厚生労働省令 第169号
現行のQMS省令は、ISO13485:2003を、一部の用語・内容を薬事法に整合させた形で修正した基準である。
医薬品医療機器等法の施行にあわせて2014年11月25日から施行。
第2章は、ISO13485:2003の各条項と整合した規定とし、第3章(GQP省令に相当)以降は国内における医療機器等の品質等の確保を目的とした追加的要求事項というように区別された。
2018年度内に第2章部分をISO13485:2016に準拠させるための省令改正が行われる予定。
ISO13485:2016に準拠させるべくQMS省令第2章部分を改正予定。
QMS省令第3章部分については第65条が削除になる(第2章の規定と重複するため)こと、体外診断薬不具合報告に関する施行規則条項番号を追加すること以外に基本的に変更なしの予定。
- QMS省令新旧比較
- 「薬事法施行令等の一部を改正する政令(案)等に関する意見の募集の結果について」の考察
- QMS省令医療機器及び体外診断用医薬品の製造管理及び品質管理の基準に関する省令(平成十六年十二月十七日厚生労働省令第百六十九号) 最終改正:平成二六年七月三〇日厚生労働省令第八七号
- QMS省令 逐条解説
- QMS省令逐条解説およびQ&A
- QMS省令作成文書一覧
改正QMS省令(2020年度)
QMS省令の改正
現在のQMS省令第2章部分(ISO13485:2003と同等)をISO13485:2016に準拠させるためにQMS省令を改正
当初では2018年6月にパブリックコメントの実施、10月に新QMS省令の公布・施行が予定されていた。
しかしながら改正手法に関し業界から意見があったため、作業が遅れている。
- 当初は全部改正によりQMS省令を改正する予定であった(省令番号が新規に付与される、条項番号が変わる)。
- 全部改正の場合には省令番号変更による影響が大きいため、業界より一部改正として欲しい旨の要望がなされた。
- 現在一部改正手法による改正とするべく再調整中(省令番号は現行のまま(厚生労働省令第169号)、条項番号は変わらず)。
滅菌バリデーション
QMS省令は2021年3月26日に改正されました。詳しくはこちら。
![](https://ecompliance.co.jp/img/%E5%95%8F%E3%81%84%E5%90%88%E3%82%8F%E3%81%9B%E3%83%9C%E3%82%BF%E3%83%B3/information.jpg)
イーコンプライアンス QMS省令情報
*万が一文中に解釈の間違い等がありましても、当社では責任をとりかねます。
本文書の改訂は予告なく行われることがあります。
関連商品
[blogcard url=”https://ecompliance.co.jp/SHOP/QMS-MHLW-00.html” title=”【2021年度改正QMS省令対応】QMSひな形一式” content=”すでに現行QMS省令に準拠したQMSを構築されているが改正対応が必要な企業、これから医療機器に参入する企業にオススメのひな形セットです。”]
It’s in fact very difficult in this active
life to listen news on Television, therefore I just use internet
for that purpose, and get the latest information.
You made some decent factors there. I seemed on the web for the problem and found most people will associate with together with your website.
hey there and thank you for your information – I have definitely picked up anything new from right here. I did however expertise a few technical issues using this site, since I experienced to reload the site many times previous to I could get it to load properly. I had been wondering if your web hosting is OK? Not that I’m complaining, but sluggish loading instances times will often affect your placement in google and could damage your high quality score if advertising and marketing with Adwords. Well I’m adding this RSS to my e-mail and could look out for much more of your respective intriguing content. Make sure you update this again soon..
With havin so much content and articles do you ever run into any problems of plagorism or copyright violation? My blog has a lot of completely unique content I’ve either created myself or outsourced but it seems a lot of it is popping it up all over the web without my permission. Do you know any methods to help stop content from being ripped off? I’d genuinely appreciate it.
I have been browsing online more than three hours today, yet I never found any interesting article like yours. It is pretty worth enough for me. In my opinion, if all webmasters and bloggers made good content as you did, the net will be much more useful than ever before.
It’s arduous to search out educated individuals on this matter, but you sound like you understand what you’re talking about! Thanks
I do not even know how I ended up here, but I thought this post was great. I don’t know who you are but definitely you are going to a famous blogger if you are not already 😉 Cheers!
I enjoy the efforts you have put in this, thankyou for all the great blog posts.
Definitely believe that which you stated. Your favorite reason seemed to be on the internet the easiest thing to be aware of. I say to you, I certainly get irked while people consider worries that they plainly do not know about. You managed to hit the nail upon the top and also defined out the whole thing without having side effect , people can take a signal. Will likely be back to get more. Thanks
I am glad to be a visitant of this double dyed blog! , thankyou for this rare info ! .
Thanx for the effort, keep up the good work Great work, I am going to start a small Blog Engine course work using your site I hope you enjoy blogging with the popular BlogEngine.net.Thethoughts you express are really awesome. Hope you will right some more posts.
As a Newbie, I am continuously searching online for articles that can aid me. Thank you
I went over this internet site and I conceive you have a lot of superb info, bookmarked (:.
Excellent read, I just passed this onto a colleague who was doing a little research on that. And he just bought me lunch since I found it for him smile So let me rephrase that: Thanks for lunch!
Hey very cool blog!! Man .. Beautiful .. Amazing .. I will bookmark your blog and take the feeds also…I am happy to find so many useful information here in the post, we need work out more techniques in this regard, thanks for sharing. . . . . .
naturally like your web-site but you have to check the spelling on quite a few of your posts. Several of them are rife with spelling issues and I find it very bothersome to tell the reality however I will certainly come again again.
I like this web site very much, Its a very nice spot to read and receive information. “God cannot alter the past, but historians can.” by Samuel Butler.
Tonic Greens, a natural health supplement, is designed to enhance immune function.
Some really interesting details you have written.Assisted me a lot, just what I was looking for : D.
Utterly pent articles, thank you for selective information. “Necessity is the mother of taking chances.” by Mark Twain.
You have brought up a very wonderful details, thanks for the post.
Hi there, just became alert to your blog through Google, and found that it is truly informative. I am gonna watch out for brussels. I will appreciate if you continue this in future. Numerous people will be benefited from your writing. Cheers!
Renew: An OverviewRenew is a dietary supplement that is formulated to help in the weight loss process.
What is Lottery Defeater Software? Lottery software is a specialized software designed to predict and facilitate individuals in winning lotteries.
What Is Sugar Defender? Sugar Defender is a new blood sugar-balancing formula that has been formulated using eight clinically proven ingredients that work together to balance sugar levels.
I used to be recommended this web site via my cousin. I am no longer positive whether or not this publish is written through him as nobody else realize such designated about my difficulty. You are amazing! Thank you!
It’s truly a great and useful piece of info. I’m happy that you simply shared this helpful information with us. Please stay us up to date like this. Thank you for sharing.
Some really prize articles on this website , saved to favorites.
Thank you a bunch for sharing this with all of us you actually recognize what you are speaking approximately! Bookmarked. Kindly also visit my site =). We will have a hyperlink exchange agreement between us!
It is in reality a nice and helpful piece of info. I’m satisfied that you simply shared this useful information with us. Please keep us informed like this. Thank you for sharing.
Perfect work you have done, this internet site is really cool with great information.
What is Java Burn? Java Burn, an innovative weight loss supplement, is poised to transform our perception of fat loss.
Hi there would you mind stating which blog platform you’re using? I’m looking to start my own blog in the near future but I’m having a tough time choosing between BlogEngine/Wordpress/B2evolution and Drupal. The reason I ask is because your design seems different then most blogs and I’m looking for something unique. P.S Apologies for being off-topic but I had to ask!
FitSpresso: An Outline FitSpresso is a weight management formula made using five herbal ingredients.
Great blog here! Also your website loads up very fast! What host are you using? Can I get your affiliate link to your host? I wish my website loaded up as quickly as yours lol
Great write-up, I?¦m normal visitor of one?¦s blog, maintain up the excellent operate, and It is going to be a regular visitor for a long time.
Hello my friend! I want to say that this post is amazing, great written and come with almost all vital infos. I would like to peer more posts like this .
Awsome blog! I am loving it!! Will be back later to read some more. I am taking your feeds also.
Thanks for all your efforts that you have put in this. very interesting information.
Great website! I am loving it!! Will be back later to read some more. I am bookmarking your feeds also.
I have been surfing on-line more than 3 hours as of late, yet I by no means found any fascinating article like yours. It?¦s pretty price enough for me. In my opinion, if all website owners and bloggers made just right content material as you probably did, the net can be a lot more useful than ever before.
Pretty element of content. I just stumbled upon your website and in accession capital to say that I acquire in fact enjoyed account your weblog posts. Any way I’ll be subscribing to your feeds or even I achievement you get admission to persistently rapidly.
Your place is valueble for me. Thanks!…
I am always searching online for tips that can aid me. Thanks!
Its excellent as your other blog posts : D, appreciate it for putting up. “Before borrowing money from a friend it’s best to decide which you need most.” by Joe Moore.
What Is ZenCortex? ZenCortex is a natural supplement that promotes healthy hearing and mental tranquility. It’s crafted from premium-quality natural ingredients, each selected for its ability to combat oxidative stress and enhance the function of your auditory system and overall well-being.
Wonderful blog! I found it while surfing around on Yahoo News. Do you have any suggestions on how to get listed in Yahoo News? I’ve been trying for a while but I never seem to get there! Thanks
I have been browsing online more than three hours today, yet I never found any interesting article like yours. It is pretty worth enough for me. In my opinion, if all website owners and bloggers made good content as you did, the net will be a lot more useful than ever before.
Exactly what I was searching for, appreciate it for putting up.
Thanks for the sensible critique. Me & my neighbor were just preparing to do some research on this. We got a grab a book from our area library but I think I learned more from this post. I’m very glad to see such wonderful info being shared freely out there.
With everything that seems to be building within this specific area, many of your perspectives are very stimulating. Having said that, I beg your pardon, but I do not give credence to your whole theory, all be it radical none the less. It would seem to me that your opinions are not totally validated and in simple fact you are generally your self not even fully confident of the argument. In any event I did appreciate reading it.
What is Gluco6? Gluco6 is a revolutionary dietary supplement designed to help individuals manage their blood sugar levels naturally.
You actually make it seem really easy with your presentation however I find this topic to be really one thing which I believe I would never understand. It seems too complex and very broad for me. I am taking a look ahead for your subsequent post, I’ll attempt to get the dangle of it!
Good write-up, I am normal visitor of one¦s web site, maintain up the excellent operate, and It is going to be a regular visitor for a lengthy time.
Thanks for the sensible critique. Me and my neighbor were just preparing to do a little research about this. We got a grab a book from our local library but I think I learned more clear from this post. I’m very glad to see such excellent info being shared freely out there.
Greetings from Los angeles! I’m bored at work so I decided to check out your site on my iphone during lunch break. I love the info you present here and can’t wait to take a look when I get home. I’m surprised at how fast your blog loaded on my phone .. I’m not even using WIFI, just 3G .. Anyways, excellent site!
I genuinely enjoy studying on this website , it has got wonderful blog posts. “Beauty in things exist in the mind which contemplates them.” by David Hume.
Thank you so much for giving everyone remarkably terrific opportunity to discover important secrets from here. It’s usually very pleasurable and also packed with a lot of fun for me and my office acquaintances to visit your web site at least 3 times every week to study the latest items you have got. And lastly, I’m actually happy with your excellent secrets you serve. Certain 3 ideas in this article are completely the most impressive I’ve had.
I have been absent for some time, but now I remember why I used to love this site. Thank you, I will try and check back more frequently. How frequently you update your web site?
As I website owner I believe the written content here is very great, regards for your efforts.
After study a few of the blog posts on your website now, and I truly like your way of blogging. I bookmarked it to my bookmark website list and will be checking back soon. Pls check out my web site as well and let me know what you think.
Thanks for another wonderful post. Where else could anybody get that kind of information in such a perfect way of writing? I’ve a presentation next week, and I am on the look for such info.
I was very pleased to find this web-site.I wanted to thanks for your time for this wonderful read!! I definitely enjoying every little bit of it and I have you bookmarked to check out new stuff you blog post.
Have you ever thought about including a little bit more than just your articles? I mean, what you say is important and all. But think of if you added some great pictures or video clips to give your posts more, “pop”! Your content is excellent but with pics and video clips, this site could definitely be one of the very best in its niche. Amazing blog!
hello there and thank you for your information – I’ve definitely picked up something new from right here. I did however expertise some technical points using this web site, as I experienced to reload the web site lots of times previous to I could get it to load properly. I had been wondering if your web hosting is OK? Not that I’m complaining, but slow loading instances times will often affect your placement in google and can damage your high quality score if advertising and marketing with Adwords. Well I’m adding this RSS to my e-mail and could look out for a lot more of your respective interesting content. Ensure that you update this again very soon..
I’ve been browsing online more than three hours these days, but I never discovered any interesting article like yours. It is beautiful worth sufficient for me. In my opinion, if all webmasters and bloggers made good content as you did, the net can be a lot more helpful than ever before. “Revolution is not a onetime event.” by Audre Lorde.
Thanks on your marvelous posting! I certainly enjoyed reading it, you can be a great author.I will remember to bookmark your blog and will come back very soon. I want to encourage you continue your great posts, have a nice day!