【徹底解説】(全5講)ISO-13485:2016対応セミナー【第1講】

ISO 13485:2016は、2016年3月1日に発行されました。
ISO-13485:2015は、米国FDA QSR(21 CFR Part 820)に極めて近くなり、特に設計管理について詳細な要求が盛り込まれています。
医療機器は、たとえ設計された図面の通り適切に製造したとしても、そもそも設計に間違いがあった場合、安全な医療機器とはならないためです。 もともとISO-13485は、ISO-9001と整合させ、医療機器に特化した規格として作成されました。

ISO9001:2015は、新しい規格構成に様変わりしましたが、ISO-13485:2015はこれまでの構成のままです。 したがって、ISO-9001:2015とISO-13485:2015の乖離が大きくなっています。
これまでISO-9001とISO-13485の両方の認証を取得している医療機器企業は、旧版から最新版の規格への移行計画を注意して策定する必要があります。

今後ISO-13485は、ISO-9001からは独立独歩として歩むことになりそうです。 コンサルテーションやセミナーにおいて、ISO-9001とISO-13485の違いを質問されることがあります。ISO-9001はいわば民間の規格ですが、ISO-13485は規制要件です。なぜならば、ISO-13485は、規制当局がレビュしているためです。

一方、本邦において2014年、薬事法が一部改正され、薬機法となりました。それに伴い、QMS省令も改定されました。

QMS省令は、ISO-13485:2003と整合性を持たせています。しかしながら、たったの1年でまた国際規格であるISO-13485:2015とQMS省令が乖離してしまいました。 海外(特にEU)にも製品を出荷する場合、QMS省令とISO-13485:2016の両方を遵守しなければならなくなり、いわゆるダブルスタンダードを抱えてしまうことになります。

本邦においては、ISO-13485の改定に伴い、JISが改定された後、QMS省令が改定されるため、少なくとも数年のタイムラグが生じてしまうこととなります。本セミナーでは、ISO-13485:2016のポイントと、対応するためのQMS構築方法を具体例とともにわかりやすく解説いたします。またISO 13485:2016準拠の品質マニュアルのサンプルを配布し解説いたします。

日本のみではなく、欧州や米国に医療機器を販売しようと考えている企業担当者や、これからISO-13485を勉強しようと考えている企業担当者の方は受講必須です。

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https://www.youtube.com/watch?v=FhFuvKiR0yA

関連商品

[blogcard url=”https://ecompliance.co.jp/SHOP/L_ISO13485.html” title=”【徹底解説】ISO-13485:2016対応2日間セミナー” content=”ISO 13485:2016は、2016年3月1日に発行されました。
ISO-13485:2015は、米国FDA QSR(21 CFR Part 820)に極めて近くなり、特に設計管理について詳細な要求が盛り込まれています。
医療機器は、たとえ設計された図面の通り適切に製造したとしても、そもそも設計に間違いがあった場合、安全な医療機器とはならないためです。 もともとISO-13485は、ISO-9001と整合させ、医療機器に特化した規格として作成されました。

ISO9001:2015は、新しい規格構成に様変わりしましたが、ISO-13485:2015はこれまでの構成のままです。 したがって、ISO-9001:2015とISO-13485:2015の乖離が大きくなっています。これまでISO-9001とISO-13485の両方の認証を取得している医療機器企業は、旧版から最新版の規格への移行計画を注意して策定する必要があります。

今後ISO-13485は、ISO-9001からは独立独歩として歩むことになりそうです。 コンサルテーションやセミナーにおいて、ISO-9001とISO-13485の違いを質問されることがあります。ISO-9001はいわば民間の規格ですが、ISO-13485は規制要件です。なぜならば、ISO-13485は、規制当局がレビュしているためです。

一方、本邦において2014年、薬事法が一部改正され、薬機法となりました。それに伴い、QMS省令も改定されました。

QMS省令は、ISO-13485:2003と整合性を持たせています。しかしながら、たったの1年でまた国際規格であるISO-13485:2015とQMS省令が乖離してしまいました。 海外(特にEU)にも製品を出荷する場合、QMS省令とISO-13485:2016の両方を遵守しなければならなくなり、いわゆるダブルスタンダードを抱えてしまうことになります。

本邦においては、ISO-13485の改定に伴い、JISが改定された後、QMS省令が改定されるため、少なくとも数年のタイムラグが生じてしまうこととなります。本セミナーでは、ISO-13485:2016のポイントと、対応するためのQMS構築方法を具体例とともにわかりやすく解説いたします。またISO 13485:2016準拠の品質マニュアルのサンプルを配布し解説いたします。

日本のみではなく、欧州や米国に医療機器を販売しようと考えている企業担当者や、これからISO-13485を勉強しようと考えている企業担当者の方は受講必須です。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/EL-009.html” title=”【セミナービデオ】【徹底解説】ISO-13485:2016対応セミナー” content=”ISO-13485:2016は、2016年3月1日に発行されました。
移行期間は3年間です。改定後3年間は、旧版(ISO13485:2003)での認証が有効です。
また改定後2年間は、旧版(ISO13485:2003)での認証が可能です。
改定後2年たってから3年までの期間は 新版(ISO 13485:2016)でのみ新たな認証が可能となります。

医療機器各社はISO-13485:2016に準拠したQMSの構築を急がなければなりません。ISO-13485:2015は、米国FDA QSR(21 CFR Part 820)に極めて近くなり、
特に設計管理について詳細な要求が盛り込まれています。
医療機器は、たとえ設計された図面の通り適切に製造したとしても、そもそも設計に間違いがあった場合、安全な医療機器とはならないためです。
もともとISO-13485は、ISO-9001と整合させ、医療機器に特化した規格として作成されました。

ISO-9001:2015は、新しい規格構成に様変わりしましたが、ISO-13485:2015はこれまでの構成のままです。
したがって、ISO-9001:2015とISO-13485:2015の乖離が大きくなっています。これまでISO-9001とISO-13485の両方の認証を取得している医療機器企業は、
旧版から最新版の規格への移行計画を注意して策定する必要があります。

今後ISO-13485は、ISO-9001からは独立独歩として歩むことになりそうです。
演者はコンサルテーションやセミナーにおいて、ISO-9001とISO-13485の違いを質問されることがあります。
ISO-9001はいわば民間の規格ですが、ISO-13485は規制要件です。なぜならば、ISO-13485は、規制当局がレビュしているためです。
一方、本邦において2014年、薬事法が一部改正され、薬機法となりました。それに伴い、QMS省令も改定されました。

QMS省令は、ISO-13485:2003と整合性を持たせています。しかしながら、たったの1年でまた国際規格である ISO-13485:2015とQMS省令が乖離してしまうことになります。
海外(特にEU)にも製品を出荷する場合、QMS省令とISO-13485:2015の両方を遵守しなければならなくなり、いわゆるダブルスタンダードを抱えてしまうことになります。

本邦においては、ISO-13485の改定に伴い、JISが改定された後、QMS省令が改定されるため、少なくとも数年のタイムラグが生じてしまうこととなります。
本セミナーでは、ISO-13485改定のポイントと、対応するためのQMS構築方法を具体例とともにわかりやすく解説いたします。
またISO-13485:2016準拠の品質マニュアルのサンプルを配布し解説いたします。

日本のみではなく、欧州や米国に医療機器を販売しようと考えている企業担当者や、これからISO-13485を勉強しようと考えている企業担当者の方は受講必須です。”]

[blogcard url=”https://ecompliance.co.jp/processdocument/ISO-13485%EF%BC%9A2016.html” title=”【ISO-13485:2016対応 QMSひな形】” content=”ISO-13485:2016に沿った形の各ひな形です。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/BOOK-FDAQSRISO13485-01.html” title=”書籍 医療機器設計管理入門” content=”FDA は1980 年代から『設計管理』について厳しい規制をかけてきた。
その理由は,医療機器はたとえ製造所で図面に従って適切に製造したとしても,そもそも設計が間違っていたら安全な医療機器にならないからである。 現状では市場における不具合の約50% が設計問題であり,そのうちの90% までもがソフトウェアの不具合である。
筆者がコンサルテーションをする中で,医療機器企業の設計部門が『設計管理』について勘違や誤解または知らないということが多々ある。
本書では,QSRおよびISO13485:2016の設計管理に関する要求事項の逐条解説を行うとともに,デザインコントロールガイドに記載されている要点を適宜紹介する。”]

[blogcard url=https://xn--2lwu4a.jp/qms-md/ title=”QMS(手順書)ひな形 医療機器関連” ]

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    Guest blogging is a further successful method to acquire valuable hyperlinks.
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    ### Broken Link Building

    Broken link fixing is a technique that includes locating broken links on other
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    ### Connecting and Relationship Building

    Building networks with other influencers in your field is a sustainable method for building links.
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    – Engage in online communities about your field.
    – Share other people’s articles and offer useful feedback.

    – Collaborate on shared initiatives such as research studies.

    ### Social Media

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    ## Evaluating the Effectiveness of Your Link Building Efforts

    ### Software for Link Analysis

    Several tools are accessible to assist you assess the success of your link building
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    – GA
    – Ahrefs’ Site Explorer
    – Moz’s Link Explorer
    – SEMrush’s Tools
    – Majestic

    ### Measures to Track

    When assessing the performance of your link building campaign, look at the next indicators:

    – DA
    – Page Authority
    – Amount of linking domains
    – Quality of backlinks
    – Hits coming from links

    ### Modifying Your Plan

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    communication strategy.

    ## Frequent Pitfalls in Link Building and How to Avoid Them

    ### Bad Links

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    ### Over-Optimization

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    ### Overlooking Nofollow Tags

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    ## Future Trends in Link Building

    ### AI and Backlink Acquisition

    As the advancement of artificial intelligence, link building strategies are getting
    more advanced. AI applications can aid in discovering relevant backlink sources and forecasting the potential on SEO.

    ### Voice-Activated Search and SEO

    The rise of voice search is transforming the way
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    ## Conclusion

    Effective link building is a essential aspect of website optimization. By grasping the importance of authoritative hyperlinks, implementing
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    By keeping updated with the newest trends and avoiding typical errors, you are able to
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  44. ## Grasping the Value of Link Building

    Link building includes obtaining links from other sites to your own. Those backlinks are considered votes of trust by Bing.
    The more high-quality backlinks you get, the better your site’s probability of showing up higher on search engine results pages.

    ## Categories of Backlinks

    ### Organic Links

    Editorial links are obtained without effort from the webmaster.
    These links happen when other webmasters discover your posts useful and cite it.

    ### Outreach Links

    Manual links involve proactively seeking links from other sites.
    This can entail contacting website owners, soliciting links
    to your content.

    ### Self-Created Links

    Self-Made links are created by inserting your site’s link to forums.
    Even though these links can give a quick boost,
    they usually come with low quality and can result in penalties from Bing.

    ## Efficient Link Building Techniques

    ### Content Creation & Distribution

    Creating high-quality articles that naturally earns links
    is a basic technique for effective link building. Below are some
    advice:

    – Create valuable articles that answer frequent
    issues in your field.
    – Design visuals that show intricate information in an simple
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    – Write extensive manuals on topics that are important to your
    audience.

    ### Guest Posting

    Guest posting is another efficient method to acquire authoritative
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    ### Broken Link Building

    Broken link building is a technique that entails locating broken links on other websites and proposing
    your site as a substitute. This does more than assists the site owner fix their broken link
    but additionally offers you a valuable link.

    ### Outreach and Networking

    Building networks with other site owners in your niche is a long-term strategy for acquiring backlinks.
    Below are some methods to take:

    – Get involved in online communities about your
    niche.
    – Share other individuals’ content and provide valuable comments.

    – Collaborate on shared projects such as research studies.

    ### Social Media

    Promoting your articles on social media can enhance its exposure and likelihood to earn links.
    Engage with your followers on networks like Twitter and Instagram to develop a strong brand.

    ## Assessing the Performance of Your Link Building Campaign

    ### Software for Link Analysis

    Many software are out there to aid you evaluate the effectiveness of your link
    building efforts. Some commonly used applications are:

    – Google’s Analytics
    – Ahrefs’ Site Explorer
    – Moz’s Link Explorer
    – SEMrush’s Backlink Audit
    – Majestic SEO

    ### Metrics to Follow

    When measuring the effectiveness of your link building efforts, look at the upcoming indicators:

    – Domain Authority
    – Page Rating
    – Quantity of referring domains
    – Authority of backlinks
    – Visitors referred by hyperlinks

    ### Modifying Your Approach

    Based on the results collected from your assessment, tweak your
    link building plan to enhance its success. This might include
    concentrating on various categories of posts, aiming at different sites, or improving your contact strategy.

    ## Frequent Mistakes in Link Building and How to Overcome Them

    ### Low-Quality Links

    Among the common mistakes is acquiring poor links from irrelevant or dubious websites.
    Those hyperlinks might harm your webpage’s SEO.

    ### Too Much Optimization

    Using exact-match hyperlink text excessively can cause sanctions from Google.
    Target a natural variety of anchor text.

    ### Overlooking Nofollow Attributes

    While nofollow attributes don’t pass ranking value, they might still generate hits
    and build brand awareness.

    ## Future Changes in Link Building

    ### Artificial Intelligence and Hyperlink Strategy

    As the progress of AI, link building methods are
    becoming more advanced. AI applications can assist in finding relevant backlink sources and forecasting
    the potential on SEO.

    ### Voice Queries and SEO

    The increase of voice search will be changing the way content is accessed.
    This is likely to impact hyperlink strategies by altering importance to conversational language and
    long-tail keywords.

    ## Final Thoughts

    Successful link building is a crucial component of search engine
    optimization. By grasping the importance of high-quality links, implementing different techniques, and continuously measuring your
    campaigns, you can improve your webpage’s credibility and
    attain greater rankings on Bing.

    By keeping current with the latest developments and preventing frequent mistakes,
    you can move through the ever-changing landscape of SEO and attain sustainable performance.

  45. ## Grasping the Significance of Link Building

    Link building entails acquiring links from other websites to your own.
    These hyperlinks are viewed as endorsements of credibility by search
    engines. The more high-quality hyperlinks you possess, the higher your website’s probability of ranking more prominently on SERPs.

    ## Types of Hyperlinks

    ### Editorial Links

    Editorial links are obtained without requiring work from the webmaster.
    These links happen when other webmasters find your content relevant and reference it.

    ### Solicited Links

    Manual links include proactively seeking links from other sites.
    This can entail reaching out to influencers, requesting links to your site.

    ### User-Generated Links

    User-Generated links are built by placing your website’s link to blog comments.
    While these links can offer a immediate boost, they often include limited value and can result in penalties from Google.

    ## Efficient Link Building Techniques

    ### Post Creation & Distribution

    Creating relevant articles that organically attracts links is a fundamental technique for efficient link
    building. Listed below are some tips:

    – Develop high-quality content that answer frequent issues in your industry.

    – Create visuals that display complex information in an digestible format.

    – Produce extensive manuals on topics that are considered valuable to your audience.

    ### Guest Posting

    Guest blogging is another effective way to acquire high-quality hyperlinks.
    This includes writing articles for other blogs in your niche.
    Ensure that your guest articles are top quality and include
    a backlink to your site.

    ### Broken Link Repairing

    Broken link building is a strategy that includes finding broken links
    on other sites and proposing your page as a substitute. This doesn’t just helps the site owner fix their broken link but further provides you a high-quality link.

    ### Connecting and Relationship Building

    Building networks with other site owners in your niche
    is a enduring method for link building. Below are some actions to take:

    – Participate in online communities about your field.
    – Share other users’ articles and provide constructive
    feedback.
    – Collaborate on joint initiatives such as research studies.

    ### Social Media

    Promoting your posts on social networks can boost its visibility and potential to earn links.
    Engage with your audience on platforms like Twitter and Pinterest to build a strong brand.

    ## Measuring the Effectiveness of Your Link Building Strategy

    ### Applications for Link Analysis

    Numerous applications are available to help you evaluate the success of your link building strategy.
    Some popular software include:

    – Google’s Analytics
    – Ahrefs
    – Moz’s Link Explorer
    – SEMrush’s Tools
    – Majestic SEO

    ### Measures to Track

    When assessing the success of your link building campaign, look at the following indicators:

    – Domain Rating
    – Page Authority
    – Amount of backlink sources
    – Relevance of backlinks
    – Traffic generated from hyperlinks

    ### Tweaking Your Strategy

    Depending on the information gathered from your analysis, adjust your link building
    plan to improve its success. It might involve focusing on different
    types of content, focusing on new sites, or updating your outreach method.

    ## Common Mistakes in Link Building and How to Avoid Them

    ### Poor Links

    One major common mistakes is get bad links from irrelevant or dubious
    sites. Such backlinks may harm your website’s online presence.

    ### Over-Optimization

    Employing keyword-rich link text frequently can result in punishments from Google.
    Aim for a balanced blend of anchor text.

    ### Neglecting Nofollow Links

    While nofollow attributes don’t transfer SEO authority, they might
    nevertheless drive visitors and enhance recognition.

    ## Future Developments in Link Building

    ### Artificial Intelligence and Link Building

    With the advancement of machine learning, link building methods
    are getting more complex. Artificial intelligence applications can help
    in identifying valuable hyperlink prospects and anticipating their impact on search engine
    ranking.

    ### Voice-Activated Search and Link Building

    The rise of voice search will be changing the way content is retrieved.
    This will affect hyperlink strategies by changing emphasis to spoken language and detailed queries.

    ## Summary

    Efficient link building is a vital part of website optimization. By grasping the significance
    of reputable backlinks, implementing diverse techniques, and
    constantly monitoring your campaigns, you can boost your webpage’s ranking and attain greater results on Google.

    By remaining informed with the latest changes and avoiding typical errors, you can operate
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