資源の運用管理(その2)

【連載】ISO-13485:2016対応の要点

【第5回】資源の運用管理(その2)

インフラストラクチャ

ISO-13485:2016では、製品要求事項適合性の確保と、混同の防止、製品の取り扱いを保証するインフラストラクチャへの要求事項が追加となった。

インフラストラクチャとは、
a) 建物、作業場所および関連するユーティリティ
b)設備 (ハードウェアとソフトウェアとを含む。)
c)支援体制 (例えば、輸送、通信または情報システム)
を指す。

建物

建物は混同を防止するために十分なスペースがなければならない。
混同の例としては、不適合品(部品、ユニット、半製品、仕掛品、完成品等)のラインへの混入が考えられる。

設備

設備は製造設備(工具、冶具、装置、システム等)や測定機器などが含まれる。
昨今ではソフトウェアが搭載された自動化システム(例:自動半田付け装置)が多用されている。コンピュータによって制御された自動化システムのことをコンピュータ化システムと呼ぶ。
また設備はソフトウェアを含めてバリデーションの対象である。

支援体制

製造された最終製品の品質保証のみならず、輸送中の機器(試薬を含む)の品質保証も実施しなければならない。
情報システムとは、製造記録や品質記録(苦情、CAPA、教育訓練、監査等)を保持するソフトウェア(コンピュータシステム)のことであり、ソフトウェアバリデーションが要求される。

保守活動

上記インフラストラクチャに対する保守活動(日常点検、定期点検、校正等)またはその欠如が製品の品質に影響を与える場合、保守活動の実施の間隔を含む保守活動の要求事項をQMSに文書化しておかなければならない。
保守活動には、製造、作業環境の管理や監視および測定に用いる設備にも含まれる。
 

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    – Create valuable articles that address common questions in your industry.

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    Below are some actions to follow:

    – Participate in discussion boards pertaining to your industry.

    – Distribute other individuals’ articles and offer useful input.

    – Partner on collaborative projects such as ebooks.

    ### Social Media

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    ### Applications for Link Analysis

    Many tools are available to help you evaluate
    the performance of your link building campaign. Some commonly used software are:

    – GA
    – Ahrefs’ Site Explorer
    – Moz Pro
    – SEMrush’s Tools
    – Majestic

    ### Indicators to Monitor

    When assessing the effectiveness of your link building strategy, take into account the next metrics:

    – Domain Authority
    – Page Authority
    – Amount of backlink sources
    – Quality of backlinks
    – Hits generated from hyperlinks

    ### Modifying Your Plan

    Based on the data obtained from your evaluation, modify your
    link building approach to enhance its effectiveness. It might
    entail focusing on other categories of posts, targeting different websites, or
    improving your outreach method.

    ## Typical Pitfalls in Link Building and How to Overcome Them

    ### Bad Links

    One of the typical errors is acquiring bad links from non-relevant or dubious pages.
    These backlinks can hurt your webpage’s SEO.

    ### Excessive Optimization

    Using exact-match link text too often can lead to penalties from Google.
    Aim for a balanced mix of link text.

    ### Ignoring Nofollow Attributes

    Although nofollow attributes aren’t convey SEO juice, they might nevertheless generate visitors and
    enhance brand awareness.

    ## Emerging Changes in Link Building

    ### Artificial Intelligence and Backlink Acquisition

    With the advancement of artificial intelligence, link building techniques are turning more
    sophisticated. Artificial intelligence tools
    can assist in identifying valuable hyperlink prospects and forecasting their impact
    on SEO.

    ### Voice Queries and Backlinks

    The rise of voice queries will be transforming the manner information is accessed.
    This is likely to impact backlink acquisition by
    changing importance to spoken phrases and long-tail queries.

    ## Summary

    Efficient link building is a essential component of search engine optimization. By grasping the value of reputable hyperlinks,
    using various strategies, and regularly measuring your strategies,
    you will improve your website’s credibility and attain better rankings
    on Bing.

    By keeping current with the latest trends and preventing typical mistakes, you will move through
    the dynamic realm of website optimization and attain enduring results.

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    ## Kinds of Backlinks

    ### Organic Links

    Organic links are obtained without any work from
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    Manual links involve actively acquiring links from other
    sites. This can include reaching out to bloggers,
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    ### User-Generated Links

    Self-Created links are made by placing your webpage’s link to directories.

    While these links can provide a quick boost, they usually have limited quality and can result in sanctions from
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    ## Successful Link Building Techniques

    ### Content Creation & Promotion

    Creating high-quality articles that automatically gains links is a
    fundamental technique for successful link building. Listed below are some advice:

    – Develop high-quality content that address
    frequent issues in your industry.
    – Design visuals that display detailed information in an easy-to-understand way.

    – Write extensive manuals on topics that are important to your audience.

    ### Guest Articles

    Guest blogging is another efficient way to acquire authoritative backlinks.

    This includes writing content for other blogs in your industry.
    Be certain that your guest posts are high value and contain a
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    ### Broken Link Repairing

    Broken link fixing is a strategy that involves finding broken links on other websites
    and recommending your site as a replacement. This not only assists the website owner fix their broken link
    but further gives you a high-quality link.

    ### Contact and Relationship Building

    Building networks with other webmasters in your industry is a sustainable technique
    for building links. Here are some methods to take:

    – Participate in online communities pertaining to your industry.

    – Promote other individuals’ content and provide useful
    comments.
    – Partner on shared initiatives such as research studies.

    ### Social Media

    Sharing your content on social platforms can enhance its exposure and potential to acquire backlinks.
    Interact with your audience on networks like Facebook and Instagram to
    build a strong digital footprint.

    ## Evaluating the Performance of Your Link Building Efforts

    ### Software for Link Analysis

    Several software are available to assist you assess the success
    of your link building campaign. Some commonly used software include:

    – Google’s Analytics
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