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Quality Manual, 39 Operational Procedures and 42 Forms (35 electronic and 7 manual)

[/vc_column_text][vc_empty_space height=”20px”][vc_custom_heading text=”Download Sample Manual and Procedures” font_container=”tag:h2|text_align:left|color:%23707070″ use_theme_fonts=”yes”][vc_row_inner][vc_column_inner width=”1/2″][vc_btn title=”ISO 13485:2016l QM-00 Index” size=”sm” align=”center” i_icon_fontawesome=”fas fa-file-pdf” add_icon=”true” link=”url:https%3A%2F%2Fwww.zenonhost.co.za%2Fwp-content%2Fuploads%2F2020%2F02%2FIso13485_QM00_Index.pdf|||” css=”.vc_custom_1582229892572{padding-top: 10px !important;padding-right: 10px !important;padding-bottom: 10px !important;padding-left: 10px !important;}”][/vc_column_inner][vc_column_inner width=”1/2″][vc_btn title=” ISO 13485:2016 Procedure QOP-42-01 Control of Documents ” size=”sm” align=”center” i_icon_fontawesome=”fas fa-file-pdf” add_icon=”true” link=”url:https%3A%2F%2Fwww.zenonhost.co.za%2Fwp-content%2Fuploads%2F2020%2F02%2FIso13485_QOP4201_DocumentControl.pdf|||” css=”.vc_custom_1582229944428{padding-top: 10px !important;padding-right: 10px !important;padding-bottom: 10px !important;padding-left: 10px !important;}”][/vc_column_inner][/vc_row_inner][vc_row_inner][vc_column_inner width=”1/2″][vc_btn title=”ISO 13485:2016 QM-01 Scope” size=”sm” align=”center” i_icon_fontawesome=”fas fa-file-pdf” add_icon=”true” link=”url:https%3A%2F%2Fwww.zenonhost.co.za%2Fwp-content%2Fuploads%2F2020%2F02%2FIso13485_QM01_Scope.pdf|||” css=”.vc_custom_1582229999639{padding-top: 10px !important;padding-right: 10px !important;padding-bottom: 10px !important;padding-left: 10px !important;}”][/vc_column_inner][vc_column_inner width=”1/2″][vc_btn title=”ISO 13485:201 Procedure QOP-82-02 Internal Quality Audits ” size=”sm” align=”center” i_icon_fontawesome=”fas fa-file-pdf” add_icon=”true” link=”url:https%3A%2F%2Fwww.zenonhost.co.za%2Fwp-content%2Fuploads%2F2020%2F02%2FIso13485_QOP8202_InternalAudit.pdf|||” css=”.vc_custom_1582230058987{padding-top: 10px !important;padding-right: 10px !important;padding-bottom: 10px !important;padding-left: 10px !important;}”][/vc_column_inner][/vc_row_inner][vc_row_inner][vc_column_inner width=”1/2″][vc_btn title=” ISO 13485:2016 QM-05 Management Responsibility” size=”sm” align=”center” i_icon_fontawesome=”fas fa-file-pdf” add_icon=”true” link=”url:https%3A%2F%2Fwww.zenonhost.co.za%2Fwp-content%2Fuploads%2F2020%2F02%2FIso13485_QM06_MngResponsibility.pdf|||” css=”.vc_custom_1582230191021{padding-top: 10px !important;padding-right: 10px !important;padding-bottom: 10px !important;padding-left: 10px !important;}”][/vc_column_inner][vc_column_inner width=”1/2″][vc_btn title=”ISO 13485 Operational Procedure QOP-73-02 Design Risk Management.pdf” size=”sm” align=”center” i_icon_fontawesome=”fas fa-file-pdf” add_icon=”true” link=”url:https%3A%2F%2Fwww.zenonhost.co.za%2Fwp-content%2Fuploads%2F2020%2F02%2FIso13485_QOP4101_RiskMng.pdf|||” css=”.vc_custom_1582230252996{padding-top: 10px !important;padding-right: 10px !important;padding-bottom: 10px !important;padding-left: 10px !important;}”][/vc_column_inner][/vc_row_inner][/vc_column][vc_column width=”1/2″][vc_gallery type=”nivo” interval=”3″ images=”6239,6240,6241″ img_size=”large” onclick=”img_link_large” title=”Document List”][/vc_column][/vc_row][vc_row][vc_column][vc_tta_accordion spacing=”5″ gap=”5″ c_icon=”chevron” c_position=”right” active_section=”1″][vc_tta_section title=”Proven in thousands of companies” tab_id=”1582221146475-518c3d31-3ee2″][vc_column_text]

Originally published in 1996, this documentation was the first template quality system for the medical device industry. Now in its fourth edition, and with over 3,000 copies sold, it has helped thousands of companies to achieve ISO 13485 registration and/or FDA compliance. It is by far the most popular and proven package on the market.

[/vc_column_text][/vc_tta_section][vc_tta_section title=”Cover both ISO 13485:2016 and FDA 21 CFR Part 820″ tab_id=”1582221146492-ec186d0c-bb7b”][vc_column_text]

This documentation covers both ISO 13485:2016 and FDA QSR (21 CFR Part 820) requirements under one quality system, and is ideally suited for companies that must comply with both the US FDA and international regulations.

It defines a quality system that is simple, natural, and free from excessive paperwork – making it easy to operate and maintain

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Extensive notes, tips, and comments are inserted directly into the template documents to help you customize the documentation for your company.

 

These notes

  • Identify and explain the requirements which are being addressed in the particular section of the document,
  • Alert you to sections where you may need to make changes,
  • Discuss alternative approaches and solutions that may be more suitable for particular types of companies.

It is like having a consultant by your side, anticipating your questions and helping you in real time as you customize the documentation.

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