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  • Procedures for suppliers to cover the control of External Providers

    1. In addition to my 27th of December question, 8.6 paragraph demands evaluations of the business continuity capabilities of relevant partners and suppliers;
    Where in the package can I find a format for conducting evaluation for partners and suppliers according to ISO 22301:2019

    You can use the same procedure and checklist used for your internal audit. Both procedure and checklist can be found in folder 10 from your ISO 22301 Toolkit.

    For additional information, see (the same concept applies to ISO 22301):

    2. And another question please. Where can i find a format to record business continuity objectives and actions and evaluation of them as 6.2.1 and 6.2.2 states
    Thank you once again.

    You can use your own document usually used for planning for documenting business continuity objectives and methods to measure them, and if you do not have such, then you can use the blank template provided in the root folder of your toolkit.

    For further information, see:

    And another question, please.
    Where in the package can i find a document to describe external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended outcome such as Pandemic in the territory, Earthquakes, and risk appetite in general and according the site territory;

    The information required by ISO 22301 clause 4.1 is addressed by the following templates:

    • Organization's activities (from clause 4.1 a)) and potential impact from disruptive incidents are addressed by template Business Impact Analysis Questionnaire (located at folder 04 Business Impact Analysis Methodology)
    • The organization's functions (from clause 4.1 a)) are addressed in all templates when an activity to be performed is required (by means of the field [job title]). Functions related specifically to the BCMS are defined in the template Business Continuity Policy, section 3.5, (located at folder 03 Business Continuity Policy)
    • Organization's product and services (from clause 4.1 a)) are addressed by template Business Continuity Policy, section 3.5, (located at folder 03 Business Continuity Policy)
    • Relations with suppliers, partners, and interested parties (from clause 4.1 a)) are addressed by template Business Continuity Strategy (located at folder 05 Business Continuity Strategy)
    • Relationships between the Business Continuity Policy and other organization's policies, objectives, and general risk management strategy (from clause 4.1 b)) are addressed by template Business Continuity Policy, section 2, (located at folder 03 Business Continuity Policy)
    • Organization's risk appetite (from clause 4.1 c)) is addressed by template Business Impact Analysis Questionnaire, section 6 (maximum acceptable outage) (located at folder 04 Business Impact Analysis Methodology)  

    This article will provide you a further explanation (the same concept applies to ISO 22301):

    This material will also help you regarding ISO 22301:

  • ISO 13485 implementation

    No, it is not mandatory for the company to go for the ISO 9001 as well. ISO 13485:2016 is a standard that is specific for Manufacturers of medical devices (Medical devices — Quality management systems — Requirements for regulatory purposes). Besides that, on the web pages of the European Commission are stated which standards are applicable for all types of medical devices:  https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices On that list, which has around 300 standards, only ISO 13485:2015 is the standard for the quality management system.

    For more information, please see the following links:

Page 235-vs-13485 of 1127 pages

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