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  • Policy vs. standard

    What is the absolute difference between a policy and a standard?

  • Processes vs. Departments

    Do we need each department providing their process on particular activities..an example of HR section..their job is normally recruitment..so do they need to documented (maintain/retain) all the process?

  • Internal and external issues and risks and opportunities prioritization


    Answer:

    Internal and external issues differ from organization to organization but there are some that are common for all organization. Internal issues can be the organizational structure, the culture of the organization, issues related to your employees (current competence vs needed competence, their needs and expectations, etc), issues related to technology and equipment your organization use, etc.

    External issues are related to the external environment in which the company operates, this can be economical and political situation in your country, legislation, but also needs and expectations of external interested parties such as your supplier, subcontractors, customers, etc.

    Determining internal and external issues is closely related to the identification of needs and expectations of interested parties and that can be e asier and can provide you with inputs on what to consider when addressing internal and external issues. There is no formal requirement to document context of the organization but it can be very useful to do so when you are doing it for the first time.

    For more information, see:
    - How to identify the context of the organization in ISO 9001:2015 https://advisera.com/9001academy/blog/2015/05/26/how-to-identify-the-context-of-the-organization-in-iso-90012015/
    - How to determine interested parties and their requirements according to ISO 9001:2015 https://advisera.com/9001academy/blog/2015/11/10/how-to-determine-interested-parties-and-their-requirements-according-to-iso-90012015/

    The crucial step in identifying risks and opportunities is to properly determine context of the organization. Once you have this information you can start thinking about the risks and opportunities regarding your QMS. There is no single way to prioritize risks and opportunities but you should start with risks and opportunities that are directly affecting quality of your products and services and customer satisfaction, or start with ones that require least resources and time and can be resolved easily. Important thing is to make plan to address risks and opportunities, meaning to define resources, responsibilities and actions to address each risk and opportunity.

    For more information, see:
    - Methodology for ISO 9001 Risk Analysis https://advisera.com/9001academy/blog/2015/09/01/methodology-for-iso-9001-risk-analysis/
    - The Role of Risk Assessment in the QMS https://advisera.com/9001academy/blog/2014/01/07/role-risk-assessment-qms/

  • Implementation of ISO 9001 over ISO 27001

    ...  ISO 9001 vs. ISO 27001 matrix (PDF) https://info.advisera.com/9001academy/free-download/iso-9001-2015-vs-iso-27001-2013-matrix/
    - ISO 9001 Implementation Diagram (PDF) https://info.advisera.com/9001academy/free-download/iso-9001-implementation-diagram/

  • Configuration Management vs Record Control

    I would like to find out the difference between Control of Records and Configuration Management. Does ask requires organisations to have both?

  • Internal records vs QMS

     I have some questions about some internal documents that my company uses on a daily basis that doesn't seem to be required by ISO 9001:2008. There are multiple logs and check sheets that the owner likes to have to easily see different things, without having to do a lot of research there is just a log. I was once told that if it affects the product then it needs to be a quality form, but if these

  • Exclusion of clause 7.3 Design and Development


    Design and development can be excluded when organization doesn't perform design of new products or development of existing products. This clause can also be excluded when the design and development are outsourced.

    Here is one article explaining design and development process: ISO9001 Design Verification vs Design Validation https://advisera.com/9001academy/knowledgebase/iso9001-design-verification-vs-design-validation/

  • Certification in Information security

    ... u “CISA vs. ISO 27001 Lead Auditor certification” : https://advisera.com/27001academy/blog/2015/05/11/cisa-vs-iso-27001-lead-auditor-certification/

    And also this article can be interesting for you “Qualifications for an ISO 27001 Internal Auditor” : https://advisera.com/27001academy/blog/2015/03/30/qualifications-for-an-iso-27001-internal-auditor/

    Finally maybe our online course can be interesting for you “ISO 27001:2013 Interna Auditor Course” : https://advisera.com/training/iso-27001-internal-auditor-course/
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