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  • The Auditing Process

    Please can you advise if the following is correct approach when auditing the various business areas we are in the second year of ISO Certification heading toward our first Surveillance Audit:

    The audit approach is this:
    1. Review previous comments made during Stage 2 Audit and design question accordingly.
    2. Design questions as per the process input/activity/output to establish evidence.
    3. Review Quality Management Principles to establish if the business area has applied Improvement, has leadership engaged staff, managed relationships with interested parties etc. and design questions accordingly.
    4. Review Risk Register to establish if the applicable risks to the area has been mitigated and if there are new risks and design questions accordingly.
    5. Review Goals and Objectives to establish if the targets have been achieved (process/business area dependents) and design questions accordingly.
    Other questions like do your new staff members aware of the Quality Policy and were it is situated.

    We are a small company so it makes sense for us to do the audits in one go with the above mentioned approach. It also reinforces the ISO principles and what is ISO all about with middle management.  

    Let me know what you think.

  • Input and output processes in manufacturing electronics processes

    What is the typical input and output processes in the manufacturing electronics processes in ISO9001: 2015 Quality management system?

  • Finance Dept documents that need to be controlled

    Does the ISO standard require any finance department documents need to be controlled? If so, what are they?

  • ISO 9001 exclusions

    I have an question with exclusions to the ISO 9001:2015. Since we do not do design and development we have been excluding this. However, when the new standard came into effect our external auditor said we can not exclude this section without replacing it. He suggested production management.
    From all the readings i have been doing on-line, I havent read you need to replace not exclude.
    Is this true? Can you clarify this exclusion?

  • Corrective Action Reports

    Hello, I just want to know when is the best time to follow-up the Corrective Action Report (CAR) from the date it was issued to someone. Thanks

  • Manual de la calidad

    Es necesario crear un manual de la calidad, o se debe elaborar un documento que describa que el sistema?

  • Systems Audit and Compliance Audit

    One thing you might be able to help me with, please, and that is that I have to understand the difference between a Systems Audit and a Compliance Audit for ISO standards and I don't really understand what this means. Thanks!

  • Remote internal audits – an increasing possibility

    I had attended the webinar and I had to miss the last 5 mins of the Q&A session. I had asked if the ISO internal audits need to be done on-site. Can you please confirm they need to be done on-site and if you have any proof in the ISO standard that is the case and where it states in the standard. Please provide that information as well. If you have the recording from the webinar, that would be great as well! Thank you,

  • ISO/TS 29001 in addition to ISO 9001

    What can ISO/TS 29001 add value to a petrochemical, or oil and gas company which has already implemented ISO 9001? Generally, what are the benefits of ISO/TS 29001 implementation?

  • QMS for medical devices

    Hi,

    I just wanted to get the exact definitions of the following terms as per medical devices QMS:

    Disposition
    Containment,
    immediate correction.
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