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  • Implementing ISO 9001:2015

    Let me clarify how I interpret your question:

    Your organization is implementing a quality management system. A quality management system requires that an organization performs internal audits by a competent person, an auditor. Normally, organizations decide that internal auditors should have a good knowledge of the standard and of good auditing practices. It is up to each organization to decide the extent of knowledge needed and the way to evidence it.

    If your organization determines that internal auditors have to go through an internal auditor course and that the evidence is the certification test, then you must have the certification test to evidence competence. If you fail to pass, you must retry. By the way, with our - Free online training ISO 9001:2015 Internal Auditor Course: https://advisera.com/training/iso-9001-internal-auditor-course/ - you have a second attempt without paying and you only repeat the part of the exam where you failed.

    You can find more information below:

  • Timeline and cost associated with getting ISO 13485 certified

    Excellent way of telling, and pleasant piece of writing to take information about my presentation focus, which i am going to present in school. save refuges

  • ISO 17025 requirements for Pharmaceutical organization

    ISO 17025 requirements apply to all laboratories for all testing, calibration and sampling. The Pharmaceutical sector, as for any other sector or accreditation program such as, e.g. Veterinary or Pesticide analysis for product registration; have national and perhaps international regulatory requirements. The requirements depend on what the “Pharmaceutical organization” activities are. A production QC laboratory might. for example, be ISO 17025 accredited as per “general” requirements for Chemical Testing. Typically an accreditation body would have a program for Pharmaceutical Laboratories or include Pharmaceutical biological, microbiological and biochemical testing and measurement under the Biological Programme. The requirements would depend on the scope which could be, for example,  Drug testing, Chemical Analysis or Pharmaceutical Testing.

    I recommend you look at your accreditation body website or call them to obtain specific requirements.

    For a list of accreditation bodies have a look at https://ilac.org/signatory-search/

    For more information on ISO 17025 see

  • Creating a template for an equipment PM plan

    You want that particular equipment at a particular moment in time to have preventive maintenance. So, you can think about something like:

    https://www.screencast.com/users/ccruz5284/folders/Default/media/95cdef33-c93c-49ab-bbe4-c599d3e91097

    It is like having a calendar scheduling preventive maintenance at each equipment.

    Normally, what to do at each preventive maintenance intervention is not included in the PM plan but at each equipment documentation.

    You can find more information below:

  • The calibration validity by tracing the calibration record

    I do not use the word “observation” since there is no ISO 9000 or ISO 19011 definition for it. I use major and minor nonconformity.

    In your audit you verified a non-conformity according to clause 7.1.5.2 b). According to your description, I would raise a minor nonconformity.

    You can find more information in the following links:

  • Conception and development in ISO 9001

    I can say that I already worked with organizations in that situation and they decided to consider clause 8.3 as non-applicable. They decided and explained that their business is not developing or designing parts, their business is manufacturing parts according to customer requirements. The molds were approved by the customer indirectly when the customer approved the injected parts.
    If your organization has already decided who is going to be your certification body, remember that you can explain to them the situation and ask for a statement.

  • Remote Access Policy and BYOD(Bring Your Own Device) Policy

    I was asked to develop a (*Subject) for a small organisation with no more that 1500 words and it's not very specific as to have user profile A,B...etc.. and their designation, their rights and all. How do I start with it?

  • List of cybersecurity risks associated with 5G technology

    I have a question "an organization is AS9100 Rev D certified but organization has no production since one year from any customer then how can compliance of QMS can be interpreted? How internal audits be conducted? How KPI be translated ? What standard say that if an organization have no customer since long time then how QMS compliance be evaluated?

  • Difference between ISO 27001 A.18.2.1 and 9.2 Internal audit

    ISO 27001 clause 9.2 speaks specifically about internal audit, whereas control A.18.2.1 defines independent review of information security - besides internal audit, such independent review can also be certification audit, 2nd party audit, etc. 

    To learn more about internal audit, sign up for this free online training ISO 27001 Internal Auditor Course https://advisera.com/training/iso-27001-internal-auditor-course/ 
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