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  • 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/ 

  • The most relevant tools supporting PPAP processes

    PPAP requirements should be determined according to customer-specific requirements. If you do not have a special customer requirement then you can use the PPAP rev 4 blue books written by AIAG as a reference manual. There are generally 19 main topics in PPAP. Some of those are given below. 

     

    • Process Flow Chart
    • FMEA
    • Control Plan
    • Part Drawing
    • Tool Drawing
    • Tool Approval 
    • Part Measurement Report
    • Part Test Reports
    • Part History Document 
    • Capability Studies
    • MSA Studies
    • Sample Part
    • Supplier Part Approval Reports 
    • Appearance Approval Report
    • Engineering Change Approval
    • IMDS Approval
    • PSW Document 
    • Etc...
       

  • Lab activities

    In ISO 17025; "laboratory activities" are one of three types of work taking place in a laboratory, i.e. either testing, calibration or sampling, (when the sample is going to be tested or calibrated). That means that the range of lab activities is the testing, calibration or sampling that is to be, or is accredited. Laboratories must define and document (i.e. decide and put in writing) a list of what testing, calibration or sampling activities conform to ISO 17025, as this will be listed on the accreditation certificate; and is what can be claimed as accredited.

    I will give you two testing laboratory examples:

    • Heavy Metals (ICP-MS) in Water for Arsenic, Cadmium, Lead, Mercury
    • Fat in Animal Feed, Cereal Foods, Cocoa products, Dairy products.

    Laboratories must perform the work themselves on an ongoing basis, and not “contract out” such work unless under controlled temporary arrangements due to an emergency.

    For more information on ISO 17025 see
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