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  • ISO 9001 and ISO 13485

    Yes, it is. You can continue implementing ISO 9001 and add the differences coming from ISO 13485. You can see that there is a lot in common, although they follow different structures.

    The following material will provide you more information:

  • Calibration of laboratory equipment

    Although I cannot tell which analyzer you are specifically referring to, as a testing laboratory, you need to start by understanding the difference between calibration and verification, and what a level of measurement uncertainty and traceability to SI is achievable and acceptable (e.g national or international traceability). This involves having a suitable calibration program and intermediate checks (verification) to meet ISO 17025 clause 6.4 equipment requirements and clause 6.5 Metrological traceability. Note that assuring your results goes beyond the analyzer, it includes all equipment used in the process – e.g analytical balances, glassware, dispensing devices, reference standards to establish the analytical calibration on the instrument.

    Regarding your reference to the difference between “external” and “internal” - External is when you contract an ISO 17025 calibration laboratory to perform validations. What you are referring to as “internal” is rather referred to as “intermediate checks” or “verification”. This is because it is possible for laboratories to calibrate internally if calibration requirements are met. Calibration laboratories must have certified reference standards with strong metrological traceability to SI and a fit for purpose, well-documented measurement uncertainty for each test property. When using a calibration laboratory, for example, to calibrate your analytical balances, they need to use a suitable class of reference weights. Depending on the class of balance, a particular class of reference weight must be used to calibrate such a balance, as they have different specifications (agreed technical parameters)  resulting in a particular level of measurement uncertainty.

    How often you do external calibrations and whether you need to perform intermediate checks (and how often), depends on the process steps and what equipment is used. For analytical balances it is straight forward – a laboratory would use a set of weights that they own, where each piece has metrological traceability to SI, where they were previously calibrated by an external calibration provider (at a suitable frequency, based on risk and need).  So here you have reported uncertainties on the calibration certificate that you confirm are acceptable for each piece. Then you perform intermediate checks (verifications) on your balances at suitable time intervals (also based on risk), across the range of use (g) of the balance.  For your analyzer, your intermediate checks could be functional, based on the instrument performance, as well as by using standard reference checks against the calibration. This involves using different standard solutions or materials than what was used in setting up the calibration on the analyzer.

    For further information see the following:

    The article What does ISO 17025:2017 require for laboratory measurement equipment and related procedures? at https://advisera.com/17025academy/blog/2019/07/25/iso-17025-measurement-requirements-of-the-standard/

    The ISO 17025 document template: Equipment and Calibration Procedure at https://advisera.com/17025academy/documentation/equipment-and-calibration-procedure//

    ILAC G24:2007 Guidelines for the determination of calibration intervals of measuring instruments (note currently under revision) available for download at https://ilac.org/?ddownload=818

    You can also refer to another Expert Advice Community Q&A  Are intermediate checks required for calibration laboratories? att https://community.advisera.com/topic/are-intermediate-checks-required-for-calibration-laboratories/

  • Marketing Auditor services

    So, you are an ISO 9001 internal auditor and you want to find clients for your audit service.

    https://www.screencast.com/users/ccruz5284/folders/Default/media/44897233-09bd-48d7-a7c8-1f49e7253b66

    Potential clients must be aware of your competence. About competence: Can you provide evidences of experience as auditor? Can you provide evidence of training as auditor? Can you provide evidence of certification as auditor to provide image and credibility?

    Potential clients must be aware of your existence. You must develop your own brand by evidencing your knowledge and experience. You evidence your knowledge when you write. You should write. Share what you know, share your experience and results, share testimonies of your clients about the outcomes of working with you. Use blogs, professional networks, trade magazines, use your LinkedIn profile, make presentations at conferences. And don’t forget to develop a network of contacts. Consultants implementing quality management systems always need an independent first party auditor. So, you can contact them and offer your services. As soon as you have enough experience as internal auditor you can contact certification bodies to offer your services as third party auditor.

    The following material will provide you more information:

  • OOS/Deviation

    I believe OOS stands for Out Of Specification. You can find help in ISO 9001:2015 clause 8.7.

    When you find OOS product you have to segregate that product to avoid unintended use and you have to decide what to do with it:

    • Ship as it is after talking with client;
    • Correct or rework the product;
    • Downgrade the product as 2nd grade or off-grade 

    The following material will provide you more information:

  • Design and development in service provision industry

    I have no experience in the security provider industry. I’m sure the industry has to follow guidelines from regulatory bodies. If they exist, they set a kind of general process to be followed. For example, I found on the internet the OCC Bulletin 2004-20, "Risk Management of New, Expanded, or Modified Bank Products and Services: Risk Management Process,". 

    I suppose that the process was updated in 2017 with this - https://www.occ.treas.gov/news-issuances/bulletins/2017/bulletin-2017-43.html So, a possible process can be:

    • After validation of the conceptual idea for the product
    • List all inputs for design and development (part of due diligence – Step A)
    • Follow the process activities (Steps A, B and C)
    • Apply controls (reviews, verifications and validations)
    • Define product specifications, advance with product registration, 
    • Market and distribute new product
    • Launch new product
       

    The following material will provide you more information:

  • Conformio implementation plan with ISO 27001

    Conformio platform has basic Document Management System features that fulfill ISO 27001 document management requirements, so you can keep all your ISO 27001 related documents in Conformio.

    This article will provide you a further explanation about the document management:

  • Roles and responsibilities for ISMS specific processes

    ISO 27001 does not prescribe roles to be defined, so organizations are free to define them according to their needs.

    Regarding responsibilities, ISO 27001 only requires the definitions of these responsibilities:

    • ensuring that the ISMS conforms to the requirements of the standard
    • reporting on the performance of the ISMS to top management.

    Other responsibilities the organizations can define according to their needs.

    These articles will provide you a further explanation about roles and responsibilities:

    These materials will also help you regarding roles and responsibilities:

  • Strategies for training employees in ISO 9001

    Try small blocks of time with very specific objectives linked to business results or business benefits.

    Use different approaches: classroom training; games that people play and simultaneously test topics related with ISO 9001 – ISO 9001 comes as answer to a problem and not as something pushed; on-job training where you start with what people do, with the purpose of what they do, with what can go wrong and how ISO 9001 can help minimize wrongs and increase rights.

    The following material will provide you more information:

  • Technical requirements for a physico-chemical lab

    Thank you a lot for this answer. The links are also very useful for implementation.

  • Requirement for laboratory recognition scheme in BIS

    1. What is the requirement for laboratory recognition scheme in BIS?

    The National Standards Body of India, the Bureau of Indian Standards (BIS), specifies the requirements for their laboratory recognition scheme on their website, available at https://bis.gov.in/wp-content/uploads/2020/06/LRS_23062020.pdf. This scheme recognizes laboratories in India or outside India as suitable for carrying out testing activities assign to it, performed on behalf of Bureau. This includes accreditation to ISO 17025:2017, along with other statutory provisions. For example, there are additional prescriptive requirements for impartiality, in addition to ISO 17025 where the laboratory has to submit a signed undertaking and a code of ethics a prescribed format that they supply.

    2. Which way it has to be aligned with BIS?"

    The national Indian standard (BIS) IS/ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories is identical to ISO/IEC 17025:2017. It is a mandatory requirement of the BIS laboratory recognition scheme that a laboratory is accredited to  ISO 17025:2017. All the test parameters of interest, prescribed in National Indian Standards must be included in the ISO 17025 scope of accreditation.

    For further information on ISO 17025, these links may be of interest:
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