Search results

Home / Search

Category:
Select
Select

11294 results

Guest

Guest

Create New Topic As guest or Sign in

HTML tags are not allowed

Select

Assign topic to the user

  • Resource Requirements

    You asked

    about Resource Requirements, 5.5 Metrological Traceability. As we are testing laboratory and not offering any calibration services does 5.5 need to stay in our Quality Manual or can I delete this?

    No, you cannot delete clause 6.5. Metrological traceability relates to measurement results, i.e in your case, your test results. All testing laboratories must establish and maintain metrological traceability of their measurement results. This is done via a documented unbroken chain of calibrations. For example, when you weigh a sample on a laboratory balance, the balance must  have a calibration with certificate where the calibration was performed according to ISO 17025 calibration requirements (e.g traceable weight set).This is one link in the chain.

    I suggest you read through the standard carefully – especially clause 6.4, 6.5 and Annex A and have a look at a similar question at https://community.advisera.com/topic/preparing-procedure-on-meteorological-traceability/. There are some links there that will help you.

    You also Asked

    17025 clause 8.1.3 Option B, our lab complies with option B so does that mean I can delete 7.2-7.9 from my Quality manual?"

    No, you can not delete clauses 7.2 to 7.9. If the laboratory already has ISO 9001 certification, then Option B applies. Clause 8.1.3 states two things. 

    Because an ISO 9001 QMS is in place, at least the intent of the management system requirements of ISO 17025, specified in 8.2 to 8.9 is met. The laboratory must include the management of tests on their scope in the 8.2 to 8.9 process, e.g. audit your test methods, and manage nonconformances and corrective actions as per your established (or modified) processes.
    The laboratory must also establish and demonstrate the consistent fulfilment of the requirements of Clauses 4 to 7. i.e add the requirements of clauses 4 to 7 to the existing ISO 9001 QMS.

    For more information and resource links, see a similar question and reply to ISO 17025 Quality Manual Option B at https://community.advisera.com/topic/iso-17025-quality-manual-option-b/

  • QMS Preventive Actions

    ISO 9001:2015 does not explicitly mention the term preventive action. However, the standard includes, in practice, the development of preventive actions by introducing the concept of the risk-based approach. When you assess the risks of a product or a process, and you decide to act, you are actually taking preventive action.

    You can find more information below:

  • Certification for some of the company's departments

    year enlarge that scope. For example, many hospitals do it. They start with a service like blood analysis, and then enlarge with radiology, and then with urology, and so on.

    So, if you use the word departments in this way, your company can do it.

    You can find more information below:

  • Available state statistics

    Processing personal data for statistics, even though the personal identifiers are removed, is still considered a personal data processing operation and it falls under GDPR, if the state is a member of EEA or if the affected data subjects are on EEA territory. However, the publishing of de-identified personal data is not considered processing of personal data, unless the data can be used to identify a data subject. The key to understanding this is the definition of “personal data” in article 4 GDPR: “any information relating to an identified or identifiable natural person (‘data subject’)”. So if the information published by a state leads to the identification of a natural person – either by another person or by an algorithm – that information is considered personal data. 

    You can find more details at this link:

  • ISO 13485 toolkit ref 11

    If you are a distributor, then you need to understand that your "production" is basically service provision. SO everywhere in the documentation that says "production," you can put "service". 
    Your point of view regarding 3.3.7 is OK. You cannot exclude this; you will just use the identification provided by the manufacturer. You need to have in your system the possibility to track to which customer went which LOT of medical devices.   

  • Security objectives in Conformio

    This approach will not cause problems in the system.

    However, by developing its own objectives, the organization will have to identify how they can be related to Conformio processes and modules (i.e., which information will be needed and where it can be found), while the suggested objectives in Conformio already have a defined logic related to them (e.g., suggested data sources), making using them easier to fulfill standard’s clauses related to security objectives.

  • ISO 27001 Internal Auditor

    First of all, sorry for this confusion.

    The toolkit you have is still current.

    The documents from sections A.5 and A.18 are not missing from the toolkit – you can find them here:

    • A.5 – all the documents from folder “08 AnnexA” cover the requirements about information security policies (A.5.1.1 and A.5.1.2)
    • A.18 – these documents are covered in the toolkit in folder "02 Procedure for identification of requirements”

    Included in the toolkit there is a List of Documents file that shows which documents cover which clauses of the standard.

  • DEVOPS position according to ISO27001

    Awesome Rhand! Thank you so much for your answer

  • Audit management

    I’m assuming that by “ISO 27001” you mean “ISO 27001 Toolkit”

    Considering that, if you plan only on managing audits, the toolkit would be the best choice, because you can use only the documents related to internal audit.

    Conformio is a platform to manage the whole implementation and maintenance of an Information Security Management System from definition of security objectives to continual improvement, which requires much more effort to manage (e.g., document management, risk assessment, and treatment, incident management, etc.).
Page 114 of 1130 pages

Didn’t find an answer?

Start a new topic and get direct answers from the Expert Advice Community.

CREATE NEW TOPIC +