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  • Addressing nonconformities in ISO 9001

    Let us look at ISO 9001:2015 clause 9.2.2 e)

    As a good practice, after completing an internal audit the results should be reported to relevant managers, those with more knowledge and authority about the areas or processes audited. Not all nonconformities have the same importance. Some are minor failures and only deserve a correction. Others are more relevant and represent a systemic or major failure of the quality management system. So, major nonconformities require both a correction, the elimination of the nonconformity, and a corrective action, an action to eliminate the cause(s) of the nonconformity.

    https://www.screencast.com/users/ccruz5284/folders/Default/media/23ba1b91-d650-4733-b049-1ee0ca13526f

    You can find more information below:

  • Launching environmental management programs

    ISO 14001:2015 no longer mentions “environmental management programs”. However, organization scan still use the concept.

    Based on strategic orientation and on its significant environmental aspects and impacts, organizations write an environmental policy with a set of commitments. Policy commitments are just words. Words that must be translated into a set of environmental objectives. Meeting the environmental objectives demands transforming the organization with a set of action plans. One can say that an environmental management program is a set of action plans in order to meet the environmental management system objectives.

    For example, last year I worked with an organization that had two noncompliance concerning legislation:

    • No monitoring of air emissions and non-approved version of chimney;
    • No monitoring of environmental sound

    Each one of these noncompliance situations gave origin to a specific action plan. The set of those two action plans could be called an environmental management program to deal with legislation. Another was about dealing with wastes, with two major individual action plans, one for wastes, and another for hazardous wastes.

    Please check below information about ISO 14001:2015:

  • Importance of data quality and data protection

    1. Why are data quality and data protection important in the organization?
    2. When considering information data management as a business resource that needs to be governed. What should this governance ensure?
    3. Using data from your data lake what do you need to consider related to GDPR?

  • Using customer's data from the questionnaire

    Thank you. Am I permitted to create this privacy policy myself?

    Yes, you can create it by yourself. Advisera has developed some templates to make it easy to develop your own privacy notice.

    You can check out our document template here: EU GDPR document template: Privacy Notice https://advisera.com/toolkit-documents/eu-gdpr/privacy-notice/

    Should individuals receive this privacy policy if they've chosen to share their contact details with me?

    Individuals should read and consent to your privacy policy when filling your questionnaire. You can insert a link on a questionnaire to allow individuals to read your privacy notice.

  • Environmental management manual

    What is the purpose of an environmental management manual?

    Answer:

    ISO 14001:2015 does not require an environmental management manual. Organizations may decide having one or not. So, if one organization decide to have an environmental management manual it is free to determine a purpose for it. Working with organizations, I advise the creation of an environmental management manual as a document to present the environmental management system, its policy, its main processes, its documents and main responsibilities.

    why language is so important in writing operating procedures?

    Answer:

    Language is important while writing operating procedures because we want a document to be clear, to be precise, to be able to be understood by those who will read and apply it.

    Please check below information about ISO 14001:2015:

  • IATF 16949 standard documents in digital form

    It is possible to find the IATF 16949: 2016 standard online.

    Since the right to sell the standard is in the IATF organization; you can buy it as pdf or hard copy from the websites of SMMT, AIAG, VDA.

    For more information, please read the follwoing article:

    • What is IATF 16949? https://advisera.com/16949academy/what-is-iatf-16949/

    • Clause 8.2.3.1

      If the delivery date is “blank” it may be considered a finding by an auditor, like me.

      Every organization works with unorganized clients. At the end of clause 8.2.3.1, one can read: “The customer’s requirements shall be confirmed by the organization before acceptance when the customer does not provide a documented statement of their requirements.”. What you report is a typical situation framed by this text from the standard. In this situation, the supplier should evaluate the best possible delivery date, as soon as possible may be interpreted as “fast”, and send an order confirmation stating what was ordered, in what quantity, at what price, to be delivered where and when. So, if that order confirmation sent has no answer, it means that the client accepted the conditions.

       

    • Control of outsourced activities

      Clause 8.1.4.3 Includes the requirements for outsourced activities as part of the purchasing requirements for the OHSMS. The gist of these requirements is that you need to control these activities when they happen, that your outsourcing meets legal requirements, and that you define the control needed to ensure OH&S requirements are covered when outsourcing. This could include identification of OH&S hazards for the supplier.

      You can learn more on hazards in this article: How to identify and classify OH&S hazards, https://advisera.com/45001academy/blog/2015/05/14/how-to-identify-and-classify-ohs-hazards/

    • Laboratory activity - where to draw the line

      You asked why a testing laboratory, who conforms to ISO 17025 requirements to verify and calibrate their own equipment, cannot offer calibration services and calibration certificates for clients.

      Although ISO 17025 is applicable to both testing and calibration laboratories, the application of the standard differs. From a laboratory point of view, there are specific laboratory activities for calibration and testing laboratories, involving different technical and performance capability of equipment, operational activities and risks. Reporting requirements are also different. For the required purpose of metrological traceability to international units, an unbroken chain of calibrations is required, linked to appropriate references. For each chain a measurement uncertainty must be calculated so that the overall uncertainty can be known. Only then can a testing lab determine if a method is adequate for use. Testing laboratories generally rely on competent calibration laboratories to meet these specific metrological needs.

      From an accreditation point of view, accreditation bodies are themselves accredited for specific scopes, where testing and calibration scopes are independent and programs are managed separately. This said, an organisation could, in principle, apply separately for accreditation as a Calibration laboratory and as a Testing laboratory, each with their different range of activities and scope of accreditation

      Have a look at another ISO 17025 answered question that all addressed this topic - Calibration of measurement equipment, available at https://community.advisera.com/topic/calibration-of-measurement-equipment//

    • New measurement system

      I assume that by “CMM” you are referring to coordinate-measuring machines.  I cannot tell if the question is in the context of a calibration laboratories service, a legal metrology verification laboratory, or generally as a product quality assurance and quality control tool for a workshop (machining and assembly) in a manufacturing sector. There are a number of standards for measuring the geometry of physical objects. The ISO publication list is available at https://www.iso.org/committee/54924/x/catalogue/ Which are relevant will depend on the application, country, sector and any other regulations.  It could be, for example, a recognised national standard or other (based on an international standard) to which a verification laboratory will be granted accreditation.

      If the context is metrology for calibration laboratory, the ISO 17025 standard will require method development and validation and the evaluation of measurement of uncertainty to prove the system to be appropriate for its defined use.  ISO 17025 requirements must be met to ensure competency to produce consistently reliable results. 

      The ISO 17025 toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/. includes the procedure for validation and verification of methods, named Test and Calibration Method Procedure, along a Test Method Development, Verification and Validation Register and Test Method Development, Verification and Validation Record. 

      Have a look at other ISO 17025 answered questions for further information which may be of interest.
      Procedures for validation and verification of methods at https://community.advisera.com/topic/procedures-for-validation-and-verification-of-methods/
      Methods verification at https://community.advisera.com/topic/methods-verification/
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