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  • ISO 9001 Benefits, scope and main requirements

    which ISO should the best we apply for? 

    Answer:

    Does your organization want to use certification as a marketing tool? To whom does your organization want to influence? Consumers? Distribution companies? Other bottlers that may want to outsource their production to your organization? Check which ISO standard is more valued by each interested party: 9001; 14001 or 22000.

    What is the best benefit and scope of ISO 9001?

    Answer:

    About the scope, as you can see in this free webinar on demand - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope - https://advisera.com/9001academy/webinar/iso-90012015-clause-4-context-of-the-organization-interested-parties-and-scope-free-webinar-on-demand/ - it is a management decision, not a technical decision. The webinar explains some if the nuances behind different scopes. About the benefits, please check in this article - Six Key Benefits of ISO 9001 Implementation -https://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/ - which benefits are more valuable for your organization considering its particular situation and context.

    What are the main requirements of ISO 9001?

    Please check this article - ISO 9001 Requirements and Structure - https://advisera.com/9001academy/knowledgebase/iso-9001-requirements-and-structure/

    You can find more information below:

  • Equipment calibration certificate/test report

    You asked

    according to iso 17025:2017, who in the laboratory is responsible for: 1- reviewing equipment calibration certificates?

    I assume you are referring to a testing not calibration laboratory, meaning that “reviewing equipment calibration certificates” refers to review of calibration certificates supplied to you by an accredited calibration laboratory.

    The person responsible for the performance of test methods influenced by the calibrated apparatus is responsible, or alternatively the technical or laboratory manager. All personnel using the calibrated apparatus should however understand the certificate and know how the result outcome (performance) could impact on the validity of the performed test methods. The review of the certificate should ensure a) the supplier is / was competent,  b) the required metrological traceability is evident (traceable to International standards),  c) the necessary uncertainty and performance parameters are reported suitably to make an objective decision on the performance and risks and d) the specification and measured performance is acceptable to use the apparatus for the purpose intended.

    You also asked

    according to iso 17025:2017, who in the laboratory is responsible for: 2- signing of test report?"

    Typically an appointed and competent “signatory” is assessed by the laboratory’s accreditation body and they take responsibility for the technical validity of results. Often the laboratory manager will co-sign a test report, taking overall responsibility for the approval of a report to go to a customer. The laboratory’ s quality assurance process should specify this, meaning what objective checks and responsibility does a “signature” indicate. A laboratory should also document responsibility for confirming the validity of the results after evaluating control parameters such as internal and external quality control monitoring and data transcription (integrity). Who this is, will depend on the organisational structure.

    The following Academy ISO 17025 document template: Testing Report Procedure may be of interest, available at https://advisera.com/17025academy/documentation/testing-report-procedure/ It outlines the requirements for writing test reports, to meet the requirements of ISO/IEC 17025:2017 for reporting test results.

  • Internal and External issues

    There is no mandatory requirement to retain records of internal and external issues determination. So, organizations are free to decide how to do it. For example, you may create a register for internal and external issues. In my case, I like to translate internal issues as positive or negative (strengths or weaknesses) and the external issues also as positive or negative (opportunities or threats). This way I record internal and external issues with a SWOT matrix. Please check how I do it in this free webinar on demand - - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope - https://advisera.com/9001academy/webinar/iso-90012015-clause-4-context-of-the-organization-interested-parties-and-scope-free-webinar-on-demand/

    You can find more information below

  • Certification requirements for SME's - Automotive

    As I mentioned before, there is no clear link with the small business regarding the implementation of IATF or the supply of parts to the OEM customer.However, in order for new businesses to obtain an IATF certificate, there is a right called ‘’letter of conformance.’’  I share the details of this below from IATF Rules 5.

    5.14 Letter of conformance The purpose of the letter of conformance is to confirm that processes exist that satisfy the requirements of IATF 16949 and these "Rules" and where the client is not able to achieve IATF 16949 certification because of:

      a) a new site without twelve ( 12) months of internal or external performance data for the automotive production and/or service parts in the scope of certification

      b) an existing site that can demonstrate it is 

    5.14.4 Eligible for certificationOnce the client has twelve ( 12) months performance data for the new site or if the client on an active bid list receives a contract from the customer requiring IATF 16949 certification, the certification process shall proceed by the same certification body with an initial audit (stage 1 readiness review and stage 2) with a maximum reduction of 50% possible in audit days for the stage 2 audit (see section 5.2 and 5.4 g).The 50% reduction applies only to the initial audit and only if the initial audit starts before the expiration date of the letter of conformance. The reduction shall not be applied to the subsequent surveillance audit cycle.A member of the audit team that performed the initial audit for the letter of conformance should be assigned to participate in the initial audit and each surveillance audit of the three (3) year audit cycle.The stage 2 audit shall start before the expiration date of the letter of conformance. lf the timing is exceeded, the client shall start over with an initial certification audit (stage 1 readiness review and stage 2) and no reduction shall be applied.

     

  • Standard approach/Framework for meeting all Quality clauses

    APQP meetings should be held with team participation for both product design and development, as well as process design and development. 

    There is no standard application, it is made according to customer-specific requirements. My recommendation is to use AIAG's APQP and PPAP manuals which are Ford, GM, Chrysler and most of automotive customer project management requirements. 

    You can organize meetings according to the requests in the clauses 8.1-8.2-8.3 of the   IATF 16949: 2016 standard and the project management phases in these manuals.

    For more information feel free to visit the following:

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