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  • Chance to avoid the de-certification process

    "My plant has an open but 100% resolved NC due to poor performance with GM. They are scheduled to have the special audit in September to close the NC but meanwhile, the performance with the customer has been degraded instead of improving. Due to the increased number of complaints, they will still stay Red with GM until at least January 2021.The question is:1. What is the chance to avoid the de-certification process?

    I recommend you to be in close contact with your certification company as this issue is very critical. You should improve your GM performance results without wasting time. I would like to give you some information about this topic about IATF rules.

    IATF revision 5 rules are written for decertification in item 8.1 "a"

    The start date of the decertification process shall be the date of any of the following:

      1. The certification body receives a performance complaint against the client from an IATF OEM member, its relevant IATF Oversight office, or any automotive customer of the client.

      2. The client advises the certification body of a special status condition from an IATF OEM. Notification from the client to the certification body shall occur within ten (10) calendar days from receipt of the special status condition or otherwise specified by the customer

    The IATF revision 5 rules are set out in article 8.2 as follows:

    8.2 Analysis of the situation

    The certification body shall undertake immediate analysis of the situation to determine the severity of the situation and risk to the customers of the certified client, taking into account, where applicable, IATF OEM customer-specific requirements. This analysis shall be completed within a maximum of twenty (20) calendar days from the start date of the decertification process. Where major nonconformities are raised, the analysis shall include a review of the client submitted root cause including the method used; analysis, results, and implemented correction (see section 8.1 a) and 8.1 c). When the affected site is part of a corporate audit scheme, the analysis shall include a review of the concern and its impact across all sites.

    According to the rules, since there is a problem with a performance from GM, the de-certification process has to be started. So because you received bad performance notification, the de-certification process has to be started.

    IATF Rules stated in revision 5, item 8.4 as follows:

    8.4 Verification

    The certification body shall verify the effective implementation of the identified corrective actions from the certified client within a maximum of ninety (90) calendar days from the start of the decertification process. The decision to conduct onsite verification shall be at the discretion of the certification body. The certification body shall maintain records of the justification of the decision.In situations where the decertification process has been initiated due to major nonconformities (see section 8.1 c), the certification body shall conduct onsite verification ( see section 5.11.4) and the onsite audit shall be considered a special audit (see section 7.2) and be entered in the IATF database.In situations where the decertification process has been initiated due to a special status condition from an IATF OEM (see section 8.1 band section 1 0.0), the certification body shall conduct onsite verification and the onsite audit shall be considered a special audit (see section 7.2) and be entered in the IATF database. In situations where the decertification process has been initiated due to a surveillance audit not conducted on time (see 8.1 e), the onsite audit shall be the rescheduled surveillance audit and be entered in the IATF database.In situations where the corrective actions are not effectively implemented, the audit team shall recommend the withdrawal of the certificate.

    Can we present a newer plan approved by GM and the NC be carried over and be reviewed during a future special audit? Thank you very much.

    In the special audit that will take place in September, you should present your detailed root cause analysis and corrective action plan. Even in this audit, the recovery trend, which is the result of your actions, should be seen on the GM portal. If there is no improvement trend, the additional time may be taken by the decision of GM and Certification company.

    As stated in IATF Rules revision 5, item 8.5: The certification body shall make a decision to reinstate or withdraw the certificate, which shall include a certification decision (see section 5.12) within a maximum of 110 calendar days from the start of the decertification process. In other words, within 110 calendar days, the certification company has to decide on the subject.

  • ISO 9001 List of Documents needed for ISO Surveillance Audit

    Unless the audit team previously specifies any particular set of documents to be seen, for example when sending the audit agenda, you must be prepared to show any documents or records. Remember that some topics are always audited: internal audits; corrective actions, complaints, management review, quality objectives, risks and opportunities and context.

    You can find more information below:

  • ISO 9001 Project Phase

    Perhaps a 2x2 matrix where you relate the former and the actual organization structure could be useful to relate any change of responsibilities and authorities among functions. Then, it is a matter of updating documentation already created.

    The following material will provide you more information:

  • Requirements for implementation of ISO/IEC 17025:2017 in quality control lab

    The application and requirements of ISO 17025 for a Quality control laboratory is the same as any other testing laboratory. The only difference is that your client is internal, being the production facility. This means that the context is different, so the way you handle, for example your risks, opportunities and impartiality could be to a different extent. The laboratory may also, for example have a basic service level agreement with production  and the reporting requirements may be simplified, on agreement with production. Depending on your sector, there could be other interested parties, such as regulators and other standards that may in fact require your quality control testing laboratory to be ISO 17025 accredited. Either way, both the laboratory and production will benefit from the efficiency provided by the management system.

    Have a look at the free demo of the ISO 17025 Documentation Toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/ to provide further support.

    The following articles may be of interest:

    Six key benefits of ISO 17025 implementation at https://advisera.com/17025academy/blog/2019/10/18/six-key-benefits-of-iso-17025-implementation/
    What is ISO 17025? at https://advisera.com/17025academy/what-is-iso-17025/

    Also have a look at similar topics in the 17025 Expert Advice Community:

    ISO 17025 for internal quality control laboratory at https://community.advisera.com/topic/iso-17025-for-internal-quality-control-laboratory/
    Is it possible for the company's internal lab to get ISO accreditation? at https://community.advisera.com/topic/is-it-possible-for-the-companys-internal-lab-to-get-iso-accreditation/
    Assuring impartiality and confidentiality (for an internal laboratory) at https://community.advisera.com/topic/assuring-impartiality-and-confidentiality/

  • ISO 9001 design and development

    Perhaps each big engineering equipment is made to order according to specific customer needs. Validation can be done through simulations and testing under intended user conditions or, for example, during installation with tests. For example, When I worked in the chemical industry my company ordered equipment, a chemical reactor for example, during installation I remember doing water-pressure tests and shaft rotation tests to confirm safety and performance.

    The following material will provide you more information:

  • Clause 4.1 internal and external issues

    We received this question:

    Thanks Rhand, for our readiness assessment the external auditors issued a finding that we did not explicitly define a policy/procedure describing the context of the organization,  they went on further to say we should determine if any internal and external issues would impact the intended outcome of the ISMS.

    You guys are saying we do not need to document the context of the organization but we should have a procedure to check internal and external issues.

    What I am going to do is add internal and external issues to our yearly compliance check with a step to ensure we determine whether any of these issues impact the intended outcome of the ISMS. Do you think this is sufficient?

    Answer: Regarding your proposed solution, adding an internal and external issues to your yearly compliance check would be sufficient to meet standards requirements.

    Please note that it is not a matter that "You guys are saying we do not need to document the context of the organization...", but that the ISO 27001 standard itself does not require such documentation. Considering the standard, the issue raised by the external auditors is at most an opportunity for improvement (not a nonconformity).

     As a suggestion, you should politely ask your external auditors for clarification about which clause part of the standard requires a policy/procedure describing the context of the organization.

    For further information, see: Explanation of the basic terminology in ISO standards https://advisera.com/27001academy/blog/2015/01/12/explanation-of-the-basic-terminology-in-iso-standards/

  • ISO Log Retention

    ISO 27001 does not prescribe keeping maintenance logs.

    For ISO 27001, the need to keep logs is defined by the results of risk assessment and applicable legal requirements, and also by the need to prove to auditors that security processes are being performed. These are the elements that will help you define which information must be logged, as well as for how long.

    These articles will provide you a further explanation about logging:

    This material will also help you regarding logging:

  • Corrective and preventive action

    As far as I understood your question you presented this scenario:

    https://www.screencast.com/users/ccruz5284/folders/Default/media/7b63b064-7e37-44dc-9898-138e60057632

    I can add more information:

    https://www.screencast.com/users/ccruz5284/folders/Default/media/8df2deda-e7f3-4ff9-8690-decbf86a5fc3

    ISO 9001:2015 no longer mentions preventive action. So, will only speak about corrective action. Go back to your production and raise a corrective action request. Start by stratifying the defects type. Use, for example, a Pareto Chart. For the more common defects try to find the root cause(s).

    You can find more information below:

     

  • Choosing certification

    Unfortunately, Advisera’s scope of work is around management systems not product certification. So, I cannot tell you which certifications are needed in each country. If its your first experience of exporting outside Asia, I would rather start with one market, perhaps the less difficult to penetrate. Find certifications required, apply and enter the market. In more mature markets it may be useful to add a management system certification for quality and/or environment. For example, in Europe I see a lot of manufacturers for mature markets applying for ISO 14001 certification to cater clients and consumers that value that message.

    Please check this information below with more detailed answers:
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