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  • Retention time of documents

    As long as there are no legal requirements, and as long as there are no customer requirements, for example on contracts, organizations are free to determine the retention time for their records.

    Normally, in these cases, I advise keeping records for 3 or 4 years, to assure that records generated during a certification cycle will be available.

    The following material will provide you information about retaining records:

  • Questions to ask during ISO 14001 audit

    About auditing HR you can focus your attention on competence requirements for employees:

    • Are competence requirements defined?
    • Are competence gaps determined?
    • Are actions to close those gaps defined?
    • Are those actions implemented?
    • Is the effectiveness of those actions evaluated?

    About the other departments, use the list of environmental aspects as the basis for developing your checklist:

    • What significant environmental aspects were determined for each department?
    • What kind of actions were defined to control operations, or to improve prevention and response to emergency situations?
    • What kind of monitoring is being followed?
    • Any nonconformities? How were they treated?

    You can find more information below:

  • CARs

    You say you document a lot of CARs, sometimes for small things. Perhaps your organization is confusing the development of corrections with the development of corrective actions. The development of actions to eliminate nonconformities, with the development of actions to eliminate the cause(s) of nonconformities.

    Whenever a nonconformity occurs an organization must correct the situation:

    https://www.screencast.com/users/ccruz5284/folders/Default/media/72e0c8d5-12cc-4ec4-a6ed-662a460eb3e9 

    The timer in the figure means that normally this must be done as quick as possible, to avoid unintended use.

    What happens can be described as below:

    https://www.screencast.com/users/ccruz5284/folders/Default/media/0257e9b3-4df8-4d4f-bf29-2e24fa4a2cba 

    An organization has a standard way of working and operates according to that standard. Then quality is check. If everything is OK the circle is closed and the organization decides to continue to use the standard. If a nonconformity is found the organization has to correct the situation and ask: Can we still trust in our standard or should we improve it? If the decision is: We need to improve the standard! The organization jumps from the cycle of control into the cycle of improvement:

    https://www.screencast.com/users/ccruz5284/folders/Default/media/42888aff-f383-4de6-ab4c-cd706e15cc33 

    A well-used CAR is only used when an organization decides that improvement is needed: An experiment has to be planned, performed and results check. If the results are positive, the decision is to make the change experimented become the new standard

    So, a CAR should not be used automatically to treat a nonconformity. A CAR should only be used when an improvement is needed.

  • Auditor certification requirements in ISO 14001

    Each organization has the authority to determine its competency requirements for its internal auditors. Normally, organizations consider that internal auditors should have knowledge of the audit criteria (ISO 14001:2015 in this case) and should have training in internal audits. You can even decide that an auditor has to study a book on audits or attend an online course and do an in-house exam. Internal auditor competence requirements can be established in a job description, for example.

    I would recommend training about ISO 14001:2015 and an internal audit course. As a plus I would recommend that you participate as auditor, making part of an audit team, in 2 or 3 internal audits. Attention, I don’t recommend that internal auditors perform global internal audits. Normally, they don’t have time and experience for that, I recommend splitting the scope of the quality management system into 3 or 4 audits along a year.

    You can find more information below:

  • FMEA:2019

    First of all, I should mention that there is no document named FMEA 2019. I guess you asked about the new FMEA, its full name is AIAG & VDA FMEA Handbook 1st Edition 2019. 

    The type of FMEA application is determined by the customer-specific requirement. If your automotive customer-specific requirement has stated that you should implement the new FMEA, then you shall be using this new FMEA application before the IATF 16949:2016 certification audit. If you do not have any customer-specific requirements regarding FMEA application, I recommend you apply the AIAG FMEA rev 4 manual due to this FMEA is already valid and useful. 

    For more information, please read the following article: 

  • What is FMEA, and how to apply it in IATF 16949 https://advisera.com/16949academy/blog/2017/09/06/what-is-fmea-and-how-to-apply-it-in-iatf-16949/

  • Annex A

    In general, justifications for applicability, or not, of controls from ISO 27001 Annex A are based on perceived risks and legal requirements (e.g., laws, contracts, or regulations).

    Considering that, these are some examples:

    • Control A.x.x is applicable to treat risks <include there the ID of the risks from the risk treatment table>
    • Control A.x.x is applicable to comply with a legal requirement <include here the name/number of the law, regulation or contract>
    • Control A.x.x id not applicable because there is no unacceptable risk or legal requirements, that demands the implementation of this control.

    Please note that included in the toolkit you have access to a video tutorial that can help you with the Statement of Applicability,  which provides examples with real data.

  • Procedures for IATF

    The procedure writing method for IATF 16949:2016 standard is not different from ISO 9001:2015 standard. 

    As you know a procedure states how the process needs to be done. 

    A procedure offers a general description of how a company meets a process requirement and the procedure consists of more specifics. 

    This includes scope, objective, responsibilities, references, application, specific tools, methods, measurements, and historical change of procedure.

     

    There are 7 steps in writing quality management system procedures for ISO 9001:2015 and IATF 16949:2016 standards. 

    These 7 procedure writing steps are listed below, respectively.

    1) Decide on the process limits.
    2) Gather the information.
    3) Align with other documents and processes.
    4) Define your document structure.
    5) Write your document.
    6) Get approval for your document. 
    7) Train the relevant employees. 
     

    For more information please to read https://advisera.com/9001academy/blog/2015/03/10/7-steps-in-writing-qms-policies-and-procedures-for-iso-9001/  and please visit our IATF 16949:2016 Documentation Toolkit ‘’ https://advisera.com/16949academy/iatf-16949-2016-documentation-toolkit/

  • ISO Obsoleted Documents

    If a document is made obsolete, it is replaced by a new version. If you later decide to return to use the structure or content that has become obsolete, you still must update the code that identifies the version again.

    Something like this:

    https://www.screencast.com/users/ccruz5284/folders/Default/media/f5b8cc0b-123a-45e2-a9f1-b8172fadf047

    Whenever you change a document you have to update the version counter. 

    You can find more information below:

     

  • Context & Interested Parties External and internal issue UNDER 45001

    Just as everything in the ISO 45001 standard, the internal and external issues from clause 4.1 need to be unique to the organization, and as such I really can’t list out the issues that will affect your company specifically. Additionally, the ISO 45001 standard is talking about top-level internal and external issues, much like those that senior management might identify in a SWOT analysis, and not necessarily the issues of individual processes or necessarily linked to interested parties..

    You can learn more about identifying these issues in the article: Defining the context of the organization according to ISO 45001, https://advisera.com/45001academy/blog/2016/02/03/defining-the-context-of-the-organization-according-to-iso-45001/

  • ISO 13485 certification

    These masks are class I medical devices, so they do not need a certified CE mark. It is enough that manufacturers have ISO 13485:2016 and masks must be done in accordance with ISO 14683:2014 Medical face masks — Requirements and test methods. Proof that these masks are prepared according to this standard must be written on the packaging and in Declaration of conformity which must provide the manufacturer.
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