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  • AS9100D Sections 9 and 10

    When the standard is asking you to use the process approach, they are not saying that each clause will comprise a process. A process is anything that you do that takes inputs, does something to them, and creates outputs (see the AS9100 introduction section 0.3). This means that you need to identify all of the processes you do (and you will find that everything you do is a process) to create your products and services, and how these interact (as per clause 4.4).

    So, you will need to identify processes such as contract review, design, purchasing, etc. as your processes and see what the requirements of those processes are to meet AS9100, customer requirements, legal requirements, and your own internal requirements. These processes interact and make up your QMS.

    As for AS9100 sections 9 & 10, companies will very often have processes that align with these sub-clauses; for instance, internal audit is a process, management review is a process, corrective action is a process, and improvement activities is a process. Monitoring and measurement may not be a process in and of itself, but all processes will need monitoring and measurement, and your company may also have some key performance indicators (KPIs) that management uses to know the QMS is working well.

     

    Since the process approach comes from the ISO 9001 management principles, you can get more information in this article from 9001Academy: ISO 9001: The importance of the process approach, https://advisera.com/9001academy/blog/2015/12/01/iso-9001-the-importance-of-the-process-approach/

    You may also want to check out this 9001Academy webinar: The Process Approach - What it is, why it is important, and how to do it, https://advisera.com/9001academy/webinar/iso-9001-process-approach-free-webinar-on-demand/

  • Appointing consultants for implementation

    The point that comes to my mind is familiarity. The person who did the Gap Analysis is already familiar with the organization, has already contacted people and, has done so with a general approach, not detailed, which allowed him/her to develop a big picture of the organization.

    The following material will provide you more information consultants and implementation:

  • Renewing mandatory documents

    Let us use the list from this article - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/

    • Scope of the QMS (clause 4.3) – Only need to be updated after a formal decision to change the scope;
    • Quality policy (clause 5.2) - Only need to be updated after a formal decision to make changes in the quality policy;
    • Quality objectives (clause 6.2) – Should be updated whenever your organization decides to update objectives, or targets or timeframe;
    • Criteria for evaluation and selection of suppliers (clause 8.4.1) Only need to be updated after a formal decision to make changes in the criteria

    The following material will provide you more information about documentation:

  • Relevance of EMS to communities

    The community, the neighborhood, the local authorities, may be relevant interested parties for an environmental management system. When an organization determines its environmental aspects and compliance obligations some may be related with these interested parties. So, implementing an environmental management system may be seen as a proactive action by an organization to be more environmentally responsible and transparent. For example, if an organization has relevant environmental aspects that impact the community, may have difficulties in expanding operations without a proactive and transparent communication with those neighbors. 

    You may find more information in the following links:

  • ISO 27001 certification coverage

    The certification coverage will depend on the ISMS scope definition. If it is issued to corporate X, then it is needed to verify which locations (i.e., addresses) were included. If the address of any subsidiary or affiliated entity is included, then it is covered by the certificate (of course this entity will have to go through all certification process together with the main Corporate X)

    Adopting a single certificate for all units or separated ones for each unit is a business decision, depending on their objectives and strategies, but in general organizations like these adopt the model of one certification for each unit, because a change on a unit does not impact the certification of other units.

    These articles will provide you further explanation about scope definition:

    This material can also help you:

  • Information security requirements

    First is important to note that, according to ISO 27001, the security requirements to be included in contracts with suppliers must be based on the results of risk assessment and legal requirements your organization must fulfill.

    Considering that, some common requirements are:

    • Right to audit: clause ensuring the organization has the right to audit and test the security controls periodically, or upon significant changes to the relationship.
    • Notification about security breaches: clause requiring the provider to inform the organization in a timely manner regarding any security breaches that may impact the organization’s business.
    • Adherence to security practices: clause requiring the provider to adhere to the organization’s security practices, and to communicate any situations where this adherence is not achievable, helping to prevent security gaps or conflicts that could impair security performance.

    This article will provide you further explanation about security clauses for contracts:

  • ISO 27001 implementation

     ISO 27001 and ISO 9001 are independent standards, so you can implement ISO 27001 without implementing ISO 9001, but it is important to note that by adopting ISO 9001 concepts can make the implementation of ISO 27001 easier.

    This article will provide you further explanation about ISO 9001 and ISO 27001:

    This material will also help you regarding ISO 9001 and ISO 27001:

  • Inventory of assets

    To fulfill the requirements of controls related to inventory of assets of ISO 27001 Annex A (controls A.8.1.1 and A.8.1.2), you do not need to have a specific policy or procedure for asset management/inventory. It is sufficient to have the records showing the asset and the owners.

    This article will provide you further explanation about inventory of assets:

  • Purpose of a company´s Data Protection Policy

    The right answer is "d. All of the above" because Data protection policy allows a company to guide its employees on key aspects of GDPR by establishing its principles in line with the GDPR and it is a key component of the accountability principle. 

    GDPR structure establishes principles on how organizations must process personal data, such principles must be adapted by each organization to their own data processing activity. 

    Answer c does not imply that the company formulates "new" principles, as principles are inside the GDPR. It implies that principles in line with GDPR are formulated into company principles to adapt to concrete company data processing. 

    I.e. GDPR does not say company how long to store collected data, it establishes the principle of minimization of processing. In the Data Protection Policy, however, the company must set a principle to help employees to deal with this principle. The company may establish that collected CVs from job applicants are deleted as soon as the job position has been covered. From this principle comes the rule to HR department "delete every CV you received as soon as the selected candidates start working and no later than the trial period ends." Therefore, in this example, there is a GDPR principle (data minimization), a company principle (collected CVs must be deleted) and a rule for the HR department. 

    In other words, Data protection policy explains how employees and company will process data and, though it is not directed to customer, it helps Supervisory Authority to verify that anything is declared in the Privacy policy (i.e. how data are processed) is coherent with principles and instruction given to employees, and with the internal company interpretation of GDPR. This is why the correct answer is d. All of the above.

    For more information, see the following article:

  • Contents of the Data Protection Policy according to GDPR https://advisera.com/eugdpracademy/knowledgebase/contents-of-the-data-protection-policy-according-to-gdpr/

     

  • Addressing TPM

    Unfortunately, our IATF 16949 documentation toolkit does not contain TPM documents. However, these are some documents in our toolkit which are related to equipment maintenance. There are some documents under our ITAF 16949 Toolkit which are related to equipment maintenance. They are located in the folder 16 Procedure for equipment maintenance and measuring equipment. You can see the link address as below. These documents are very limited for TPM activities.

    Feel free to check out our IATF 16949 Documentation Toolkit and the List of documents here:

  • IATF 16949:2016 Documentation Toolkit:  https://advisera.com/16949academy/iatf-16949-2016-documentation-toolkit/

    IATF 16949 clause 8.5.1.5 defines requirements for total productive maintenance activity, but it does not define how it needs to be documented.

    As you know, TPS is a system of maintaining and improving the integrity of production and quality systems through machines, equipment, process, and employees to add value to the organization.

    Toyota production system defines TPM activities and there are different levels of TPM, from level 1 to level 5.It is not easy to apply full TPM in the first step; this is a culture for management for all organization activities, not only maintenance but also full systematic of organization management with Quality, Production, Maintenance, HSE, Planning,etc.

    You can find more detailed documentation in Toyota TPM culture, TPM books and/or TPM trainings. 

    Documents and forms that can be included as follows:

    a) Daily machine control forms by operators

    b) Weekly, Monthly, 3 Monthly, 6 Monthly, Yearly (accordign to machine/equipment situation and handboook) maintenance plan ans records

    c) Machine maintenance wotk instructions for new maintenance

    d) Break down records with MTTR and MTBF target and results

    e) OEE targets and results

    f) Spare parts for machines and equipments, minimum amd maximum levels

    g) Machine break down reaction plans and operator trainings

    h) Break down analyses and corrective action plans for improvements.
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