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There is no definition on this subject in the IATF 16949: 2016 standard or the ISO 9001: 2015 standard. This issue may vary from company to company.
In some organizations, all training documents are stored by the HR department. In some companies, HR department stores only for office staff, and for workers who are production employees, the relevant department stores. In short, this subject varies according to the size and structure of the companies.
According to IATF 16949:2016 standard, while making audit plans for the system and for the manufacturing process, it should be considered risk-based.
These risks should be determined as follows:
The risk level should be determined according to these situations and the frequency of audits should be determined in a 3-year period. There is no requirement for one audit per year. If there is no risk, a process can be audited once in 3 years, or if there is a risk, another process can be audited 3 times a year.
The IATF 16949: 2016 standard explains as follows.
For System Audit; The organization shall audit all quality management system processes over a three-year audit cycle, according to an annual program, using the process approach to verify compliance with this Automotive QMS Standard. Integrated with these audits, the organization shall sample customer-specific quality management system requirements for effective implementation. The complete audit cycle remains three years in length. The quality management system audit frequency for individual processes audited within the three-year audit cycle shall be based upon internal and external performance and risk. Organizations shall maintain justification for the assigned audit frequency of their processes. All processes are required to be sampled throughout the three-year audit cycle and audited to all applicable requirements in the IATF 16949 standard, including ISO 9001 base requirements, and any customer-specific requirements.
For Manufacturing Process Audit; Each audit does not have to cover all shifts in one audit (for example an audit of the pressing process could be done on shift 1 and 2, sampling shift changeover in year 1, and then in year 2 or 3 an audit undertaken on the third shift for pressing). However, all manufacturing processes must be audited on all shifts over a three-year cycle, the frequency depending on risk, performance, changes, etc.
For more information, see:
ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes - is a standard that is applicable for all manufacturers of medical devices, it is considering the quality management system of the manufacturing the medical device.
EN 14683:2019 Medical face masks. Requirements and test methods – is a standard that covers requirements under which medical masks must be produced and which tests must be performed to prove that medical masks are in compliance with this standard.
So, those two standards complement each other, which means that medical masks must be designed and made according to the EN 14683:2019, but the manufacturer must have implemented a quality management system in accordance with ISO 13485:2016.
For more information about ISO 13485:2016 please see the following articles:
Start by thinking about who the cemetery’s customers are. What kind of services does the cemetery offer to its customers? From all the services provided, will all of them be part of the quality management system (QMS)?
For example, without the proper vocabulary of the area, I can imagine something like: we provide services of burials, cremations, exhumations, and transfers.
The scope defines and communicates the borders of the QMS. Consider the purpose of the scope, it should clearly describe the type of Products and Services covered by the system and provide sufficient information, preventing the transmission of erroneous or misleading information about what the organization covers in the QMS and what it is able to provide to its customers.
The following material will provide you more information:
You can set a project implementation budget target and look at the realization rate of this budget. The project implementation budget target should be set on an individual project basis. The project budget should be determined on a project basis. When you define the project budget, you should take into consideration of;
- Number of the tool to be made,
-the new machine to be taken cost,
- the number of samples to be made,
- investment cost,
- Product validation, test cost
- New test machine investment
- travel cost to customer or supplier site,
- supplier investments,
- etc.
No, it is not mandatory to put in place such processes while implementing a QMS based on ISO 9001:2015. Please check the content of the antepenultimate paragraph of clause 0.4 of ISO 9001:2015.
Please check this free webinar on-demand - 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/ - where I explain how to develop process mapping, drawing a model of how an organization works, based on the process approach, and how to draw a flowchart describing each process.
The following material will provide you information about processes:
Please note that ISO 27701 was developed as an extension of ISO 27001 and ISO 27002. Considering that, ISO27001/GDPR toolkit is approximately 80% compliant with ISO 27701. The remaining 20% refers to small adjustments to include the protection of privacy in the context of the documents (e.g., where a document states “information security”, it now should state “information security and privacy”, and applicable controls should consider complementary privacy protection measures), and the inclusion of applicable controls specifically developed for ISO 27701 (in a total of 49 controls).
For further information, read:
These articles will provide you a further explanation about ISO 27001:
These materials will also help you regarding ISO 27001:
Records are specific types of documents used to evidence that activities were performed and/or results were achieved, and to be compliant with ISO 27001 standards you need to keep some records about incident handling, such as the incident log, for a period of time-related to some need defined by the organization, or by a legal requirement that must be fulfilled (e.g., a law, regulation or contract). Once the retention period is over you can dispose of the record, simply by deleting them, or through specific procedures to prevent them to be accessed once disposed of.
Additionally, once a record is created, it cannot be amended, so access to such records need to be controlled.
This article will provide you a further explanation about managing records:
These materials will also help you regarding records management:
Let me clarify how I interpret your question:
Your organization is implementing a quality management system. A quality management system requires that an organization performs internal audits by a competent person, an auditor. Normally, organizations decide that internal auditors should have a good knowledge of the standard and of good auditing practices. It is up to each organization to decide the extent of knowledge needed and the way to evidence it.
If your organization determines that internal auditors have to go through an internal auditor course and that the evidence is the certification test, then you must have the certification test to evidence competence. If you fail to pass, you must retry. By the way, with our - Free online training ISO 9001:2015 Internal Auditor Course: https://advisera.com/training/iso-9001-internal-auditor-course/ - you have a second attempt without paying and you only repeat the part of the exam where you failed.
You can find more information below: