Answer:
By QMS file I believe you mean knowing what documents and records are required. Also important to understand ISO 9001 structure and read something about the PDCA cycle and the process approach.
Answer:
An organization is an open system that interacts with the outside world. For example, new technology can make the product or the production process obsolete. For example, legislation can imply changes in the way a product is manufactured or is sold on the market. For example, political changes can support or hinder exports for your organization’s main market.
An organization has also its own inside world that can affect its performance like, for example: difficulties in finding new employees; outdated manufacturing equipment that does not allow efficiency levels required by the competition prices; lack of know-how about selling online.
Answer:
When an auditor performs an audit, he or she compares the reality with the audit criteria. If the reality is not according to the audit criteria, we have a Non-Conformity. If the reality is according to the audit criteria, we have a Conformity.
Even when the auditor identifies a Conformity he or she can also find, due to his experience, an Opportunity for Improvement. Some auditors also use word Observation.
Based on ISO 19011:2018 one can say that:
Non-Conformity – it is when an audit criteria, a requirement is not fulfilled
Conformity - it is when an audit criteria, a requirement is fulfilled
ISO 19011:2018 and ISO 9000:2015 do not have definitions either for Opportunity for Improvement or for Observations. Nevertheless ISO 19011:2018 states that the findings of an audit can lead to opportunities for improvement but onl y defines improvement. An activity to improve performance.
So, the evidence presented indicates that a requirement has been effectively implemented, but based on auditor experience and knowledge, the organization can take advantage of modifying its approach.
Answer:
I can give you my own experience; I have done that several times without problems raised by certification bodies.
If you check the definition of auditor on ISO 19011:2018 versus the one on ISO 19011:2011 you can see that the independence requirement was dropped. See also ISO 9001:2015 clause 9.2.2 c), what is important is to ensure objectivity and impartiality. I work on that by preparing my checklists and leaving audit reports that describe precisely what I found.
Both work just the same as long as the deletion or anonymization is permanent.
Official versions
Answer:
That E stand for the official version in English. For example, the French version has EN ISO 9001:2008 (F) where the F stand for the official version in French.
Answer:
The basis for an environmental management system is your list of environmental aspects and impacts, the way your organization interacts with the environment. You can relate each environmental aspect and impact with the processes where they are originated. So, you only need to plan for the processes where relevant environmental aspects and impacts occur, and for those associated with compliance obligations even if they are not considered significative.
> 1. On the process map will follow turtle diagram of each processor flow chart ok?
Answer 1:
Turtle diagram and flowchart are both useful for describing different topics about a process.
The turtle diagram systematizes a whole set of information about a process:
See -
The flowchart describes the flow of activities and who participates between the inputs and the outputs:
See -
> 2) process Acquire materials and services we will have even if we don’t buy any material for production ok?
Answer 2:
Perhaps the name is not the best one, but the idea is to capture the activities about Picking up the materials and everything until assembling starts. Besides the materials and components, are there not any important products or services that your organization acquires from suppliers?
ISO 9001 and nonprofit organizations
Answer:
Yes, nonprofit organizations can apply for ISO 9001 certification. You can look into hospitals and governmental organizations, for example.
The following material will provide you information ISO 9001: