I was wondering if agile and ISO 9001 can work together, especially regarding document control?
I had a discussion with company GM about Document Contorl which raised this question. I am in the process of design and implementation of ISO 9001:2015, currently my focus is Document Control. I suggested my manager that we need to have document approval and version check for documents which are within the scope of QMS. She challenged that and said this can be agaist of Agile ( as we have some document and procedure (like recruitment procedure) and some other documents on Microsoft Teams. As you know on Teams there is no document control and version check.
Again asking my question, I want to know for example, is it neccessary to have a strict Document control (version check - approval) over the documents which are not directly related to products such as our Recruitment Procedure or recruitment policies?
About your procedures, there is only the need to ensure that they are approved by an authorized role/function. Version identification is not so important in digital documents because people using them will always be using the latest version, the version in use.
With Microsoft Teams you must ensure that the procedure was approved by an authorized person. From your description seems that it is possible to write a new procedure, evidence of who approved it, and the notifications to the users. The version in use is the current version. If anyone needs to check a previous version can go back in the timeline and see the previous version and approval, and notifications, like in a blockchain.
Your initial concern is not a barrier to using agile with ISO 9001. We are used to thinking in terms of a paper office, we need to be creative to think in terms of a digital office.
Question: “Is it necessary to have such training and records to show that all employees (managers and HR employees) who are involved in the recruitment process are trained in the company recruitment procedure?”
Answer: Please check clause 7.2 – “retain appropriate documented information as evidence of competence” – ISO 9001:2015 only requires this kind of record to evidence competence. If you want more you can use more. Please check clause 7.1.6 – “The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This knowledge shall be maintained and be made available to the extent necessary.” - all employees (managers and HR employees) who are involved in the recruitment process must have the knowledge necessary for its operation.
A good practice is to list the knowledge requirements for each role and then ensure that actions are developed in order to provide it. Training effectiveness is measured when assessing if people are competent.
I have a question "an organization is AS9100 Rev D certified but organization has no production since one year from any customer then how can compliance of QMS can be interpreted? How internal audits be conducted? How KPI be translated ? What standard say that if an organization have no customer since long time then how QMS compliance be evaluated?