Quality management system guide – How to implement ISO 9001: 2015?
The ISO 9001 standard requires us to establish a procedure for supervision (management) of documentation and supervision (management) of records, to be able to:
- in the scope of document management
- unequivocally indicate current documents and distinguish them from archival ones
- indicate who and when approved these documents for use
- indicate who withdrew the document and when
- in the scope of records management
- indicate where and what records are made
- who has access to them and on what rights
- where and how long are they stored
- who destroys them and after what time
To be fully clear about what we manage, I have to explain what are document and record according to ISO 9001. I will limit the suffering caused by quoting definitions;)
Document – all files, documents and plates (including metal plates on a fence or wall) that tell us how to work and how to behave.
Examples of documents: company statute, articles of association, company regulations, work regulations, any regulations, guides, procedures, process descriptions, process maps, including graphic ones, employment contracts, contracts with suppliers, contracts with customers, other contracts, standards, acts , regulations, information boards, warning boards and others.
Record – all files, paper records generated by us during work.
Examples of records: meeting notes, e-mails, system entries (ERP, CRM, other), invoices, Stock Issue Confirmation files, inter-warehouse transfer files, inspection reports, non-compliance cards, work logs, inspection logs and others.
Since we have this knowledge and the information from the chapter “How to manage documentation”, we can start creating a document management procedure.
Before writing, or even better, drawing a routine, we need to figure out:
- Author – who can create work order documents? (without contracts)
- if there are few of us – all employees
- if there are many of us – only managers
- How to forward to approver? – e-mail
- Approver – who will approve these documents?
- How will he approve them? – by uploading to Google Drive
- Who will he inform and how
- if there are few of us – all of us by e-mail
- if there are a lot of us – the approver should send e-mail information to assistant , who will inform rest of us, also by e-mail.
- Who completes the register of entries?
- Do we arrange checking the employees’ familiarity with the document? If so, who is examining?
- Who can submit changes? All?
- How can he report changes? E-mail?
Once we have established the above facts, we can start writing (or drawing) what I recommend, documentation management procedures. I will not bore you with writing this procedure, I will show you examples of procedures that we use at home and with our clients. Link to the documentation management procedure from our store.
We still have to manage documentation. We solve it very simply. When the document is approved for use, the register of entries (its template can be found here – List of entries and documents) should be filled with new items or modify the already existing entries. Of course, in the register you list the types of entries that will be generated in the company.
Ready!
Once you have the procedure, it is enough for the Owner or the President to introduce it, and you can approve the remaining documents in accordance with this procedure. Such a procedure is necessary for the document management procedure and other documents approved in accordance with it to take legal force and be binding (which allows them to be invoked as evidence in an labour or civil court).
