The quality management system is accompanied by the QMS documentation. Even though ISO 9001 standard in 2015 refused a large amount of mandatory documentation, every organisation communicates and exists with documents. In this article, we will look at what is meant by “QMS documentation” and, accordingly, what document structure to identify. This will help to manage the QMS documentation properly.

The very definition of “QMS Documentation” sounds very strange, as we always talk about a management system. In other words, dividing the documents in the company’s application into

QMS documentation and

NON-QMS documentation

is not correct. We will consider all documents with reference to the requirements of the quality management system and define documentation management for each type of document.

Structure of QMS documentation

The structure of QMS documentation is usually represented by the following groups of regulatory documents and responsibilities:

• Top-level documents that regulate the procedures, processes and interactions of a wide range of company actors. The following document names are used here: Organisational Standard, Standard Operating Procedure, Regulations, Provision. Responsibility for QMS documentation management at this level rests with the quality manager.
• HR documents. This group includes job descriptions, regulations of subdivisions, temporary work regulations, staff schedules, organizational structure, orders, etc. HR documents are managed by the HR Department
• OH&S documentation, fire safety documentation. This group of documentation is of interest not only to the organisation’s QMS but also to external auditors. Documentation in this part is managed by a responsible employee or OH&S department.
• Process documentation, design and engineering documentation. Documentation is maintained by the relevant service.
• Quality control documentation. This includes sampling procedures, production control programmes, test methods, instructions for the preparation of test equipment. This block of QMS documentation is managed by the person responsible for quality control.

The departments also have in use:

• Records (documents reflecting evidence of activities carried out)
• External regulatory documents, statutory and legislative acts (EN standards, external Specifications, Construction Rules and Regulations, MD, ISO standards, Laws, Ministerial Orders, Government Decrees, Labor Code, etc.)

It is logical to assign the management of this group of documents to the department which:

• Creates, and therefore accumulates records
• Uses external documents, and therefore ensures that the organisation monitors the relevance and availability of regulations.

Using these structure guidelines, the management of the documentation can then be easily established. The rules will be divided into uniform requirements for documents and records, as well as defining special cases for the management of one type of document or another.

expert@orexpro.com

26.02.22