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    ISO 9001 Knowledge base

    How to structure quality management system documentation

    Usually, when people think of Quality Management System documentation, they envision loads of documents and unnecessary bureaucratic procedures. This is because companies often go overboard when documenting their Quality Management Systems. However, this doesn’t need to be the case.

    It is true that the international standard for Quality Management Systems (ISO 9001) requires certain documentation (see this article: List of Mandatory Documents for ISO 9001). The purpose and the benefits of the QMS documentation are manifold: it provides a clear framework of the operations in an organization, it allows consistency of processes and better understanding of the QMS, and it provides evidence for the achievement of objectives and goals. When designing QMS documentation, you should focus on efficiency and create processes and documents that are applicable in your organization.

    QMS documentation hierarchy

    The QMS documentation can consist of different types of documents. Usually, it includes documents such as the Quality Policy, Quality Manual, procedures, work instructions, quality plans, and records. The QMS documentation can be represented as a hierarchy, as shown in the diagram below:

    ISO 9001 QMS documentation – How to structure it

    ISO 9001 requires different types of information to be documented; however, not all information needs to be documented as separate documents. It is flexible, so that the organization to decide on the size of the documentation and the level of details documented. For example, small companies can include documented procedures in the QMS manual.

    How to structure your QMS documentation

    The international standard ISO 10013:2001 Guidelines for quality management system documentation gives directions for effective dimensioning of the QMS documentation, as well as an overview of recommended contents and structure of the different QMS document types. The following recommendations take into consideration the ISO 10013 guidelines.

    1) Quality Policy. A policy represents a declarative statement by an organization. A Quality Policy should state the commitment of the organization to quality and continual improvement. Usually, this policy is used for promotional purposes and should be displayed in the organization’s premises and posted on websites, so a clear and short Quality Policy is convenient and is the general practice.

    The Quality Policy defines the quality objectives to which the organization strives. The quality goals of organizations are defined by quantifying the quality objectives.

    2) Quality Manual. The manual should fit your organization. The structure and the content of the manual can vary depending on the size of the organization, the complexity of its operations, and the competence of the personnel. Small organizations can document the entire QMS in one manual. On the other side, large international organizations may have several different quality manuals. Generally, the manual includes the QMS scope, exclusions from the standard, references to relevant documents, and the business process model. The Quality Policy and the objectives can be part of the manual as well.

    The Quality Manual should include most of the following elements: title and table of contents; scope of the QMS; exclusions from ISO 9001, versioning information, and approval; Quality Policy and objectives; QMS description, the business process model of the organization; definition of responsibilities for all personnel; and references to relevant documents and relevant appendices. More information on how to document an effective Quality Manual can be found in this article: Writing a short Quality Manual.

    3) Quality procedures. Quality procedures can have different formats and structures. They can be narrative, i.e., described through text; they can be more structured by using tables; they can be more illustrative, i.e., flow charts; or they can be any combination of the above.

    Quality procedures should include the following elements:

    • Title – for identification of the procedure
    • Purpose – describing the rationale behind the procedure
    • Scope – to explain what aspects will be covered in the procedure, and which aspects will not be covered
    • Responsibilities and authorities of all people/functions included in any part the procedure
    • Definitions and lists of all records that result from the activities described in the procedure
    • Document control – identification of changes, date of review, and approval and version of the document should be included in accordance with the established practice for document control
    • Description of activities – this is the main section of the procedure; it relates all the other elements of the procedure and describes what should be done, by whom and how, when and where. In some cases, “why” should be clarified as well. Additionally, the inputs and the outputs of the activities should be explained, including the needed resources.
    • Appendices may be included, if needed.

    4) Work instructions. Work instructions can be part of a procedure, or they can be referenced in a procedure. Generally, work instructions have a similar structure to the procedures and cover the same elements; however, the work instructions include details of activities that need to be realized, focusing on the sequencing of the steps, tools, and methods to be used and required accuracy.

    Training of personnel and the use of competent personnel can decrease the need for highly detailed work instructions. More detail on this topic can be found in Using Competence, Training and Awareness to Replace Documentation in your QMS.

    5) Records and forms. In order to demonstrate that your processes met their requirements, you will want to keep some evidence; this is where forms and records are used. A record is what has been chosen by the process owner to demonstrate that the process and activities have been conducted in the way prescribed in the procedures and work instructions. Forms are the blank templates to be filled in with information that will become these records. Make your records and forms practical by being concise and simply recording the information required; do not make employees write essays to complete the form and create the record.

    Good QMS documentation is essential for an effective Quality Management System

    Dimensioning the QMS documentation based on your organizational needs is essential for a functional QMS. Moreover, properly structured documentation will make your operations much easier, while incorrect documentation will bring you nothing but trouble.

    Click here to download a white paper: Checklist of Mandatory Documentation Required by ISO 9001:2015, with more detailed information on the most common ways to structure and implement mandatory documents and records.