Usually, when people think of quality management system documentation, they envision loads of

documents, and unnecessary and 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 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 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 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 have documented procedures that will be included 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 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 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 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; 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.

2) 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.

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;
 Records that result from the activities described in the procedure should be defined and
listed;
 Document control – identification of changes, date of review, 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 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.

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.

« How to Write Good Quality Obje... 5 Main Changes Expected in ISO... »

If you enjoyed this article, subscribe for updates

Improve your knowledge with our free resources on ISO 9001 standard.

Email*

You may unsubscribe at any time.

For more information on what personal data we collect, why we need it, what we do with it, how
long we keep it, and what are your rights, see this Privacy Notice.

FREE ISO 9001 CONSULTATION

Iciar Gallo
ISO 9001 Expert,
Advisera

GET FREE ADVICE

Popular posts

Recent posts

 List of mandatory documents required by ISO 9001:2015

 ISO 9001 Requirements and Structure
 Five Main Steps in ISO 9001 Internal Audit
 How to Write Good Quality Objectives
 How to identify the context of the organization in ISO 9001:2015