TO BE OR NOT TO BE?

That is the question organizations face with the new revision of ISO 9001. Since a quality manual is no longer required, you must determine if having one adds value to your company. So, what is a quality manual?

A quality manual is a document that states the company’s intentions for operating the processes within the quality management system. It can include policies for all areas of the business that affect your ability to make high quality products and meet your customers’ and ISO’s requirements. These policies define how your department managers will implement procedures within the boundaries specified in the quality manual.

An important note: many other quality management system standards based on ISO 9001 are still requiring a quality manual. If your standard requires one, then you must maintain a quality manual.

USES

Here are some uses for a quality manual.

  1. To communicate management’s expectations to employees
  2. To demonstrate the company’s plan to conform to the requirements of ISO 9001:2015
  3. To demonstrate the fulfillment of Clause 5.3, that organizational roles, responsibilities and authorities are assigned, communicated and understood
  4. To provide a starting point for auditors:
    1. Internal
    2. Customer
    3. ISO Certification Body

CONTENT

For users of ISO 9001:2015, the contents of your quality manual are completely up to you. But, remember that everything you say you do, you must show evidence that you really do it! So be careful what you include and make sure the policies reflect actual practices. Here are some common topics included in quality manuals.

Quality policy

Explanation of the company’s documentation structure

Organizational chart

Policy statements for each applicable ISO requirement

Reference to operating procedures

Of course, your quality manual may not cover each of these, and it may include much more. The trick is to find a balance between all that could be in there and what really needs “to be”.

DEVELOPMENT

To develop a quality manual, you might consider these steps:

  1. List policies to be written (note any ISO requirements that do not apply).
  2. Draft policies based on applicable ISO requirements.
  3. List operating procedures or refer to them as appropriate.
  4. Determine format and structure of the manual and make the first draft.
  5. Circulate the draft manual for input from all departments and address inadequacies identified.
  6. Attain a formal approval and release.

EXAMPLE

As an example of how the quality manual policies should reflect the requirements of ISO 9001:2015 see the following section from a quality manual. Notice how the requirement itself precedes the company specific policy and records information.

XX Management Review

XX.1 Requirement: Top management conducts planned reviews of the QMS to ensure its suitability, adequacy, effectiveness and alignment with the strategic direction considering:

the status of actions from previous management reviews;

changes in external and internal issues that are relevant to the QMS;

information on the performance and effectiveness of the quality management system, including trends in:

  • customer satisfaction and feedback from relevant interested parties;
  • the extent to which quality objectives have been met;
  • process performance and conformity of products and services;
  • nonconformities and corrective actions;
  • monitoring and measurement results;
  • audit results;
  • the performance of external providers;
  • the adequacy of resources;
  • the effectiveness of actions taken to address risks and opportunities;
  • opportunities for improvement.

The outputs of management review are to include decisions and actions related to:

opportunities for improvement;

any need for changes to the quality management system;

resource needs.

Retain documented information as evidence of the results of management reviews.

XX.2 Policy: Our management reviews are planned and occur on a [interval] basis. At a minimum, these reviews are attended by:

President

VP, Business Development

VP, Operations

Quality Manager

The Management Reviews are scheduled and a meeting agenda consisting of all required inputs is prepared.

Outputs from Management Reviews include the actions and decisions relating to any opportunities for improvement, needed changes to the QMS and resource needs.

XX.3 Records: The meeting minutes and outputs are retained on the [record name].