Quality Manual and ISO 9001:2015

Autor: Martin Dudek       Date: July 2021

Česká verze článku ZDE.

To have or not to have the Quality Manual?

With the advent of the revised ISO 9001:2015 standard, the obligation to have the Quality Manual among the documented procedures disappeared. It is therefore a question whether to keep this document and continue to maintain it.

Many companies, especially smaller ones, had the Quality Manual structured in chapters according to the standard. It was like an ‘annotated edition’ of the standard from the company’s perspective. Often, these Quality manuals were created by external consultants or consulting firms who followed a template. As a result, the Quality Manuals for different companies (where the consulting firm operated) was differed only in the company name and logo. However, such the Quality Manual was not engaging or beneficial for most employees. This is one of the reasons why some companies have made the decision not to pay for adapting Quality Manual to the ISO 9001:2015 chapter structure and they simply canceled the document.

However, I am of the opinion that this document makes sense because it can document some things that are required by the standard or that the company documents as standard. In addition, for some norms and standards that follow ISO 9001:2015 (eg IATF 16949:2016), this document is further required.

Contents of the Quality Manual

The Quality Manual should include the following:

  • Company strategy
  • Overview of interested parties
  • Scope of the quality system
  • Applicability of the quality system
  • Determination of company processes (process map, links between processes)
  • Individual process cards (including externally controlled ones)
  • Organizational structure of the company
  • Determination of responsibilities for communication in the company

Then in the attachment:

  • Table with the assignment of chapters of the ISO 9001:2015 standard to individual processes. If the handbook is a document for several standards and systems (IATF, EMS, BOZP, BRC…), then of course add the chapters of these standards as well.
  • Information required by related norms or standards, such as a matrix describing how specific customer requirements are addressed in the company’s quality management system (see IATF 16949:2016).

On the other hand, I do not recommend including the Context of the Organization in the Quality Manual. Compared to the manual, this document is updated more often in practice (or should be updated more often). For example, recently, practically all companies dealt with the aspect of the coronavirus, which had an impact on the availability of employees, or subsequently dealt with the rise in energy prices, which increased costs.

I also recommend against including any risks in the Quality Manual. After all, this document is relatively accessible, and in some companies, it is still common practice to share the manual with customers. There is no guarantee that the manual will not reach a competitor.

Structure of the Quality Manual

Regarding the structure of the Quality Manual, there is no reason or requirement given by the standard to have the manual prepared in the structure of the chapters of the standard.

A sample of the rough version of the Quality Manual, which does not copy the chapters of the standard, can be found HERE.

I have not written any Quality Manual in the structure of the chapters of the standard. With the advent of ISO 9001:2000 came a clear requirement to apply a process approach. So it seemed logical to me to build the structure of the Quality Manual on the processes of that company.

The Quality Manual compiled in this way is more understandable for people in the company. This structure also has an advantage when introducing other system standards in the company. You can easily create one manual for an integrated system, because you map the requirements of each other system standard to the individual macro processes described in that manual. After all, standards such as ISO 14001:2015 or ISO 45001:2015 in chapters 5.1. c) directly request.

Conclusion:

 Although the ISO 9001:2015 standard no longer requires having the Quality Manual, I am of the opinion that this document makes sense. In this article, I also wanted to present a somewhat unconventional layout of the manual, which is particularly suitable for integrated system.

 

Literature:

ISO 9001:2015 Quality management systems – Requirements

IATF 16949:2016 Quality management system for organizations in the automotive industry.