Does ISO Require a Quality Manual?

4 Mins read

The answer to this question, “Does ISO require a quality manual?” is two parts. Firstly, only ISO 9001 had historically asked organizations to create a quality manual, as it was the only standard focused on quality management, quality assurance and implementing a Quality Management System (QMS). As this is the only standard focused on quality management principles, organizations did not need to develop a quality manual. Secondly, the 2015 revision of the ISO 9001 standard has removed the requirement for a quality manual.

Now, you may be excited after reading this, and in your exhilaration, you may be thinking of shredding your old quality manuals and never looking back. However, even if the standard doesn’t need it, developing one still has many advantages. In this article, we will talk about what a quality manual is, its advantages and its disadvantages so that you are informed and can make an appropriate decision about creating or refuting a quality manual.

What is a quality manual? A document including QMS description

A quality manual is a document that includes the description of a QMS of an organisation. The goal of the quality manual is to deliver information to different levels of management, serve as a framework for meeting the requirements of the QMS and convey leadership commitment to the QMS. Here, it is essential to distinguish a quality manual from a quality plan. A quality plan is a collection of documents utilised to specify resources, practises and sequence of activities related to maintaining the quality of a particular project, service or product. So, a quality manual contains the quality policy and the other details of the QMS.

To get inform about the ISO 9001 stage 1 audit, you can read the linked article on Edara Systems website.

Advantages of ISO 9001:2015 quality manual

Before the release of the 2015 update, the ISO 9001 standard required organisations to include three items in their quality manual, namely:

  • A detailed description of the interaction between the QMS and its different processes.
  • Scope statement describing the details of the QMS, including its details, inclusion and justification for any exclusions of the ISO 9001 standard.
  • The documented procedures were established to maintain the QMS and a reference to each procedure.

Unfortunately, many organisations interpreted the instructions for a documented scope, reference to your procedures and a description of the QMS as a means to precisely copy the terminology or verbiage from the standard itself. Many organisations made the mistake of copying every word and just changing a few. As a result, the quality manual became lengthy and inefficient, reducing its ability to: 

  • Present a succinate and concise overview of the system.
  • Present a structure to the documentation.
  • Provide an appropriate location for storing the objectives, policy and scope.
  • Allowing managers to overview the sequence of the interaction of processes.

There are different types of ISO certification, which are beneficial for organisation based on their activities. One of the most common types of ISO is ISO 27001, which many companies apply for. If you want to know what is ISO 27001? Read the linked article and learn about the 2 main parts of this certificate.

What are the disadvantages of a quality manual?

Despite having so many advantages, the reality is that no one reads the contents of a quality manual, except for a few certification auditors who were strict and masochistic. One of the prime reasons why ISO removed the need for a quality manual is that it had become an unnecessary bureaucratic burden on organisations. Unfortunately, the aim of the quality manual was always to serve as a collection of all the necessary information related to the QMS. Still, organisations began to see it as a necessity to achieve compliance. Consequently, organisations began to create extensive quality manuals with unnecessary and duplicated information.

ems or ISO 14001 is one of the most useful types of ISO certification for companies. To learn about the benefits of ISO 14001, enter the website of Edara Systems and read the relevant article.

ISO 9001 consultant to follow ISO quality manual template

Now, the problem is that a clear, short and lucid quality manual gives the impression that an organisation actually knows what they are doing. Moreover, the quality manual is helpful as it is representative of your QMS. When big companies shortlist their suppliers, they often ask to see your quality manual in addition to your ISO 9001 certificate.

At this point, it is very natural to feel confused. Yes, a quality manual is helpful, but only if it focuses on “quality” and not “quantity.” So, you may be wondering what to do next.

Let us give you an example that will give you a lot of clarity. Imagine that you have a child, and they do not seem to be their “usual self.” So, you take them to a pediatrician, and the doctor can recognise the problem just by listening to the case study. Why? Because the doctor has clinical experience in handling thousands of children. Similarly, an ISO 9001 consultant has the expertise in developing, implementing and troubleshooting many QMS. By observing your processes in action and seeing how your organisation operates, they can give you the best advice on creating your quality manual.

Edara Systems consultants will help you get ISO certified

In this article we have discussed the answer to the “Does ISO require a quality manual?

“ question. Only ISO 9001 demanded organisations create a quality manual, but this demand was made obsolete with the 2015 version. The quality manual’s advantages are that it provides a snapshot of the system, helps create the documentation structure, serves as an appropriate location for storing objectives and allows managers to overview the sequence of interactions. To reap the maximum benefits from your quality manual, keep it short and concise. A good ISO 9001 consultant will help you create the quality manual that your organisation deserves.

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