What is a Quality Management System?

A Quality Management System or ‘QMS’ is a system of interrelated processes and procedures that are used to define and control how quality policies are implemented and quality objectives are achieved. It is usually documented in a Quality Manual.

Typically a Quality Manual will contain the following:

 

 

Table of Contents

The Table of Contents in the Quality Manual is like any other contents page, it serves to outline the different areas of the manual to allow for quicker referencing access. This is particularly useful if the system documentation is based on a LAN or company intranet, as the manual can be set up to allow instant click through access.

Scope Definition

The Scope Definition is designed to outline the activities in which the company intends to meet the requirements of the standard. It usually includes an overview of purpose of the Quality Management System and then specifically defines the products and services provided by the company that will be covered by the system.

Documentation Access

This section of the Quality Manual clearly defines who can access the system on read and write basis, where and how the system can be accessed and who is responsible for monitoring access to the system.

An Introduction to ISO 9001:2015

The introduction to the standard explains what the standard is, what its purpose and limitations are and why it is relevant to the company. Although it may seem a little uneccessary and repetitive it is worth bearing in mind that not all users of the quality system will have had experience of working to these type of requirements before. Subequently it can be a useful reference point for those who remain unsure as to the scope and limitations of the Quality Management System

Quality Policy Statement

Written and signed by the person with overall responsibility for the Quality Management System, the Quality Policy Statement describes the company’s ongoing commitment to implementing and continually reviewing the system in accordance with the ISO 9001:2015 standard, to achieve the highest possible levels of quality for their products and services.

Chart of Continual Improvement and Process inter Relationships

The Chart of Continual Improvement and Process inter Relationships is a flow chart diagram representing the different aspects of the business and how they interact. The diagram demonstrates different examples of the interdependency of the different areas of the business. For example analysing customer feedback and using this information to improve products and services can in turn improve customer satisfaction. Satisfied customers are more likely to return and recommend the company which creates more business. The importance of maintaining and using the links between different areas of the business can make all the difference between a successful and a highly successful business.

Organisation Chart

The organisation chart represents a company in a graphical format. This visual chart shows how authority, responsibility and information will flow within an organisation. It usually depicts different management functions (accounting, finance, human resources, marketing, sales, service, production, R&D, etc.) and their subdivisions as boxes linked with lines along which decision making power travels downwards.

Typical Example of an organistational chart: Engineering Comapny Example

Quality Management System Exclusions

Not every company will be able to operate to all sections of the standard. For example if the company does not design or manufacture any products themselves, then the section of the standard relating to product design and manufacture will not be relevant. The Quality Management System Exclusions section of the Quality Manual is where any such non-relevant elements of the standard should be stated.

Table of Procedures

The Table of Procedures should be a list of all documented procedures. By procedures I refer to those procedures written to ensure that the company meets the various aspects of the standard. I do not refer to work instructions – the step-by-step guides that many organisations write to assist staff in completing day-to-day tasks withing the business. There should be a seperate provision in the Quality Management System to store these outside the Quality Manual.

Document History

One of the main changes in instigating a system of quality management to meet ISO standards is the introduction of traceability. All changes to QMS documentation, paticularly to procedures, should be documented. At the bottom of the Quality Manual and all procedures there should be a Document History. The History should consist of the issue number (which takes the next sequential number each time a change is made) the reason for the re-issue and the name of the person who approved the re-issue.

Before any changes are made to QMS documentation a copy should be placed in a file archive so that there is an audit trail.