Developing a Quality Management Sytem

    latest edition containing 2015 out now!

The quality management system contained in this e-Book is probably the most complete ISO 9001:2015 compliant example of a generic Quality Management System (QMS) that can, with very little trouble, be suitably customised to suit all types of organisations - no matter whether they are manufacturers, suppliers or end users.

Consisting of a Quality Manual (supported by the four main Quality Processes, 31 Quality Procedures and 16 Work Instructions) this QMS covers every element of the standard and is guaranteed to meet (and sometimes exceed) the requirements of ISO 9001:2015.

This is an excellent resource for any small or medium sized business looking to work towards ISO certification, without having the expense of a consultant doing the work for you.

CONTENTS

For convenience, it is divided into four parts.

User Instructions

This section will not make up your completed QMS but provides background and context for the standard as well as instructions on how to customise the documents to suit your business, and ensure that you meet the requirements of the standard.  It is advised that you read this document first before embarking on customisation.

Part 1 - The Quality Manual

This describes the basic policies of an organisation’s QMS and the processes that are required to implement them.

It defines:

  • how an organisation can meet the requirements and recommendations of ISO 9001:2015;
  • how an organisation’s QMS should be developed and implemented;
  •  the associated documentation (e.g. Quality Processes, Quality Procedures and Work Instructions) that are required fulfil the requirements of the Quality Manual.

Part 2 - Quality Procedures

Quality Procedures (QPs) form the bulk of any QMS and describe how the policy objectives of the Quality Manual can be met in practice and how its processes are controlled. They contain the basic documentation used for planning and controlling all activities that impact on the quality of an organisation’s products and services.

Each QP is unique and conforms to the specific requirements contained in the ISO 9001:2015 standard (although, in reality, they often cover far more) and are an efficient method of controlling every aspect of an organisation’s business.

This Part of the Quality Manual consists of 31 separate QPs that not only cover common processes (such as Document Control, Internal Audits, Training, Health & Safety and Customer Satisfaction etc.) but also include the latest requirements for Risk Management & Improvement, Gap Analysis and Marketing.

Part 3 - Work Instructions and Templates

Part 3 consists of 16 Work Instructions (WIs) describing how to perform specific operations and have been produced cover all of the relevant activities of the QMS described in Parts 1 and 2 so as to ensure that everyone in your organisation can all work to the same format.

WIs describe how individual tasks and activities are to be carried out and show, in detail, what is to be done, who should do it and when it has to be completed. They can, for example, cover simple issues such as making travel and hotel arrangements to more complex issues such as the structure of reports.

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