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Quality Systems Workbook

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What is a Quality System? 

A Quality System sets out the standards that you are working to, and how you are going to meet them. The system should define what people, actions and documents are going to be employed in order to carry out the work in a consistent manner, leaving evidence of what has happened. It may include manuals, handbooks, procedures, policies, records and templates. The terminology used is less important than the purpose and use of the documents. The fundamentals of a Quality System are the same regardless of what your work is. The same principles can be applied whether you are an academic research laboratory, a medical device manufacturer or a hospital clinical trials unit

Understanding, interpreting and implementing a Quality System is a skill in its own right.

The aim of this Workbook is to provide tools and a practical approach to develop a Quality System that works for the user.

The Workbook concentrates on the core, underlying principles of quality which are pivotal - explicitly or implicitly - to all quality management standards that impact on research and development.

These principles are also fundamental to the conduct of efficient, reliable and credible scientific and clinical work and will help the user to design and implement a practical Quality System that works for their organisation to make it more productive and compliant.

The workbook may also help users in the task of persuading others of the importance of such a system. It is aimed at the doers within the Outreach target audience who will either have been delegated the task or are volunteers who have seen the need for a Quality System.

The Workbook is available to both RQA Members and non-members as a free download.

As part of the Outreach Working Party remit the easy accessibility of this Workbook was felt to be critical to its implementation by the target audience. It is envisaged that from the starting point provided in the Workbook users will become more familiar with the concepts of working in quality environments, and will discover the usefulness of accessing more of RQA's services and products.