Developing an iso 13485-certified quality management system, Juuso, Ilkka

This short, easy-to-understand reference tool also helps organisations to quickly set up an ISO 9001:2015 compliant Quality Management System for themselves at minimal expense and without high consultancy fees.

Now in its fourth edition, ISO 9001:2015 In Brief consists of a number of chapters covering topics like:

• What is Quality? - An introduction to the requirements and benefits of quality, quality control and quality assurance
• What is a QMS? - The structure of a Quality Management System and associated responsibilities.
• Who produces Quality Standards? - An opportunity to see how interlinked the various Standards Bodies are today.
• What is ISO 9001:2015? - The background to this particular standard, how it has grown and developed over the years and what 'Annex SL' is all about.
• What other standards are based on ISO 9001:2015? - Details of other standards that replicate or are broadly based on ISO 9001:2015.
• What to do once your QMS is established - Process improvement tools, internal auditing and the road to ISO 9001:2015 certification.

This is supported by:
Annex A - A summary of the requirements of ISO 9001:2015 - including an overview of the content of the various clauses and sub clauses, the likely documentation required and how these would affect an organization. A cross-reference to the previous ISO 9001:2008 Clauses is also provided as well as a complete bibliography and glossary.

This short, easy-to-understand reference tool also helps organisations to quickly set up an ISO 9001:2015 compliant Quality Management System for themselves at minimal expense and without high consultancy fees.

Now in its fourth edition, ISO 9001:2015 In Brief consists of a number of chapters covering topics like:

• What is Quality? - An introduction to the requirements and benefits of quality, quality control and quality assurance
• What is a QMS? - The structure of a Quality Management System and associated responsibilities.
• Who produces Quality Standards? - An opportunity to see how interlinked the various Standards Bodies are today.
• What is ISO 9001:2015? - The background to this particular standard, how it has grown and developed over the years and what 'Annex SL' is all about.
• What other standards are based on ISO 9001:2015? - Details of other standards that replicate or are broadly based on ISO 9001:2015.
• What to do once your QMS is established - Process improvement tools, internal auditing and the road to ISO 9001:2015 certification.

This is supported by:
Annex A - A summary of the requirements of ISO 9001:2015 - including an overview of the content of the various clauses and sub clauses, the likely documentation required and how these would affect an organization. A cross-reference to the previous ISO 9001:2008 Clauses is also provided as well as a complete bibliography and glossary.

Now in its fourth edition, this text includes essential material on process models, generic processes and detailed coverage of auditor questionnaires. Part II includes a series of useful checklists to assist auditors in compiling their own systems and individual audit check sheets. The whole text is also supported with a glossary of terms as well as explanations of acronyms and abbreviations used in quality.

ISO 9001:2015 Audit Procedures is for auditors of small businesses looking to complete a quality audit review for the 2015 standards. This book will also prove invaluable to all professional auditors completing internal, external and third party audits.