Quality Manual Table of Contents Section Topic ISO 13485:2016 Reference Sections 0 Corporate Overview 0 1 Scope 1 2 Normative References 2 The Quality Manual outlines the structure of the documentation used in the quality management system. The Quality Manual is the top tier of our Table of Contents Section Element. 1.0 Scope and Policy. 2.0 Amendments and Revisions to the Quality Manual. 3.0 Organization. Work or desk instructions are utilized in support of this Quality Manual to improve the control of a specific operation or evaluation, but in no circumstances shall 4.3.1 Quality Manual Pyco LLC has established and maintains a Quality Manual. The Quality Manual includes a Table of Contents and eight binders that include procedures, documents and forms necessary to effectively manage the Quality Management System. For Pyco LLC, the Alabama Specialty Products, Inc. ISO9001:2015 Quality Manual Page 3 of 38 Table of Contents Quality Management System Manual Clause Content Description Page 8.5.1 Control of Productions and Service Provision 31 8.5.2 Identification and Traceability 31 Our quality manual template addresses these requirements in 20 pages of text, while the procedures carry the burden of defining how compliance to a requirement is acheived at an operational level. Think about how you will manage the documentation, who is responsible for what content (e.g • Description of how the manual will be maintained, reviewed and updated • Quality policy • State the purpose for the quality manual, i.e., it is a set of documents that describe the structure and contents of the laboratory's QMS. TABLE OF CONTENTS: List the titles and parts of the manual organized in the order in which they appear. ISO 15189 Quality Manual. Order Quality Manual. Table of Contents. Introduction Quality Policy Statement 1.0 Scope 2.0 References 3.0 Terms and Definitions 4.0 Management Requirements 4.1 Organization and Management Responsibility 4.2 Management System 4.3 Docume