ISO 13485 QUALITY MANUAL DOCUMENT      

This ISO 13485-compliant boilerplate Quality Manual in Microsoft Word meets all ISO 9001 & 13485 requirements for a quality manual document as described below, and is used to define and document the intention, design, objectives, strategy, exclusions and management support of the organizations quality management system.  To complete this boilerplate, you the customer will simply need to insert the information specific to your organization, such as your quality policy statement, and any exclusion(s) to the ISO standard.  All AccuFast Consulting boilerplate documents contain notes and tips for the completion of the document and implementation of the process.  PLEASE NOTE:  This quality manual does not contain any documented procedures, but it references them.  The documented procedures required by ISO 9001 and ISO 13485 are offered separately.           
 

ISO 13485 sections 4.2.1.b, & 4.2.2.a, b, & c

TERMS & DEFINITIONS
QUALITY MANUAL AND QUALITY SYSTEM SCOPE & EXCLUSIONS
QUALITY (MANAGEMENT) SYSTEM GOALS & OBJECTIVES
ORGANIZATIONAL STRUCTURE
QUALITY POLICY STATEMENT
COMMITMENT TO QUALITY POLICY STATEMENT
QUALITY SYSTEM DOCUMENTATION STRUCTURE
QUALITY SYSTEM - PROCESS APPROACH
(CUSTOMER’S NAME) PROCESSES & INTERACTIONS
QUALITY MANAGEMENT SYSTEM REQUIREMENTS (All ISO 9001 requirements except Exclusions)