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Document No.: Page: 1 of 3
MDSAP QMS F0001.1.002
Version Date: Effective Date:
2016-10-11 2015-09-17
Responsible Office/Division
Title: Project Manager:
MDSAP QMS Policy and Objectives Liliane Brown, USFDA
Quality Policy
The policy for all participating Medical Device Single Audit Program (MDSAP)
Regulatory Authorities (RAs) is to promote current and best practices for the
development and management of activities for a third party regulatory auditing
program for medical devices.
The participating MDSAP Regulatory Authorities will strive to achieve effective,
world-class development and management of the Medical Device Single Audit
Program through:
• demonstrated compliance with MDSAP QMS Program policies and
procedures;
• consistent adherence to high ethical standards of conduct, as individuals and
organizations;
• decisions based on objective evidence generated through observation and
analysis whenever possible; and,
• using intelligence gathered through program implementation to continually
improve program performance.
Management is to maintain and promote this quality policy to ensure that it:
• is appropriate for the purpose of MDSAP
• demonstrates a commitment to meet requirements and to continually improve
the effectiveness of the quality management system
• provides a framework for defining, establishing, documenting and reviewing
quality objectives
• is a valued foundation for quality objectives, and
• is communicated and understood within the MDSAP “community”.
Uncontrolled when printed:
For
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