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ANSI/AAMI/ISO 13485:2003 Checklist
Medical Devices |
ANSI/AAMI/ISO Standard 13485:2003 Medical
Dvices
Quality management systems- Requirements
for regulatory purposes
Evidence Product Checklist
by Andy Coster
E-Book
71 Pages
Published June
2004
Download (PDF) 160 KB
Item No.: RCG24SEPTRCG
List Price: US $ 149.00
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Description
Checklist for ANSI/AAMI/ISO Standard 13485:2003
Medical devices - Quality management systems- Requirements for regulatory
purposes ISO 13485. Being a “stand-alone” quality system standard for medical
devices, this standard represents a major change in concept and goes much
further than ISO 9001 in requirements for documentation. The checklist
is an invaluable tool to ensure that all the required documentation is
identified for an organization. It clearly defines the procedures, plans,
records, documents, audits and reviews that are required or suggested.
This checklist is a “must have” for all quality managers involved in ANSI/AAMI/ISO
Standard 13485:2003 certification, presenting all the required items that
are necessary to demonstrate evidence of conformity. It includes many suggestions
for items that are not specifically required by the standard but “hinted
at” in the text. The checklist uses a classification scheme of physical
evidence comprised of procedures, plans, records, documents, audits, and
reviews. This standard calls out or suggests over 300+ items of physical
evidence. The checklist clarifies what is required for compliance by providing
an easy-to-use product evidence list that will assist any organization
to meet the requirements of this important standard. The purchase of this
checklist includes four hours of free consultation during 60 days after
date of purchase, providing answers to questions about the standard and
checklist. Using the checklist saves time and money, and will aid in meeting
certain regulatory requirements! The Checklist is a quality product at
a reasonable price! |
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