Product Detail:
The Checklist is an invaluable tool to ensure all the required documentation is identified for your organization. It clearly defines the procedures, plans, records, documents, audits and reviews that are required or suggested.
This 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.
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.
General Principles of the ANSI/AAMI/ISO Standard 13485:2003 Medical devices - Quality management systems- Requirements for regulatory purposes Checklist
This checklist was prepared by analyzing each clause of this document for the key words
That signify a:
- Policy
- Procedure
- Plan
- Records
- Document (Including Manuals, Reports, Scripts and Specifications)
- Audit
- Review
The product provides information on
1- Quality management system
- General requirements
- Documentation requirements
2- Management responsibility
- Management commitment
- Customer focus
- Planning
- Responsibility, authority and Communication
- Management review
3- Resource management
- Provision of resources
- Human resources
- Infrastructure
- Work environment
4- Product realization
- Planning of product realization.
- Customer-related processes
- Design and development
- Purchasing
- Production and service Provision
- Control of monitoring and measuring devices
5- Measurement, analysis and improvement
- General
- Monitoring and measurement
- Control of nonconforming product
- Analysis of data
- Improvement
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