Guidance Documents
ISO 13485:2016
Clause 4: General Requirements
Specifies the criteria for the entire Quality Management System Documentation, including:
- Quality Manual with Scope of the QMS
- Required Procedures
- Required Forms & Records
- Control of Documents
- Control of Forms
- Quality Objectives
Clause 5: Management Responsibility
Provides guidelines for the management function in the QMS.
Clause 6: Resource Management
Provides necessary resources.
Clause 7: Product Realization
- The production of the product or service
- Planning
- Customer related processes and Customer Feedback
- Design
- Purchasing
- Process control
- Identification and Traceability
- Customer Property
Clause 8: Measurement, Analysis and Improvement
Specifies guidelines for process improvement and monitoring
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