| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 07.03.2014 12:38:15 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 8.3 Control of nonconforming product |
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Overview- Organisation Chart
- Staff
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- SOPs
- Templates
- Software tools
- Equipment
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- Products
- Compliance
Compliance
ISO 13485:2016-08 Qualitätsmanagement- ISO 13485:2012-11 Quality management
- ISO 13485 Requirements
- 3 Terms and definitions
- 4 Quality management system
- 5 Management responsibilities
- 6 Resource management
- 7 Product realization
- 8 Measurement, analysis and improvement
- 8 Measurement, analysis and improvement
- 8.1 General
- 8.2 Monitoring and measurement
- 8.3 Control of nonconforming product
8.3 Control of nonconforming product
«Functional» 8.3 Identify products which are not conform to product requirements- «Functional» 8.3 a) Take action to eliminate the detected nonconformity
- «Functional» 8.3 b) Authorizing its use, release or acceptance under concession
- «Functional» 8.3 c) Take action to preclude its original intended use of application
- «Functional» 8.3 Ensure that nonconforming product is accepted by concession only if regulatory requirements are met.
- «Functional» 8.3 Records of the nature of nonconformities and subsequent actions
- «Functional» 8.3 Re-verification after nonconforming product is corrected
- «Functional» 8.3 Take action appropriate to the effects when nonconforming products is detected after delivery
- «Functional» 8.3 Document rework process if product needs to be reworked (one or more times)
- 8.4 Analysis of data
- 8.5 Improvement
- Annex ZB.2 Relationship with Annex II of MDD 93/42/EEC
- ISO 14971 Risk management
- IEC 62304 Software life-cycle processes
- IEC 62366 Usability
- CFR 820 Code of Federal Regulations Title 21
- Council directive 93/42/EEC, Annex II
- ISO 27001 Information technology - Security techniques
- IEC 60601-1 Processes
- Sandbox