Remote / Virtual Audits - Internal or Vendor Audits - The Audit
Conduct per the Audit Plan, adjusted by any client / team feedback.
The Audit CGMP Sub-clause Matrix (ISO 13485 or 21 CFR 211, or 820, etc):
EU ISO 13485:2016
COMPLIANCE AUDIT MATRIX
Clause Description Reviewed (‘Y’ or ‘N’) / Comments
4 Quality
Management System
4.1 General requirements
4.2 Documentation Requirements
4.2.1 General
4.2.2
Quality manual
4.2.3
Medical device file
4.2.4 Control of documents
4.2.5 Control of records
5 Management
Responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.4.1
Quality objectives
5.4.2 QMS planning
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
5.5.2 Management responsibility
5.5.3 Internal communication
5.6 Management review
5.6.1 General
5.6.2 Review input
5.6.3 Review output
6 Resource
Management
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment and contamination
control
6.4.1 Work environment
6.4.2 Contamination control
7 Product
Realization
7.1 Planning of product realization
7.2 Customer-related processes
7.2.1 Determination of requirements
related to
product
7.2.2 Review of requirements related
to product
7.2.3 Customer communication
Subpart Description Reviewed
(‘Y’ or ‘N’) / Comments
7.3 Design and development
7.3.1 General
7.3.2 Design and development planning
7.3.3
Design and development inputs
7.3.4 Design and development outputs
7.3.5 Design and development review
7.3.6 Design and development verification
7.3.7 Design and development validation
7.3.8 Design and development transfer
7.3.9 Control of design and development
changes
7.3.10
Design and development files
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
7.5 Production and service provision
7.5.1 Control of production and service
provision
7.5.2 Cleanliness of product
7.5.3 Installation activities
7.5.4 Servicing activities
7.5.5 Particular requirements for
sterile medical devices
7.5.6 Validation of processes for
production / Service provision
7.5.7 Particular requirements for validation
of processes for sterilization and
sterile barrier systems
7.5.8 Identification
7.5.9 Traceability
7.5.9.1 General
7.5.9.2 Particular requirement for
implantable medical
devices
7.5.10 Customer
property
7.5.11
Preservation of product
7.6 Control of monitoring and measuring
devices
8 Measurement,
Analysis and Improvement
8.1 General
8.2 Monitoring and Measurement
8.2.1 Feedback
8.2.2 Complaint handling
8.2.3 Reporting to regulatory
authorities
8.2.4 Internal audit
8.2.5 Monitoring and measurement
of processes
8.2.6 Monitoring and measurement
of product
8.3 Control of nonconforming product
8.3.1 General
8.3.2 Actions in response to
non-conforming product
detected after delivery
8.4 Analysis of data
8.5 Improvement
8.5.1 General
8.5.2 Corrective action
8.5.3 Preventive action
# # #
-- jel@jelincoln.com
No comments:
Post a Comment