Quality Management Systems for Drugs and Devices
5
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 Customer Requirements
7.2.2 Review of Requirements Relating to the
Product
7.2.3 Customer Communications
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 and
Service Provision
7.5.7 Particular Requirements for Validation of
Process for Sterilization and Sterile Barrier
Systems
7.5.8 Identification and Traceability
7.5.9 Customer Property
7.5.10 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 Nonconforming
Product Detected Before Delivery
8.3.3 Actions in Response to Nonconforming
Product Detected After Delivery
8.3.4 Rework
8.4 Analysis of Data
8.5 Improvement
8.5.1 General
8.5.2 Corrective Action
8.5.3 Preventive Action
ISO 13485:2016
ISO 13485:2016 was published on 26 February 2016. A
comparison of ISO 13485:2003 and ISO 13485:2016
is shown in Table 1-3. ISO 13485:2016 makes it easier
to model internal audits on the Medical Device Single
Audit Program (MDSAP) approach, and in particular,
introduces its new scoring system for nonconformances.
The new grading system attempts to apply a more
objective standard to determining the risk associated
with a given issue, eliminating the concepts of “major”
or “minor” nonconformance. In short, the system assigns
a numerical risk score for each quality system prob-
lem (nonconformance) identified in an internal audit).
Nonconformances related to areas of the QMS that
have an indirect impact on safety and performance (e.g.,
documentation, management responsibility, resource
management) would receive a lower score than those
5
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 Customer Requirements
7.2.2 Review of Requirements Relating to the
Product
7.2.3 Customer Communications
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 and
Service Provision
7.5.7 Particular Requirements for Validation of
Process for Sterilization and Sterile Barrier
Systems
7.5.8 Identification and Traceability
7.5.9 Customer Property
7.5.10 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 Nonconforming
Product Detected Before Delivery
8.3.3 Actions in Response to Nonconforming
Product Detected After Delivery
8.3.4 Rework
8.4 Analysis of Data
8.5 Improvement
8.5.1 General
8.5.2 Corrective Action
8.5.3 Preventive Action
ISO 13485:2016
ISO 13485:2016 was published on 26 February 2016. A
comparison of ISO 13485:2003 and ISO 13485:2016
is shown in Table 1-3. ISO 13485:2016 makes it easier
to model internal audits on the Medical Device Single
Audit Program (MDSAP) approach, and in particular,
introduces its new scoring system for nonconformances.
The new grading system attempts to apply a more
objective standard to determining the risk associated
with a given issue, eliminating the concepts of “major”
or “minor” nonconformance. In short, the system assigns
a numerical risk score for each quality system prob-
lem (nonconformance) identified in an internal audit).
Nonconformances related to areas of the QMS that
have an indirect impact on safety and performance (e.g.,
documentation, management responsibility, resource
management) would receive a lower score than those