Quality Management Systems for Drugs and Devices
11
Mandatory procedures and documents for an ISO
13481-compliant system are shown in Figure 1-3.
An ISO 13485-certified QMS can support regula-
tory compliance in a number of jurisdictions, as shown
in Table 1-4. The data to support regulatory submission
depend on properly trained and qualified person-
nel performing tests, standard operating procedures,
properly calibrated test equipment, documentation and
configuration control of test articles, design controls,
etc.—all QMS elements. This is an ongoing process with
links between the QMS and postmarketing surveillance
(PMS). From an ISO perspective, PMS is one of the
key QMS activities listed in Clause 8 linking to CAPA,
complaint handling and adverse event/vigilance report-
ing, etc. At some point, changes driven by CAPA may
require a new regulatory submission.
Figure 1-3. Mandatory Procedures and Documents for ISO 13485:2003
4.2 4.2.1 Quality manual, quality policy and quality objectives
4.2.3 Control of documents
4.2.4 Control of records
6 6.2.2 Competence, awareness and training*
6.3 Infrastructure
6.4 Work environment
7.1 Planning of product realisation
7.3 Design and development
7.4 Purchasing
7.5.1 7.5.1.1 Production and service provision-Control of production and service provision
7.5.1.2.1 Cleanliness of product and contamination control
7.5.1.2.2 Installation activities
7.5.1.2.3 Servicing activities
7.5.2 7.5.2.1 Validation of processes for production and service provision**
7.5.2.2 Particular requirements for sterile medical devices
7.5.3 Identification and traceability
7.5.5 Preservation of product
7.6 Control of monitoring and measuring devices
8.1 General***
8.2 8.2.1 Feedback
8.2.2 Internal audit
8.2.4 Monitoring and measurement of product
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 8.5.1 General (advisory notices and adverse events)
8.5.2 Corrective action
8.5.3 Preventive action
*National or regional regulations might require the organization to establish documented procedures for identifying training
needs.
**The organization shall establish documented procedures for validating computer software applications (and changes
to such software and/or its application) for production and service provision affecting the product’s ability to conform to
specified requirements. Such software applications shall be validated prior to initial use.
***National or regional regulations might require documented procedures for implementation and control of the application
of statistical techniques.
11
Mandatory procedures and documents for an ISO
13481-compliant system are shown in Figure 1-3.
An ISO 13485-certified QMS can support regula-
tory compliance in a number of jurisdictions, as shown
in Table 1-4. The data to support regulatory submission
depend on properly trained and qualified person-
nel performing tests, standard operating procedures,
properly calibrated test equipment, documentation and
configuration control of test articles, design controls,
etc.—all QMS elements. This is an ongoing process with
links between the QMS and postmarketing surveillance
(PMS). From an ISO perspective, PMS is one of the
key QMS activities listed in Clause 8 linking to CAPA,
complaint handling and adverse event/vigilance report-
ing, etc. At some point, changes driven by CAPA may
require a new regulatory submission.
Figure 1-3. Mandatory Procedures and Documents for ISO 13485:2003
4.2 4.2.1 Quality manual, quality policy and quality objectives
4.2.3 Control of documents
4.2.4 Control of records
6 6.2.2 Competence, awareness and training*
6.3 Infrastructure
6.4 Work environment
7.1 Planning of product realisation
7.3 Design and development
7.4 Purchasing
7.5.1 7.5.1.1 Production and service provision-Control of production and service provision
7.5.1.2.1 Cleanliness of product and contamination control
7.5.1.2.2 Installation activities
7.5.1.2.3 Servicing activities
7.5.2 7.5.2.1 Validation of processes for production and service provision**
7.5.2.2 Particular requirements for sterile medical devices
7.5.3 Identification and traceability
7.5.5 Preservation of product
7.6 Control of monitoring and measuring devices
8.1 General***
8.2 8.2.1 Feedback
8.2.2 Internal audit
8.2.4 Monitoring and measurement of product
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 8.5.1 General (advisory notices and adverse events)
8.5.2 Corrective action
8.5.3 Preventive action
*National or regional regulations might require the organization to establish documented procedures for identifying training
needs.
**The organization shall establish documented procedures for validating computer software applications (and changes
to such software and/or its application) for production and service provision affecting the product’s ability to conform to
specified requirements. Such software applications shall be validated prior to initial use.
***National or regional regulations might require documented procedures for implementation and control of the application
of statistical techniques.