Class IV nIVD applications content and classification guidance: Quality management system
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Chapter 6: Quality management system
Folder name: 6-QMS
Note: No files or content should be included at this level. Only sub-folders of this folder should contain documents.
6.12 Production and service controls
Folder name: 6.12-Production-ServCtrlsProcedures
IMDRF common content
ISO 13485 Elements –SOPs and device specific documentation implementing sub clause 7.5.
IMDRF Health Canada content
- Detailed manufacturing flow diagram
- Summary of in-process acceptance activities for subject device
- Process validation master plan
- List of processes that have not been validated
- For each process validation considered critical to the safety and effectiveness of the device:
- Protocols/procedures for the validated process
- Process validation report
- The procedures for monitoring and controlling the process parameters of a validated process should be fully described
- State the frequency of re-validation
Note:
- Manufacturing flow diagram is required to describe the methods used in, and quality controls used for, the manufacture, processing, packaging, storage and, where appropriate, the installation of the device. Sufficient detail must be provided to enable the judgement of the appropriateness of the quality controls in place.
- If multiple facilities are involved in the manufacture of a device, the applicable information for each facility must be submitted. If the information is identical for a number of sites, this should be stated.
Heath Canada guidance
If process results could not be fully verified during routine production by inspection or testing, the results of process validation studies must be presented. Process validation data should include test data and methods, information on controls, number of samples examined, frequency of testing, and why process validation was used (for example, routine end product tests have insufficient sensitivity, reliability of a changed process is unknown, etc.). The procedures for monitoring and controlling the process parameters of a validated process should also be fully described. Process validation related to sterilization or shelf life should be captured under separate headings of sterilization or shelf and need not be included in this section. Also: reference may be made to a product’s proprietary information submission for this information.
Classification
New applications: Required
Amendment applications: Conditionally required – If applicable to the amendment
6.15 Device-specific quality plan
Folder name: 6.15-DeviceSpecificQualityPlan
IMDRF Health Canada content
The review requirement for a quality plan is not met by the ISO 13485 certificate alone, instead refer to ISO 10005. A quality plan should specify “which processes, procedures and associated resources will be applied by whom and when to meet the requirements of a specific project, product, process or contract…”. This information may be provided in an application in the form of a flow chart, process map, document matrix, table or text description. A quality plan specific for the subject device should link device requirements to the processes, resources and projects used by the manufacturer in producing that device.
Classification
New applications: Required
Amendment applications: Conditionally required – If applicable to the amendment
6.17 Other quality system information
Folder name: 6.17-OtherQualitySystemInformation
IMDRF common content
Heading for other information that may be important to the submission but that does not fit in any of the other headings.
Classification
New and amendment applications: Conditionally required – When information is requested by the regulator (through guidance documents or other communication) but does not belong in any of the other headings of this chapter.