Monitoring & Measurement of Products & Processes

1. Purpose

This document provides the process for monitoring & measurement of Products and Processes in compliance with ISO 13485.

2. Approval

(Version at end of page)

Signed V5 MR 14.10.2021

3. Scope

The process covers the process for Monitoring & Measurement of Products and Processes.

4. Responsibilities

Approval: Author of the Document, Marelize Robertson

Changes: Author of the Document, Dean Kowalski

5. Definitions

Monitor - To watch closely in order to observe, record, or detect; - an act of surveillance. 

Measurement - The act of determining the actual traits of something (such as dimensions, capacity, etc.).

Product/ Process Failure/ Fault - Non-conformance to requirements. 

Rework - The action of redoing a production procedure for an item / batch in order to correct a defective/ faulty aspect/s (e.g.: packaging/ labelling/ out of specification) mainly in regard to disposable products. 

Repair - Is to restore (something damaged, faulty, or worn) to the original safety and performance condition to put the item back into acceptable working order again. 

Maintenance - This is required for preserving the condition of an item (infrastructure, machinery, products).

Refurbishment - The process used to return medical devices to a condition of safety and effectiveness comparable to when new and without significantly changing the equipment's performance, safety specification and/or intended use as in its original registration. 

6. Abbreviations

SOP - Standard Operating Procedure

QMS - Quality Management System

M&M - Monitoring & Measurement

7. References

ISO 13485 clauses 8.2.

SOP Non-Conformance Corrective Action (NCCA)

SOP Change Management

SOP QMS Auditing

SOP Data Analysis

8. Procedure

Monitoring and Measurement of Products and Processes (ISO 13485 8.2.5 & 6)

8.1. Process

a) Product

Manufacturing - supplier management & production QC

Distribution - sales and warehousing

b) Processes 

system processes e.g. Change Control, Management Review, Training etc are M&M through Internal Auditing with Data Analysis according to relevant SOP

operational processes - refer Operations

8.1.1. Monitoring and Measurement of Processes

The organisation shall apply suitable methods for monitoring and, as appropriate, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate.

8.1.2. Monitoring and Measurement of Product

The organisation monitors and measures the characteristics of the product to verify that product requirements have been met. This shall be carried out at applicable stages of the product realisation process in accordance with the planned and documented arrangements and documented procedures - refer work instructions/ operational procedures.

Evidence of conformity to the acceptance criteria is maintained and the identity of the person authorising release of product is recorded through evidence of a signature. As appropriate, records identify the test equipment used to perform measurement activities.

Product release and service delivery does not proceed until the planned and documented arrangements have been satisfactorily completed; as required by the implemented procedures 

(NOT APPLICABLE as products not covered RE For implantable medical devices, the organisation shall record the identity of personnel performing any inspection or testing)

The process is established and defined for inspection and testing activities, as applicable and required by relevant procedures, to verify that products and materials conform to specified requirements throughout the product realisation process by identifying appropriate:

1. References, e.g. specifications or legal and regulatory requirements

2. Methodology, e.g. random sampling, non-destructive testing or in-process monitoring

3. Documents, e.g. inspection and test plans

4. Acceptance criteria, e.g. defined by ISO standards, legal or regulatory requirements

5. Responsibilities, e.g. authority for acceptance

Materials, components, sub-assemblies and finished products should be prevented from use, assembly or dispatch until the required inspections are completed. Modified products should be fully re-inspected and re-tested against the acceptance criteria; through rework SOP as required.

8.1.3. Measuring the Effectiveness 

The effectiveness of the monitoring and measurement of product / process is often determined by looking for documentary evidence that product requirements have been achieved and the planned arrangements have been met. Trends in the rates of product failure must be monitored as should the effectiveness of corrective actions when dealing with non-conformances.

8.1.4. Process / Product Failure / Fault

The SOP Non Conformance Corrective Action (NCCA) is followed and should a process require review and change the SOP Change Management is followed

9. Risk Based Approach

In the event of non-compliance follow SOP Non-Conformance Corrective Action.

The Risk Assessment to is found in SOP Preventative Action Risk Assessment refer Document.