The organization is required to measure and monitor the competence of the medical devices to its requirements: customer, quality and regulatory.  The purpose is to prevent the organization form realizing with a status report about the quality. Now, there is no chance on earth that we could allow that

Paragraph 8.2.4.1 – Monitoring and measurement of product

The organization is required to develop, conduct, control, measure and monitor (I think I mentioned everything and in the right order) in order to ensure conformance with specifications. The ISO 13485 Standard requires a record or another firm real and valid evidence for the medical device's competence to the requirements (customer and regulatory). The measurements shall provide them. The measurements are to be referred to specific criteria. The measurements are to be referred to specific regulations (where required).  The measurements shall be according to a quality plan (as required in paragraph 7.1). The measurements of the medical device shall be conducted throughout all the realization processes:

• Development processes
• Acceptance processes
• Production processes
• Delivering processes

Quality Plan

Let's stop for a moment and concentrate on the quality plan. I want to explain the relation between the quality plan and paragraph 8.2.4. Quality plan is a list of requirements or activities (criteria) that the organization must follow and fulfill in order to deliver the medical device according to the requirements (customer's or regulatory). One of the purposes of the quality plan is to supply with the means to evaluate the medical device. The organization shall plan, conduct and perform measurement activities in order to evaluate the medical device as part of the quality plan. The organization shall also define the resources required to maintain activities such as production resources, special employees, special training or qualifications, documented instructions, measuring devices, and the required documentation. You ought to know that it all by now. In other words the measurements and the monitoring shall suit the quality plan.

The next step is to measure your product and to ensure that it follows the requirements. In order to make it easier to measure and analyze, set a quantitative criteria (as part of the quality plan). When analyzing the medical device one can measure (just for the example):

• Functionality
• Efficiency
• Portability
• Usability
• Credibility

Documenting the methods

The measurement shall be conducted according to defined methods for measuring and monitoring. The methods are required to be documented.  At this point the ISO 13485 Standard refers us to paragraph 7.5.1.1 - Production and service provision, where it is required to maintain documentation (of any kind) related to the product realization processes and it the documentation must be available at any time for the appropriate employees. Documentation shall include:

• Documented procedures as required in this standard
• Any documented requirement (regulatory, customer's etc.)
• Work instructions
• Reference material
• Reference measurements procedures
• Diagrams
• Flow charts
• Routing charts
• Operation instructions

So says paragraph 7.5.1.1!!!

Since we are dealing with measuring and monitoring of the medical device, the ISO 13485  Standard  requires including the appropriate documentation (required for measuring and monitoring) under the control of the production and the service provision: reference material, reference measurements procedures, Work instructions or any kind of documentation to describe the measurements activities. The make a complicated story simpler, when defining the documentation required to maintain the control over the production and service provision, include the measuring and monitoring processes as well.

Records of the measurements

Records of the medical device's measurements shall be maintained. The records shall provide appropriate evidences for the medical device conformance to the requirements. The records shall show a comparison of the sampled product to the requirements. . the records shall include:

• Details about the measurement (date, product, etc.)
• The acceptance activities performed
• Results of the measurement
• The approver of the product

The release of the medical device

The measurements records shall include the approval from an authorized function. The approval would confirm that the medical device conforms to the requirements. Then, and only then the organization is allowed to release the medical device. The ISO 9001 Standard allows release of a product even when it does not conform all the requirements, conditioned that the customer had approved release. The ISO 13485 Standard do not approve. The ISO 13485 Standard requires achieving all (defined in a quality plan) requirements and only then the organization may release the product. Customer's approval is not sufficient in this case. Why? This is because customer's approval may not be an objective decision and therefore omitting some requirements. The ISO 13485 Standard cannot allow that! Always remember: people's life may depend on these medical devices. 

Paragraph 8.2.4.2 - Particular requirement for active implantable devices and implantable devices

This requirement does not appear in the ISO 9001 Standard.

This requirement refers to two categories of medical devices: active implantable devices and implantable devices. Any individual that carries out inspection or measurements of medical devices included in these categories must be identified and recorded. How? It is quite simple. The next one is only a suggestion – it may not suit your organization. Job description, work instructions, procedures -   all these may bear the identification, the definition. Who is responsible and what must he do. In any way you are required to record the measurements - just add the record of the personal that conducted the inspection.