Equipment maintenance according to ISO 13485 is one of the process described in the section 7 of the standard, and specifically in the section 7.6.
The correct maintenance and calibration of the equipment has a direct impact on all the process where the specific equipment is used, that could be manufacturing operations, design and development, servicing, etc. Having a solid and reliable quality system process for the maintenance of the equipment is a key factor for the maintenance of quality and safety of the device.
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In this post we will go trough the main requirements associated to the management of equipment for medical device company, mainly according to ISO 13485.
Control of monitoring and measuring equipment
The control of equipment shall be performed through the whole life cycle, during standard operation but also during maintenance and storage. This is a key requirement for an efficient equipment maintenance according to ISO 13485.
It is the responsibilities of the organization to determine what are the requirements associated to the correct maintenance of the equipment. These requirements may include, for example:
- Periodic Calibration
- Periodic planned maintenance
- Extraordinary maintenance
The standard, moreover, reports clearly the responsibility of the manufacturer fo have a procedure in place for the management of the equipment, with clear responsibilities defined within the organization.
Equipment Calibration and Verification as per ISO 13485
One of the key requirement of the section 7.6 of the standard is the necessity to have equipment calibrated or verified at specified intervals, in order to ensure the validity of the measurements performed.
The ISO 13485 mentions the wording calibration and verification and, often, it is not very clear what is the difference between these two terms. In order to clarify any doubt, calibration ensures the measurement accuracy of an instrument compared to an known standard and, more precisely, it is defined as follows:
The operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, use this information to establish a relation for obtaining a measurement result from an indication.
Verification, instead, ensures the correct operation of equipment or a process according to its stated operating specifications. Basically, it consists on the identification of specific requirements related to the equipment and the verification that these requirements are still fully fulfilled at the time when the verification activity takes place. In fact, verification is defined as:
“Provision of objective evidence that a given item fulfils specified requirements“.
Other Requirements for Equipment Maintenance according to ISO 13485
There are some other requirements associated to the management of the equipment mentioned in the section 7.6 of ISO 13485 version 2016.
These requirements are:
- Necessity to evaluate the need adjustments for equipment and record when adjustments are performed
- Clear identification of the equipment and of its associated calibration status
- Keep equipment under control in order to avoid adjustments that may impact the measurements performed
- ensure protection of the equipment during handling, maintenance and storage.
Management of non-conforming equipment
When the equipment is found out of calibration and, in the meantime, it has been used for measurements activities, for example during manufacturing operations, the deviation needs to be managed through the CAPA process.
In this context, it is essential that a risk assessment is performed to evaluate the impact of the out of the calibration status on the measurements already performed. The consequence of this deviation may highly depend from the type of measurements performed by the equipment. if the measurement is related to safety property of the device, and the associated risks is no longer acceptable, the deviation needs to be handled through the field safety corrective action process.
Software Validation
Often equipment are used in combination with software in order to perform the specific measurements. The section 7.6 specifies as well the requirements for software validation, claiming that validation is needed before the begin of the use of the software and after any changes performed to the software, if it is deemed necessary.
As usual, a risk based approach shall be implemented in order to proportionate the efforts of the validation activities based on the risk associated to the specific software application.
Control of Equipment Procedure
In QualityMedDev shop, a Control of Equipment Procedure fully aligned with the requirements of ISO 13485 is provided. This procedure is a 8-pages document, fully editable as it is provided in word, and it is fully aligned with the requirements we have been just discussing for management of measuring equipment under the ISO 13485 requirements.
Do not hesitate to download this procedure.
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Within our WebShop, a wide range of procedures, templates, checklists are available, all of them focused on regulatory topics for medical device compliance to applicable regulations. Within the webshop, a dedicated section related to cybersecurity and compliance to ISO 27001 for medical device organizations is also present.
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