| The organization shall define the monitoring and measurements required in order to provide evidences for product's conformity. Naturally, the requirements for monitoring and measurements are based on the medical device's requirements. When defining the requirements for product's monitoring and measurement, the organization shall refer to the next issues:
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ISO 9001
| ISO 13485
| The organization shall determine a method for monitoring and measurements processes and/or products needed to provide evidences for product's conformity.
| The organization shall determine and document in a procedure a method for monitoring and measurements processes and/or products needed to provide evidences for product's conformity.
| The organization must determine which are the monitoring and measuring devices required to provide the evidences for product's conformity.
Monitoring and measuring devices include inspection, measurements, and tests equipment. The equipment can be either mechanical or electronically.
In order to ensure valid results, the monitoring and measuring equipment shall meet the next requirements:
| The organization must determine which are the monitoring and measuring devices required to provide the evidences for product's conformity.
Monitoring and measuring devices include inspection, measurements, and tests equipment. The equipment can be either mechanical or electronically.
I In order to ensure valid results, the monitoring and measuring equipment shall meet the next requirements:
| The monitoring and measuring devices shall be calibrated within specific time intervals (routinely) or before use, according to international or national standard measurements. In cases where such standard does not exist, the calibration and the basis for the calibration process (physical or calculating) shall be recorded.
| The monitoring and measuring devices shall be calibrated within specific time intervals (routinely) or before use, according to international or national standard measurements. In cases where such standard does not exist, the calibration and the basis for the calibration process (physical or calculating) shall be recorded.
| The monitoring and measuring devices shall be adjusted with a master measuring device according the process or the requirement.
| The monitoring and measuring devices shall be adjusted with a master measuring device according the process or the requirement.
| The monitoring and measuring devices shall be identified in order to determine the calibration's status and the calibration's validity.
| The monitoring and measuring devices shall be identified in order to determine the calibration's status and the calibration's validity.
| The monitoring and measuring devices shall be safeguarded from adjustment that would invalidate the measurements results.
| The monitoring and measuring devices shall be safeguarded from adjustment that would invalidate the measurements results.
| The monitoring and measuring devices shall be protected from damage and deterioration that might affect the calibration during storage, handling and transportation.
| The monitoring and measuring devices shall be protected from damage and deterioration that might affect the calibration during storage, handling and transportation.
| When a monitoring and measuring devices was found inappropriate for use, the organization must act as indicated:
- The organization shall evaluate the validity of prior measurements taken with the inappropriate monitoring and measuring devices. When possible, the organization shall track products that were measured with the damaged monitoring and measuring devices and re-measure them.
- Appropriate measures shall be taken on the monitoring and measuring devices and products affected according to the evidences of the inappropriate monitoring and measuring devices.
- These activities must be recorded and included under the records control procedure as required in paragraph 4.2.4 – control of records.
| When a monitoring and measuring devices was found inappropriate for use, the organization must act as indicated:
- The organization shall evaluate the validity of prior measurements taken with the inappropriate monitoring and measuring devices. When possible, the organization shall track products that were measured with the damaged monitoring and measuring devices and re-measure them.
- Appropriate measures shall be taken on the monitoring and measuring devices and products affected according to the evidences of the inappropriate monitoring and measuring devices.
- These activities must be recorded and included under the records control procedure as required in paragraph 4.2.4 – control of records.
| Records of calibration processes are to be kept and included under the records control procedure as required in paragraph 4.2.4 – control of records.
| Records of calibration processes are to be kept and included under the records control procedure as required in paragraph 4.2.4 – control of records.
| When computer software is used to perform measurements of defined requirements, the organization shall validate the ability of the software to perform the measurements. Validation is to be done before the use of the software.
| When computer software is used to perform measurements of defined requirements, the organization shall validate the ability of the software to perform the measurements. Validation is to be done before the use of the software.
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In order to ensure valid results submitted to the product's requirements, measurement equipment shall be calibrated or verified at specified intervals according to defined criteria (for example standards), uniquely identified (could be related to specific products of processes, for example) and protected from damage, deterioration or inadvertent adjustment during storage, use, handling or transportation. Place the equipment in a safe closet… The additional requirement that the ISO 13485 Standard poses, is to establish and maintain a documented procedure describing the calibration activities. The procedures shall provide clear instruction for storage activities, handling activities, and operation activities in order to maintain the equipment preservation and to prevent from their accuracy and fitness to be damaged. The procedure shall include the records required to prove these activities. The procedure shall be available to the relevant employees at the relevant work stations. The organization must provide evidences of calibration activities including calibration results. A laboratory, that calibrates scales and pH monitors (just for the example), shall maintain a Procedure that describes the calibration activities, the time intervals, and the required results. The results shall include accepted tolerances. The procedure shall be kept at the premises of the laboratory and shall be available to any relevant employee. Every measurement device shall be documented. The documentation must include identification of the device, its location, instruction regarding its calibration process, the standard (international, national or independent) for reference, the status of its calibration (including dates and precise results), and the validity of the calibration. The validity refers here is to when, where, and by whom the next calibration should be performed. When computer software is required to perform the measurements, the organization must validate the ability of the software to perform the measurements. Validation is to be done before the use of the software. Usually calibration is perceived as non-relevant activity for software. But it is. And both the ISO 9001 Standard and the ISO 13485 Standard know it. And they require it. When the organization makes a use of software for measurements for product validation, the organization shall: - Assess the effect of the software's activities on the product and its quality.
- Manage the configuration of the software in order to control any changes that may affect the accuracy and fitness of the measurement.
Which of the software components shall be controlled? - The data evaluated by the software - to ensure that the data is valid.
- The features of the software – to ensure that the activities are appropriate.
- The hardware.
- Any equipment connected to the hardware.
When the calibration is performed by an external laboratory, the external lab shall be accredited and certified. The certification must be appropriate to the nature of the organization and more important to the nature of the medical device. It is recommended the lab shall be accredited to the ISO 17025. |
