ISO 9001 is a quality management system for manufacturers (product producers) and service providers. Other more specific standards exist for specialized industries such as automotive, pharmaceuticals, and Oil and Natural Gas, but ISO 9001 remains integrated with them.
In order for a calibration process to be properly implemented, we must have in-house calibration management.
What is calibration and why do we need calibration?
Read up our previous post >> What is Calibration and Reason for Calibration
Calibration management is governed by ISO 9001: 2015 Standards, which include specific clauses outlining the requirements for proper implementation.
ISO 9001 Calibration Requirements
What are the ISO 9001 Calibration requirements? The related clauses where calibration requirements are provided are listed below. These are the clauses with calibration requirements that have a direct impact on the calibration results:
- Clause 7.1.2 People.
- Clause 7.1.4 Environment for the operation of processes.
- Clause 184.108.40.206 General monitoring and measuring requirements
- Clause 220.127.116.11 Measurement traceability.
- Clause 7.2 Competence.
- Clause 9.1.1 General requirements for monitoring, measurement, analysis, and evaluation
For the publication we would highlight only 3 from the clauses listed above.
Clause 7.1.4 Environment for the operation of processes
This clause necessitates the monitoring and control of the environment in order for calibration to be performed correctly. Environmental conditions that influence the final output of calibration results should be monitored and controlled, as per ISO 17025 requirements.
The following are some examples of environmental conditions that we must monitor and control:
- Proper lighting
Not all of the items listed above must be controlled at the same time in a lab. This is determined by the criticality and the impact it can have on the calibration process.
Temperature and humidity are the two environmental conditions that are always controlled because almost all instruments require them for proper operation, as detailed in their specifications.
Clause 7.1.5. monitoring and measuring requirements
Monitoring and measuring instruments are instruments that we use to perform measurements.
“It is either we perform a measurement to monitor and control a process or we perform measurement for verification of the output of our process.”
Keeping this in mind, all monitoring and measurement instruments should be controlled.
The control provided are:
- The instrument to be used should be suitable. Suitable means it covers the range and accuracy requirement. For every monitoring and measuring instrument we use, we should ensure that the usable range can be covered and as much as possible, it has higher accuracy than the process to be measured. Recommended is to maintain the Test Uncertainty Ratio.
- Every monitoring and measuring instrument should be maintained to ensure confidence while using or within its calibration interval. Maintained means:
a. Properly monitored for its statuses like locations, labels, and calibration due dates.
b. Preventive maintenance is performed
c. Intermediate check is performed.
Records of Implementation of the above requirements should be maintained that can be used as evidence of implementation during audits.
Clause 7.2 Competence
As defined from ISO 19011 competence is: “demonstrated personal attributes and demonstrated ability to apply knowledge and skills “.
Clause 7.2 and 7.1.2, which is about People are related to each other. ISO 9001 clause 7.1.2 requires that “The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.”
In relation to calibration, the People, which are the personnel involved in performing calibration should be competent or have the necessary competency.
Personnel Competency is one of the main requirements that we must meet. All factors that influence the quality of calibration performed depend on the knowledge, skills, experience, and education of Personnel.
You may have a high-end calibrator, a good calibration procedure, and a well-equipped facility but the person in charge is not suitable for the calibration activity performed, then the calibration results may be invalidated.
To be competent means:
1. Has the necessary competence requirements such as appropriate education, training, or experience;
2. Pass the competency evaluation
3. Authorized to perform important laboratory activities
4. Monitored competency and continued education
All the records and recorded information resulted from this process should be maintained and used as evidence of competency.