One of the main standards that require the implementation and proper execution of calibration is ISO 9001:2015. ISO 9001 calibration requirements do not differ from ISO 17025. Your knowledge of ISO 17025 is a big advantage when implementing ISO 9001 calibration requirements.

What are the Clauses in ISO9001 where the need for calibration is required, supported, and emphasized?

Below are the related clauses for calibration implementation under ISO 9001:2015: Clause 7.1.5 – Monitoring and Measuring Resources and Clause 9.1 – Monitoring, Measurement, analysis, and Evaluation:

1. Clause 7.1.4 Environment for the Operation of Processes

• The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. – managing an internal calibration lab or simply calibration implementation is one of the processes that contribute to product quality and therefore environmental control is necessary (see element no 10 below).

2. Clause 7.1.5.1 General Monitoring and Measuring Requirements

• The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. (covers the 13 elements below).

• The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources. (see element 12 below)

1. the resources provided are suitable for the specific type of monitoring and measurement activities being undertaken.  (see element no. 1 below)

2. the resources provided are maintained to ensure their continuing fitness for their purpose.  (see element no. 13 below)

3. Clause 7.1.5.2 Measurement traceability

• In order to maintain proper traceability (unbroken chain of comparison) to provide confidence to measurement results, measuring equipment shall be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards (see element 9 below);

• properly identified in order to determine their status (see element 7 below);

• safeguarded from adjustments, damage, or deterioration that would invalidate the calibration status and subsequent measurement results. (see elements 5 and 7 below)

• The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary. – this will fall under the process of “reviewing measurement results” and “handling out-of-tolerance conditions” which differs to every industry.

  The important thing is that we have a system in place to backtrack and review necessary calibration data when problems are suspected in our calibration results in order to take the necessary actions.

  Read more about this clause in this post. >>5 Mistakes When Using a Calibration Certificate that You Need to Correct

4. Clause 9.1.1 General requirements for monitoring, measurement, analysis, and evaluation

• The organization shall determine:
  a) what needs to be monitored and measured; (see element 1 below)

  b) the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results; (see element 6 below)

  c) when the monitoring and measuring shall be performed; (see element 1 below)
  
  d) when the results from monitoring and measurement shall be analyzed and evaluated. (see element 13 below)