ISO 9001:2015 Clause 188.8.131.52, titled "Measurement Traceability," addresses the requirements for ensuring that measuring equipment used for monitoring and measurement is traceable to international or national measurement standards.
Detailed Explanation of clause 184.108.40.206
Calibration or Verification: Measuring equipment should be calibrated or verified, or both, at specified intervals or before use. Calibration ensures that the equipment provides accurate and reliable measurements. The calibration process involves comparing the equipment's measurements to known standards that are traceable to international or national measurement standards. If no such standards exist, the organization should document the basis used for calibration or verification.
Documented Information: The organization is required to retain appropriate documented information as evidence of the basis used for calibration or verifications. The basis documentation justifies and describes the methods and standards used when no international or national measurement standards are available for calibration.
Equipment Identification: Measuring equipment must be clearly identified to determine its status. This identification helps in tracking and managing the calibration status of each piece of equipment.
Safeguarding: Measuring equipment should be protected from adjustments, damage, or deterioration that could invalidate its calibration status and subsequent measurement results. This includes preventing unauthorized personnel from making adjustments that could affect the equipment's accuracy.
Validity of Previous Results: If, during calibration or verification, it's determined that measuring equipment is unfit for its intended purpose, the organization must assess whether the validity of previous measurement results has been adversely affected. If so, appropriate corrective actions should be taken.
Example Pharmaceutical Manufacturing Facility
In a pharmaceutical manufacturing facility, various instruments are used to measure and monitor critical parameters during drug production. These instruments include thermometers, pressure gauges, and pH meters. To ensure that the measurements are accurate and traceable, the organization follows a calibration schedule. For instance, the pH meters are calibrated against known buffer solutions with traceability to national measurement standards. The calibration intervals are clearly defined, and each pH meter is labeled with an identification number.
The organization also takes steps to safeguard the equipment by keeping them in controlled conditions and ensuring that only trained personnel are allowed to perform calibrations. If, during routine calibration, an instrument is found to be out of specification and unfit for its intended purpose, the organization assesses whether previous measurements made with this instrument might have been affected. If so, appropriate actions are taken to address the potential impact on customers or product quality.
Basis Used for Calibration or Verification
The "basis used for calibration or verification," as mentioned in ISO 9001:2015 Clause 220.127.116.11, refers to the documented information that justifies and describes the methods and standards used when no international or national measurement standards are available for calibration.
Explanation of Why this is Important:
Lack of International or National Standards: In some situations, especially in highly specialized industries or for unique measurement equipment, there may not be internationally or nationally recognized measurement standards available. These standards serve as reference points against which measuring equipment can be calibrated for accuracy.
Traceability and Consistency: The purpose of documenting the basis for calibration or verification is to ensure traceability and consistency in measurement processes. Even without official standards, having documented procedures and methods helps the organization maintain control over the calibration process and ensures that measurements are accurate and reliable.
Auditing and Verification: During audits or inspections by external parties (e.g., certification bodies or regulatory agencies), having well-documented procedures for calibration or verification provides evidence of the organization's commitment to measurement quality and accuracy.
Documented Information: When no official standards exist, organizations are required to create their own documented procedures that define how they will calibrate or verify the equipment. This documented information should include the following:
Methods: Describe the specific methods and procedures to be used for calibration or verification. This might include step-by-step instructions for calibration processes.
References: If there are any available industry-specific standards or guidelines, they should be referenced in the documentation.
Rationale: Explain why the chosen methods are appropriate for calibration. This might include scientific principles, historical data, or expert opinions.
Measurement Data: If available, any historical calibration or verification data that support the chosen methods.
In summary, the basis used for calibration or verification is the set of documented procedures, methods, and rationale that an organization follows to calibrate or verify its measuring equipment when no international or national measurement standards are available. These procedures help maintain measurement accuracy and provide a basis for audit and verification processes.
ISO 9001:2015 Clause 18.104.22.168 Measurement Traceability
Compliance with clause 22.214.171.124 is crucial to maintain the accuracy and traceability of measurement results, particularly in industries where measurement precision is critical to product quality and safety.