ISO 9001:2015 Clause Measurement traceability

ISO 9001:2015 Requirements

When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:
a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information;
b) identified in order to determine their status;
c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.
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.

1) Measurement Traceability

Measurement traceability refers to the ability to establish a clear, documented, and unbroken chain of comparisons between a measurement result and a reference standard of known accuracy. It ensures that the measurement result is reliable, accurate, and consistent by providing a link to a recognized and validated reference point. Traceability is essential for maintaining the integrity of measurements in various fields, including manufacturing, testing, research, and quality control. Key points about measurement traceability:

  1. Reference Standard: At the core of traceability is a reference standard that has a known and documented relationship to an internationally recognized measurement system or standard. This could be a physical artifact, instrument, measurement procedure, or even a software standard.
  2. Unbroken Chain: Traceability requires an unbroken chain of comparisons, where each step in the comparison is documented and validated. This chain ensures that the measurement result can be linked back to the original reference standard.
  3. Accuracy and Consistency: Traceability helps ensure that measurements are accurate and consistent across different laboratories, facilities, or instruments, regardless of their location.
  4. International Standards: Traceability often involves referencing internationally accepted measurement standards maintained by organizations like the International System of Units (SI) or National Metrology Institutes.
  5. Calibration: Calibration is a common method used to establish traceability. Equipment is calibrated against traceable reference standards to ensure accuracy.
  6. Documentation: Accurate documentation is essential for traceability. Records of calibration, comparison, and any adjustments made are crucial for demonstrating the traceability chain.
  7. Quality Assurance and Compliance: Traceability is a fundamental aspect of maintaining quality and meeting regulatory and industry requirements. It supports conformity assessment, quality control, and data integrity.
  8. Audit and Verification: Traceability provides a transparent and verifiable basis for audit and verification processes, ensuring the reliability of measurement results.
  9. Risk Management: Traceability helps identify potential measurement errors or discrepancies and allows organizations to take corrective actions to mitigate risks.
  10. Continuous Improvement: Regularly reviewing and updating traceability processes ensures ongoing accuracy and relevance, especially as measurement technology evolves.

In summary, measurement traceability ensures that measurement results are credible, consistent, and accurate by establishing a clear connection to a recognized reference standard. It’s a fundamental concept in various industries where accurate measurements are crucial for product quality, safety, and compliance.

2) Calibration of monitoring and measuring equipment

Calibration of monitoring and measuring equipment is a crucial process in various industries to ensure the accuracy and reliability of the measurements taken by those instruments. This process involves comparing the measurements of the equipment to a known standard to determine any deviations or inaccuracies. Here’s a step-by-step overview of the calibration process:

  1. Identify Calibration Standards: Calibration standards are highly accurate reference instruments that are used to establish a known value for the quantity being measured. These standards could be physical artifacts, electronic devices, or other well-established measurement references.
  2. Select Calibration Intervals: Determine how often each piece of equipment needs to be calibrated. This depends on factors such as the instrument’s intended use, manufacturer recommendations, industry regulations, and the instrument’s stability over time.
  3. Preparation: Ensure that the equipment to be calibrated is clean, functional, and properly warmed up (if applicable). This helps reduce errors during the calibration process.
  4. Perform Calibration: The actual calibration process involves comparing the measurements of the equipment being calibrated with the measurements of the calibration standard. This comparison helps identify any deviations or inaccuracies.
    • Adjustment: If the equipment being calibrated shows significant deviations from the calibration standard, adjustments might be necessary. Some instruments allow for manual adjustments, while others might require professional calibration services.
    • Record Measurements: Document all the measurements taken during the calibration process. This documentation is essential for tracking the instrument’s performance over time.
  5. Calculate Deviations: Calculate the deviations between the measurements obtained from the equipment and the calibration standard. This gives a clear indication of the instrument’s accuracy and potential errors.
  6. Generate Calibration Certificate: After the calibration is complete, a calibration certificate is usually issued. This certificate includes details about the instrument, the calibration standards used, the results of the calibration, any adjustments made, and the date of calibration.
  7. Adjust Calibration Schedule: If significant deviations or inaccuracies are found, adjustments might be required to the calibration schedule. This could involve more frequent calibrations, repairs, or replacements of the equipment.
  8. Maintain Calibration Records: Maintain a detailed history of calibration records for each piece of equipment. These records are essential for audits, quality control purposes, and compliance with industry standards.
  9. Audit and Verification: Regularly audit the calibration process to ensure that it is being followed correctly. This could involve internal audits or external audits by regulatory bodies.
  10. Training: Ensure that personnel responsible for performing calibrations are properly trained and have a clear understanding of the calibration procedures.

Calibration is essential for maintaining the accuracy and reliability of measurements, which in turn contributes to product quality, process efficiency, and compliance with industry standards and regulations. It’s important to adhere to established calibration procedures and guidelines specific to your industry.

3) Verification of monitoring and measuring equipment

Verification of monitoring and measuring equipment is a process that ensures the equipment is functioning within specified tolerances and provides accurate and reliable measurements. Unlike calibration, which involves comparing measurements to a known standard, verification focuses on confirming that the equipment’s performance meets the defined requirements. Here’s an overview of the verification process:

  1. Establish Performance Criteria: Determine the performance criteria that the equipment needs to meet. This includes factors like accuracy, precision, resolution, and other relevant specifications.
  2. Preparation: Ensure that the equipment is in proper working condition and is ready for verification. This might involve cleaning, warming up (for certain types of equipment), and checking for any obvious defects.
  3. Perform Verification Tests: Conduct specific tests or procedures that evaluate the equipment’s performance against the established criteria. These tests are designed to cover a range of conditions that the equipment might encounter during its normal use.
  4. Compare Results: Compare the measurements obtained from the equipment being verified with the expected values or performance criteria. This comparison helps identify whether the equipment is operating within acceptable tolerances.
  5. Record Results: Document the results of the verification tests, including the measurements obtained and any deviations from the expected values. Proper documentation is essential for tracking the equipment’s performance over time.
  6. Analysis: Analyze the results to determine whether the equipment meets the defined performance criteria. If the equipment is found to be out of tolerance, further investigation might be needed to identify the cause.
  7. Decision Making: Based on the analysis, decide whether the equipment is suitable for its intended use. If the equipment fails to meet the specified criteria, further action might be required, such as maintenance, repair, recalibration, or replacement.
  8. Adjustment: If the equipment’s performance is found to be outside acceptable limits but can be adjusted, perform the necessary adjustments to bring it back into compliance.
  9. Documentation: Maintain a record of all verification activities, including the results, dates of verification, any adjustments made, and any actions taken based on the results.
  10. Regular Verification: Establish a schedule for regular equipment verification. The frequency of verification might depend on factors like the criticality of the equipment, the environment it operates in, and industry regulations.
  11. Personnel Training: Ensure that the personnel responsible for equipment verification are adequately trained in the procedures and methods used.
  12. Quality Management: Integrate equipment verification into your organization’s quality management system to ensure consistent and reliable verification practices.

Verification is essential for ensuring that monitoring and measuring equipment continues to provide accurate and reliable measurements. It helps identify potential issues before they impact the quality of products or processes. Verification complements the calibration process and contributes to maintaining overall measurement integrity.

4) When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results

Measurement traceability is considered a requirement and an essential part of providing confidence in the validity of measurement results in various contexts, especially in industries and applications where accuracy and reliability of measurements are crucial. Here are some scenarios where measurement traceability is essential:

  1. Many industries are subject to regulations and standards that require measurement traceability. Regulatory bodies often mandate that measurement results be traceable to recognized national or international measurement standards. This ensures that measurements are consistent, comparable, and of known accuracy.
  2. In industries like manufacturing, pharmaceuticals, and aerospace, maintaining product quality is paramount. Measurement traceability is vital to ensure that products meet specified requirements and that processes are operating within acceptable limits.
  3. Laboratories seeking accreditation or certification, such as ISO/IEC 17025 for testing and calibration laboratories, need to demonstrate measurement traceability as part of the accreditation process. This is to show that they adhere to recognized standards and can produce reliable and accurate measurement results.
  4. When different organizations collaborate or exchange products, components, or materials, measurement traceability is essential to ensure consistency and reliability across the supply chain. Traceable measurements help prevent disputes and facilitate smooth operations.
  5. In scientific research, precise and accurate measurements are fundamental to generating reliable data and drawing meaningful conclusions. Measurement traceability ensures that experimental results can be reproduced by other researchers and that the scientific community can build upon established knowledge.
  6. Medical diagnostics, drug development, and patient treatment often rely on accurate measurements. Measurement traceability is critical to ensure patient safety, proper dosages, and effective medical interventions.
  7. Monitoring environmental parameters such as air quality, water quality, and emissions requires accurate measurements for regulatory compliance and understanding the impact of human activities on the environment.
  8. Legal and forensic investigations often require accurate measurements as evidence in court proceedings. Measurement traceability ensures the validity and reliability of this evidence.
  9. In international trade, research collaboration, and global communication, measurement traceability ensures that data from different sources can be compared and understood accurately.
  10. In industries where incorrect measurements could lead to safety hazards, financial losses, or legal liabilities, measurement traceability is essential for managing and mitigating risks.

In summary, measurement traceability is considered a requirement when accuracy, reliability, comparability, and consistency of measurement results are vital. It provides the necessary foundation for building confidence in the validity of measurements and supporting informed decision-making across various fields.

4) Measuring equipment shall be calibrated or verified, or both, at specified intervals, or prior to use

Measuring equipment should be calibrated, verified, or both, at specified intervals or prior to use to ensure accurate and reliable measurements. This practice is essential for maintaining the quality of measurements and the integrity of the data or results obtained from the equipment. The frequency of calibration, verification, or both, depends on factors such as the type of equipment, its intended use, industry standards, regulatory requirements, and the level of accuracy required. Adhering to these practices helps prevent errors, ensures compliance with standards, and maintains the overall reliability of measurement processes.

5) Measuring equipment shall be calibrated or verified against measurement standards traceable to international or national measurement standards

Calibrating or verifying measuring equipment against measurement standards traceable to international or national measurement standards is a fundamental practice for ensuring the accuracy and reliability of measurements. Here are the key reasons for this requirement:

  1. Accuracy and Consistency: International or national measurement standards are established based on rigorous and well-defined principles. Calibrating or verifying equipment against these standards ensures that measurements are accurate, consistent, and comparable across different laboratories and industries.
  2. Traceability: Measurement traceability is a crucial aspect of demonstrating the reliability of measurements. When equipment is calibrated against standards that are themselves traceable to recognized international or national standards, a clear traceable path is established, giving confidence in the accuracy of the measurements.
  3. Interoperability: Traceable measurements enable data exchange and collaboration between different organizations and countries. Accurate and traceable measurements are essential for meaningful scientific research, trade, and regulatory compliance.
  4. Quality Assurance: Calibrating against traceable standards is a key component of quality assurance systems. It ensures that the measuring equipment is performing within specified tolerances, reducing the risk of errors, defects, and non-conformities.
  5. Compliance: Many industries have regulations and standards that require measurements to be traceable to recognized standards. Calibrating or verifying equipment against traceable standards is necessary to comply with these requirements.
  6. Credibility and Trust: Organizations that can demonstrate that their measurements are traceable to internationally or nationally recognized standards earn credibility and trust among customers, partners, and regulatory bodies.
  7. Data Integrity: Traceable measurements enhance the integrity of data collected, analyzed, and reported. Accurate measurements contribute to reliable decision-making, reporting, and research outcomes.
  8. Risk Mitigation: By ensuring that measurements are traceable to recognized standards, the risk of making incorrect decisions, producing faulty products, or facing legal disputes is significantly reduced.
  9. Continual Improvement: Regular calibration against traceable standards provides feedback about the performance of measuring equipment. If deviations are identified, adjustments can be made to improve accuracy and reliability.
  10. Regulatory Compliance: Regulatory agencies often require measurement traceability as part of compliance with standards. Accurate and traceable measurements facilitate smoother interactions with regulatory bodies.

In summary, calibrating or verifying measuring equipment against measurement standards traceable to international or national standards is a fundamental practice that ensures accuracy, reliability, and consistency in measurements across various fields and industries. It is a critical component of maintaining quality, complying with regulations, and building trust in measurement results.

6) When no such standards exist, the basis used for calibration or verification shall be retained as documented information;

When there are no specific international, national, or recognized standards available for calibration or verification of measuring equipment, it’s crucial to establish a documented basis for calibration or verification. This documented information serves as a reference point and helps ensure that measurements are accurate, consistent, and reliable. Here’s why retaining documented information in such cases is important:

  1. Consistency: Even in the absence of established standards, having a documented basis for calibration or verification ensures that the same methods and procedures are consistently applied each time the equipment is calibrated or verified. This consistency is essential for reliable measurements.
  2. Traceability: While direct traceability to international or national standards might not be possible, the documented basis creates a traceable path for the calibration or verification process. This traceability helps demonstrate the reliability and integrity of the measurement results.
  3. Transparency: Documenting the basis used for calibration or verification makes the process transparent and understandable to others. This is especially important for audits, quality control, and sharing information with stakeholders.
  4. Continual Improvement: Keeping documented information about the calibration or verification basis allows for ongoing evaluation and improvement of the process. If new information becomes available, adjustments can be made to enhance accuracy and reliability.
  5. Quality Management: Documented information forms an essential part of quality management systems. It provides evidence of adherence to procedures and aids in ensuring that measurement processes are controlled and consistent.
  6. Regulatory Compliance: In situations where specific standards are lacking, regulatory bodies might still require organizations to demonstrate that they have a systematic and reliable approach to calibration or verification. Documented information helps meet these compliance requirements.
  7. Historical Reference: Over time, personnel might change, and the equipment might undergo modifications. Documented information serves as a historical reference that allows future operators to understand and follow the established calibration or verification methods.
  8. Decision-Making: Having a well-documented basis for calibration or verification enables informed decision-making regarding the accuracy and reliability of measurement results.

In summary, when no recognized standards are available, documenting the basis for calibration or verification is a crucial practice for ensuring measurement accuracy and reliability. This documented information serves as a foundation for maintaining consistency, traceability, and quality in the absence of established standards.

7) Measuring equipment shall be identified in order to determine their status

Identifying measuring equipment is a fundamental step in managing and ensuring the accuracy, reliability, and compliance of measurement processes. Here’s why identifying measuring equipment is important:

  1. Traceability: Each piece of measuring equipment needs to have a unique identification that allows it to be tracked throughout its lifecycle. This traceability ensures that the equipment’s history, calibration status, maintenance, and usage can be accurately recorded and referenced.
  2. Status Determination: The identification of measuring equipment is essential for determining its current status. This includes whether the equipment is calibrated, verified, under maintenance, out of service, or due for calibration. Knowing the status helps prevent the use of equipment that might be inaccurate or unreliable.
  3. Calibration and Verification Scheduling: Proper identification enables accurate scheduling of calibration and verification activities. By knowing when each piece of equipment is due for calibration, organizations can maintain a systematic and timely calibration schedule.
  4. Preventing Mixing of Equipment: In environments where multiple measuring instruments are used, proper identification helps prevent mixing equipment that might have different calibration statuses or accuracy levels.
  5. Compliance and Auditing: Regulatory bodies and external auditors often require documentation of the calibration and verification status of measuring equipment. Proper identification ensures that this information can be readily provided and validated.
  6. Quality Control: Identifying measuring equipment is vital for quality control purposes. It ensures that only calibrated and verified equipment is used for critical measurements, reducing the risk of errors and non-conformities.
  7. Maintenance Management: Equipment identification aids in tracking maintenance activities. It allows for the association of maintenance records with specific equipment, helping to ensure that the equipment is kept in good working condition.
  8. Equipment Performance Analysis: Identifying equipment enables the tracking of historical performance data. This information can be used to analyze trends in measurement accuracy, identify potential issues, and improve the measurement process.
  9. Data Integrity: By associating specific equipment with measurement results, the integrity of the data is enhanced. It’s clear which equipment was used for which measurements, aiding in traceability and analysis.
  10. Efficient Resource Allocation: Identification allows for efficient allocation of resources. It helps prioritize which equipment needs calibration or maintenance, ensuring that resources are utilized effectively.

In summary, proper identification of measuring equipment is essential for maintaining accurate and reliable measurement processes. It supports traceability, compliance, quality control, and effective resource management. Identifying equipment forms the basis for managing its lifecycle and ensuring its proper usage and maintenance.

8) Measuring equipment shall safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.

Safeguarding measuring equipment from adjustments, damage, or deterioration is essential to ensure that the calibration status remains valid and that subsequent measurement results can be trusted. Here’s why this practice is crucial:

  1. Measurement Integrity: Preventing unauthorized adjustments or changes to measuring equipment ensures that the equipment remains calibrated and that measurement results are accurate and reliable. Any adjustments made without proper authorization could introduce errors and compromise the quality of measurements.
  2. Consistency: Keeping equipment safeguarded from adjustments helps maintain consistency in measurement processes. When equipment remains in its calibrated state, measurements can be compared over time, and trends can be analyzed more accurately.
  3. Compliance: Many industries have regulatory requirements or standards that mandate the protection of measuring equipment to prevent unauthorized adjustments. Adhering to these requirements helps organizations stay compliant with industry regulations.
  4. Data Reliability: Accurate measurements are the foundation of reliable data. Safeguarding equipment prevents the introduction of errors that could lead to incorrect data and subsequent flawed decisions or conclusions.
  5. Risk Mitigation: Unauthorized adjustments or damage to measuring equipment can lead to faulty measurements, which in turn can result in poor product quality, safety hazards, or regulatory non-compliance. Safeguarding equipment helps mitigate these risks.
  6. Quality Control: Properly maintained and safeguarded equipment contributes to consistent quality control processes. It ensures that measurements are accurate and conform to established standards.
  7. Audit Trail: Keeping a record of authorized adjustments, maintenance activities, and any potential damage helps establish an audit trail. This documentation is valuable for tracking the equipment’s history and for audits and assessments.
  8. Longevity: Protecting equipment from damage and deterioration extends its operational life. Well-maintained equipment remains reliable over time, reducing the need for frequent replacements.
  9. Professionalism: Organizations that take measures to safeguard their measuring equipment demonstrate a commitment to professionalism, accuracy, and quality. This enhances their reputation and builds trust among customers and stakeholders.
  10. Resource Efficiency: Safeguarding equipment reduces the likelihood of equipment breakdowns or malfunctions caused by unauthorized adjustments or neglect. This results in fewer disruptions to operations and better utilization of resources.

In summary, safeguarding measuring equipment from adjustments, damage, or deterioration is a critical practice for maintaining the accuracy, reliability, and integrity of measurement processes. By protecting equipment, organizations ensure that their measurement results are consistent, compliant, and trustworthy.

9) The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit

When measuring equipment is found to be unfit or out of calibration, it’s essential for the organization to assess whether the validity of previous measurement results has been adversely affected. Here’s a systematic approach to determine the potential impact on previous measurement results:

  1. Review Equipment History: Examine the historical records of the measuring equipment in question. This includes calibration records, maintenance logs, adjustment history, and any relevant documentation. Identify the dates of the most recent calibration, adjustments, and any maintenance activities.
  2. Identify Critical Measurements: Determine if the equipment in question was used for critical measurements that have a direct impact on product quality, process control, compliance, or customer requirements. Focus on measurements where accuracy is paramount.
  3. Assess Timeframe: Consider the time elapsed since the last valid calibration or verification. The longer the period since the last calibration, the higher the likelihood that the measurement results could have been adversely affected.
  4. Measurement Tolerance: Evaluate the tolerance or allowable error for the measurements performed by the unfit equipment. Compare this tolerance to the potential drift or inaccuracy caused by the equipment’s unfitness. If the drift is significant in relation to the tolerance, there’s a higher likelihood of impact.
  5. Statistical Analysis: If applicable, perform a statistical analysis of historical measurement data. Identify any trends or patterns that might indicate a deviation from expected results. This can help quantify the impact on data integrity.
  6. Risk Assessment: Conduct a risk assessment to determine the potential consequences of using measurements from unfit equipment. Consider factors such as safety risks, product quality, regulatory compliance, and financial implications.
  7. Review Process Changes: Analyze whether there have been any changes in measurement processes, personnel, materials, or other variables that could have contributed to variations in measurement results. This could help differentiate between equipment-related issues and process-related changes.
  8. Sample Re-Testing: Depending on the criticality of the measurements and the resources available, consider re-testing a representative sample of previous measurements using properly calibrated equipment. Compare the re-test results with the original results to assess the impact.
  9. Communication with Stakeholders: If you determine that previous measurement results might have been adversely affected, communicate with relevant stakeholders. This could include customers, regulatory agencies, and internal teams. Provide transparent information about the situation, your assessment, and any corrective actions taken.
  10. Corrective Action: Take appropriate corrective actions to address the issue with the unfit equipment. This could involve recalibration, repairs, adjustments, or replacement of the equipment.
  11. Documentation: Maintain detailed records of your assessment, findings, and actions taken. This documentation is essential for audits, quality management, and continuous improvement.

Ultimately, the approach to determining the impact on previous measurement results will depend on the context, the criticality of the measurements, and the resources available. The goal is to make informed decisions that ensure accurate and reliable data, even when equipment fitness is compromised.

10) The organization shall take appropriate action when the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit

When the validity of previous measurement results has been adversely affected due to finding that measuring equipment is unfit, the organization should take appropriate actions to address the situation, minimize the impact, and prevent similar issues in the future. Here’s a recommended course of action:

  1. Isolate Equipment: Immediately remove the unfit equipment from use to prevent further incorrect measurements and potential negative consequences.
  2. Assess Impact: Evaluate the extent of the impact on previous measurement results. This might involve reviewing the data, assessing the significance of the deviations, and identifying the affected processes, products, or services.
  3. Notify Stakeholders: Inform relevant stakeholders, including internal teams, customers, and regulatory authorities if applicable. Provide clear and transparent communication about the situation, the impact, and the actions being taken.
  4. Re-Evaluate Data: If feasible, review the measurement data that was collected using the unfit equipment. Determine if the deviations were within acceptable tolerances or if any decisions, processes, or products need to be re-evaluated.
  5. Corrective Actions: Take appropriate corrective actions to address the situation:
    • Equipment Correction: If the issue with the equipment can be resolved, initiate repairs, adjustments, or recalibration to bring it back into a fit state.
    • Replacement: If the equipment cannot be restored to a fit state, consider replacing it with new or properly calibrated equipment.
    • Data Correction: If the impact on data is significant, consider whether any data need to be corrected, re-validated, or reanalyzed.
    • Process Improvement: Investigate the root cause of the equipment’s unfitness. Identify if there were any systemic issues that led to this situation and implement process improvements to prevent recurrence.
  6. Preventive Measures: Implement measures to prevent similar issues in the future:
    • Enhanced Monitoring: Implement regular monitoring and checks of equipment to detect any signs of unfitness early.
    • Calibration Schedule: Establish a robust calibration schedule for all measuring equipment and adhere to it.
    • Quality Checks: Introduce additional quality checks to verify the accuracy of measurements before critical decisions are made.
    • Training: Ensure that personnel are adequately trained on proper equipment use, handling, and maintenance.
  7. Documentation: Maintain comprehensive records of the entire incident, including the identification of the unfit equipment, impact assessment, corrective actions taken, communications with stakeholders, and any preventive measures implemented.
  8. Continuous Improvement: Incorporate lessons learned from the incident into your organization’s continuous improvement processes. Use the experience to enhance measurement procedures, quality control practices, and equipment management.
  9. Validation and Verification: If applicable, re-validate or re-verify processes or products that were affected by incorrect measurements to ensure they meet required standards.
  10. Auditing and Review: Periodically review and audit your equipment management processes to ensure ongoing compliance, accuracy, and reliability.

Taking prompt and comprehensive actions will help the organization rectify the situation, prevent future incidents, and maintain the integrity of its measurement processes and data.

Documented Information Required

Though there is no mandatory requirement, it deals with measurement traceability, which is the ability to trace measurement results back to international or national measurement standards. To demonstrate measurement traceability, organizations are required to maintain certain documents and records as evidence of their adherence to this clause. Here’s what is typically required:

  1. Calibration Records: These records document the calibration activities performed on measuring equipment. They include details such as the date of calibration, calibration standard used, calibration procedure, measurement results, any adjustments made, and the calibration certificate provided by the calibration service provider.
  2. Measurement Standards Documentation: This includes documentation related to the measurement standards used for calibrating equipment. It might include certificates of traceability, documentation of calibration cycles for these standards, and information about the accuracy and validity of the standards.
  3. Calibration Certificates: These are certificates provided by the calibration service provider after calibrating the equipment. They include information about the calibration standards used, the results of the calibration, any adjustments made, and the uncertainty associated with the calibration.
  4. Measurement Procedures: Detailed procedures for performing measurements using the calibrated equipment. These procedures outline the steps to take, the equipment to use, and the techniques to follow to ensure accurate and reliable measurements.
  5. Equipment Identification: Records that identify each piece of measuring equipment, including its unique identification number, description, location, calibration due date, and history of past calibrations.
  6. Measurement Reports: Reports generated from measurements taken using the calibrated equipment. These reports should include details such as the measurement results, units of measurement, date and time of measurement, and any relevant environmental conditions.
  7. Traceability Records: Documentation that establishes the traceability of measurements back to international or national measurement standards. This could include documents demonstrating the measurement chain and showing how each step is traceable to recognized standards.
  8. Audit Trail: Records of internal audits and assessments related to measurement traceability. These records show that the organization is periodically reviewing its measurement processes for compliance and effectiveness.
  9. Change Control Documentation: Records of any changes made to measuring equipment, measurement procedures, or calibration methods. These records show that changes were properly evaluated and approved.
  10. Training Records: Documentation of training provided to personnel who handle measuring equipment, conduct measurements, and perform calibrations. This ensures that employees are competent in their measurement-related tasks.

It’s important to note that the specific documents and records required may vary based on the organization’s size, complexity, industry, and the scope of its quality management system. However, the overall goal is to establish a clear trail of evidence that demonstrates the organization’s commitment to maintaining measurement traceability and ensuring the accuracy and reliability of its measurements.

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