Calibration Requirements of ISO 9001:2015
Establishing an ISO 9001-Compliant Calibration Management System
What is ISO 9001:2015?
ISO 9001:2015 Quality management systems — Requirements is a quality management standard developed by the International Organization for Standardization (ISO), which provides a framework for implementing and maintaining a quality management system (QMS). It is used by over one million organizations, large or small, in over 170 countries in many industry segments. Calibrating monitoring and measuring equipment is a crucial aspect of a QMS. GageList is a leading ISO 9001 calibration solution that supports compliance with all flavors of ISO 9001.
Calibration Requirements of ISO 9001:2015
The specific calibration requirements of ISO 9001:2015 are primarily addressed in Clause 7.1.5 “Monitoring and measuring resources.” Organizations should establish and maintain a calibration process that meets the following requirements:
- Determine necessary monitoring and measuring resources: Identify what equipment needs to be calibrated to ensure valid and accurate measurement results.
- Ensure the suitability of monitoring and measuring resources: Ensure that the selected measuring equipment is suitable for its intended purposes.
- Calibration or verification of monitoring and measuring resources: Calibrate or verify equipment at specified intervals or before use, as necessary. Use traceable measurement standards for calibration wherever possible.
- Identification of monitoring and measuring resources: Uniquely identify each calibrated instrument through labels, asset tags, or other identification methods, so that its calibration status can be easily determined.
- Safeguarding the validity of results: Ensure that the equipment is properly stored, handled, and maintained to preserve its accuracy and reliability. Protect it from damage, deterioration, or unintended adjustments.
- Control of externally provided monitoring and measuring resources: Ensure that all calibration service providers used are competent and their calibration results are valid and traceable.
- Retaining documented information: Keep records of the calibration process, including the basis used for calibration, calibration results, and any necessary adjustments. Retain documented information as evidence of the organization’s efforts to maintain the accuracy of its monitoring and measuring resources.
Calibration-Related Clauses in ISO 9001:2015
- Clause 7.1.5 “Monitoring and measuring resources” addresses requirements directly applicable to calibration:
- Clause 188.8.131.52: General – Outlines general requirements for organizations to determine and provide necessary monitoring and measuring resources to ensure valid and reliable results.
- Clause 184.108.40.206: Measurement Traceability – Specifically deals with calibration and traceability requirements for monitoring and measuring equipment when measurement traceability is a requirement, and covers the requirements for calibration or verification, identification, safeguarding the validity of results, and control of externally provided monitoring and measuring resources.
There are additional related clauses that provide context or complement the calibration requirements:
- Clause 4.4: Quality Management System and its Processes – Emphasizes the need to establish, implement, maintain, and continually improve a quality management system, which includes the calibration process.
- Clause 6.1: Actions to Address Risks and Opportunities – Emphasizes the need to plan actions to address risks and opportunities in the QMS, which may involve the calibration process.
- Clause 7.5: Documented Information – Outlines requirements for creating and updating documented information, which includes maintaining records of the calibration process.
- Clause 8.4: Control of Externally Provided Processes, Products, and Services – Addresses responsibility for ensuring the competence of external providers, including those providing calibration services.
- Clause 8.5.1: Control of Production and Service Provision – Requires implementation of necessary controls for production and service provision, which includes the use of suitable monitoring and measuring resources.
- Clause 9.1: Monitoring, Measurement, Analysis, and Evaluation – Discusses the need to evaluate the effectiveness of the QMS, which includes monitoring and measuring processes and equipment.
- Clause 9.2: Internal Audit – Requires an organization to conduct internal audits at planned intervals to determine whether the QMS conforms to the organization’s own requirements for its QMS, as well as the requirements of the ISO 9001 standard.
By understanding and implementing these clauses, an organization can ensure that its monitoring and measuring resources are properly calibrated and maintained, which contributes to the overall effectiveness of its QMS.
How GageList Helps Meet ISO 9001:2015 Calibration Requirements
GageList is an online calibration management software designed to help organizations manage their calibration processes more efficiently. It helps companies meet the calibration requirements of ISO 9001:2015 in the following ways:
- Secure, Centralized Record-Keeping: GageList allows UNLIMITED USERS to have secure, role-based access control (at no extra cost) to ensure that only authorized personnel can view, modify, or manage calibration records and equipment information, safeguarding the validity of results and complying with ISO 9001:2015 requirements. GageList allows organizations to store all their calibration records in one secure, cloud-based platform, making it easy to manage gage data from anywhere, any time, on any device.
- Information Security: Gagelist is SOC2 compliant, demonstrating commitment to high levels of security, processing integrity, availability, confidentiality, and privacy. GageList stores data securely on cloud servers, with regular backups and data encryption, ensuring that calibration records are protected and available when needed for audits or other quality management activities.
- Calibration Scheduling and Reminders: GageList sends automatic notifications and reminders for upcoming calibrations or verifications, ensuring that organizations calibrate their equipment at specified intervals and in compliance with ISO 9001:2015.
- Calibration History and Traceability: GageList stores the complete calibration history of each piece of equipment, making it easy to maintain traceability and demonstrate compliance with ISO 9001:2015 requirements.
- Customized Reports: GageList lets users generate customized reports on various aspects of the calibration process, such as calibration due dates, equipment status, and calibration history. These reports can be used to evaluate the effectiveness of the calibration process and support decision-making.
- External Calibration Service Management: GageList helps organizations manage external calibration service providers, helping to ensure that external providers are competent, and their calibration results are valid and traceable, in line with ISO 9001:2015 requirements.
- Documented Procedures and Work Instructions: GageList can store and manage documented procedures and work instructions related to the calibration process, helping organizations maintain consistency and accuracy in their calibration activities.
- The GageList Difference: GageList is recalibrating calibration with game-changing features no other platforms offer:
If you have additional questions about implementing a calibration program to support compliance with ISO 9001:2015, please feel free to reach out to our Customer Success Team.