A Laboratory Management System is the backbone of all calibration laboratory activities. Having an effective management system enables a laboratory to control costs, improve the measurement accuracy and consistently deliver valid calibration results.
For calibration laboratories, the management system is based on the requirements of ISO/IEC 17025 “General Requirements for the Competence of Testing and Calibration Laboratories”. The management system requirements a calibration laboratory needs to develop to conform to ISO/IEC 17025 are similar to most of the major management system principles and standards, such as ISO 9001 for manufacturing processes and ISO 14000 for environmental management systems. Those systems are designed to ensure that the quality of the laboratory’s activities is maintained and that they meet the needs and requirements of the customer.
Management System Requirements
The key management system requirements are related to the organization of the laboratory, the control of documents and records, monitoring the management system through audits and corrective actions and the interaction with the customer. The key topics are summarized below.
Management System and Organization
It is important that a complete management system is implemented, maintained, and continually improved. A Quality Manual is written that outlines the management system with supporting policies, procedures and work instructions created to ensure the quality of the laboratory results. An organizational hierarchy and the responsibilities and tasks of the laboratory management and staff are defined within the range of the laboratory activities.
Document and Record Control
The development and maintenance of all documents related to the management system are controlled by ensuring that each document is uniquely identified, approved prior to use and distributed to the appropriate laboratory personnel. The documents are reviewed regularly and updated as necessary. A master list is kept that maintains the identification and revision levels of all the documents.
The laboratory not only controls the internal quality manual, procedures and forms developed within the laboratory, but it also controls external equipment manuals, software, and standards and regulations.
Laboratory records, such as calibration certificates and measurement values are stored so that they are secure, confidential, and can be readily retrieved. The data is protected from unauthorized changes and deletions to ensure data integrity throughout the retention time of the record.
Internal audits are conducted to verify that the laboratory complies with their internal policies and procedures and the requirements of any external standards. Any audit findings related to the management system are documented within the laboratory corrective action process and the findings are used for the continual improvement of the laboratory activities and management system.
Corrective Action Process
Any deviations from the management procedures or laboratory activities that are identified are investigated within a corrective action process to determine the cause of the deviation and to prevent it from reoccurring. Corrective actions can be triggered through nonconformances, customer complaints, internal or external audits, management reviews, and observations by laboratory staff.
The first step in the process is to investigate the issue and identify the root cause of the deviation. The investigation can be performed by laboratory individuals or by a laboratory team, depending on the severity of the deviation. The appropriate actions are then implemented within the laboratory to eliminate or minimize the issue. After implementation, the corrective action is monitored and evaluated to determine the effectiveness of the action and to ensure that the issue does not reoccur.
Each calibration laboratory strives to provide its customers with the best measurement results and customer experience. The management system in the laboratory has specific requirements for the communication with customers on their calibration requirements such as calibration methods and calibration intervals.
The laboratory regularly collects feedback from the customers to assist with the improvement of the laboratory’s activities. Any customer complaints are documented, evaluated and resolved in a timely manner.