ISO 17025 compliancy requirements

ISO 17025 lays down process requirements that should be consistent and reproducible for testing and calibration labs. Being ISO/IEC 17025 compliancy requires labs to show that they follow the quality management system. It helps labs to provide proof of their operating skills and their ability to produce valid results. ISO 17025:2017 is the latest version of ISO which helps prepare labs for addressing questions related to risks and opportunities.  ISO 17025 standards are used to confirm a Laboratory’s potential to create reliable test and calibration data, including proper handling and transportation of test items. ISO 17025 forms the basis for labs to get accreditated from a regulatory body.

ISO 17025 compliancy is provided by LabCollector and its add-ons like Lab Service Management (LSM). Final validation is however always needed to be performed on the end-user side. The following checklist is provided as a guide, but AgileBio also provides prechecked certificates and tests to facilitate the lab auditing.

ISO provides the checklist in the form of below categories:-

1. Scope

This part explains which type of laboratories require what type of management systems. You can read about it more on the ISO website.

LabCollector advantages:

• LabCollector helps all types of testing and calibration labs to meet the ISO 17025 standards.

2. Confidentiality of data

The management of the lab must be done impartially no factor should be able to compromise the system. The lab system and all its personnel must be responsible for all the lab activities management and to protect the confidentiality of any information related to an individual or customer unless stated by the law.

LabCollector advantages:

• Secure storage of data in servers
• Restricted access to the LC system defined by an admin
• Group access restriction
• Data backup and recovery secure

3. User-level control

Every personnel in the lab must be impartial and must have proper training or education or skills required for the respective lab activity. The lab shall retain all the data & documents that determine the competence of the personnel. The lab should define precisely the duties of the given person and the system to be able to trace all the activities performed by the specific person.

LabCollector advantages:

• Custom module creation that can be dedicated to all the personnel information.
• User-level specifications allow accessing certain activities only. (Read more about it in this KB)
• Admin validations in the test systems to ensure reviewing of data such as protocols and results in LSM add-on.

4. Environmental conditions & Equipment monitoring

The environmental conditions of the labs should not hamper the validity of the results. For this, all the data related to environmental conditions should be monitored and documents in a timely fashion. All documents required for equipment handling, transportation, etc should be retained.  Equipment maintenance and calibration should be done in a timely fashion with all the data during the process should be documented. Equipment that needs service should not be allowed to use for obtaining any results.

LabCollector advantages:

• A standardized protocol to follow lab activities can be added to our Lab Service Management (LSM) add-on.
• Data logger allows us to monitor, control and record environmental conditions.
• Equipment module allows the storage of all the data about the given equipment including, specific ID, calibration/maintenance date, serial number, unique identification, storage location, etc.
• Maintenance system in equipment module ensure keeping a tab on all equipment functionalities, calibrations, and maintenance.
• The equipment module can be customized to store any relevant and necessary information about any equipment.
• Equipments marked out of service cannot be used in LabCollector to obtain results.
• Equipment module can generate alerts for equipments requiring maintenance.

5. Sample handling & documentation control

The lab should carefully review all the requests, tenders and contracts to see if all the requirements are met by the lab. The selection, verification and validation of all lab procedures should be done appropriately. The sample handling plan and method should be described and executed precisely. ISO 17025 ensures that each testing and calibration laboratory must follow data confidentiality & protect the proprietary rights of the customers of the laboratory. The lab should have a systematic procedure to store all the data related to transportation, receipt, handling, storage, etc of calibration items. 

LabCollector advantages:

• Custom module addition to store all relevant data.
• The Document module allows the storage of all document types.
• LabCollector usage, add-on manuals are all readily available.
• Sample module is dedicated to recording all data relevant to sampling such as sample date, derivation, quantity, ID, date, person responsible, storage, etc.
• All modules allow the addition of custom fields to include all information required.

6. Audit logs and data backup

All the changes done during the tests and calibration should be documented to form a backup log.

• Audit trail in LabCollector and LSM add-on allows viewing of all changes done by any user to any data.
• Conservation of old data, versionning & audit trail allows to keep a track of any changes done in Labcollector.

7. Validation of results & reports

 ISO 17025 requires the labs to review the results before and authorize them with help of admin or supervisor. This is to ensure that the data entered is correct and if not can be asked to be repeated.

LabCollector advantages:

• Lab Service Management (LSM) add-on allows the generation of equipment calibration results.
• LSM allows validation and reviewing of results before finishing the tests.
• LSM can generate reports that have a unique ID and all relevant details.
• The Document module allows the storage of all reports.