Documents and Records Required for an ISO/IEC 17025 Management System
When laboratories are going for accreditation, there are specific ISO/IEC 17025:2017 documentation requirements that need to be fulfilled. These documents are used to design and develop testing and calibration laboratories. There are several categories of such requirements for better understanding and defining quality systems in laboratory as per the ISO/IEC 17025:2017 standard. The document categories are as following:
Policies
Policies are covered in Clause 8 of the standard.
8.2.1 Option A – Management reviews to include policies and objectives
8.2.2 Management system documentation
8.2.1 for competence, impartiality and consistency
8.9.1 Management Review related to fulfillment
8.9.2c Management Review — suitability of policies and procedures
Documents
5.3 Document the range of laboratory activities
5.5c Document all procedures
6.2.2 Document competence requirements of personnel
6.3.2 Environmental condition requirements
6.4.13 f Document records of reference materials
6.5.1 Document unbroken chain of calibrations
7.1.1 All lab requirements documented
7.2.1.2 Documentation; document methods and supporting documentation for methods
7.2.1.7 Method deviations
7.4.2 Identification of test or calibration items
7.8.6.1 Decision rule for statement of conformity
7.8.7.1 Basis for opinions and interpretations
7.8.8.2 Amendments to reports
7.9.1 Complaints process
7.11.2 Changes to laboratory software
8.1.1 Document the entire management system
8.1.2 Option A management system
8.2.1 Laboratory management shall document the management system
8.2.4 Documentation included in or linked to the Management System
8.3.1 Option A document control
8.3.2 d Document available and distribution contracted
Procedures
5.5 c Document Laboratory procedures to ensure consistent activities
5.6 b Personnel identification deviations
6.2.5 Procedures and records in lab
6.3.3 Environmental conditions monitoring
6.4.3 Equipment handling, etc.
6.4.10 Intermediate check of equipment
6.5.3 b Reference measurement procedures
6.6.2 External services
7.1.1 Review of requirements, tenders
7.1.1 d Meet customer requirements
7.2.1.1 Selection of methods
7.2.1.2 Assuring methods up to date / available
7.2.2.4 Method validation
7.4.1 Handling of test or calibration items
7.7.1 Monitoring validity of results
7.10.1 Non-conforming work
8.9.2 c Management review suitability of policies and procedures
Records
6.2.5 Personnel records from (a-f)
6.3.3 Records of environmental conditions
6.4.13 Equipment records which influence laboratory activities
6.6.2 Procedure and records for external services
7.1.8 Requests tenders and contracts, records of reviews and changes
7.2.1.5 Records of method verification
7.2.2.4 Records of method validation
7.3.3 Records of sampling data
7.4.3 Records of deviations from specified conditions for test items
7.4.4 Test item storage conditions
7.5.1 Technical records for each lab activity
7.5.2 Amendments to technical records
7.7.1 Data from assuring the validity of results
7.8.1.2 Calibration certificates or test reports
7.8.7.3 Opinions and interpretations communication
7.9.3 b Complaints
7.10.2 Nonconforming work
8.4.1 Control of records
8.4.2 Controls needed for records
8.7.3 Corrective action records
8.8.2 e Internal audit records
8.9.2 Management review records
8.9.3 Records of Management review outputs
Processes
7.9.1 Complaints
7.9.2 Complaint handling
7.9.3 Complaint handling elements
7.11.2 Control of data – LIMS
8.2.4 Management system documentation
8.9.3 a Management review effectiveness
Review
6.2.6 Personnel review results
6.3.4 Measures to control facilities
6.4.7 Calibration program reviewed
6.6.2 Laboratory requirements for external services
7.1.1 Requests, tenders, controls
7.1.6 Contract review
7.1.8 Contract review changes
7.2.1.6 Method development
7.7.1 Validity of results
7.7.2 Quality assurance monitoring
7.8.1.1 Reporting of results
7.9.6 Complaint outcome
8.3.2 Document control reviewed
8.7.1 b / d C/A root cause effectiveness
8.9.1 Management review
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