Laboratory Quality Manual

A comprehensive Laboratory Quality Manual that addresses the principles of International laboratory quality standard ISO 17025.

ISO 17025 prescribes standards for good laboratory practice. The Laboratory Manual specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling and is applicable to all organizations performing tests and/or calibrations. It is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing activities. The manual is a management system for quality, administrative and technical operations.

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Laboratory Quality Manual Sample

The laboratory quality manual consists of 26 pages covering fundamental requirements for Good Laboratory Practices. Sections included in the Laboratory Quality manual include:

  • Quality System
  • Organisation and Management
  • Document Control
  • Responsibility & Authority
  • Personnel
  • Laboratory Accommodation and Environment
  • Personnel Hygiene
  • Confirmation of Work and Client Requirements
  • Handling Test Items
  • Test Methods
  • Bench Practices
  • Assuring Quality of Results
  • Equipment, Calibration and Measurement Traceability
  • Calibration Standards / Reference Materials
  • Reporting Test Results
  • Records
  • Purchase of Outside Services, Supplies and Laboratory Consumables
  • Non-Conforming Work
  • Monitoring for Improvements
  • Internal Audits
  • Management Review
  • Complaints
  • Subcontracting

Laboratory Document Templates

The package also includes the following Laboratory Document Templates:

  • A quality policy
  • An annual complaint trend analysis tool
  • A sample microbiological & chemistry procedure templates
  • Sample laboratory records
  • Sample plans
  • Laboratory Reports

A Comprehensive Laboratory Audit Checklist

Control of all Laboratory operations can be assessed using this audit checklist including:

  • Laboratory Environment
  • Location in relation to other activities
  • Control of entry of non-laboratory personnel
  • Protective clothing and equipment for visitors/non-laboratory personnel
  • Temperature monitoring
  • Documented Work instructions
  • Annual service/calibration
  • Balance accuracy check
  • Chemicals and Reagents
  • Staff initials / Signatures
  • Equipment monitoring/calibration records
  • Traceable back to sample
  • Proficiency Testing
  • Internal Audits
  • Test methods (adequate and available to staff)
  • Equipment operating/monitoring instructions
  • Equipment calibration instructions
  • Records of training
  • Reporting structure inside the laboratory
  • Reporting structure outside the laboratory to clients
  • Protective laboratory equipment

Every Laboratory’s policy should be to provide competitive services of the highest standards of performance and reliability. By achieving this goal a Laboratory will consistently satisfy the needs and expectations of its internal and external customers and achieve success. This level of quality is achieved through adoption of a Laboratory Management System that meets the requirements of the ISO 17025 standard and reflects the competence of the Laboratory to existing customers, potential customers, and independent authorities. With this Laboratory Quality Manual Package we are confident that you can achieve this goal.

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