Introduction
ISO 17025 is the international standard for testing and calibration laboratories making them competent and reliable. Documentation is one of the key ISO 17025 certification requirements. Nepalese laboratories requiring accreditation have to implement and have vast documentation proving that they are ISO 17025 compliant. This article is the final word on the requirement for ISO 17025 documentation in Nepal, such as essential documents, best practices, and compliance.
Importance of ISO 17025 Documentation
Accreditation is attained and maintained by requiring documentation for ISO 17025. Documentation benefits laboratories in the following manner:
- To ensure accuracy and consistency of testing and calibration.
- For meeting the requirements of international standards.
- To ensure efficiency with standardization of laboratory processes.
- For preparing for audits and inspections by accrediting agencies.
- To gain customer trust through higher standards.
Documents of Compliance with ISO 17025
A. Quality Management System (QMS) Documents
- Quality Manual: States the policies, extent of accreditation, objectives, and requirements for compliance of the laboratory.
- Quality Policy: Formal statement of the commitment of the laboratory towards maintaining quality standards.
- Organizational Structure: Declares the responsibility, powers, and duties in the laboratory.
B. Standard Operating Procedures (SOPs)
- Test and Calibration Methods: Step-by-step descriptive procedures for the individual tests and calibrations that must be carried out.
- Equipment Handling and Maintenance: Equipment handling, maintenance, and calibration SOPs in the laboratory.
- Sample Handling and Storage: Receipt process of sample, storage procedure, and disposal process.
- Non-Conformance and Corrective Actions: Error, deviation, and corrective action procedure.
C. Records and Logs
- Training Records: Employee training records, employee qualification, and competency test record.
- Equipment Calibration Records: Calibration activity record, maintenance schedule, and performance test.
- Test Reports and Certificates: Full record of test result, measurement, and issued certificate.
- Internal Audit Reports: Internal audit result, corrective actions, and improvements.
D. Risk Management and Improvement Documents
- Risk Assessment Reports: Plans for reducing risk and determining risks that affect test quality.
- Customer Feedback Records: Customer feedback, complaints, and corrective actions.
- Continuous Improvement Plans: Plans and programs for continuous improvement.
Best Practices in Documentation for ISO 17025
The following best practices can be adopted by Nepalese labs for effective documentation:
- Use Clear and Concise Documentation: Do not employ complexity and be comprehensive.
- Standardize Format and Template: Utilize standardized procedure forms, reports, and records.
- Implement Document Control Measures: Implement version control, approval, and security storage.
- Train Staff on Documentation Process: All staff members must be trained and implement documentation processes.
- Review Documents from Time to Time: Update existing documents based on change and process improvement.
Common Documentation Problems and Solutions to Solve Them
A. Incomplete or Inconsistent Documentation
Solution: Regular inspections and internal audits to guarantee completeness and consistency.
B. Lack of Staff Awareness
Solution: Offer periodic training and refreshers on ISO 17025 document requirements.
C. Ineffective Management of Heavy Documents
Solution: Implement a computerized document management system to facilitate ease of storage and retrieval.
D. Lack of Updating Documents from Time to Time
Solution: Offer responsible staff to update and review the documents.
Implementation Steps of ISO 17025 Documenting in Nepal
Step 1: Identify Current Documentation Status
Conduct a gap analysis to identify missing or outdated documents.
Step 2: Establish a System of Documentation
Establish procedures of preparation, authorization, and document control.
Step 3: Training of Staff in Document Control and Handling
Offer training periods for document control and handling.
Step 4: Document Processes Establishment
Utilize numbering methods, approval schemes, and safeguards over storage.
Step 5: Periodic Review and Revisions of Documents
There are to be routine audits to test documentation processes.
Conclusion
ISO 17025 records are the minimum requirement in Nepalese laboratory accreditation. Records promote compliance, improve working efficiency, and improve laboratory credibility. Compliance with best practice compliance, problem-solving, and systematic documentation allow laboratories to easily acquire and maintain ISO 17025 certification.
Visit https://qms.com.np/ to learn more about ISO.
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