ISO 17025 - Management Requirements
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ISO 17025:2005 Quality Manual Template for laboratory accreditation.
4.2 Management System
The Quality Manual should be organized in a format that allows easy access and provides specific procedures in locations where the procedures are being performed.
Many members of athe lab staff should be involved in developing the manual. An editor should be selected to ensure consistency throughout the documents.
Analytical methods that are used as written can be referenced by the Quality Manual without necessarily being included.
Revision of documents can best be managed by maintaining the Quality Manual as a controlled document ensuring that all versions in use are the most current version.
Reference other lab procedures or manuals as appropriate.
Develop a plan for writing the manual and stick to it.
Encourage staff to write and follow SOPs to ensure that procedures are performed in a consistent manner.
Include a mechanism for measuring continuous improvement and review of the quality management system.
Download an example of a Quality Manual; provided by www.e-shoq.com
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4.3 Document Control
4.4 Review of Requests, Tenders, and Contracts
Procedures are required for the review of requests, tenders and contracts.
4.5 Subcontracting of Tests and Calibrations
When a laboratory subcontracts tests and/or calibrations, the subcontractor laboratory must meet the same ISO 17025 requirements. Click here to locate ISO 17025 accredited laboratories.
4.6 Purchasing Services and Supplies
Procedures are required for the selection and purchasing of services and supplies it uses.
4.7 Service to the Customer
This section deals with communication, advice and guidance for customers in technical matters, and opinions and interpretations based on results.
Procedures are required for the resolution of complaints received from customers.
4.9 Control of Nonconforming Testing
Procedures are required for any aspect of testing/calibration work or results do not conform.
4.10 Improvement (New requirement to 2005 version)
Laboratories will need to demonstrate continual improvement. The quality program should provide for the process and requirements for changing and improving the program. Levels of authority and responsibility are delineated and the personnel directly involved in the changes are identified. Quality program documentation will need revision as changes in procedures are made. Measurables for quality improvement should be established, monitored, and reported to management. Each successive round of assessment should result in the quality system itself becoming better.
4.11 Corrective Action
Selection and Implementation of Corrective Actions - deficiencies in the management system (4.1 to 4.15) are considered nonconformances requiring corrective action(s). The ISO 17025 clauses 5.1 to 5.8 must be in place for a laboratory to be operational. Deficiencies or problems with these systems would require correction, but not corrective action. Deficiencies may arise from clauses 5.9 or 5.10 and this would require corrective action. For more information contact firstname.lastname@example.org
Monitoring of Corrective Actions
A useful reference is:
4.12 Preventive Action
Procedures are required for preventive action for potential nonconformities.
A useful reference is:
4.13 Control of Records
Procedures are required for identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records.
4.14 Internal Audits
The internal audit serves as the lab's way of determining the correct implementation of its management system. This audit is carried out in accordance with a defined procedure and is conducted at predetermined dates. The essential outcome is to determine whether the lab complies with its own management system and the requirements of ISO 17025.
Every lab should include performance and systems audits in its quality assurance program. It is suggested that the following be considered:
1. The use of trained auditors to conduct performance and system internal audits, with performance audits conducted by lab personnel independent of the activity audited and system audits by an audit unit or Quality Assurance Officer reporting directly to a level of management above the lab level.
2. Performance audits covered on a regular basis for all analysts, including such items as review of written analytical reports, oral review of analytical reports on-site work reviews, check sample examinations, and intra- and interlaboratory proficiency sample review.
3. System audits be well planned and conducted by a trained audit team in order to minimize the disruption of the lab's operations.
4. Audit observations be based on the standard against which the lab is being audited.
5. The site visit be constructive and lab personnel be briefed on observations before the team leaves.
6. The report of the audit be prepared as quickly as possible and submitted to the facility for comment.
7. The report highlight deficiencies in operations on a priority basis and make recommendations for corrective actions.
8. Disagreements on findings be resolved before the report is completed and submitted to management.
9. Follow-up site visits be conducted to see that appropriate corrections were made.
Asia Pacific Laboratory Accreditation Criteria (APLAC) Guidance Document TC002 - Internal Audits
Labs that do not have the internal resources to complete an audit can hire an outside auditor/consultant to perform their internal audits. The following document may be useful in establishing a contract with a consultant.
4.15 Management Review
Management reviews are ISO 17025's way of ensuring that the laboratory is involved in continuous process improvement. Like Preventive Action, management reviews tend to seek out areas for improvement rather than simply responding to issues of compliance.
APLAC Guidance Document TC003 - Management Review