ISO 17025 Information

Interpretation of the ISO/IEC 17025:2005 Standard

Management Requirements
Outline:
4.1 Organization
4.2 Management system
4.3 Document control
4.4 Review of requests, tenders, or contracts
4.5 Subcontracting
4.6 Purchasing services and supplies
4.7 Service to the customer
4.8 Complaints
4.9 Control of nonconforming testing and/or calibration work
4.10 Improvement
4.11 Corrective action
4.12 Preventive action
4.13 Control of records
4.14 Internal audits
4.15 Management review


Summary:
4.1 Organization
The purpose of this section is to ensure that the lab is able to produce a result that reflects the actual characteristics of the item tested. Several issues may  evolve in a lab that prevent independence of judgement. This section intends to minimize the effect of these issues by requiring the lab to identify what potential conflicts of interest exist and define the policies and procedures to avoid the possibility of impropriety. The lab is also required to define its organizational structure, key management personnel, and its place within any parent organization

4.2 Management system
The lab's management system consists of its quality manual and all documentation required by ISO 17025. The minimum requirements for a quality manual include:
- a quality policy statement
- the roles and responsibilities of the technical management and the quality manager
- the overall structure of the documentation and references to supporting procedures

The quality manual outlines the organization and scope of the laboratory. See the following link for more information:
ISO 17025 Quality Manual
AND
www.17025.com

4.3 Document control
The goal of document control is to ensure that all personnel have access to the most up-to-date procedures required to perform their jobs. To ensure that documents are kept current, the standard requires a procedure to ensure that:
- documents are reviewed and revised periodically (where necessary)
- obsolete documents are removed from use
- retention of obsolete documents includes suitable marking as such.

4.4 Review of requests, tenders, or contracts
Tests in the lab are initiated through a request. The request may be a result of a formal contract, a purchase order request, or a submission of a sample. The laboratory must define procedures fro reviewing work to determine:
- the requirements of the contract are understood (i.e., methods, turnaround time, and report format)
- whether the laboratory has the capability and capacity to do the work
- whether the test is right for the client's needs

4.5 Subcontracting
Subcontracting involves taking any portion of the contracted work (see section 4.4) and utilizing another laboratory (i.e., another legal entity). The laboratory that subcontracts the work to another party must be able to demonstrated that the subcontractor is competent to perform the work in question and complies with ISO 17025.

4.6 Purchasing
Purchased items include calibration services, chemical, reagents, test supplies, maintenance contracts, and equipment. Suppliers provide the products and services that allow the lab to perform the tests.

4.7 Service to the customer
The lab provides the customer with the opportunity to clarify or make changes to their work request. The lab must also allow customers to monitor the performance of their work providing confidentiality of other customers' work.

4.8 Complaints
The lab must define their policies and procedures for handling of complaints from customers or other parties.

4.9 Control of nonconforming testing and/or calibration work
Test work may not meet requirements when:
- defects in test equipment occur
- errors are found in testing technique
- test items are not stored properly
- test items are not prepared properly
- environmental conditions fail.

The lab must follow the its procedures to ensure that nonconforming work is evaluated for significance and the customer is notified where necessary. It many be necessary to halt further work until the problem is eliminated.

4.10 Improvement
The laboratory must implement policies to address continually improving the management system.

4.11 Corrective action
Corrective actions are taken when it is determined that a situation that has resulted in nonconforming work may recur or where there is evidence of departures from quality or technical procedures. The corrective action system follows the following steps:
- identify root cause
- select appropriate actions to eliminate the problem and prevent recurrence
- monitor corrective actions to ensure effectiveness
- introduce special audits when circumstances cast doubt on compliance with its own procedures.

4.12 Preventive action
The laboratory must identify needed improvements and potential sources of nonconformities.

4.13 Control of records
The laboratory must establish and maintain procedures for quality and technical records:
- identification
- collection, 
- indexing,
- access,
- filing,
- storage,
- maintenance,
- disposal

4.14 Internal audits
The laboratory must conduct internal audits to verify that operations continue to comply with the management system.

4.15 Management review
The laboratory's top management must review the management system to ensure continuing suitability and effectiveness.