ISO/IEC 17025 Resource Center
Laboratory accreditation
Technical

ISO17025 - Technical Requirements 

5.2 Personnel

Basic ISO 17025 training provided by AOAC International. See course descriptions for detail.

ISO 17025 training in Canada can be obtained at Accademia Qualitas.

 MS PowerPoint template for laboratory training.

 Training certificate template for training providers to give participants/attendees.

 

SHOQ QA Manuals Inc.

ISO 17025:2005 Quality Manual Template for laboratory accreditation.

www.e-shoq.com

 

 

Generic performance review templates for your employees:

Example 1

Example 2

The following considerations should be made when designing a lab personnel management program:

- give each employee a good understanding of specific responsibilities and the organization's employee development policy
- develop job qualification requirements, position descriptions, and performance standards for each position
- train recruiters in interview techniques and applicant evaluation
- develop and document orientation and training programs for new employees
- prepare short and long range training plans for the development and advancement of lab personnel
- prepare a formal employee appraisal program including evaluation criteria
- maintain personnel files containing information on education, experience, salary, training, promotions, appraisal, and other personnel activities
- encourage employees to assess their own performance and training needs



5.3 Accommodation and Environmental Conditions

This section deals with ensuring that environmental conditions do not invalidate the results or adversely affect the required quality of any measurement.

It also outlines that incompatible areas must be separated.

Biological Testing Laboratories should review the following resource for biosafety guidelines:

Laboratory Biosafety Guidelines
 

5.4 Tests and Calibration Methods and Method Validation

Search AOAC International's Official Methods of Analysis

Effivalidation - Method Validation and Uncertainty software. This package is designed to support ISO 17025 accredited testing laboratories. Details and demo versions can be found at
Effichem - Method Validation Software


Download the measurement uncertainty calculator from Agilent: http://metrologyforum.tm.agilent.com/download3.shtml

A useful book recently published in December 2006 is:

 

5.5 Equipment

All equipment being used in the lab must be properly maintained, calibrated, and operated by authorized personnel. If the lab needs to borrow a piece of equipment from another area due to unforeseen circumstances, the lab still maintains the responsibility to verify that the borrowed equipment complies with the standard with respect to its use.

Equipment inventory spreadsheet from Microsoft.

Measuring and Test Equipment Master List

Calibration tools, resources and white papers can be found at Blue Mountain Quality Resources

Management of equipment should include:
1. Establishing criteria and specifications for the purchase of important pieces of equipment.
2. Checking and test equipment against specifications, before placing into use.
3. Designing a preventive maintenance program for equipment and establish suitable checks to see that the program is implemented and maintained.
4. Developing and maintaining a supplies management program to ensure the quality of reagents used in day-to-day operations, paying particular attention to primary reference standards, working standards, and standard solutions.
5. Deciding on the kinds of purified water that are necessary and develop suitable tests and testing intervals to ensure that quality of water used in analytical work and in the final cleaning of glassware.
6. Purchasing class A volumetric glassware and performing the calibrations and recalibrations that are necessary to achieve reliable results.
7. Establishing procedures for cleaning and storing glassware with due consideration for the need for special treatment of glassware used in trace analysis and for bacteriological purposes.
8. Discarding chipped or etched glassware and damaged plasticware.

 
5.6 Measurement Traceability

The formal definition of "traceability is given in the International Vocabulary of Basic and General Terms in Metrology (VIM - 1993) as: "6.10 traceability: property of the result of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons all having stated uncertainties."


5.7 Sampling

Search Google for Codex Stan 234. This document is titled "Recommended Methods of Analysis and Sampling".


5.8 Handling of Test and Calibration Items

ISO 22000 information


5.9 Assuring the Quality of Test and Calibration Results

An Example Control Chart produced in MS Excel by Microsoft Corporation.

Where proficiency testing programs are available, the laboratory must participate. An example of an accreditation program is as follows:

http://www.aoac.org/proficiencytesting/proficiency.html

 

5.10 Reporting the Results

General

Test reports and calibration certificates

Test reports

Calibration certificates

Opinions and interpretations

Testing and calibration results obtained from subcontractors

Electronic transmission of results

Format of reports and certificates

Amendments to test reports and calibration certificates

 

The final section of the standard specifies a series of items to be included on a test report / calibration certificate. These include:

- name and address of laboratory

- date of test

- method used

- name and address of customer

- date of sampling

- location where sampling was carried out

- reference to sampling plans and procedures

- environmental conditions during sampling

- conditions during calibration

- uncertainty of measurement

- traceability information

- before and after results

Information about Laboratory Information Management Systems (LIMS) can be found at Starlims.