TYPICAL STEPS IN PLANNING FOR INITIAL ACCREDITATION

1. Decide that accreditation is desirable for your laboratory; request an application package for accreditation in the Medical field of testing; purchase a copy of ISO 15189; print out the ISO 15189 Fax Confirmation form and fax to A2LA to obtain a 15189 Full Text Assessor Checklist; identify who is to be responsible for meeting accreditation requirements and make the relevant resources available.

2. Read the A2LA General Requirements for Accreditation of Medical Testing and any applicable specific program requirement documents; evaluate how the criteria applies to your laboratory; identify clauses that do not apply or apply only to a limited extent, and identify the reasons for their non-applicability.

3. Identify the person in charge of the quality system (e.g., the quality manager). A quality system that functions well cannot come about without top management support and commitment (a requirement laid down in the criteria). In a large laboratory, the coordination of these activities may be too large a task for the top manager; it is for him or her to decide on how to handle this important subsidiary function. He or she may have to be assisted by someone who would be responsible for the development and maintenance of the documented quality system.

4. Discuss the relevant paragraphs of the criteria thoroughly with those directly involved in the subjects discussed. Identify the laboratory's weak points and the practices and procedures that must be revised.

5. Examine whether organizational arrangements, practices and procedures meet the requirements laid down in the criteria and make improvements on the basis of this examination. This stage may be time-consuming but necessary in order to obtain accreditation. The investment of time is often justified by the resulting improvement in management: developing better procedures and improving reliability and accuracy of testing.

6. Document the policies, organizational arrangements and procedures in a quality manual and related documentation. Ensure that this fulfills the requirements of ISO 15189 and that the personnel concerned know and accept the content.

7. As a general rehearsal for the accreditation assessment, verify through internal audits and management reviews whether the arrangements and procedures described in the quality manual do in fact work, and whether they meet ISO 15189 requirements. Do this carefully.

9. Return your completed application to A2LA to initiate an assessment of your laboratory. A2LA will notify you of the name(s) and provide brief curricula vitae of the assessor(s). If you have justifiable objections, changes in the assignment(s) can be made.

TYPICAL STEPS IN PLANNING FOR ANNUAL REVIEW OF ACCREDITATION

1. Provide an up-to-date laboratory organization chart identifying by name, the key personnel involved for each function - highlight the changes you have made since your last A2LA assessment.

2. If your laboratory is part of a larger organization, provide a chart of its position and reporting relationships within that organization.

3. Provide your documented proficiency testing plan of how your laboratory is meeting and will continue to meet the minimum proficiency testing participation requirements outlined in ISO 15189 Section 5.6 (i.e. proficiency testing, interlaboratory comparison, performance evaluation) and the A2LA document, A2LA Proficiency Testing Requirements For Medical Testing Laboratories.

4. Unless you have a prior agreement in which results of your proficiency testing activities are sent to A2LA directly, using the PT Data Cover Sheet, provide a copy of summary results which have become available within the last year (or since our last request for such information) along with your corrective action response for any unacceptable values obtained.

5. Review and sign the Conditions for Accreditation form (pages 7 and 8 of the application)and return it to A2LA.

6a.      Provide the results of your latest internal audit of your laboratory per ISO 15189 Section 4.14.

6b.     Provide the results of your latest management review of your laboratory per ISO 15189, Section 4.15.