How to prepare your diagnostic laboratory for ISO 15189 accreditation

1. Define your scope

Decide which tests, disciplines and sample types you want accredited. A realistic scope that you can defend is better than an ambitious one you cannot support. Many laboratories start with a core set of tests and add more later.

2. Run a gap analysis

Compare your current practice, clause by clause, with the requirements of the standard. The result should be a prioritised list of gaps, so you know what to fix first and how big the job is.

3. Build the quality management system

This means a quality manual, procedures, work instructions and records that reflect how your laboratory actually works. Documents that describe an idealised process nobody follows are one of the most common problems at assessment.

4. Make sure staff are competent and trained

Define roles, train people, and keep records showing that each person has been assessed as competent for the tasks they perform. The whole team should understand the system, not only the quality manager.

5. Verify your methods and control your results

Show that your methods perform as claimed in your laboratory. Put internal quality control in place, review it routinely, and take part in external quality assessment or proficiency testing for the tests in your scope.

6. Control equipment, reagents and the environment

Keep equipment maintained and calibrated, with traceability for measurements. Manage reagent and consumable lots, storage conditions and the laboratory environment, and keep the records.

7. Run internal audits and a management review

Audit your own system against the standard, record the findings, fix them, and hold a management review that looks at performance and decides improvements. These are required activities and assessors will ask to see them.

8. Do a mock assessment

A realistic internal assessment, ideally by someone who has assessed laboratories before, is the best way to find what an assessor will find. Closing those findings before the real assessment makes a large difference.

9. Apply and support the assessment

After you apply to NABL, assessors visit your laboratory. Prepare your team, keep records easy to find, and respond promptly to any non-conformities raised.

How long does it take?

It depends heavily on where you are starting. A laboratory with solid existing practice moves faster than one building a quality system from scratch. We give every laboratory a realistic timeline after a gap analysis.