It is for medical laboratories in hospitals, clinics, private practice and public health services.

• A gap assessment compares current practice with the requirements.
• Examination methods are verified or validated and quality controls are applied to each test.
• Impartiality risks are identified and managed.
• An internal audit and a management review are completed.
• An accreditation body assesses the applicant and grants a defined scope of accreditation.

The number of schemes, methods or sites in scope drives most of the cost. Assessor days are charged by the accreditation body.

Time depends on the scope and on how much of the system already exists. Surveillance assessments follow once accreditation is granted.

ISO 15189 is used for accreditation, not certification. Accreditation is granted by an accreditation body that works to ISO/IEC 17011.