REVIEW Reproductive genetics Accreditation of the PGD laboratory

Accreditation according to an internationally recognized standard is increasingly acknowledged as the single most effective route to com-prehensive laboratory quality assurance, and many countries are progressively moving towards compulsory accreditation of medical testing laboratories. The ESHRE PGD Consortium and some regulatory bodies recommend that all PGD laboratories should be accredited or working actively towards accreditation, according to the internationally recognized standard ISO 15189, ‘Medical laboratories—Particular requirements for quality and competence’. ISO 15189 requires comprehensive quality assurance. Detailed management and technical requirements are defined in the two major chapters. The management requirements address quality management including the quality policy and manual, document control, non-conformities and corrective actions, continual improvement, auditing, management review, con-tracts, referrals and resolution of complaints. Technical requirements include personnel competence (both technical and medical), equip-ment, accommodation and environment, and pre-analytical, analytical and post-analytical processes. Emphasis is placed on the particular requirements of patient care: notably sample identification and traceability, test validation and interpretation and reporting of results. Quality indicators must be developed to monitor contributions to patient care and continual improvement. We discuss the implementatio