Regulations Governing Accreditation and Outsourced Accreditation Management of Drugs Testing Institutions Article 14

The central competent health authority shall regularly audit the equipment, personnel organization, quality management, operating procedures, testing capacity, and test records of the accredited testing institutions and may require the testing institutions to submit reports of the testing procedures conducted within the accreditation scope. When necessary, the central competent health authority may conduct irregular audit.The central competent health authority may require the testing institutions to take, at their own expenses, proficiency testing activities organized by the central competent health authority, or administered by other proficiency testing providers as entrusted or recognized by the central competent health authority.Testing institutions are not entitled to evade, obstruct, or refuse the audit procedure, report submission, and proficiency testing participation requirement prescribed in the foregoing two paragraphs.