Malaysia legislation
Section 14
Section 14
(a)
the premises of the pathology laboratory to ascertain that it complies with the site plan, building layout plan, design, construction material and any other prescribed requirements;
Act 674
(b)
any equipment, material or any other thing found in the pathology laboratory to ascertain that it complies with the requirement or standard as may be prescribed; and
(c)
any record, policy, standard operating procedure, clinical practice guideline, document pertaining to quality management system, manpower requirement, organizational structure or any other matters connected therewith.
(2)
Where the authorized officers find that the pathology laboratory does not comply with any of the matter specified under subsection (1), they shall give a written notice to the applicant of the non-compliance and any rectification which shall be made within a specified time and re-inspect the pathology laboratory after the expiry of that period.
(3)
The authorized officers shall submit a report of the inspection to the Director General as soon as practicable.
Reasons for refusal to grant licence