Which documents and policies does a Malaysian clinic need for Act 586 and MSQH?

Act 586 asks for a policy statement for patients, a patient grievance mechanism, incident reporting and a quality programme. MSQH then asks to see the written SOPs, minutes, quality projects and patient feedback that show each standard working.
What the law asks for
Act 586 requires a policy statement on the facility's obligations to patients, a plan for a patient grievance mechanism, the reporting of unforeseeable or unanticipated incidents to the Director General, and programmes to ensure the quality and appropriateness of care.1 The Ministry's FAQ adds that the complaints policy, billing procedure, staff identification and organisation chart must be displayed where patients can easily see them.2
For licensed facilities, the person in charge provides a policy statement covering staff identification, billing procedures, valid consent, and patients' rights to information, to the grievance procedure and to a medical report, and reviews written policies at least once every five years.3
What MSQH asks to see
MSQH's medical clinic guide lists the documents a survey team reviews, from the mission statement and organisation chart to quality activities, minutes of the year before the survey, human resource policies, patient and staff surveys, and compliments and complaints with their follow-up.4 The clinic standards name the written SOPs criterion by criterion.5
| Clinic standard | Written SOPs and documents it names |
|---|---|
| Access to Care | SOP for urgent cases, practice policy for urgent, non-urgent and chronic cases, patient register or appointment book |
| Clinical Governance, Practice | Valid registration certificate, equipment maintenance list, SOP on access to medical records, list of services with charges |
| Safety | Clinical practice guidelines in use, SOP on risk management, SOP on fall prevention, list of incident reports with analysis and action |
| Ethical Practice | Informed consent form, chaperone notice, confidentiality pledge and declarations, notice on where and to whom to complain |
| Quality Improvement Activities | Patient satisfaction survey, records of quality activities, clinical review of cases |
- Start from the law. Write the policy statement, the grievance mechanism and the incident reporting procedure first, because Act 586 requires them whether or not you seek accreditation.
- Map every criterion. List each MSQH criterion and the SOP or record it asks for, with an owner.
- Write what you do. Describe the process the team actually follows, so a surveyor's interview matches the document.
- Point to the record. For each SOP, name where the evidence of it lives, in the clinical system or in your own files.
- Display what patients must see. Complaints policy, billing procedure, staff identification, organisation chart and the certificate of registration.
- Review on a date. Put a review date on every policy, and keep the minutes that show it was reviewed.
- Document ______ Required by Act 586, MSQH or both ______
- MSQH standard and criterion ______
- Owner ______ Approved by ______ On ______
- Evidence it is followed lives in ______
- Displayed to patients yes or no ______ Where ______
- Next review ______
Next, organising the evidence behind each document. The MOH and MSQH hub lists the six clinic standards in full.
Questions
Which documents does Act 586 itself require?
A policy statement for patients, a patient grievance mechanism, incident reporting and quality programmes, with the detail set by the 2006 Regulations.
What must a clinic display to patients?
Its certificate of registration, and its complaints policy, billing procedure, staff identification and organisation chart, where patients can easily see them.
How often should policies be reviewed?
For licensed facilities, the duties of the person in charge set at least once every five years. Most clinics review sooner, whenever practice changes.
Sources
- 1Malaysian Society for Quality in Health, 1998Private Healthcare Facilities and Services Act 1998 (Act 586)Read source
- 2Ministry of Health Malaysia, Medical Practice Division, 2025Soalan-soalan lazim berkaitan penguatkuasaan Akta 586, 17 June 2025 (Malay)Read source
- 3Ministry of Health Malaysia, Medical Practice Division, 2026Duties and Responsibilities of Person in Charge of Private Healthcare Facilities and Services, 6 April 2026Read source
- 4Malaysian Society for Quality in Health, 2024Medical Clinic Accreditation Survey Process Guide, March 2024Read source
- 5Malaysian Society for Quality in Health, 2024Medical Clinic Standards, 2nd editionRead source
Written by the wai team from the Ministry of Health Malaysia and the Malaysian Society for Quality in Health guidance, checked on 16 October 2026. This is guidance, not legal advice. Neither the Ministry of Health nor MSQH endorses wai or any software.
