STANDARD 4: Quality Management System

4.1 General

1.The dental organization shall develop, implement, and maintain an effective, ongoing, quality management system.

This system shall be established with consideration to scope of practice, resources, and complexity.

2.The dental organization management shall implement points of control to assure: 

a) patient safety;

b) patient focus; 

c) customer satisfaction; 

d) provision of quality services that are monitored and evaluated to achieve intended results; 

e) management review of core processes, adverse patient events, non-conforming products, and corrective actions as determined to be necessary;

f) appropriate infection prevention and control methodology;

g) maintenance of a physical environment in accordance with national law and this standard; 

h) control of inappropriate use of non-conforming products; 

i) appropriate continuing education as per national law and this standard; 

j) maintenance including calibration (as required by the manufacturer) of any high-risk equipment; 

k) radiation safety and exposure control of patient and staff as per national law and relevant regulations; 

l) appropriate patient pain control methods to assure patient satisfaction within ethical parameters; 

m) narcotic and opioid control practices in keeping with national law.

3. In provision of service, the dental organization shall establish methods to provide appropriate: 

a) patient evaluation, management, and follow up as required by standard of care and appropriate ethical considerations; 

b) sterilization, decontamination, and validation processes as required by national law.

Related documents shall be maintained; 

c) appropriate patient identification and procedure explanation; 

d) a process for discharge of a patient including instructions and follow-up information; 

e) other critical requirements of national law or this standard.

4. Documented information shall be maintained according to national law or this standard. 

4.2 Control of Documented Information

1. The dental organization shall develop and implement a policy for the control of documented information.

2. Documented information required by the dental organization, this standard, or other regulatory standard shall be controlled to ensure: 

a) availability for use as needed; 

b) adequate protection from loss of confidentiality or content.

3. Document control shall address the following universal activities:

a) appropriate identification; 

b) distribution, access, retrieval, and use; 

c) storage and preservation; 

d) control of changes (e.g.version control); 

e) retention and disposal.

4. Important documented information of external origin shall be identified and controlled.

NOTE 1 Documented information includes information which by its character and importance shall be either retained and/or maintained. This includes documents of internal and external origin determined to be necessary for the maintenance of the dental organization as stated above. This information and the appropriate storage methodology may take multiple forms, i.e. hard copy, digital storage, video, audio, etc.