SAHealth have both a medical device ISO13485 QMS, which incorporates PHARMACY requirements; that is aspects to SAHPRA Medicines GWP, where relevant and where the word "medical device" is read also as Medicine where applicable. There is also a specific procedure for Medicines refer PHARMACY

ISO 13485:2016(E) 0.2 Clarification of concepts

In this International Standard, the following terms or phrases are used in the context described below.

— When a requirement is qualified by the phrase “as appropriate”, it is deemed to be appropriate unless the organization can justify otherwise. A requirement is considered appropriate if it is necessary for:

— product to meet requirements;

— compliance with applicable regulatory requirements;

— the organization to carry out corrective action;

— the organization to manage risks.

— When the term “risk” is used, the application of the term within the scope of this International Standard pertains to safety or performance requirements of the medical device or meeting applicable regulatory requirements.

— When a requirement is required to be “documented”, it is also required to be established, implemented and maintained.

— When the term “product” is used, it can also mean “service”. Product applies to output that is intended for, or required by, a customer, or any intended output resulting from a product realization process.

— When the term “regulatory requirements” is used, it encompasses requirements contained in any law applicable to the user of this International Standard (e.g. statutes, regulations, ordinances or directives). The application of the term “regulatory requirements” is limited to requirements for the quality management system and the safety or performance of the medical device.

In this International Standard, the following verbal forms are used:

— “shall” indicates a requirement;

— “should” indicates a recommendation;

— “may” indicates a permission;

— “can” indicates a possibility or a capability.