1.1 Organisations seeking certification or approval, should develop, document, implement, and maintain a Quality (Safety) Management System with appropriate internal quality assurance (QA) procedures. Quality Management System, Quality Assurance and Quality Control are explained in the definition section (section 3) of this OTAC.
1.2 Figure 1 attempts to illustrate the inter-relationship between QMS and SMS as an integrated system.
1.3 The QA process complements that of safety assurance, with each having requirements for analysis, documentation, auditing and management reviews to assure that certain performance criteria are met. While safety assurance specifically monitors the effectiveness of safety risk controls, QA typically focuses on the organisation’s compliance with regulatory requirements.
1.4 The complementary relationship between safety assurance and QA allows for the integration of certain supporting processes. Therefore, a QMS should be seen as an integral part of the application, management and maintenance of a Safety Management System (SMS), see OTAC SMS-1.
1.5 The fundamental objectives of both SMS and QMS may be summarised as:
- Error/threat reduction
1.6 This OTAC provides guidance on essential elements of a basic Quality Management System (QMS).
Figure 1 – The inter-relationship between QMS and SMS