Quality Management System (ISO 9001)

OMNI QMS: ISO 9001

OmniEMR is certified for §170.315(g)(4) Quality management system. Our quality management system follows the ISO 9001:2015 standard. The clauses below summarize the key ISO 9001 principles our QMS applies to the development, documentation, and change control of OmniEMR.

Clause	Description	Reference
0.1 General	This international standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. The process approach enables an organization to plan its processes and their interactions. The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted on. Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise.	ISO 9001, p. 6
0.3.1 General	The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results.	ISO 9001, p. 7
0.3.2 Plan-Do-Check-Act cycle	The PDCA cycle can be applied to all processes and to the quality management system as a whole. The PDCA cycle can be briefly described as follows: Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers’ requirements and the organization’s policies, and identify and address risks and opportunities; Do: implement what was planned; Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results; Act: take actions to improve performance, as necessary.	ISO 9001, p. 8
7.5.2 Creating and updating	When creating and updating documented information, the organization shall ensure appropriate: (a) identification and description (e.g. a title, date, author, or reference number); (b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic); (c) review and approval for suitability and adequacy.	ISO 9001, p. 19
8.3.6 Design and development changes	The organization shall identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements. The organization shall retain documented information on: (a) design and development changes; (b) the results of reviews; (c) the authorization of the changes; (d) the actions taken to prevent adverse impacts.	ISO 9001, p. 22