ISO 9001 Quality Management System for Healthcare Organisations
What is ISO 9001 for Healthcare Organizations?
The ISO 9001 Quality Management System Standard has been used by healthcare organisations for many years. The standard aligns with ISO 14001:2015, Environmental Management, ISO 45001:2018 Health and Safety Management. This enables leaders to make decisions more easily on the allocation of time, money and people. The common high-level structure enables the alignment of Strategic Intent in clause 4, Leadership in clause 5 and Planning in clause 6 at the initiation of the Management System. There are many other industry critical issues addressed as you progress through the standard. Achieving ISO 9001:2015 is not easy and Quest Management brings years of experience with the standard to enable you to achieve registration.
How can ISO 9001:2015 for Healthcare Organizations help your organization?
ISO 9001:2015 takes you into running your organization as a management system. System thinking enables you to integrate the many processes in your organization and ensure they are linked. Linkage is vital. One of the fundamental principles of system thinking is known as the ‘butterfly effect’. A small event at the front end of a system can lead to major consequences at the delivery end. If that event is an error in customer requirements, the delivery result could be disastrous. An integrated Management System significantly reduces the chance of that happening.
How can Quest Management Consulting help?
Quest Management’s experience in ISO 9001:2015, and broader abilities in standards such as ISO 14001:2015, Environmental Management and ISO 45001, Health and Safety, make us a perfect fit for working with organizations in Healthcare. Yurek Pharmacy, A supplier of intravenous medications and ambulatory equipment to a rural population. The ISO 9001 registration provided a platform for continual improvement of the business. Clark Pharmacy, a similar organization registered to ISO 9001 with Quest Management’s guidance. HLO, a home care agency working closely with the Ontario Community Care Access Centres provided home care to a widely dispersed rural community. The Quest Management Leadership Workshop ensured an understanding of the Leadership role in implementing ISO 9001. Sterling Industries, a manufacturer of medical devices was taken through to ISO 9001 registration in preparation for ISO 13485. ISO 13485:2016 is the latest version of the Medical Device standard.
Quest Management’s Experience in Healthcare Organisations
A number of home care organizations have been taken to registration. The Ontario Home Care Association (OHCA) is the professional association supporting a wide range of Homecare Agencies across the Province of Ontario. Management System Development and support at the annual conference were both provided. OHCA used Quest Management education to engage its members in ISO 9001. Integra Homecare switched to ISO 9001 after bad experience with a non-ISO standard. Home Instead achieved a series of registrations to ISO 9001 for homecare agencies that provided home support services to the elderly or ill. The management system structure enabled growth of each business in a structured and organized manner. The Canadian Hearing Society provides hearing counselling and hearing aids to address a wide range of hearing disabilities. They were taken to successful ISO 9001 Registration.
Quest Management’s other Experience
Our broader experience of standards such as ISO 14001 enables us to address the important environmental issue of Healthcare. As global leaders in Innovation Management, Quest Management has been deeply involved in developing ISO 56002, the guidelines on Innovation Management. We bring that innovation experience to the table with all our work in Healthcare.