ISO 9001 For Healthcare

Healthcare Quality Management through the Application of ISO 9001


Using the ISO Family of Standards, the organization can establish a comprehensive Quality /Business Management System which:

  • The logos will increase the stature of the Company in the Market place and help to enlarge the customer base.
  • Facilitates improved understanding of roles & responsibilities among employees; and enhanced communication and coordination between departments.
  • Requires the establishment of measurable improvement objectives and accountability to those objectives through monitoring, measuring and reporting.
  • Results in improved systems, processes, and outcomes.

Why ISO 9001:2015 certification for healthcare?

ISO 9001:2015 certification is utilized in a variety of ways as a vehicle for healthcare organizations to:

  • Identify systemic risks and breakdowns and close gaps or loopholes.
  • Define key interfaces between processes, departments and staff.
  • Streamline workflow and maximize resource utilization.
  • Proactively prevent problems from occurring.
  • Provide ways to detect and correct errors and problems.
  • Ensure conformance to and effectiveness of documented processes.
  • Focus on patient and provider needs and expectations.
  • Maximize customer satisfaction.
  • Facilitate compliance to healthcare quality certifications, accreditation standards and regulatory requirements.

Benefits of ISO 9001:2015 as a tool for managing Healthcare Quality

ISO 9001:2015 offers a means for evaluating processes at an organizational level. It also enables the organization to define organization specific goals and methods for quality management. Finally, ISO 9001:2015 offers a monitoring or audit system for maintaining the healthcare quality management system.

  • If a healthcare provider is certified to ISO 9001, any other survey process for healthcare quality certifications will be much simpler and less costly regarding both preparation and compliance demonstration. Provides a solid basis for compliance with all imposed requirements and healthcare quality certifications (e.g., JCAHO, Central, State and Municipal regulations).
  • Systemic risks and breakdowns are recognized and addressed.
  • Development of “Best practice” hospital-wide processes, with reference to supporting documentation.
  • Ensures conformance to and effectiveness of documented processes.
  • Focuses on Patient Care, Satisfaction, and Safety.
  • Reduce errors associated with “hand-offs”.
  • Improve documentation and records.
  • Maximize customer satisfaction.
  • Improve employees’ understanding of roles and responsibilities within the healthcare quality management system.
  • Strengthen customer/community/ Insurance companies confidence and relationships.
  • Foundation for on-going improvement initiative.
  • What makes ISO unique is that it relies on the individual organization to establish, document, implement and maintain a quality management system and continually improve its effectiveness.


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