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ISO 9001 Certification in the Healthcare Sector

Certification of your quality management system demonstrates your commitment to consistency, continuous improvement, and customer satisfaction, including within the healthcare setting where, in this case, we are referring to the patient.

These are tangible benefits that play an important role in building a sustainable culture that aims for high-performance medical delivery. The ISO 9001 standard provides specific requirements for a Quality Management System that will improve the ability to consistently provide care that meets the needs of patients, as well as legal and regulatory requirements.

Independent assessment and certification of your quality management system provides a clear demonstration to stakeholders that you are working to implement an effective quality management system in your organization.

Why ISO 9001 for Healthcare?

Improving quality and increasing patient safety through the implementation of a Quality Management System is the best way to provide patient-centered care. ISO 9001 provides a model for a quality management system that focuses on the effectiveness of clinical, business, and support processes to ensure high-quality care.

The standard promotes the adoption of a process approach that emphasizes requirements, added value, performance, and process effectiveness, and continuous improvement through objective measurements.

Previous versions of ISO 9001 were tailored to manufacturing industries and required extensive system documentation. The current version is more generic and can be applied to organizations of any size and sector. Therefore, it is increasingly recognized as a standard suitable for healthcare organizations that wish to provide high-quality, patient-centered healthcare.

Why would certification be beneficial to your organization?

Certification of your management system according to ISO 9001 demonstrates your organization's ability to meet the requirements and needs of patients.

It will help you:

  • Ensure quality and safety in patient treatment;
  • Identify and manage risks to patients, staff, and the entire organization;
  • Determine, manage, monitor, and improve complex and related processes;
  • Comply with relevant international and national legal requirements;
  • Implement best practice routines and procedures;
  • Prevent the occurrence of incidents;
  • Identify areas for improvement to ensure continuous improvement of its quality management system;
  • Assure patients, authorities, and other stakeholders that you have implemented a well-functioning management system, capable of committing to continuous improvement.

How can you get started?

To implement a certified quality management system, it is necessary to know the requirements of ISO 9001 and set clear objectives for the implementation and evaluation of the management system. Certification and continuous improvement of your management system is a real journey that never ends.

These are important steps to get started:

  • Become familiar with the ISO 9001 standard;
  • Make an assessment of your current management system;
  • Take action to improve areas that need improvement to prepare for certification;
  • Ensure the commitment of top management and the entire organization.

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