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System Certifications: ISO 9001 in the Healthcare Field

Certification of your quality management system demonstrates your commitment to consistency, continuous improvement, and customer satisfaction, also within the healthcare sector, when, in this case, we are talking about the patient.

These are tangible benefits that play an important role in building a sustainable culture that aims at delivering high medical performance. 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 offers a clear demonstration to interested parties that you work to apply 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 useful for your organization?

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

It will help you:

  • to ensure quality and safety in patient treatment;
  • to identify and manage risks for patients, staff and the entire organization;
  • to determine, manage, monitor and improve complex and related processes;
  • to comply with relevant international and national legal requirements;
  • to implement best practice routines and procedures;
  • to prevent the occurrence of incidents;
  • to identify areas for improvement to ensure continuous improvement of its quality management system;
  • to 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 put in place a certified quality management system, it is necessary to know the requirements of the ISO 9001 standard 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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