BLOG Implementing ISO standards in healthcare organizations

ISO standards

Healthcare organizations implement ISO standards for several compelling reasons, all of which contribute to meeting customer’s needs, striving to exceed client expectations, and generally improving the quality, safety, and efficiency of healthcare delivery. From enhancing patient care protocols to streamlining administrative processes, ISO standards serve as a blueprint for excellence in healthcare management. There are many goals and profits that will follow after ISO implementation.

Goals and profits

Some key reasons why healthcare organizations choose to implement ISO standards might include:

  • Enhanced Quality of Patient Care:
    • ISO standards, such as ISO 9001 and ISO 15189, emphasize the importance of quality management systems and quality assurance in healthcare.
    • Implementing these standards helps healthcare organizations focus on delivering high-quality patient care by establishing and maintaining effective processes.

  • Patient Safety Improvement:
    • ISO standards incorporate requirements and guidelines for risk management, patient safety, and the prevention of adverse events.
    • By implementing ISO standards, healthcare organizations can enhance patient safety measures, reducing the likelihood of errors and improving overall patient outcomes.

  • Standardization of Processes:
    • ISO standards provide a framework for standardizing and streamlining processes across healthcare organizations.
    • Standardization helps improve efficiency, reduce variations in care, and enhance the consistency of healthcare services.

  • Global Recognition and Trust:
    • ISO standards are internationally recognized, and certification demonstrates an organization’s commitment to meeting global best practices.
    • Having ISO certification can enhance the reputation and trustworthiness of a healthcare organization, attracting patients and partners both domestically and internationally.

  • Regulatory Compliance:
    • ISO standards often align with regulatory requirements in many countries.
    • Implementing ISO standards can help healthcare organizations stay compliant with regulatory bodies and demonstrate adherence to industry-specific regulations.

  • Continuous Improvement:
    • ISO standards promote a culture of continuous improvement through processes such as internal audits, management reviews, and corrective and preventive actions.
    • Healthcare organizations can identify areas for improvement, address non-conformities, and continually enhance their systems and services.

  • Efficient Resource Management:
    • ISO standards provide guidelines for effective resource management, including personnel, facilities, and information.
    • By implementing these standards, healthcare organizations can optimize resource allocation and improve overall operational efficiency.

  • Risk Management:
    • ISO standards incorporate risk management principles, helping healthcare organizations identify, assess, and manage risks effectively.
    • This focus on risk management contributes to better decision-making and a more proactive approach to potential issues.

  • Improved Communication:
    • ISO standards emphasize the importance of communication within an organization and with external stakeholders.
    • Clear communication channels facilitate better collaboration, coordination, and information exchange, leading to improved patient care and organizational efficiency.

  • Competitive Advantage:
    • ISO certification can provide a competitive advantage in the healthcare industry.
    • Strengthened reputation and extended market reach.
    • Healthcare organizations with ISO certification may be preferred by patients, partners, and insurers who value a commitment to quality and safety.
    • Cost-efficiency.

ISO standard documentation

Implementing ISO standards in healthcare organizations helps to establish a systematic approach to quality and safety, align with international best practices, and continually improve processes for the benefit of patients and stakeholders. It enhances the overall effectiveness and reputation of healthcare services, contributing to better patient outcomes and organizational success.

The dynamics of change in today’s economy and the growing awareness and demands of consumers are forcing modern organizations to continuously improve the quality of products and services. The most popular tools for supporting decision-making processes are efficient management systems built on the basis of international standards.

ISO certification examples

ISO Certifications (and other, ISO-related procedures) commonly seen within the healthcare industry are mostly: 

  • ISO 9001 Standard – Quality Management System – use it to achieve operational efficiency, continuously improve your organization, reduce costs, gain a competitive advantage, and improve your corporate image.

  • ISO 45001 Standard – Occupational Health and Safety Management System.

  • ISO 7101:2023 – Healthcare organization management – it represents the inaugural global agreement standardizing healthcare quality management. It outlines the prerequisites for adopting a systematic strategy to establish enduring, high-quality health systems. 

  • ISO 13485:2016 – Medical devices, Quality management systems, Requirements for regulatory purposes.

This facilitates organizations, regardless of their size, structure, or geographical location, to establish a culture of excellence that begins with robust leadership at the helm. Embracing a healthcare framework centered on the well-being of individuals involves prioritizing person-centric care, fostering respect, compassion, collaborative production, fairness, and maintaining dignity. The process also involves recognizing and mitigating potential risks and ensuring the safety and welfare of both patients and the workforce. Service delivery is regulated through well-documented processes and information. Additionally, there is a commitment to ongoing monitoring and evaluation of both clinical and non-clinical performance. The organization is dedicated to a continuous improvement approach, seeking to enhance both its processes and overall outcomes continually.

Other standards, not strictly healthcare-related, are:

  • GDPR Standard: General Data Protection Regulation
  • ISO 14001 Standard: Environmental Management System
  • ISO 27001 Standard:  Information Security Management System.

ISO 134852016 Medical devices

Key steps in Implementing ISO standards in healthcare organizations

Implementing ISO standards involves a systematic and well-planned approach. The International Organization for Standardization (ISO) has developed various standards applicable to healthcare, such as ISO 9001 (Quality Management System) and ISO 13485 (Medical Devices). While specific steps can vary depending on the ISO standard in question (e.g., ISO 9001 for quality management, ISO 14001 for environmental management, ISO 27001 for information security), the following are general steps that can guide the implementation process:

1. Leadership Commitment

Obtain commitment and support from top management. Leadership buy-in is crucial for the successful implementation of ISO standards. Allocate necessary resources, including personnel, time, and budget.

2. Establish a Steering Committee

Form a cross-functional team or steering committee responsible for overseeing the implementation process. Include representatives from relevant departments.

3. Create an Implementation Team

It might be Sponsor, Project Manager, Business Process Owner (BPO), Quality representatives, and other stakeholders (internal and external). Form a cross-functional team with members from different departments and assign responsibilities and roles to team members.
Engage your entire team with good internal communication.

4. Create an Internal Auditors Team

Share your ISO 9001 knowledge and encourage your employees to become internal auditors.

5. Training and Awareness

Provide training to employees about the relevant ISO standard requirements. Raising awareness about the importance of ISO standards and their impact on patient safety and quality of care is really crucial from the beginning of the initiative.

6. Discovery phase

Preparation of all the relevant information about the organization and business.
Hiring a legal / law consultant might help in many cases.

  • Scope Definition – clearly define the scope of the ISO implementation. Determine the processes, departments, and locations to be included in the certification scope.
  • Process Mapping – map out key processes within the organization. Identify inputs, outputs, and interactions between processes. Identification of areas for improvement is also valuable. This helps in understanding the workflow and improving efficiency.
  • Communication – communicate upcoming changes and the project’s goal to staff, ensuring that everyone is aware of the organization’s commitment to quality and the ISO implementation process.

7. Implementation phase

Implement all the relevant information, preparing the standards, procedures like policies, SOPs (Standard Operating Procedures), and instructions:

  • Gap Analysis – conduct a thorough gap analysis to assess the organization’s current state against the requirements of the chosen ISO standard. Identify areas of non-compliance and improvement opportunities – determine areas that need improvement to meet the requirements of the chosen ISO standard. Previous processes and procedures in the organization are compared with the requirements of the standard. Any potential gaps or nonconformities are indicated so that corrective action can be taken immediately. This is also a great opportunity for the organization to improve its operations before the formal certification process begins. 
  • Scope Definition – clearly define the scope of the ISO implementation. Determine the processes, departments, and locations to be included in the certification scope.
  • Quality Policy(ies) and Objectives – develop a quality policy that aligns with the organization’s goals and meets the requirements of the ISO standard. Establish measurable quality objectives (KPIs) that support the policy.
  • Document Management – establish a document control system to manage policies, procedures, and records. Ensure that documentation is accessible, up-to-date, and aligns with ISO requirements.
  • Training and Awareness – provide training to employees to create awareness of ISO standards and ensure that personnel understand their roles and responsibilities in the implementation processes. Plan the onboarding and periodic training process for employees.
  • Risk Assessment and Management – identify and assess risks related to the implementation of ISO standards. Develop strategies to mitigate and manage these risks effectively. Establish risk management procedures during the operational phase.
  • Process Mapping – map out key processes within the organization and prepare a requirements traceability matrix to check that your quality system fulfills all regulatory requirements. 
  • Implementation of Controls – implement necessary and proper controls to ensure compliance with ISO standards. This may include monitoring and measurement processes, as well as the implementation of corrective and preventive actions.
  • Corrective and Preventive Actions – implement corrective actions to address identified non-conformities and preventive actions to avoid potential issues in the future.
  • Change Control – implement change management procedures to control the planning and implementation of changes during quality system operation.
  • Deviation and Incident Management – implement proper procedures for the management of non-conformities within the quality system.
  • Audits – develop procedures for internal and external audits.
  • Security – implement procedures to maintain IT security, information security, and data integrity.
  • Operational instructions – develop work instructions and manuals for your organization’s needs and internal processes.  

8. Prepare your organization for the internal audits that will take place during the certification process:

  • Conduct internal audits to assess the organization’s compliance with ISO standards.
  • Internal audits will assess the organization’s compliance with ISO standards.
  • Identify non-conformities and areas for improvement.

9. Get ready for the external audit conducted by the certifying institution.

  • Engage a certification body for external assessment and certification, if desired. Prepare for and undergo the certification audit.

10. Sustain the ISO standards within the organization:

  • Management Review – hold regular management reviews to evaluate the effectiveness of the implemented quality management system. Use the review to make informed decisions for continuous improvement.
  • Review all the applicable documents, maintain preventive and corrective actions.
  • Conduct regular audits of your ISO 9001 system to make sure it is constantly being improved.
  • Continuous Improvement – foster and promote a culture of continuous improvement. Use feedback from audits, reviews, and incidents to make ongoing improvements to processes and the quality management system.
  • Communication activities.
  • Build your employees’ commitment through training and incentive packages.

Implementing ISO standards by companies contributes to achieving many goals and profits. It does not only cover the need to care for patients’ health and safety but also standardizes the processes, improves communications, ensures continuous improvement; provides recognition and trust, and increases reputation. There are a few steps and points to take into consideration while implementing ISO. By following those key steps, healthcare organizations can successfully implement ISO standards and enhance the quality of their services while ensuring compliance with international standards.

Diana Kidacka
Engagement / Project Manager and Implementation Consultant

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