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ISO 7101:2023

ISO 7101:2023 Healthcare Organisation Management

What is ISO 7101?

The ISO 7101 certification is awarded to businesses that implements an Healthcare Quality Management (HQM) and is compliant with the requirements of the international Standard. 

ISO 7101:2023 is the most recent version of the standard. 

ISO 7101 stands as the inaugural international standard for healthcare quality management. It outlines a set of requirements for establishing a systematic approach towards sustainable, top-tier health systems. This standard empowers organisations of all sizes, structures, and geographic locations to:

  • Cultivate a culture of quality, beginning with robust top management.

  • Embrace a healthcare ethos centered on people-centric care, emphasizing respect, compassion, co-production, equity, and dignity.

  • Identify and mitigate risks effectively.

  • Ensure the safety and well-being of both patients and the workforce.

  • Regulate service delivery through well-documented processes and information.

  • Monitor and evaluate performance across clinical and non-clinical domains.

  • Continuously enhance processes and outcomes to drive ongoing improvement.

Why is ISO 7101 Important?

Certification to ISO 7101 is one way to demonstrate to stakeholders and customers that you are committed and able to manage a robust Healthcare Quality Management. Holding a certificate issued by an accreditation body may bring an additional layer of confidence, as an accreditation body has provided independent confirmation of the certification body’s competence. 

As with other ISO management system standards, companies implementing ISO 7101 can decide whether they want to go through a certification process.

Some organisations choose to implement the standard in order to benefit from the best practice it contains, while others also want to get certified to reassure customers and clients.

As per the ISO Survey 2021, over 50,000 certificates were reported in more than 140 countries and from all economic sectors, ranging from IT Security, agriculture, manufacturing to social services.

Benefits Of ISO 7101

  •  Refined quality of healthcare delivery.

  •  Improved patient safety.

  •  Cost-efficiency.

  •  Enhanced operational effectiveness.

  •  Strengthened reputation and extended market reach.

How much does ISO 7101 cost?

Prices for ISO 7101 certification will vary based on the size and complexity of your business.

To receive your personalised quote, simply fill in you requirements on our contact us page  or book a Initial Free Consultation.


Key Requirements

ISO 7101:2023 outlines requirements for a systematic approach to sustainable, high-quality health systems within healthcare organizations. Here are the key requirements:

Leadership and Commitment:

  • Top management must demonstrate commitment to quality and patient safety.

  • Establish a quality policy and objectives.

Patient-Centered Care:

  • Ensure care is respectful, compassionate, and patient-centered.

  • Involve patients in decision-making.


Risk Management:

  • Identify and assess risks related to patient safety and quality.

  • Implement risk management processes.


Documented Processes and Information:

  • Document processes, procedures, and policies.

  • Maintain records related to quality and safety.


Performance Evaluation:

  • Monitor and evaluate clinical and non-clinical performance.

  • Use data for improvement.

  • Continual Improvement

  • Implement processes for continual improvement.

  • Address non-conformities and take corrective actions.


Human Resources:

  • Ensure competent and motivated workforce.

  • Provide training and development.


Infrastructure and Work Environment:

  • Maintain facilities, equipment, and work environment.

  • Ensure safety and hygiene.

  • Patient Safety:

  • Implement measures to prevent harm to patients.

  • Report incidents and learn from them.


Communication and Information:

  • Communicate effectively within the organisation.

  • Provide information to patients and families.

Remember, ISO 7101 is a comprehensive standard that promotes quality, safety, and sustainability in healthcare systems. Organisations can use it to enhance their operations and improve patient outcomes. For the full details, you can refer to the ISO 7101:2023 standard. 

DIY ToolKits

  • Align your information security activities with industry best practice, proving to stakeholders that you take information security seriously.

  • Guarantee compliance with this comprehensive suite, which includes 2 extra standards.

  • Halve your implementation costs and time pre-written, customisable templates, procedures and documents.

  • Our ISO 7101 Toolkit was developed by the global framework experts.

  • Meet local and global security laws, such as the GDPR (General Data Protection Regulation).

  • NO annual subscription. 

  • Only a one off payment.


Don't get caught out when your ISO 7101 compliance obligations change – with CFS DIY Kits, you've got everything covered.

How can we help your organisation to become ISO 7101 certified?

Our process helps your business to become ISO 7101 certified for success.
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Our team of consultants and auditors has provided certifications to clients ranging from SMEs to blue chip organisations across a broad spectrum of verticals and industries



Our processes add value at every stage, without taking up unwarranted management time. We commit to providing you with the best possible value for money – including a price promise from the outset, along with the ability to stagger payments at no extra cost.

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At Cyber Framework Solutions we remove the paperwork and red tape, making your whole experience uncomplicated making sure you get the best possible frameworks that applies to your business .


How long does certification last?

The initial certificate will last for one year and after a successful recertification audit, you will be issued a 3-year certificate. In order to maintain your certificate during this period, you are required to successfully undergo one mandatory audit a year.

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