ISO 7101: what the healthcare quality standard requires, and how certification works
For hospitals, clinics and other healthcare organisations in the UK, the US and Europe: what ISO 7101 covers clause by clause, how it differs from ISO 9001, who can certify you, and the evidence to have ready.
ISO 7101:2023 is the international standard for quality management systems in healthcare organisations. Any organisation that provides healthcare can use it and seek certification against it. It’s voluntary: you choose whether to use it and whether to certify.
| What | The facts |
|---|---|
| Full name | Healthcare organization management: Management systems for quality in healthcare organizations: Requirements |
| Published | 3 October 2023, first edition, 35 pages, from ISO’s committee for healthcare organisation management (ISO/TC 304) |
| Who it’s for | Any organisation that provides healthcare services, of any type or size, public or private |
| Is it a legal duty? | No. ISO says the standard doesn’t override your legal responsibilities |
| Structure | On ISO’s common structure for management system standards, the same clause order as ISO 9001, and on the Plan-Do-Study-Act cycle |
| Certification | By a certification body, after a stage 1 and a stage 2 audit, with surveillance audits and a recertification audit after three years |
| Accreditation | In the UK, UKAS is running a project programme with BSI and CHKS and hasn’t granted accreditations yet. In Italy, Accredia set its rules on 15 October 2025 |
| Where to buy it | From ISO for CHF 159, or a national edition, such as BS ISO 7101:2023 from BSI |
What is ISO 7101?
ISO 7101:2023 sets the requirements for a quality management system in a healthcare organisation: the policies, processes, roles and records you use to plan care, deliver it safely, check how well it works and improve it. ISO calls it “the first international consensus standard for healthcare quality management”.
ISO published it on 3 October 2023. Its technical committee for healthcare organisation management, ISO/TC 304, wrote it, and the American National Standards Institute (ANSI) held the committee’s secretariat at the time.
The standard asks top management to lead on quality. It builds people-centred care, the management of risk, and the safety and wellbeing of patients and staff into the system, and it asks you to monitor clinical and non-clinical performance and keep improving your processes and results.
It follows ISO’s common structure for management system standards, so its clauses run in the same order as ISO 9001 and ISO 14001, and it uses the Plan-Do-Study-Act cycle. It refers to no other standard, so you can use it on its own.
Who ISO 7101 is for, and whether you need it
The standard applies to any organisation that provides healthcare services, whatever its type, size or services. It names ministries of health, public and private health systems, hospitals, clinics, and non-governmental organisations and agencies that provide healthcare. ISO says it suits anyone from a small clinic to a large hospital.
It’s voluntary. ISO’s FAQ says the standard doesn’t override your legal responsibilities, and it lists four ways to show you meet it, from declaring it yourself to certification by an outside body. Your legal duties still come from where you work:
- England: Regulation 17 on good governance and CQC’s assessment framework set the duty. CQC’s guidance doesn’t mention the standard. Its well-led report on Great Ormond Street Hospital (July 2025) describes a quality governance framework there that draws on ISO 9001, ISO 7101 and ISO 31000. Our CQC well-led guide covers what CQC looks for.
- US: a hospital in Medicare must run a quality assessment and performance improvement (QAPI) programme under 42 CFR 482.21, and the rule doesn’t mention ISO. Accreditation that CMS approves comes from accrediting organisations such as the Joint Commission and DNV, and we found no mention of ISO 7101 on either’s website (5 November 2026). Hospitals accredited by DNV achieve ISO 9001 certification at the end of their fourth annual survey. Our Joint Commission guide covers accreditation.
- Ireland: HIQA’s National Standards for Safer Better Healthcare set the standards, and its website doesn’t mention ISO 7101. Our guide to staying HIQA compliant covers them.
- Elsewhere in Europe: national law sets the quality duties, such as section 135a of Social Code Book V in Germany and the Wkkgz in the Netherlands, and in France the Haute Autorité de Santé certifies every health establishment every four years. Our healthcare QMS guide covers each country.
ISO lists the benefits it expects from the standard: better quality of care, improved patient safety, lower costs, more effective operations, and a stronger reputation and wider reach. A certificate gives commissioners, partners and patients independent evidence that your quality system works.
What ISO 7101 requires, clause by clause
The requirements sit in clauses 4 to 10. The clause names below come from the standard’s own contents, and the evidence column is our guide to the records that show each part working. The full text sets the exact requirements, so check each one against your copy.
| Clause | What it covers | Evidence to have ready |
|---|---|---|
| 4 Context of the organization | Your organisation and its context, what your stakeholders need and expect, and the scope of your quality management system | A written scope, your stakeholders and their needs, and the issues you reviewed |
| 5 Leadership | Leadership and commitment, the healthcare quality policy, roles, responsibilities and authorities, service user focus and access to care | The approved quality policy, named roles and leadership meeting minutes on quality |
| 6 Planning | Risks and opportunities, including risk culture and risk management processes, quality objectives and the plans to meet them, and planning changes | A risk register with owners and actions, quality objectives with targets and owners, and change plans |
| 7 Support | Resources, competence, awareness, service user, clinical and external communication, and documented information, including information systems, electronic records and the audit of records | Training and competence records, document control with versions and approvals, and records audits |
| 8.1 to 8.9 Operation | Operational planning, facilities, contingency plans and equipment, waste and environmental responsibility, materials, service users’ belongings, emerging technologies, service design, external providers and the provision of services | Maintenance and equipment logs, contingency plans, supplier checks, and care pathways and procedures |
| 8.10 and 8.11 People-centred care and ethics | Service user experience and how you assess it, compassionate care, inclusivity and diversity, health literacy, co-production, workforce wellbeing, and ethics | Patient feedback and surveys, complaints and the changes made, staff wellbeing measures, and your ethics policy |
| 8.12 Patient safety | Knowledge and learning in safety, patient identification, medication safety, surgical safety, infection prevention and control, preventing falls, pressure ulcers and thromboembolism, diagnostic safety and blood transfusions | Incident reports and learning responses, safety audits and the actions closed |
| 9 Performance evaluation | Monitoring and measurement, including healthcare quality indicators, the internal audit programme and management review | Quality indicator reports, the audit programme and audit reports, and management review minutes and actions |
| 10 Improvement | Continual improvement, and nonconformity and corrective action | A corrective action log with causes, owners and checks that each action worked, and improvement projects |
Clauses 4 to 7, 9 and 10 follow the structure every ISO management system standard shares, with healthcare additions such as access to care, risk culture, clinical communication and the audit of records. Most of the healthcare content sits in clause 8: facilities and equipment, waste, emerging technologies, service design, people-centred care, ethics and patient safety.
Free ISO 7101 gap checklist: see where you stand on every clause
Every clause of ISO 7101 in one file, with the evidence that shows each one and columns for where that evidence lives in your system today and who owns it. Use it to plan the work before you choose a certification body.
- Every clause of ISO 7101, from the context of the organisation (clause 4) to improvement (clause 10), with its sub-clauses
- The healthcare clauses picked out: access to care, people-centred care, ethics and patient safety
- For each one: the evidence that shows it, where that evidence lives in your system today and who owns it
- An Excel file that also opens in Google Sheets
You fill it in yourself.
| Clause | Evidence that shows it | Where it lives in your system | Owner |
|---|---|---|---|
| 5.2 Healthcare quality policy | The approved policy, its review date and how staff were told about it | ||
| 8.12.4 Medication safety | Medication incident reports, audit results and the actions taken | ||
| 9.2 Internal audit | The audit programme, the audit reports and the findings closed |
Enter your email to get the free ISO 7101 gap checklist
Our team will be in touch within one working day to send the checklist.
Request received
Thanks. Our team will be in touch within one working day to send the ISO 7101 gap checklist.
Could not send that request
Something went wrong on our side. Please try again, or use our contact form and our team will send the checklist over.
ISO 7101 and ISO 9001: what’s different
| ISO 9001 | ISO 7101 | |
|---|---|---|
| Written for | Any organisation | Organisations that provide healthcare services |
| ISO committee | ISO/TC 176, quality management | ISO/TC 304, healthcare organisation management |
| Structure | ISO’s common structure, clauses 4 to 10 | The same structure, so the two can run as one system |
| Healthcare requirements | None | Access to care, people-centred care, ethics, patient safety and healthcare quality indicators |
If you already hold ISO 9001, you have the structure, and most of your gap is the healthcare content. BSI says ISO 7101 integrates with other ISO standards, such as ISO 9001 and ISO 14001.
You don’t need ISO 9001 first. The standard has no normative references, and Accredia, Italy’s accreditation body, says ISO 9001 certification is not a prerequisite for certification to it.
How to get ISO 7101 certification
Certification means a certification body audits your system against the standard and issues a certificate. The usual route:
- Buy the standard and read it. ISO sells ISO 7101:2023 for CHF 159, and national standards bodies sell their own editions, such as BS ISO 7101:2023 from BSI.
- Compare what you do now with each clause. A gap analysis shows what’s in place, what’s partly there and what’s missing. Our free gap checklist sets out every clause for it.
- Set the scope and fill the gaps. Decide which services and sites the system covers, then write the quality policy, objectives, risk processes and procedures the clauses ask for.
- Run the system and keep its records. The auditor will want to see it working: quality indicators, incident learning, service user feedback and completed actions.
- Hold an internal audit and a management review. Both are clauses of the standard (9.2 and 9.3), so run at least one of each before the certification audit.
- Choose a certification body. Ask whether its ISO 7101 certificates carry accreditation and whether its auditors know healthcare. ISO/IEC TS 17021-15:2023 sets the competence that auditors of this standard need.
- Pass the stage 1 and stage 2 audits. Stage 1 checks you’re ready, stage 2 is the main audit of the system in practice, and the certificate follows.
- Keep the certificate. Surveillance audits follow during the cycle, and a recertification audit after three years.
Certification bodies have started issuing certificates. SGS presented its first ISO 7101 certificate to Chi Mei Medical Center in Taiwan on 23 July 2025, and BSI has piloted the standard with hospitals in Tamil Nadu, India.
Choosing a system to run your quality management in? Our healthcare QMS guide sets out what a provider’s system must do in the UK, the US and Europe.
Who can certify you in the UK, US and Europe
An accredited certificate means a national accreditation body has checked that the certification body is competent to certify against that standard. For ISO 7101, accreditation is still new. What we found for the main markets, as at 5 November 2026:
| Where | Accreditation for ISO 7101 | Edition of the standard |
|---|---|---|
| UK | UKAS is running a project accreditation programme with BSI Assurance UK and CHKS, and will grant the first accreditations once it’s complete | BS ISO 7101:2023, from 31 October 2023 |
| US | We found no ISO 7101 programme at ANAB, ANSI’s accreditation board | ISO 7101:2023 |
| Italy | Accredia set its rules for accrediting ISO 7101 certification on 15 October 2025 | UNI ISO 7101:2024, from 15 February 2024 |
| Netherlands | We found no ISO 7101 programme at RvA | NEN-ISO 7101:2023 |
| Germany | We found no accredited ISO 7101 certification body named by DAkkS | ISO 7101:2023, sold by DIN Media |
| Ireland and France | We found no ISO 7101 programme at INAB or COFRAC | ISO 7101:2023 |
Certification bodies that say on their own websites that they certify to ISO 7101 include BSI, CHKS, SGS, Bureau Veritas in Japan and CSQA in Italy. None of those pages claims accreditation for these certificates, so ask before you sign.
Or go into your ISO 7101 audit with every finding closed
CompliantCare’s Audit Management builds your audit programme from templates for any standard, with scheduling and reminders. Your team runs each audit on any device and captures the evidence as it goes. Every finding becomes an action with an owner and a deadline, chased to completion and verified, and the next cycle builds on what changed. That’s the Plan-Do-Study-Act cycle ISO 7101 uses, with the evidence kept.
Common questions
What is ISO 7101?
ISO 7101:2023 is the international standard for quality management systems in healthcare organisations. It sets the requirements for how an organisation that provides healthcare plans, delivers, checks and improves the quality of its care, and an organisation can seek certification against it.
When was ISO 7101 published?
ISO published ISO 7101:2023 on 3 October 2023, as its first edition. The UK edition, BS ISO 7101:2023, followed on 31 October 2023.
Is ISO 7101 mandatory?
No. It's a voluntary standard, and ISO says it doesn't override your legal responsibilities. Your legal duties still come from where you work: in England, the regulations and CQC; in the US, the Medicare conditions of participation and your accreditor; in Ireland, HIQA's standards.
Who can use ISO 7101?
Any organisation that provides healthcare services, whatever its type, size or services, public or private. The standard names ministries of health, health systems, hospitals, clinics, and non-governmental organisations and agencies that provide healthcare.
What is the difference between ISO 7101 and ISO 9001?
ISO 9001 is the general quality management standard for any organisation. ISO 7101 follows the same structure and adds requirements written for healthcare, including access to care, people-centred care, ethics, patient safety and healthcare quality indicators.
Do you need ISO 9001 before ISO 7101?
No. ISO 7101 refers to no other standard, and Accredia, Italy's accreditation body, says ISO 9001 certification is not a prerequisite for ISO 7101 certification.
How do you get ISO 7101 certification?
Buy the standard, compare what you do now with each clause, fill the gaps, run the system and keep its records, and hold an internal audit and a management review. Then book a certification body for a two-stage audit: stage 1 checks you are ready, and stage 2 is the main audit of the system in practice.
How long does ISO 7101 certification last?
Certification bodies run it on a cycle: surveillance audits after the certificate is issued, then a recertification audit after three years.
Who certifies ISO 7101 in the UK?
BSI and CHKS both offer ISO 7101 certification, and they are the two certification bodies in UKAS's project accreditation programme for the standard. As at 5 November 2026, UKAS says it will begin granting accreditations once that programme is complete.
Where can I get the ISO 7101 PDF?
ISO sells ISO 7101:2023 as a PDF for CHF 159, and national standards bodies sell their own editions, such as BS ISO 7101:2023 from BSI in the UK, NEN-ISO 7101:2023 in the Netherlands and UNI ISO 7101:2024 in Italy.
Does CQC recognise ISO 7101?
CQC's guidance doesn't mention ISO 7101, and certification doesn't change what CQC assesses: the regulations, including Regulation 17 on good governance, and its own assessment framework. CQC's July 2025 well-led report on Great Ormond Street Hospital describes a governance framework there that draws on it.
Does the Joint Commission accept ISO 7101?
We found no mention of ISO 7101 on the Joint Commission's or CMS's websites (5 November 2026). Hospitals accredited by DNV, another accrediting organisation that CMS approves, achieve ISO 9001 certification at the end of their fourth annual survey.
Where can I get an ISO 7101 gap checklist?
Enter your work email in the form on this page and our team will send the free ISO 7101 gap checklist: an Excel file, which also opens in Google Sheets, with every clause, the evidence that shows it, and columns for where that evidence lives and who owns it.
References
- ISO: ISO 7101:2023, Healthcare organization management: Management systems for quality in healthcare organizations: Requirements
- ISO: ISO/TC 304, Healthcare organization management
- ISO: Quality management in healthcare
- ANSI: Inside ISO 7101, the first international standard for healthcare quality management (4 October 2023)
- ISO/FDIS 7101:2023 preview: foreword, introduction, scope and terms (PDF)
- DIN Media: ISO 7101:2023-10, table of contents
- ISO: ISO/IEC TS 17021-15:2023, competence requirements for auditing healthcare quality management systems
- UKAS: ISO 7101:2023 for management systems of healthcare organisations, development programme
- UKAS: Expression of interest, ISO 7101:2023 healthcare management systems (24 September 2024)
- Accredia: Technical circular DC 40/2025 on accrediting UNI ISO 7101:2024 certification (15 October 2025, PDF, Italian)
- BSI: ISO 7101 Healthcare organization management
- BSI Knowledge: BS ISO 7101:2023
- BSI: Introduction to ISO 7101 (brochure, PDF)
- BSI: How ISO 7101 is transforming hospital care in India
- CHKS: Healthcare organisation management, ISO 7101
- SGS: SGS issues its first ISO 7101 certification to Chi Mei Medical Center in Taiwan (28 August 2025)
- Bureau Veritas Japan: ISO 7101 certification (Japanese)
- CSQA: UNI ISO 7101 certification
- UNI: UNI ISO 7101:2024
- NSAI Standards: NEN-ISO 7101:2023
- CQC: Great Ormond Street Hospital, well-led assessment (23 July 2025)
- eCFR: 42 CFR 482.21, Quality assessment and performance improvement program
- CMS: Accrediting organizations
- DNV: NIAHO accreditation for hospitals
For general information only. It reflects our understanding of ISO 7101 and of what ISO and the accreditation and certification bodies publish, as of November 2026, so check iso.org and your certification body for the current position.