They are 25 standards, made by Welsh Ministers in 2011 under the Care Standards Act 2000, that apply to every independent hospital, independent clinic and independent medical agency in Wales. HIW uses them to judge quality, safety and effectiveness, and to decide whether a service is meeting the Independent Health Care (Wales) Regulations 2011.12
Where the standards come from
The National Minimum Standards for Independent Health Care Services in Wales were published in April 2011.1 They set out minimum standards, and the Welsh Government expects most providers to meet them and many to exceed them. Where a standard is not met, the document lists the regulation that may be breached, as a guide rather than a complete legal reference.2
The regulations themselves are the Independent Health Care (Wales) Regulations 2011. They have been amended in places since 2011, for example by the Private Dentistry (Wales) Regulations 2017, and legislation.gov.uk lists no outstanding effects on them today.34 HIW inspects against the Act, the Regulations and the standards together.5 Clinics in England work to a different framework, set out on the CQC hub for England.
The 25 standards
| Standard | Name |
|---|---|
| 1 | Governance and Accountability Framework |
| 2 | Equality, Diversity and Human Rights |
| 3 | Health Promotion, Protection and Improvement |
| 4 | Emergency Planning Arrangements |
| 5 | Citizen Engagement and Feedback |
| 6 | Participating in Quality Improvement Activities |
| 7 | Safe and Clinically Effective care |
| 8 | Care Planning and Provision |
| 9 | Patient Information and Consent |
| 10 | Dignity and Respect |
| 11 | Safeguarding Children and Safeguarding Vulnerable Adults |
| 12 | Environment |
| 13 | Infection Prevention and Control (IPC) and Decontamination |
| 14 | Nutrition |
| 15 | Medicines Management |
| 16 | Medical Devices, Equipment and Diagnostic Systems |
| 17 | Blood Management |
| 18 | Communicating Effectively |
| 19 | Information Management and Communications Technology |
| 20 | Records Management |
| 21 | Research, Development and Innovation |
| 22 | Managing Risk and Health and Safety |
| 23 | Dealing with Concerns and Managing Incidents |
| 24 | Workforce Planning, Training and Organisational Development |
| 25 | Workforce Recruitment and Employment Practices |
Three standards that most clinics are tested on
Standard 1, Governance and Accountability Framework. A document setting out lines of reporting, accountability and responsibility for every service, and any delegation from the registered provider to the responsible individual or manager, signed by someone with authority.2
Standard 20, Records Management. Records that are accurate, complete, understandable and contemporaneous, stored securely and retrievable in good time. A records management policy, a nominated person responsible for records, checks that records are completed at the time, protection from unauthorised use, and effective back-up where records are electronic.2
Standard 23, Dealing with Concerns and Managing Incidents. Complaints, incidents, near misses and claims, together called concerns, reported and responded to in good time, investigated openly by people with the skills to do it, with support for patients and staff and lessons shared. An incident reporting procedure that looks for underlying causes and the risk of recurrence.2
- Mark the standards that apply. All 25 apply in principle, but some, such as nutrition or blood management, will have little content for an outpatient clinic. Note why.
- Read the elements for each. Each standard lists elements to be in place at registration and ongoing. Use them as your checklist.
- Point to the evidence. For each element, name the record, policy or audit that shows it, and where it is kept.
- Map to HIW's themes. HIW reports each standard under one of its three themes, so group your evidence the same way.
- Review once a year. Record what changed, what you learned from concerns, and what you will improve next.
- Standard ______ Applies to us, yes or no ______
- Elements in place ______
- Evidence and where it lives ______
- Owner ______ Last reviewed ______
- Gap and action ______
Questions
Do the National Minimum Standards apply to small clinics?
Yes. HIW says the standards apply to all independent healthcare services in Wales, regardless of size and type.
Are the standards law?
The standards are made under the Care Standards Act 2000. The legal requirements are in the Act and the Independent Health Care (Wales) Regulations 2011. HIW uses the standards to judge whether a service is complying with the Regulations.
Have the 2011 Regulations been replaced?
No. As of 15 October 2026 they remain in force, amended in places since 2011, with no outstanding effects listed on legislation.gov.uk.
Sources
- 1Welsh Government, 2011The National Minimum Standards for Independent Health Care Services in Wales (2011 No.16)Read source
- 2Welsh Government, 2011National Minimum Standards for Independent Health Care Services in Wales, full textRead source
- 3legislation.gov.uk, 2011The Independent Health Care (Wales) Regulations 2011Read source
- 4legislation.gov.uk, 2026Changes to legislation, The Independent Health Care (Wales) Regulations 2011Read source
- 5HIW, 2025How does HIW inspect independent services?Read source
Written by the wai team from Healthcare Inspectorate Wales guidance, checked on 15 October 2026. This is guidance, not legal advice. HIW does not endorse wai or any software.