The CQC fundamental standards are regulations 9 to 20A of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. There are 14 of them. CQC calls them the standards below which care must never fall, and every registered provider and registered manager must meet them.
Some breaches are criminal offences. The regulator can prosecute care given without consent, a failure to tell someone in person after a notifiable safety incident, a rating not on display, or a complaints summary or governance report not sent within 28 days of its request, even when no one comes to harm. It can prosecute a breach of safe care, safeguarding under 13(1) to (4), or nutrition when the breach causes avoidable harm, a significant risk of harm, or a loss through theft.
The 14 fundamental standards
Regulation 8(1) is the rule that applies them: a registered person must comply with regulations 9 to 20A in carrying on a regulated activity. In the order the regulations set them out:
| Reg | Standard | What it requires, in short |
|---|---|---|
| 9 | Person-centred care | Care and treatment that is appropriate, meets the person's needs and reflects their preferences, assessed and planned with them. |
| 9A | Visiting and accompanying in care homes, hospitals and hospices | Except in exceptional circumstances: visits for people who stay overnight or live there, no discouraging care home residents from going out on visits, and a companion for people at hospital or hospice appointments. |
| 10 | Dignity and respect | Privacy, support for autonomy, independence and involvement in the community, and due regard to the person's protected characteristics. |
| 11 | Need for consent | Care and treatment only with the consent of the relevant person. For someone aged 16 or over who lacks capacity, acting under the Mental Capacity Act 2005. |
| 12 | Safe care and treatment | Risks assessed and reduced as far as reasonably practicable, competent staff, safe premises and equipment, safe management of medicines, and infection prevention and control. |
| 13 | Safeguarding service users from abuse and improper treatment | Systems that prevent abuse and investigate any allegation at once. No discrimination, unnecessary or disproportionate restraint or degrading treatment, and no deprivation of liberty without lawful authority. |
| 14 | Meeting nutritional and hydration needs | Enough suitable food and drink to sustain life and good health, and help to eat and drink where needed, wherever the service provides accommodation or an overnight stay, or meeting those needs is part of the care. |
| 15 | Premises and equipment | Clean, secure, suitable, properly used, properly maintained and appropriately located, with hygiene to match their use. |
| 16 | Receiving and acting on complaints | An accessible system to receive, record, handle and respond to complaints, each one investigated and acted on, and a summary sent to CQC within 28 days of a request. |
| 17 | Good governance | Systems that assess, monitor and improve quality and safety, manage risk, keep accurate records and act on feedback, and a written report sent to CQC within 28 days of a request. |
| 18 | Staffing | Enough suitably qualified, competent, skilled and experienced staff, with the support, training, supervision and appraisal their work needs. |
| 19 | Fit and proper persons employed | Staff of good character with the qualifications, competence, skills, experience and health for their work, recruitment procedures that check this, and the information in Schedule 3 kept for each person. |
| 20 | Duty of candour | Openness with people about their care. After a notifiable safety incident: telling the person in person, with an apology and a true account, giving support, and following up in writing. |
| 20A | Requirement as to display of performance assessments | The latest CQC rating, with its date, on show at each location, at the principal place of business and on the provider's website. |
Why some lists give 13 standards
Lists of 13 fundamental standards predate regulation 9A, on visiting and accompanying in care homes, hospitals and hospices. It came into force on 6 April 2024, and CQC’s own list of the standards includes it.
Regulations 4 to 7: requirements for directors and managers
Regulations 4 to 7 set the requirements for the people who carry on and manage a service. Regulation 5 sets the fit and proper test for directors, and regulation 7 covers registered managers. They come before the fundamental standards in the same regulations, and CQC’s guidance for providers covers them too.
Regulation 12: safe care and treatment
Regulation 12 requires providers to give care and treatment in a safe way. Its second paragraph lists what that includes: assessing the risks to people’s health and safety, doing all that is reasonably practicable to reduce them, making sure staff have the qualifications, competence, skills and experience to work safely, keeping premises and equipment safe, having enough equipment and medicines, managing medicines properly and safely, and preventing and controlling infection. Where another service shares or takes over someone’s care, providers plan that care together, in good time.
CQC’s guidance accepts that care and treatment carry some risk. It will not treat care as unsafe where a provider can show it took all reasonable steps to keep people safe and to manage those risks. The same guidance expects providers to report incidents inside the service and to the relevant outside bodies, have competent staff investigate them, act on what they find and share the learning.
A breach is a criminal offence when it results in avoidable harm, or a significant risk of harm, to someone using the service, and CQC can prosecute without serving a warning notice first. The 2009 Registration Regulations use the same number for the statement of purpose.
Regulation 17: good governance
Regulation 17 requires systems or processes, set up and run effectively, that make sure the provider meets this part of the regulations. They must let the provider assess, monitor and improve the quality and safety of its services; assess, monitor and reduce risks; keep a secure, accurate, complete and contemporaneous record for each person; keep the records it needs about staff and about running the service; seek and act on feedback; and evaluate and improve how it handles that information.
CQC’s guidance expects regular audits measured against regulations 4 to 20A, and a system with scrutiny and overall responsibility at board level or equivalent. Our inspection checklist sets out the governance, audit and risk evidence to have ready.
Only regulation 17(3) is an offence: failing to send CQC, within 28 days of a request, a written report on how the provider assesses and improves quality and manages risk, with its plans for improvement. No harm needs to follow, and the regulator can prosecute without a warning notice. For the rest of the regulation, it uses its other powers. In the 2009 regulations, number 17 is the duty to notify CQC of the death or unauthorised absence of a person detained or liable to be detained under the Mental Health Act 1983.
Regulation 18: staffing
Regulation 18 requires enough suitably qualified, competent, skilled and experienced staff to meet the requirements of this part of the regulations. Staff must get the support, training, professional development, supervision and appraisal their duties need, and the chance to gain further qualifications where appropriate. Providers must also let registered professionals show their own regulator that they still meet its standards.
CQC’s guidance expects providers to review staffing levels and skill mix continuously, and to train all staff to interact appropriately with people with a learning disability and autistic people, at a level suited to each role.
The regulator cannot prosecute a breach of regulation 18. It can take other regulatory action. In the 2009 regulations, number 18 is notification of other incidents, which CQC notifications covers.
Two sets of CQC regulations use the same numbers
The regulator’s guidance for providers covers two sets of regulations, and both number theirs from 1 to 27. The fundamental standards are in the 2014 Regulated Activities Regulations. The statement of purpose, notices and notifications are in the Care Quality Commission (Registration) Regulations 2009. So every number up to 27 means something in each set:
| Number | Registration Regs 2009 (registration and notifications) | Regulated Activities Regs 2014 (the fundamental standards) |
|---|---|---|
| Reg 12 | Statement of purpose | Safe care and treatment |
| Reg 13 | Financial position | Safeguarding service users from abuse and improper treatment |
| Reg 14 | Notice of absence | Meeting nutritional and hydration needs |
| Reg 15 | Notice of changes | Premises and equipment |
| Reg 16 | Notification of death of service user | Receiving and acting on complaints |
| Reg 17 | Notification of death or unauthorised absence of a person detained or liable to be detained under the Mental Health Act 1983 | Good governance |
| Reg 18 | Notification of other incidents | Staffing |
| Reg 19 | Fees | Fit and proper persons employed |
| Reg 20 | Requirements relating to termination of pregnancies | Duty of candour |
When a policy, an action plan or a report cites a regulation number without naming its instrument, check which one it means. Notifications are 2009 regulations; the fundamental standards are 2014 regulations. For the notification side, see CQC notifications: what you must report and when.
Which fundamental standards can CQC prosecute?
Regulation 22 makes a breach of some standards a criminal offence, and the regulator can prosecute those without serving a warning notice first. Schedule 5 also sets a fixed penalty for each offence: CQC can give a penalty notice, and paying it within 28 days ends any liability for the offence.
| Regulation | When a breach is an offence | Fixed penalty |
|---|---|---|
| 11 Need for consent | Any breach, with no harm needed | £4,000 for a provider, £2,000 for a registered manager |
| 16(3) Complaints summary for CQC | Any breach: not sent within 28 days of the request | £300 |
| 17(3) Governance report for CQC | Any breach: not sent within 28 days of the request | £300 |
| 20(2)(a) and (3) Telling the person, in person, after a notifiable safety incident | Any breach, with no harm needed | £1,250 |
| 20A Display of the rating | Any breach, with no harm needed | £100 |
| 12 Safe care and treatment, 13(1) to (4) safeguarding, 14 nutrition and hydration | When the breach causes avoidable harm, a significant risk of such harm, or a loss of money or property through theft, misuse or misappropriation | £4,000 for a provider, £2,000 for a registered manager |
| Every other standard: 9, 9A, 10, 15, 18, 19, and the other parts of 13, 16, 17 and 20 | Not an offence. CQC can take other regulatory action | None |
So CQC can prosecute a provider that fails to display its rating, or fails to tell someone in person after a notifiable safety incident, even when no one came to harm.
The defence
Regulation 22(4) provides a defence: that the registered person “took all reasonable steps and exercised all due diligence to prevent the breach”.
That phrase should be familiar — it is the same standard the Employment Rights Act 2025 applies to harassment prevention from 30 October 2026. And it works the same way here: it is an evidential defence. “All reasonable steps” is not a state of mind, it is a folder. Dated risk assessments, training records, audits with findings tracked to closure, and a governance trail showing someone looked and acted.
A service with the same practice and no records has the same defence available and no way to run it.
Fundamental standards, quality statements and the five key questions
The fundamental standards are the law. CQC’s assessment framework is how the regulator checks and rates a service against them. It asks five key questions of every service: is it safe, effective, caring, responsive and well-led? Each question has a set of quality statements under it, which CQC says relate directly to the regulations.
The framework is changing. CQC’s March 2026 update says its new sector frameworks will use key lines of enquiry framed as structured questions, which replace the current quality statements, and that consultation feedback supported removing scoring. Its 27 August 2026 update gives no start date. Our guide to the new assessment frameworks sets out what changes and when.
None of this changes regulations 9 to 20A. Only an amendment to the 2014 regulations can change a standard, as the amendment that added regulation 9A did in 2024.
A service can also hold a good rating and still breach a standard. Dr Penny Dash’s review of the single assessment framework, published by CQC in October 2024, found over 96 assessments, around 10% of those carried out by then, rated “good with a breach”. Under the previous method, a breach of a fundamental standard ruled out a rating of good.
Common questions
How many CQC fundamental standards are there? Fourteen: regulations 9 to 20A of the 2014 Regulated Activities Regulations. Lists of 13 predate regulation 9A, on visiting and accompanying, which came into force on 6 April 2024.
How many CQC regulations are there? The regulator’s guidance for providers covers two sets. The 2014 Regulated Activities Regulations hold the 14 fundamental standards, the requirements for providers, directors and registered managers (regulations 4 to 7) and the offences (regulations 22 to 24). The 2009 Registration Regulations hold the statement of purpose, notices, notifications and fees, among other duties (regulations 12 to 22A).
What are the 5 CQC standards? The regulator asks five key questions of every service: is it safe, effective, caring, responsive and well-led? People often call these five the CQC standards. The fundamental standards are the 14 regulations behind them. Our inspection checklist sets out what inspectors look for under each question.
What is CQC Regulation 12? Safe care and treatment, in the 2014 regulations: care and treatment given in a safe way, with risks assessed and reduced, competent staff, safe premises, equipment and medicines, and infection control. In the 2009 Registration Regulations, regulation 12 is the statement of purpose.
What is CQC Regulation 17? Good governance, under the 2014 regulations: systems that assess, monitor and improve quality and safety, manage risk, keep accurate records and act on feedback. Only 17(3), sending CQC a governance report within 28 days of a request, is an offence. Regulation 17 of the 2009 regulations is a notification duty about detained patients.
What is CQC Regulation 18? Staffing, under the 2014 regulations: enough suitably qualified, competent, skilled and experienced staff, with the support, training, supervision and appraisal they need. CQC cannot prosecute a breach of it. In the 2009 regulations, regulation 18 is notification of other incidents.
What is CQC Regulation 19? Fit and proper persons employed: staff of good character with the qualifications, competence, skills, experience and health for their work, recruitment procedures that check this, and the information in Schedule 3 kept for each person. Regulation 5 sets the fit and proper test for directors.
Which CQC regulations can lead to prosecution? In the 2014 regulations, a breach of regulation 11, 16(3), 17(3), 20(2)(a) and (3) or 20A is an offence with no harm needed. A breach of 12, 13(1) to (4) or 14 is an offence when it causes avoidable harm, a significant risk of harm, or a loss through theft. Under the 2009 regulations, failing to send a required notification is also an offence.
What happens if a provider breaches a fundamental standard? CQC can take regulatory action on any breach. For the offences in regulation 22, it can also prosecute or give a fixed penalty notice. Before registering a service, the regulator checks that the service is likely to meet the fundamental standards.
Is the duty of candour a fundamental standard? Yes, regulation 20. Parts of it are offences with no harm needed: telling the person in person, with an apology and a true account, after a notifiable safety incident. Our duty of candour guide sets out what counts as a notifiable safety incident and the steps the regulation requires.
Are the fundamental standards changing in 2026? No. The last change to the standards added regulation 9A on 6 April 2024. The newest amendment to the 2014 regulations, made in April 2026, leaves the standards as they are. It brings medical treatment at sports grounds and at sporting and cultural events into CQC regulation: registration applications from 7 September 2026, in full from 6 December 2027. The new assessment frameworks change how the regulator assesses services. See our guide to the new assessment frameworks.
What is the difference between fundamental standards and quality statements? The fundamental standards are law, set in regulations. The quality statements are CQC’s assessment framework, and the regulator plans to replace them with key lines of enquiry. Breaching a standard can be a criminal offence; falling short against the framework affects a rating.
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Related: what the CQC is and how it regulates · CQC notifications and the 2009 regulations · CQC KLOEs and the 2026 reform · all 34 quality statements and the crosswalk tool
Sources: The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014/2936) · Regulation 8: General · Regulation 22: Offences · Schedule 5: Fixed penalty offences · The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2026 (SI 2026/495) · The Care Quality Commission (Registration) Regulations 2009 (SI 2009/3112) · CQC: The fundamental standards of care · CQC: Regulations for service providers and managers · CQC: Regulation 12 · CQC: Regulation 17 · CQC: Regulation 18 · CQC: Offences · CQC: The 5 key questions we ask · CQC: Our March update · CQC: August 2026 update · CQC: Review of the single assessment framework and its implementation
This page explains the regulations as published on legislation.gov.uk and CQC’s guidance on cqc.org.uk, which we checked on 19 October 2026. It is general information, not legal advice.