CQC fundamental standards explained: regulations 9 to 20 for care home managers

The CQC fundamental standards are the legal minimum that every registered care home in England must meet, set out in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. Regulations 9 to 20 cover person-centred care, dignity, consent, safe care, safeguarding, nutrition, premises, complaints, governance, staffing, recruitment and the duty of candour. This guide explains each one the way a registered manager needs to understand it: what it actually asks for, what evidence meets it, and where homes most often fall short.

The short answer

The fundamental standards are the regulations CQC enforces against. The five key questions (safe, effective, caring, responsive, well-led) are how CQC assesses and rates you; the regulations are what you can be found in breach of. Every quality statement in the single assessment framework maps back to one or more of regulations 9 to 20, so if your home meets the regulations with evidence, the rating tends to follow. The regulations most often breached in care home reports are 12 (safe care and treatment), 17 (good governance) and 18 (staffing), and those three deserve most of your attention.

At a glance: the list of CQC regulations that matter most

What are the 5 CQC standards, and how do they differ from the fundamental standards

People search for the 5 CQC standards and usually mean the five key questions: is the service safe, effective, caring, responsive and well-led. Those are not standards in the legal sense. They are the lens CQC uses to look at a service and the headings under which it is rated. The fundamental standards are different. They are regulations with legal force, and a breach can lead to a requirement notice, a warning notice, conditions on registration, or in the most serious cases prosecution.

The two fit together neatly. Each key question is built from quality statements, and each quality statement draws on particular regulations. Safe leans on regulations 12, 13, 15, 18 and 19. Effective leans on 9, 11, 14 and 18. Caring leans on 10. Responsive leans on 9 and 16. Well-led leans on 17 and, for the provider, regulation 5 on directors. When a report says the service was in breach of regulation 17, that is why the well-led rating dropped. A fuller map of the statements is in our guide to the single assessment framework quality statements.

Regulation 9: person-centred care

Regulation 9 requires care to be appropriate, to meet the person's needs, and to reflect their preferences. In practice it means an assessment before or soon after admission, a care plan built from that assessment with the person and those who matter to them, and reviews when needs change. It also requires you to design care with a view to achieving the person's preferences and ensuring their needs are met, which is the legal root of person-centred planning in learning disability and mental health services.

Evidence looks like a plan that is specific to the person rather than a template, with their own words where possible, their goals, their routines, and the things that matter to them. It includes review dates that were kept, changes recorded after incidents or hospital stays, and involvement of the person, family or an advocate. Where a resident cannot take part in planning, the evidence is how you found out what matters to them from people who know them and from observation. The care plan should be the working document staff actually use, not a folder that comes out for reviews.

Regulation 10: dignity and respect

Regulation 10 asks that people are treated with dignity and respect, that their privacy is protected, that they are supported to be autonomous and independent, and that their protected characteristics are respected. It is short in the regulations and enormous in practice, because it is judged mostly by what inspectors see and hear.

Evidence is behaviour first: staff knocking before entering, using people's chosen names, explaining before providing personal care, not talking over someone in a hoist, not discussing residents in corridors. Records support it: daily notes that describe the person's choices, plans that state how they want personal care done, and feedback from residents and relatives. Breaches often arise from culture rather than policy, so team meeting minutes and supervision notes that show dignity being discussed, and complaints about attitude being taken seriously, are the evidence that a manager is on top of it.

Regulation 11: need for consent

Regulation 11 requires that care and treatment are only provided with the consent of the person, and that where a person lacks capacity to consent, the Mental Capacity Act 2005 is followed. It is the regulation that turns the MCA from a training topic into a registration requirement.

The evidence trail is decision-specific capacity assessments where there is reason to doubt capacity, best interests decisions recorded with the people consulted, and consent recorded for the things that need it: the care plan, photographs, bed rails, sharing information, covert medication. Consent forms signed by relatives without a lasting power of attorney or deputyship are a common and avoidable failure. So is a single global statement that a person lacks capacity. Where restrictions amount to a deprivation of liberty, DoLS authorisation is needed and sits alongside regulation 13. Keep a DoLS tracker with the application, authorisation, expiry and conditions for each person.

Regulation 12: safe care and treatment

Regulation 12 is the broadest of the fundamental standards and the one most often cited in enforcement. It requires you to assess the risks to people's health and safety and do all that is reasonably practicable to mitigate them, to have staff with the qualifications, competence, skills and experience to keep people safe, to manage medicines properly and safely, to prevent and control infection, to keep premises and equipment safe, and to work with other providers where care is shared.

The medicines strand

Inspectors check medicines under regulation 12 by following individual residents: the prescription, the MAR chart, the stock, the PRN protocol and the care plan entry. Gaps on MAR charts, unexplained stock discrepancies, missing PRN protocols and unrecorded covert administration are the common findings. NICE guideline NG67 is the reference point; your eMAR or paper system should let you audit against it.

The risk strand

Every identified risk should have an assessment that says what the risk is, how likely and serious it is, what you do about it, and when it is reviewed. Falls, choking, pressure damage, self-neglect, behaviour that challenges and absconding are the usual ones. Assessments that identify risk but stop there, or that are never revised after an incident, are breaches waiting to be written up.

Regulation 13: safeguarding service users from abuse and improper treatment

CQC regulation 13 requires systems to prevent abuse and to respond when it is suspected. It also prohibits discrimination, restraint that is not a proportionate response to a risk of harm, and deprivation of liberty without lawful authority. In learning disability and mental health homes the restraint and restriction provisions are the ones that bite, because everyday practices such as locked doors, removed items or one-to-one supervision can amount to restriction.

Evidence includes a safeguarding log with each concern, the action taken, referrals to the local authority and CQC notifications; staff who can describe what abuse looks like and how to report it, including outside the home; and restraint or restriction records that show the least restrictive option was used, for the shortest time, with a review afterwards. Positive behaviour support plans and ABC records demonstrate that behaviour is understood rather than merely controlled. Our guide to safeguarding adults in care homes goes further into the referral process.

Regulation 14: meeting nutritional and hydration needs

Regulation 14 requires that people receive suitable and nutritious food and hydration in sufficient quantities to sustain life and good health, that their dietary needs and preferences are met, and that support to eat and drink is provided where needed. It sounds simple and is regularly breached, usually through weight loss that nobody noticed and fluid charts that were never totalled.

Evidence is a nutritional screening tool such as MUST on admission and at set intervals, weights recorded and reviewed, referrals to the GP or dietitian when scores change, IDDSI levels recorded for anyone with swallowing difficulties and communicated to the kitchen, and food and fluid charts that are added up and acted on rather than just filled in. Choice matters too: menus, alternatives, snacks available between meals, and cultural or religious requirements documented and met.

Regulation 15: premises and equipment

CQC regulation 15 requires premises and equipment to be clean, secure, suitable for the purpose, properly used, properly maintained and appropriately located. It covers the building, the grounds, hoists, beds, wheelchairs, call systems, kitchens and the standards of cleanliness throughout.

The evidence is largely certificates and schedules: fire risk assessment and drills, gas safety, electrical installation and portable appliance testing, legionella risk assessment and water temperatures, LOLER inspection of lifting equipment, servicing of beds and hoists, cleaning schedules and infection control audits. Suitability is judged by observation: whether the environment supports people with dementia, whether a learning disability home looks and feels like a home, whether a nursing floor has the equipment its residents need. Keeping fire, cleaning and equipment records in one system with due dates avoids the classic finding of an expired certificate nobody had noticed.

Regulation 16: receiving and acting on complaints

Regulation 16 requires an accessible system for identifying, receiving, recording, handling and responding to complaints, and for investigating them and taking necessary and proportionate action. It also requires you to provide CQC with a summary of complaints and responses when asked.

Evidence is a complaints log that shows every complaint, verbal as well as written, the investigation, the outcome, the response to the complainant and any change made. Residents and relatives should be able to say how they would complain, and the policy should be available in a format people can understand, including easy read where appropriate. A home with no complaints in a year is not automatically doing well; the inspector will ask how you know people feel able to raise concerns.

Regulation 17: good governance

Regulation 17 is the manager's regulation. It requires systems and processes to assess, monitor and improve the quality and safety of the service, to assess and mitigate risks, to maintain accurate, complete and contemporaneous records for each person and for the running of the service, to seek and act on feedback, and to evaluate and improve practice. Breaches of regulation 17 appear in a very large share of care home reports rated Requires Improvement, because it is where every other failing shows up as a failure to notice.

Records

Accurate, complete and contemporaneous means written at the time, by the person who did the care, and reflecting what actually happened. Notes written the next day, blank MAR boxes, and care plans that have not been updated after a change are all record-keeping breaches under this regulation.

Audit and improvement

You need a schedule of audits, the results, an action plan and evidence of closure. A dashboard that shows overdue reviews, missed doses and open incidents in real time makes this far easier; Kiwi and other compliance tools exist for this purpose, but a spreadsheet run faithfully will also satisfy the regulation.

Regulation 18: staffing

CQC regulation 18 requires sufficient numbers of suitably qualified, competent, skilled and experienced staff, and requires that staff receive the support, training, professional development, supervision and appraisal they need to do their job. It is not to be confused with regulation 18 of the separate Registration Regulations 2009, which covers statutory notifications; managers mix the two up constantly.

The evidence has two halves. For numbers, a dependency or staffing tool that links resident needs to staff hours, a rota that matches it, and records of what happens when someone calls in sick. For competence, an induction that covers the Care Certificate for new care staff, a training matrix with mandatory training in date, competency assessments for medicines and moving and handling, supervision at the frequency your policy states, and annual appraisals. In learning disability and autism services, the Oliver McGowan mandatory training is expected. Inspectors will compare the rota with the floor on the day and ask staff whether there are enough of them.

Regulation 19: fit and proper persons employed

Regulation 19 CQC guidance is clear that recruitment must be safe and that you must hold the information listed in Schedule 3 of the regulations for every person employed: proof of identity, a DBS check at the appropriate level, satisfactory evidence of conduct in previous employment, references, a full employment history with gaps explained, evidence of qualifications where relevant, and evidence of physical and mental fitness for the role.

Inspectors select files at random. Common failures are a single reference where two were required by your own policy, a DBS check started but not received before the person worked unsupervised, and employment gaps left unexplained. Ongoing fitness matters too: a system for staff to declare changes, and action taken when concerns arise. Agency staff are covered because you must satisfy yourself that the agency has done these checks and hold the profile they send.

Regulation 20: duty of candour

Regulation 20 requires you to act in an open and transparent way and, when a notifiable safety incident occurs, to tell the person or their representative in person as soon as reasonably practicable, give an account of what happened, say what further enquiries will be made, apologise, and follow up in writing. A notifiable safety incident is one that appears to have resulted in death, severe or moderate harm, or prolonged psychological harm.

The evidence is a record of each notifiable incident showing the conversation, the date, who was told, the apology, the written follow-up and the outcome of any investigation. Managers sometimes worry that an apology admits liability; the regulations say it does not. The far greater risk is an incident with harm that the family learned about from somewhere else. Incident review tools that prompt the candour steps and hold the letters against the incident make this easier to evidence.

Regulations 4 to 7: the provider and the registered manager

Alongside 9 to 20 sit a handful of regulations about the people running the service. Regulation 5 requires directors and equivalents to be fit and proper persons, and CQC can take action where they are not. Regulation 7 sets requirements for registered managers: of good character, with the qualifications, competence, skills and experience needed, and able to supply the Schedule 3 information about themselves. Regulation 6 deals with the requirement for a registered manager where the provider is an organisation.

For a small provider where the owner is also the nominated individual and sometimes the registered manager, these regulations mean keeping the same standard of file on yourself that you keep on staff, and being able to demonstrate your own competence and development. Inspectors will ask what support and oversight the registered manager receives from the provider.

Regulation 20A and the display of ratings

Regulation 20A requires providers to display their most recent CQC rating conspicuously at every premises where a regulated activity is delivered and on their website. The poster must be the one CQC produces or in the format it specifies, and it must be where people would see it, typically the entrance. Failure to display is a breach in its own right and one of the few CQC can issue a fixed penalty notice for.

Check that the rating displayed is the current one after any re-rating, that the website version links to the report, and that a home rated Requires Improvement has not quietly moved the poster. Inspectors do check on arrival, and it is an unnecessary way to start a visit badly.

How CQC enforces the fundamental standards

CQC's enforcement policy sets out a ladder. Most breaches lead to a requirement notice, which is a formal statement in the report that you are in breach and must send an action plan. More serious or repeated breaches lead to a warning notice with a deadline. Beyond that CQC can impose conditions on registration, suspend or cancel it, and for certain regulations prosecute without first serving a notice where a breach has caused avoidable harm or a significant risk of it. Those prosecutable regulations include 12, 13 (in part), 14 and 20.

For a manager the practical point is that the same finding can sit at different rungs depending on harm, history and your response. A medicines error found by your own audit, reported and learned from, is a very different matter from one found by the inspector in a home whose last report also raised medicines. Candour and evidence of improvement are what move you down the ladder.

Which fundamental standards come up most in care home reports

Reading recent reports for care homes rated Requires Improvement or Inadequate, three regulations dominate: 12, 17 and 18. Regulation 12 because medicines, risk assessment and infection control are checked on every visit and are easy to evidence badly. Regulation 17 because when anything else fails, the question of why the manager's systems did not catch it follows. Regulation 18 because staffing pressure is real and rotas rarely lie.

Regulations 11 and 13 appear next, usually together, where capacity and restriction have not been handled properly. Regulation 9 appears where care plans are generic. Regulation 19 appears where recruitment files are incomplete. Regulations 10, 14, 15, 16 and 20 appear less often but are each capable of dropping a key question to Requires Improvement on their own. Our article on what a Requires Improvement rating means looks at how these breaches translate into ratings.

How the regulations map to the five key questions

When you plan evidence, it helps to see which regulation feeds which rating. Safe draws on 12 (risk, medicines, infection control), 13 (safeguarding, restraint), 15 (premises), 18 (numbers) and 19 (recruitment). Effective draws on 9 (assessment), 11 (consent and MCA), 14 (nutrition) and 18 (training, supervision). Caring draws on 10 (dignity) and 9 (involvement). Responsive draws on 9 (person-centred planning, end of life) and 16 (complaints). Well-led draws on 17 (governance, records, feedback), 20 (candour) and 5 and 7 (leadership).

The value of this map is that it tells you where a single weak record system does damage. Poor daily notes are a regulation 17 records failure, but they also undermine evidence for 9, 10 and 14 because inspectors cannot see the plan being followed, dignity in practice, or food and fluid intake.

Building an evidence map for your home

An evidence map is a one-page document that lists each regulation and, next to it, where the evidence lives, who owns it, and when it was last checked. It is the most useful preparation document a manager can have, and it doubles as a governance tool. Here is how to build one.

1. List regulations 5, 7 and 9 to 20A down the left-hand side.
2. For each, write the two or three pieces of evidence an inspector would ask for, using the table above as a start.
3. Next to each piece of evidence, record where it is held (system, folder, office), who is responsible, and the audit that checks it.
4. Walk the map with your deputy and pull a sample of each item. Note anything missing, out of date or inconsistent.
5. Turn every gap into an action with a date and an owner on your improvement plan.
6. Review the map monthly and after every incident, complaint or change in staffing.
7. Keep the map with your first-hour document pack so any senior can use it if an inspector arrives.

A self-audit checklist against the fundamental standards

Use this checklist quarterly. Each line corresponds to a regulation and a common finding.

• Every resident has a care plan that names their preferences and goals in their own terms, reviewed in the last month or after change (regulation 9).
• Observation of two mealtimes and two personal care episodes this quarter showed dignity and choice (regulation 10).
• Every restriction and every consent has a capacity assessment where needed and a lawful decision-maker (regulation 11).
• Medicines audit completed with no unexplained gaps, stock reconciled, PRN protocols in place (regulation 12).
• Safeguarding log reconciled with local authority referrals and CQC notifications (regulation 13).
• MUST scores and weights reviewed, referrals made where scores changed, fluid charts totalled (regulation 14).
• All premises certificates and servicing in date; cleaning and IPC audits complete (regulation 15).
• Complaints log complete with responses and learning (regulation 16).
• Audit schedule met, action plan current, records audit shows contemporaneous entries (regulation 17).
• Rota matches dependency tool; training matrix has no expired mandatory training; supervision on schedule (regulation 18).
• Recruitment files complete for all starters this quarter (regulation 19).
• Every notifiable safety incident has a recorded candour conversation and letter (regulation 20).

Records as the thread through every standard

Almost every regulation is evidenced, at least in part, by records, and regulation 17 makes the quality of those records a requirement in itself. That is why the record system is worth attention. A system that prompts for the missing field, timestamps every entry, keeps versions of risk assessments, and lets a manager see gaps the same day supports all twelve standards at once. Structured daily logs with body maps make regulation 10, 12 and 14 evidence a by-product of ordinary care rather than a separate task.

Paper can meet the standards, and many homes rated Good still use it. The difference is effort. On paper, the manager has to go looking for the gap; a well-designed digital record brings the gap to the manager. In a home with agency staff, night shifts and a rota that changes weekly, that difference is often what separates a breach of regulation 17 from a clean report.

Common mistakes

• Confusing the five key questions with the fundamental standards and preparing for the rating without checking the regulations.
• Mixing up regulation 18 (staffing) with regulation 18 of the Registration Regulations (notifications) and missing one of them.
• Treating regulation 17 as paperwork rather than as the system that should find every other breach first.
• Consent recorded from relatives who have no legal authority to give it.
• Risk assessments that identify a risk and never say what is done about it or when it is reviewed.
• Recruitment files with a single reference or unexplained employment gaps.
• Duty of candour handled by phone with no written record, or not handled at all because nobody decided the harm was moderate.
• Rating poster showing an old rating, or missing from the website.

What good looks like on inspection day

The inspector asks for the evidence map and finds it in the first-hour pack. For regulation 12 they follow three residents' medicines from prescription to cupboard and find every dose accounted for, with a PRN protocol for each as-required medicine and a note of the home's own last audit findings. For regulation 11 they find decision-specific capacity assessments for bed rails and for sharing information with family, and a DoLS tracker with renewals requested before expiry. For regulation 13 the safeguarding log matches the local authority referrals and the CQC notifications line by line. For regulation 18 the rota matches the dependency tool and the staff on the floor, the training matrix has nothing overdue and supervision records show real conversations. For regulation 17 the audit schedule is met, the action plan has closed items with evidence, and the manager describes the two things that most need to improve before being asked. For regulation 20, the one notifiable incident of the year has a recorded conversation with the family, an apology and a letter. The inspector spends the afternoon watching care because the paperwork answered its own questions.

Final conclusion

The fundamental standards are not a checklist to be completed before an inspection; they are the legal shape of a well-run home, and a manager who understands them can predict most of what a report will say before the inspector arrives. Learn regulations 9 to 20 well enough to explain each one in a sentence, build an evidence map that shows where each is met, and let regulation 17 do its job by running the audits that find your own gaps first. Do that and the rating takes care of itself.

Frequently asked

What are the CQC fundamental standards?

They are the minimum legal standards of care set out in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, mainly regulations 9 to 20. They cover person-centred care, dignity, consent, safe care, safeguarding, nutrition, premises, complaints, governance, staffing, recruitment and the duty of candour. CQC can take enforcement action where they are breached.

What are the 5 CQC standards?

The five CQC standards people usually mean are the five key questions: safe, effective, caring, responsive and well-led. These are how CQC assesses and rates a service rather than legal standards. The fundamental standards are the regulations behind them.

What is CQC regulation 18?

Regulation 18 of the Regulated Activities Regulations covers staffing: enough suitably qualified, competent, skilled and experienced staff, with the training, supervision and appraisal they need. A different regulation 18, in the Registration Regulations 2009, covers statutory notifications to CQC. Managers should be careful not to confuse the two.

What does CQC regulation 13 cover?

Regulation 13 covers safeguarding people from abuse and improper treatment. It requires systems to prevent and respond to abuse and prohibits discrimination, disproportionate restraint and deprivation of liberty without lawful authority. In learning disability and mental health homes the restraint and restriction provisions are checked closely.

Which fundamental standards are breached most often in care homes?

Regulations 12 (safe care and treatment), 17 (good governance) and 18 (staffing) appear most often in reports rated Requires Improvement or Inadequate. Regulations 11 and 13 follow, usually where capacity and restriction have not been handled properly. Focusing audit effort on these five covers most of the risk.

Can CQC prosecute a care home for breaching the fundamental standards?

Yes, for certain regulations. Where a breach of regulations such as 12, 14 or 20 has caused avoidable harm or a significant risk of it, CQC can prosecute without first serving a warning notice. Most breaches are dealt with by requirement or warning notices and an action plan.

What is regulation 19 CQC?

Regulation 19 requires providers to employ only fit and proper persons and to hold the Schedule 3 information for each: identity, DBS check, references, conduct in previous employment, full employment history and evidence of fitness. Inspectors check recruitment files at random on most visits.

Do the fundamental standards apply to learning disability and mental health homes?

Yes. They apply to every provider registered with CQC in England regardless of service type. In these homes, regulations 11 and 13 on consent, restriction and restraint, and regulation 9 on person-centred care, are applied with particular attention through the Right support, right care, right culture guidance.

Sources

• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
• CQC: guidance for providers on meeting the regulations
• CQC: single assessment framework guidance
• CQC: enforcement policy
• Mental Capacity Act 2005 Code of Practice
• GOV.UK: Care Act 2014 statutory guidance
• NICE guideline NG67 Managing medicines in care homes
• Skills for Care: Care Certificate standards