The QualCert Level 6 Diploma in Healthcare Compliance and Regulations is a career-focused qualification designed to equip learners with the knowledge and practical skills required to navigate complex regulatory environments within healthcare.
This diploma offers an in-depth understanding of regulatory frameworks, risk management, and compliance strategies essential for maintaining operational excellence and legal accountability in health and social care settings.
The QualCert Level 6 Diploma is equivalent to the final year of an undergraduate degree and is recognised both nationally and internationally. It is designed for professionals who play a critical role in ensuring healthcare providers meet legal and regulatory obligations. The course covers a broad range of topics, including healthcare legislation, governance, quality assurance, risk management, and ethical compliance.
Learners develop practical competencies that can be applied in a wide range of healthcare environments, from NHS trusts and private hospitals to residential care and community services.
The QualCert Level 6 Diploma in Healthcare Compliance and Regulations is an essential qualification for professionals committed to maintaining the highest standards in healthcare delivery. It provides learners with the tools and insight to manage legal responsibilities, reduce organisational risk, and support safe, ethical, and compliant services. As healthcare continues to evolve, so too does the importance of those who ensure it remains accountable.
Course Contents of QualCert Level 6 Diploma in Healthcare Compliance and Regulations:
The QualCert Level 6 Diploma in Healthcare Compliance and Regulations consists of a structured set of study units designed to provide learners with in-depth and comprehensive knowledge. The qualification includes a total of 1200 Total Qualification Time (TQT), 600 Guided Learning Hours (GLH), and awards 120 credits.
| Unit Ref# | Unit Title | Credits | GLH | TQT |
| QC28075- 1 | Regulatory Frameworks in Healthcare | 20 | 100 | 200 |
| QC28075-2 | Clinical Governance and Quality Assurance | 20 | 100 | 200 |
| QC28075-3 | Legal and Ethical Compliance in Healthcare | 20 | 100 | 200 |
| QC28075-4 | Data Protection, Confidentiality, and Information Governance | 20 | 100 | 200 |
| QC28075-5 | Risk Management, Auditing and Organisational Compliance | 20 | 100 | 200 |
| QC28075-6 | Safeguarding, Duty of Care and Incident Reporting in Healthcare Settings | 20 | 100 | 200 |
Entry requirements for the QualCert Level 6 Diploma in Healthcare Compliance and Regulations:
Minimum Age
- Applicants must be at least 19 years old at the time of enrolment.
Educational Background
Applicants should meet one or more of the following academic criteria:
- Hold a Level 5 qualification in healthcare, health and social care, public health, compliance, or a related field
- Possess a Higher National Diploma (HND), foundation degree, or equivalent qualification
- Hold a bachelor’s degree (or equivalent) in healthcare, legal studies, management, or other relevant disciplines
- International qualifications comparable to the above are accepted, subject to evaluation
Work Experience
- Ideally, candidates should have 1–2 years of relevant experience in healthcare compliance, risk management, regulatory affairs, healthcare administration, or quality assurance
- Applications from those without experience but with strong academic backgrounds will also be considered
Language Proficiency
Applicants must demonstrate English language proficiency through one of the following:
- IELTS Academic score of 6.0 overall, with no component below 5.5
- TOEFL iBT score of 79 or above
- PTE Academic score of 50 or higher
- Cambridge English B2 First (FCE) with Grade C or above
- Prior education conducted in English (evidence required and subject to approval)
Learning outcomes for the QualCert Level 6 Diploma in Healthcare Compliance and Regulations:
Regulatory Frameworks in Healthcare
- Understand national and international regulatory bodies and their roles
- Examine legal obligations of healthcare providers under UK legislation
- Analyse the impact of policies such as CQC, NHS England, NICE, and public health regulations
- Explore regulatory trends and challenges in healthcare compliance
- Develop procedures to maintain compliance across various care settings
Clinical Governance and Quality Assurance
- Understand the principles of clinical governance in healthcare organisations
- Develop quality assurance systems aligned with healthcare standards
- Evaluate performance through audits, KPIs, and feedback mechanisms
- Promote accountability, transparency, and continuous improvement
- Apply governance strategies to promote patient safety and service excellence
Legal and Ethical Compliance in Healthcare
- Explore healthcare-specific laws and ethical frameworks
- Understand responsibilities regarding informed consent and mental capacity
- Analyse cases of negligence, malpractice, and ethical breaches
- Interpret the ethical implications of clinical and administrative decisions
- Apply legal and ethical principles to everyday healthcare scenarios
Data Protection, Confidentiality, and Information Governance
- Understand GDPR and UK Data Protection Act obligations
- Implement confidentiality protocols for patient and organisational data
- Manage records and information access securely
- Examine the risks associated with data breaches and cyber threats
- Apply information governance frameworks in clinical and administrative systems
Risk Management, Auditing and Organisational Compliance
- Conduct risk assessments in clinical and non-clinical environments
- Develop internal auditing tools and compliance monitoring processes
- Respond to compliance failures with corrective and preventive action plans
- Lead organisational investigations and regulatory reporting
- Promote a culture of risk awareness and proactive compliance
Safeguarding, Duty of Care and Incident Reporting in Healthcare Settings
- Understand adult and child safeguarding legislation and frameworks
- Apply duty of care principles in healthcare delivery
- Manage and report safeguarding concerns in line with regulatory expectations
- Maintain accurate records of incidents and responses
- Support staff training and protocols for safeguarding and incident escalation
The Level 6 Diploma in Healthcare Compliance and Regulations is designed for individuals seeking to develop or formalise their expertise in regulatory frameworks, governance, and legal compliance within healthcare environments. It is ideal for:
- Healthcare professionals responsible for maintaining compliance with legal and regulatory standards
- Clinical governance officers, compliance managers, and quality assurance personnel
- Health and social care managers aiming to strengthen their understanding of regulatory requirements
- Legal and administrative staff working in healthcare regulatory environments
- Risk and audit professionals in hospitals, clinics, care homes, and public health bodies
- Graduates of healthcare, law, management, or public policy programmes looking to specialise in compliance
- Individuals transitioning into compliance or governance roles within the healthcare sector
This course is suitable for both UK-based and international learners who wish to align their knowledge and skills with UK and international healthcare compliance standards.