Regulatory Requirements for Health Care Systems

Definitions & Purpose of
Licensure, Certification &


  • Licensure is a process by which a governmental authority grants permission to an individual practitioner or health care organization to operate or to engage in an occupation or profession.
  • Licensure regulations are generally established to ensure that an organization or individual meets minimum standards to protect public health and safety Licensure to individuals
  • Licensure to individuals is usually granted after some form of examination or proof of education and may be renewed periodically through payment of a fee and/or proof of continuing education or professional competence.

Organizational licensure

Organizational licensure is granted following an on-site inspection to determine if minimum health and safety standards have been met. Maintenance of licensure is an ongoing requirement for the health care organization to continue to operate and care for patients.


Accreditation is a formal process by which a recognized body, usually a non-governmental organization (NGO), assesses and recognizes that a health care organization meets applicable pre-determined and published standards.

Accreditation standards

Accreditation standards are usually regarded as optimal and achievable, and are designed to encourage continuous improvement efforts within accredited organizations.

Accreditation Decision

An accreditation decision about a specific health care organization is made following a periodic on-site evaluation by a team of peer reviewers, typically conducted every two to three years.

Accreditation is Voluntary

Accreditation is often a voluntary process in which organizations choose to participate, rather than one required by law and regulation.

The Major Purposes of Accreditation

  • Improve the quality of health care by establishing optimal achievement goals in meeting standards for health care organizations.
  • Stimulate and improve the integration and management of health services
  • Establish a comparative database of health care organizations able to meet selected structure, process, and outcome standards or criteria
  • Reduce health care costs by focusing on increased efficiency and effectiveness of services
  • Provide education and consultation to health care organizations, managers, and health professionals on quality improvement strategies and “best practices” in health care
  • Strengthen the public’s confidence in the quality of health care, and Reduce risks associated with injury and infections for patients and staff


Certification is a process by which an authorized body, either a governmental or non-governmental organization, evaluates and recognizes either an individual or an organization as meeting pre-determined requirements or criteria.

  • Although the terms accreditation and certification are often used interchangeably, accreditation usually applies only to organizations, while certification may apply to individuals, as well as to organizations.

Individual Practitioners Certification

When applied to individual practitioners, certification usually implies that the individual has received additional education and training, and demonstrated competence in a specialty area beyond the minimum requirements set for licensure.

  • An example of such a certification process is a physician who receives certification by a professional specialty board in the practice of obstetrics.

Organization Certification

When applied to an organization, or part of an organization, such as the laboratory, certification usually implies that the organization has additional services, technology, or capacity beyond those found in similar organizations.

Licensure, Certification and Accreditation; how they contribute to improving quality in healthcare

Three Aspects of Quality

  1. Measurable Quality
  2. Appreciative Quality
  3. Perceptive Quality

Quality Health Care Quality Evaluation Approaches

The three primary approaches for evaluating health care quality accreditation, licensure, and certification use standards to determine the level of quality achieved by an individual or organization.

  • Selecting the right approach or combination of approaches requires a careful analysis and prioritization of user needs.

Use of Data from the External Quality Improvement System

  • Support comparisons of performance
  • Shape health care services delivery in new settings
  • Demonstrate whether a predetermined rate of beneficiary coverage for preventive services is being achieved
  • Ensure efficient use and allocation of limited health care resources
  • Identify and create centers of excellence
  • Integrate structures and services of several organizations Licensure
  • Established to protect basic public health and safety
  • Licensure standards address the minimum legal requirements or qualifications health care professionals and organizations need to operate
  • They also guarantee appropriate adoption of new medical practices and provide a framework to accommodate amendments to existing practices.


  • Hospitals and health care facilities
  • Governments or regulatory authorities grant licenses when facilities meet defined levels of quality Certification
  • Distinguished from accreditation by its application to both individuals and organizations
  • Recognition of individuals who have demonstrated specialized knowledge and skill and to organizations that have the ability to practice in a certain area or specialty.

How Certification Can Affect Quality Of Care

  • Most medical specialty boards require re-certification
  • If an individual does not meet the standards, certification can be withdrawn.
  • Verification of performance, however, does not include a review of actual care processes or patient outcomes.
  • The American Board of Medical Specialties (ABMS) & The American Medical Association Council on Medical Education (AMA/CME)
    • Maintain a rigorous process of review for new boards in emerging medical specialties (e.g., the American Board of Medical Genetics). How Certification Can Affect Quality Of Care
    • The American Medical Association, through its American Medical Accreditation Program, have started to evaluate individuals within their work environment.
    • Voluntary, standards-based evaluation
    • Reviewers conduct an evaluation of credentials and qualifications, actual practice conditions, environment of care, clinical processes, and patient outcomes.
  • For organizations, lack of proper certification can affect funding
  • Certification distinguishes organizations as capable of practicing or delivering services in a specialty area


  • Accreditation focuses on continuous improvement strategies, achievement of optimal quality standards, and ongoing education and consultation.
  • Effective accreditation programs have well-defined missions; pre-determined infrastructure and authority for the program; participation from health professionals in standards development and interpretation; and relevant, objective, and measurable standards. A Strong Accreditation Program
  • Encourages professionals to continuously seek to improve quality despite resource limitations
  • Provides sustained management of field operations
  • Ensures a fair, valid, and credible process
  • Establishes an accreditation database of information to determine compliance, pinpoint problem areas, or highlight opportunities for improvement Accreditation Standards
  • Optimal and achievable
  • Developed by a consensus
  • Published and reviewed and revised periodically

Accreditation Standards

  • Provides a visible commitment
  • Comprehensive review of the competencies of the organization
  • Evaluation and management tool

The Accreditation Process

  • Combination of self and external organizational assessments based on pre-established standards
  • Focuses on continuous improvement strategies

Patient-Centered Standards

  • Access to Care and Continuity of Care
  • Care of Patients
  • Patient and Family Rights
  • Patient and Family Education
  • Assessment of Patients Health Care Organization Management Standards
  • Quality Improvement and Patient Safety
  • Facility Management and Safety
  • Prevention and Control of Infections
  • Staff Qualifications and Education
  • Governance, Leadership, and Direction
  • Management of Information

Does accreditation cause improved quality of services?

WHO found that, of twelve experiences with external quality assessments in eight countries, the majority showed evidence of improved services quality. Does accreditation cause improved quality of services? Well-designed and implemented accreditation processes can result in an increase in the quality of healthcare services.

What is the Evidence?

 “Accreditation programs, if undertaken with careful planning, strong government support, and organizational commitment, have the potential to improve the quality of care available in hospitals and medical laboratories in many developing countries. Where understanding and support exist, accreditation programs and other external quality assessment methods are desirable and sustainable ways of improving care in developing countries”

  • Montagu, D. 2003. Accreditation and Other External Quality Assessment Systems for Healthcare. The Quality Assurance Project Study in South Africa.  

The Quality Assurance Project implemented the first randomized control trial to measure the impact of accreditation in a developing country setting.

  • J. Warren Salmon et al. October 2003. “The Impact of Accreditation on the Quality of Hospital Care: KwaZulu-Natal Province, Republic of South Africa.” Quality Assurance Project: Operations Research Results.3232

Can Accreditation Improve Quality and Patient Outcomes?

The answer is YES IF

  • Taken seriously
  • Leadership is committed
  • Considered a framework to improve quality
  • Considered a means not an end
  • Becomes the responsibility of everyone in the organization


  • Clients are more satisfied Larger share of the market
  • Pride of the employees in their workplace Retention of excellent human resources
  • Safer environment Less risk less liability
  • Quality culture Continuous improvement

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