Svensk Certifiering – ISO certifiering för företag i alla branscher

SS-EN 15224

Quality standard for healthcare organizations.

What is SS-EN 15224?


SS-EN 15224 is based on ISO 9001 but is complemented with requirements, interpretations, and specifications for clinical processes. ISO 9001 uses certain terms and definitions that may be unfamiliar within the healthcare sector. The private healthcare sector often places higher demands on the organization’s quality management system compared to other industries. By applying the standard as part of continuous improvement efforts — which can then be certified by Svensk Certifiering — additional value is created. This added value can also be utilized in marketing and in contacts with authorities.

SS-EN 15224 is designed to also provide value for organizations with research and educational processes within healthcare.

Svensk Certifiering Norden AB meets the requirements of ISO 17021 for management system certification bodies and is accredited by Swedac for certifications in quality, environment, and occupational health and safety. This product is not accredited by Swedac.

Why certify your company?

Benefits of ISO certification:

  • Fewer misunderstandings, incidents, and nonconformities
  • Systematic development of the organization
  • Preventive initiatives instead of corrective actions
  • All healthcare staff become involved in quality work
  • The certificate provides proof of an effective management system in accordance with regulatory requirements
  • Reporting of identified errors and deficiencies during authority inspections
  • Certificates are often a requirement from customers
  • Your organization gains greater trust among patients

Read more about ISO certification.

Eight advantages of certification that are immediately noticeable in your organization:

  1. Higher productivity and resource utilization
  2. Lower costs
  3. Better communication between staff and management
  4. Greater precision in operational control
  5. Proof of management according to customer requirements
  6. Employees gain a better understanding of the overall picture
  7. Increased competitiveness
  8. More focus on the right priorities

The standard is well established and accepted by the market worldwide.
Certification also demonstrates responsible conduct towards customers, staff, and owners.

Why choose Svensk Certifiering?

Svensk Certifiering focuses on ensuring that the management system creates business and economic value for your organization. It also means that the management system should be as user-friendly as possible – feel free to contact us to learn more about our focus and success factors. Svensk Certifiering has a customer satisfaction index (NKI) of 4.75 out of 5 and is the fastest-growing certification body in Sweden.

Svensk Certifiering also reviews:

  • Management’s responsibility and commitment
  • Achievement of organizational objectives
  • Requested and delivered care
  • Analysis of collected information
  • Internal audits
  • Improvements, corrective and preventive actions

Specific focus areas planned for the audit may include medication management, operational control, clinical activities, logistics, marketing and sales, purchasing processes, emergency preparedness, document control, and monitoring, measuring, and testing equipment.

Svensk Certifiering Norden AB is accredited by SWEDAC to perform audits and certifications of management systems according to ISO 9001, ISO 14001, ISO 45001, ISO 27001, and ISO 13485.

Svensk Certifiering Norden AB is accredited by SWEDAC for personnel certification according to the specification Authorized Fire Alarm Engineer SBF 1007:5.