EN 15224

 

What is EN 15224?

EN 15224 focuses on the quality management systems for healthcare services. This standard also serves as a variant of the ISO 9001 standard to include healthcare and clinical risk management.

Once certified, organisations can proudly promote themselves as certificate holders in any of their promotional materials and can include the URS certification logo free of charge.

 

Who requires an EN 15224 certification?

Organisations that have a focus on providing healthcare to patients should consider becoming certified in EN 15224. Associated sectors with this standard include:

 

• Hospitals


• Clinics


• Rehabilitation centres


• Medical devices


• Telecommunications

How can EN 15224 benefit your business?

Becoming certified for EN 15224 can bring a wide range of benefits to your organisation, including:

 

• Reducing your organisations liability risk


• Demonstrating a focus on patient safety


• Increasing the reputation of your organisation


• Improving the quality of your processes

How can you prepare for an EN 15224 Certification?

Although the thought of starting the certification process may seem daunting, there are a variety of steps you can take to make the process to becoming certified far more streamlined:

 

• Familiarise yourself with the EN 15224 standard


• Conduct a gap analysis to highlight any necessary improvements


• Provide training to staff to ensure the competency of your employees meets the standard requirements


• Carry out an internal audit to identify areas that do not meet the standard requirements

What are the key requirements for EN 15224?

When working towards becoming certified for EN 15224, there are various areas that will be a focus during the audit. These areas include:

 

• Customer focus


• Leadership


• People engagement


• Risk based thinking

What clauses make up the structure of EN 15224?

 

Clauses 1-3 – Introductory clauses:

The first three clauses of EN 15224 introduce the main aspects of the standard, including the scope and its application to organisation sectors, other published standards that are referenced throughout, and the definitions of terms that are included within the standard.

Clause 4 – Context of the organisation:

Clause 4 focuses on the role that 5he organisation plays in relation to the standard scope. This includes understanding the organisations context, scope of the QMS and the needs of interested parties.

 

Clause 5 – Leadership:

Clause 5 sets out the requirements for top management to be able to demonstrate their leadership skills and commitment to the Quality management system. This is achieved by implementing policies and identifying organisational roles and responsibilities.

 

Clause 6 – Planning:

Clause 6 introduces the requirements that accompany all planning process realting to the quality management system. This includes addressing risks and opportunities, achieving quality objectives, and planning for changes.

 

Clause 7 – Support:

Clause 7 focuses on the means of supporting the quality management system from implementation to improvement. This is achieved by setting requirements resources, competency, communication and the documentation of information relating to the QMS.

 

Clause 8 – Operation:

Clause 8 identifies the core requirements involved with the operation of a quality management system. Progressing from the planning and control of the system, through design and development, to the release.

 

Clause 9 - Performance evaluation:

Clause 9 includes the methods and requirements for monitoring and evaluating the organisation’s QMS. This is done through analysis, internal audits and management reviews to flag any improvement opportunities for the following clause.

 

Clause 10 – Improvement:

In this final section, clause 10 highlights the need for continuous improvement, and the methods that can be utilised to achieve it. This clause focuses on nonconformities and corrective actions, and provides requirements relating to how an organisation responds to them.

 

How long will your EN 15224 certificate be valid for?

Your EN 15224 certificate will be valid for at least three years; dependent on the type of site that is being certified.  

 

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