+39 0331 636601 +39 0331 302337 info@sisiispezione.com Via Canova, 8 - Busto Arsizio (VA) - ITALY
+39 0331 636601 +39 0331 302337 info@sisiispezione.com Via Canova, 8 - Busto Arsizio (VA) - ITALY

Management Systems Certification for Specific Health Care Sector

BS/DIN/SN EN 15224, Establishing confidence and trust in your Healthcare Facility

Health care sector is a multidimensional and complicated segment, strictly regulated, based on international and local norms as well as operational frames, and, consequently, its compliance to these relevant pre-requisites should be always adequately proven as valid.

According to the Euro barometer and WHO 2014 Facts, 20‐40% of health expenditure is wasted due to poor quality in care.Despite technological advances in healthcare, well-informed ‘consumers’ of healthcare services (patients, health insurances, corporate byers), are rather skeptical and lack of confidence in healthcare services, unless a  ‘seal of quality’ is identified and awarded to the healthcare facility.

The Quality Management System BS/DIN/SN EN 15224 is the specified standard for healthcare facilities in order to sufficienty meet the special needs of healthcare services (hospitals, clinics, inpatients and outpatient facilities, diagnostic centers) and specialized units such as IVF, dental facilities, rehabilitation centers, post-treatment facilities, etc. 

Swiss Approval International healthcare quality experts based on international experience developed a guideline of standard analysis and implementation, by integrating specific considerations and international best practice, based on the principles below:        

  • Healthcare quality is based on patient-centered care perceptions and it correlates to the provision of appropriate care to the right patient at the right time.
  • Reliability in healthcare services can be satisfied by the application of risk management procedures, the implementation of clinical management and patients’ safety protocols’ as well as by performance evaluation and quality improvement mechanisms.

Within the setting of BS/DIN/SN EN 15224 certification, patient safety is undertaken as a prime goal to be accomplished by the modern healthcare systems and, therefore, a strong safety culture is essential to be established in business orientation and strategy.

Swiss Approval certification according to BS/DIN/SN EN 15224 is the leading way to:

  • Effectively managing healthcare enterprise’ and patients’ risks
  • Applying quality control procedures within the healthcare setting
  • Evaluating clinical effectiveness
  • Adequate and up – to date staff training
  • Continuously improving clinical performance

SiSi in cooperation with Swiss Approval International, through their international auditors’ team, guarantees its competency to guide healthcare providers to an effective and appropriate adjustment to BS/DIN/SN EN 15224 standard criteria, ensuring feasibility and continuous improvement, maximising benefit in terms of safety and quality assurance in the healthcare services’ settings.

UKAS Accredited No 9742

 

ISO 13485 – Medical Devices Quality Management System

Introduction to Medical Devices Quality Management System 

Regulatory requirements in Medical Devices Manufacturing Industry, are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. More and more, organizations in the Medical Devices manufacturing Industry, are expected to demonstrate their quality management processes and ensure best practice in everything they do. Medical Devices manufacturing sector, requires evidences of documented management system and effective monitoring of all construction activities.

SWISS APPROVAL is an accredited Body as:

  • Certification of Medical Devices Quality Management Systems in accordance with EN ISO 13485:2012
  • Certification Body of Quality Assurance Systems in accordance with E.C. Directives
Definition of Medical Device

A medical device is a just a product, which could be a machine, an instrument, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.

SWISS APPROVAL EN ISO 13485 Certification Body for Medical Devices Management System

Swiss Approval is an accredited Certification Body for EN ISO 13485, regarding:

  • Non Active Medical Devices
  • General Non Active, Non Implantable Medical Devices
  • Devices for Wound Care

Accreditation according Normative Regulation:

  • EN ISO 13485:2012
Certification to ISO 13485

Certification to ISO 13485, is an added Value for any Medical Devices Manufacturer. Third-party accredited certification by SWISS APPROVAL, can demonstrate to regulators that the Company have met the requirements of the standard.

Market Demands

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series.

ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance.

It is more prescriptive in nature and requires a more thoroughly documented quality management system.

ISO 13485 was launched to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes.

It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

Benefits of being certified to ISO 13485

Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and demonstrate commitment to quality. Additionally, certifying by SWISS APPROVAL also affects:

  • Increase access to more significant markets worldwide
  • Increase efficiency, cut costs and monitor supply chain performance
  • Demonstrate that you produce safer and more effective medical devices
  • Meet regulatory requirements and customer expectations
SWISS APPROVAL Accreditation, in Accordance with E.C. Directives

Swiss Approval is an accredited Certification Body for FULL QUALITY ASSURANCE SYSTEM – [Annex II], regarding:

  • Non Active Medical Devices
  • General Non Active, Non Implantable Medical Devices
  • Devices for Wound Care

Accreditation according Normative Regulation:

  • Directive 93/24 EEC
  • EN ISO 13485:2012

Reccomendation for industry:

  • ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry.
  • ISO 13485 is the quality management system standard accepted as the basis for CE Marking Medical Devices under European Directives. 
  • Increasingly, ISO 13485 is being required, or is at least beneficial, in supporting regulations around the world.

 

Medical Tourism Certification Programs

Medical Tourism Certification Programs is the key answer to the continous growing medical tourism market for Health Care Providers.

SiSi, is promoting Medical Tourism Certification Programs, through TEMOS Germany, which is an affiliated Certification Company for the Medical Tourism International market.

Temos has been specializing in international patient management and respective services since 2005. It is the only certification body worldwide assessing and validating the quality of medical service providers from the international patient and medical traveller perspective, based on “Quality Made/Med in Germany”

For hospitals, clinics and primary care

Hospitals and clinics The aim of this certification program is to validate and optimize the hospital’s medical and non-clinical services for international patients within the hospital and for the post-treatment and discharge procedures. Primary care facilities (incl. medical centres, outpatient centres, etc.) play an important role in the treatment of travellers, tourists, expatriates, or residents since most for the medical problems of this group of patients can be resolved by primary care facilities.

For dental practices and clinics

For dental practices and clinics that intend to treat or already focus on dental tourists. The aim of this certification program is to validate and optimize the dental clinic’s medical and non-clinical services for medical tourists including the complete patients’ care cycle before travelling abroad, at the dental clinic and for the post-treatment and post-discharge procedures including the follow-up.

For Rehabilitation facilities

Certification program for: • Acute care hospitals with rehabilitation facilities
• Rehabilitation centres for in- and outpatient rehabilitation
• Rehabilitation centres for in-patient rehabilitation
• Rehabilitation centres for out-patient rehabilitation

For reproductive clinics and centers

For healthcare organizations that offer Crossborder Reproductive Care (CBRC) and Assisted Reproductive Technologies (ART).

For eye clinics and centers

For eye clinics that covers all modern eye care methodologies and treatments.

For medical travel providers

For medical tourism companies (facilitators, medical travel coordinator, etc.) that provide services for patients that seek medical treatment abroad.