From its many years of operation as a Notified Body for Medical Devices (with identification code 0653 according to the requirements of Community Directive 93/42) it has acquired expertise in the specific field, which it now leverages through collaborations with other bodies.
The Board of Directors is appointed by a joint ministerial decision of the Ministries of Health and Finance with a 3-year term.
EKAPTY operates in accordance with the requirements of the standard ELOT ΕΝ ISO/IEC 17021-1 "Conformity assessment - Requirements for bodies providing audit and certification of management systems – Part 1: Requirements”, as well as the standard ELOT EN ISO/IEC 17065 “Conformity assessment – Requirements for bodies certifying products, processes and services” and has Civil Liability coverage for the certification activities it offers.
The body issues certificates stating the compliance of products, services, processes and management systems with the requirements of National, European and International standards and Legislation.
EKAPTY currently evaluates and certifies management systems in accordance with the requirements of the standards:
- EN ISO 9001, Quality Management Systems – Requirements
EN ISO 9001:2015 is a standard which defines the requirements that a quality management system must meet. ISO 9001 certification demonstrates the ability of each organization to meet and exceed the expectations of its customers. It is used as a basis for many other specific standards, e.g. EN ISO 14001, EN ISO 45001.
It has been designed to be flexible enough to be used by different types of businesses, therefore it does not specify the goals related to “quality” or “meeting customer needs”. Instead, it requires organizations to set these goals themselves and to continually improve their processes in order to achieve them. Once these goals have been achieved, the re-evaluation of the quality management system is imperative in order to continuously improve.
The implementation of a quality management system can help a company to have a better internal management that can contribute in increasing the efficiency, productivity and profit, maintaining and increasing the customer base, quality of products/ services which is perfectly measured while minimizing defects and increasing productivity, improving the company's position in the local and international market, legal compliance through understanding the relevant institutional and regulatory requirements and ultimately customer satisfaction.
- EN ISO 13485, Medical Devices – Quality Management Systems – Requirements for regulatory purposes
EN ISO 13485 is an internationally recognized standard that defines the quality system requirements of organizations operating in the field of medical devices. The evaluation of its implementation and the certification ensure that the medical device or service provided complies with the legal and regulatory framework and leads to end products/ services that are safe for the final user. EN ISO 13485 is thus a safety credential for final users.
EN ISO 13485 concerns organizations involved in one or more stages of the life cycle of a medical device, such as:
- design
- manufacture
- installation
- maintenance
- marketing
- storage
- technical support
- scientific support
- repackaging
- education
Key points of the standard are the risk approach for the design and implementation of the product, the validation of the procedures, the compliance with legal and regulatory requirements, the ongoing training of company staff and the existence of traceability and recall procedures with reference to the relevant principles.
It is an internationally recognized standard of quality and safety for the manufacture of medical devices while the certification according to ISO 13485 helps companies, through better control of their processes, to continuously improve and strengthen their position in international and local markets.
EN ISO 13485: 2016 is the pre-eminent standard for a manufacturer of medical devices to comply with the instructions of the Regulation (EU) MDR 2017/745.
- EN ISO 14001 - Environmental Management Systems – Requirements with guidance for use
The ISO 14000 series constitute the family of standards for "Environmental Management" and aims to support organizations/businesses in establishing a structured management system in order to:
- minimize the ways in which business operations cause negative environmental impacts (to the atmosphere, water, or soil),
- ensure compliance with applicable laws, regulations, and other requirements (national, EU, or international) related to environmental issues, and
- continually improve corporate environmental performance.
EKAPTY audits and certifies organizations and businesses in the broader field of Health and the Medical Device industry according to ISO 14001, based on common practices for system audit processes as defined in ISO 19011.
Through a parallel audit process, EKAPTY can assess compliance with all three management systems: ISO 9001, ISO 13485, and ISO 14001.
The ISO 14001 standard sets the criteria for the design, implementation, measurement, and monitoring of Environmental Management Systems (EMS).
The ISO 14001 standard provides the framework that an organization/business can follow to implement the necessary measures and procedures that characterize an efficient and effective EMS.
ISO 14001 can be applied by any organization/business in the Health and Medical Device sector seeking to improve resource efficiency, reduce waste generation, minimize operating costs, and achieve financial benefits.
The use of ISO 14001 establishes a supervisory mechanism for implementing operational processes and involving employees and other interested parties (suppliers, customers), so that corporate environmental performance can be measured, assessed, and improved.
- ISO 37001, Anti-bribery Management Systems – A practical guide
ISO 37001:2016 is a Management System standard that aims to help public and private organizations plan, implement, and operate an effective management system that identifies, prevents, and mitigates bribery within the organization. It also aims to promote and enhance transparency in all organizational activities.
A Management System structured according to the requirements of ISO 37001:2016 can operate harmoniously and collaboratively with any other existing Management System within an organization.
The key Benefits for an Organization that implements a Management System structured according to the requirements of ISO 37001:2016 include, among others:
- Early identification and prevention of bribery risks and incidents.
- Raising awareness among employees about bribery and preventing financial loss resulting from such practices.
- Improvement of the efficiency of departments handling financial matters within the organization.
- Establishing a good reputation in the market and gaining international recognition.
- EN ISO 15224 - Quality Management Systems – EN ISO 9001:2015 for healthcare
This international standard specifies requirements for a quality management system when a healthcare organization:
- needs to demonstrate its ability to consistently provide healthcare product or service that meets customer and applicable statutory and regulatory requirements, and
- aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer requirements, applicable statutory and regulatory requirements and requirements related to the quality aspects; appropriate, correct care; availability; continuity of care; effectiveness; efficiency; equity; evidence/knowledge based care; patient centred care including physical, psychological and social integrity; patient involvement; patient safety and timelines/accessibility.
All the requirements of this International Standard are generic and are intended to be applicable to any health care organization, regardless of its type or size, or the products and services it provides.
This standard is focused on requirements for management of clinical processes. Organizations that also include research or education processes in their quality management system could use the requirements in this standard where applicable.
This standard aims to specify and complement the requirements in EN ISO 9001:2015 to the specific conditions for healthcare providing mainly services and where customers are mainly patients.
EKAPTY is an independent Management Systems and Products Certification Body. The independence and impartiality of EKAPTY is ensured by the legal framework of its establishment and operation, its financial independence (not subsidized-financed by the government), the operation of the Independent Certification Council (ICC) and its organizational structure. At the same time, the body ensures confidentiality towards its customers, at all levels of operation.
It should be noted that EKAPTY, in order to maintain its demanding operating standards and its cooperation with other bodies, relies on the experience and the know-how of its experienced and specialized personnel that staff the working groups at all stages of certification (technical and clinical evaluation of medical devices, audits and on-the-spot inspections, maintenance of certification, etc.).
