Accora has a dedicated Quality and Compliance function which works continuously to improve internal processes and procedures to ensure high quality is maintained across all business areas.
Our Quality Management System is certified to ISO 9001:2015 and is designed to meet the requirements of ISO 13485:2016 and 21 CFR 820.
Continuous improvement is sought by conducting internal audits across all departments, including our third-party suppliers, to ensure good quality and that we continue to comply with all applicable regulations and requirements.
Our quality policy:
Accora’s mission is to bring innovation and advancement to care provision. It does this by designing products to meet the needs of care home providers and facilities, and healthcare clinicians. Accora’s aim is to provide a quality service to customers and all stakeholders by committing to:
- Providing high quality, assistive technology and innovative products at affordable prices
- Identifying performance targets and quality objectives to continually improve the business
- Regularly reviewing and redirecting the Company, in the light of external influences
- Providing the physical resources needed to achieve the targets
- Providing professional development of personnel
- Recognizing that continual improvement applies to all aspects of the organization
- Ensuring that environmental factors are considered and monitored
- Providing a safe working area by giving health and safety a high priority
The Company’s reputation for quality is safeguarded and enhanced through the implementation of the Quality Management System, which includes regular auditing of its processes, to ensure compliance and continuous improvement.
EU Medical Device Regulation MDR 2017/745:
The Medical Device Regulation 2017/745 is currently superseding the Medical Device Directive 93/42/EEC. The implementation date, originally set to May 2020, has been postponed to May 2021. The new regulation has been incorporated into Accora’s Quality Management System and is being implemented across all of Accora’s CE marked products.
FDA – Food and Drug Administration inspections:
The United States Food and Drug Administration (FDA) conduct regular inspections to the US Quality System Regulation (QSR) 21 CFR 820. The last FDA inspection was successful and was carried out in April 2019.
Our products follow a strict design and development process which ensures safety and conformity to state-of-the-art standards relevant to various country specific requirements. The products are Class I medical devices which are self-certified to the MDR 2017/745 and / or MDD 93/42/EEC and have full technical files and design history.