Medical Device Management, ISO Standards, ISO certification Ireland
What is ISO 13485:2016?
ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
While it remains a stand-alone document, ISO 13485:2016 is generally harmonised with 9001:2015. A fundamental difference, however, is that ISO 9001:2015 requires the organisation to demonstrate continuous improvement, whereas ISO 13485:2016 requires only that the organisation demonstrates the quality system is implemented and maintained.
Who does the system apply to?
The system applies to personnel from medical device manufacturing industries who have a working knowledge of ISO 9000. The system also relates to supervisors and managers working in the following areas:
Benefits of ISO 13485:2016
- ISO 13485:2016 is globally recognised as the “best quality practices” from organisations within the medical device industry.
- This certification gives a Shorter Sales Cycle – less time is needed to earn prospective customers’ trust and confidence.
- ISO 13485:2016 certification means higher customer satisfaction. The delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements satisfies the customer.
- Striking improvement is noticed in stakeholder relationships – including staff, customers, and suppliers.
- ISO 13485:2016 helps the organisation to understand how statutory and regulatory requirements impact an organisation and its customers. Thus it helps in legal compliance.
- An organisation needs this certification to provide improved performance in areas such as increasing sales, timeliness in getting products to the global marketplace, reducing costs, decreasing number of errors, lessening wastage, better utilisation of time and resources, and lowering product failures.
- Certification like ISO 13485:2016 enhances the image of the company in the eyes of customers, employees, and shareholders and all.
- Helps in improved risk management – this is done through greater consistency and traceability of products and using risk management techniques.
- ISO 13485:2016 is a framework for implementation of actions which ensures achievement of planned result and maintaining effectiveness of those processes which are applicable to customer, quality and regulatory requirements.
Stages to Implementation
- See how existing policies and practices align with the requirements of the standard.
- Determine the needs of the organisation.
- Establish policy and objectives.
- Conduct initial review.
- Determine necessary processes and responsibilities.
- Provide resources to attain objectives.
- Establish methods for monitoring and analysis.
- Determine efficiency and performance indicators.
- Establish means to effective operational control.
- Review and monitor for continual improvement in efficiency.
QMS Solutions service to you
- QMS Solutions will design, develop, draft and implement your complete Medical Device Management System in consultation with you.
- We will also provide in-house training on all aspects of your new Medical Device Management System, tailored to your specific training needs and business requirements
Steps to Certification
- Following initial quotation, an assessor will review your company’s product, processes, procedures, facilities, work environment and resources.
- Conduct an Initial Review and prepare a current state assessment and gap analysis.
- Develop Draft Policy, Objectives, Plans, Processes, Programme, Procedures and Records as per ISO 13485:2016 to include applicable exceptions.
- Review and approve the above documentation with the client, as per agreed project approach.
- Handover / implementation of your Medical Device Management System
- Provide in-house training where appropriate.
- After a period of 3 months QMS Solutions will review the establishment of the Medical Device Management System and seek registration where appropriate.
- Follow-up audits and pre-audits are conducted on request in advance of the client’s annual independent audit.