ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices.
Its primary objective is to facilitate harmonized medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing and calls for.
- Implementation of a Quality Management System with several enhancements
- Risk Management approach to product development and product realisation
- Validation of processes
- Compliance with statutory and regulatory requirements
- Effective product traceability and recall systems
Initial Certification Audit
The assessment process for achieving certification consists of a two stage Initial Certification Audit as follows:
Stage 1 - the purpose of this visit is to confirm the readiness of the organisation for full assessment. The assessor will:
confirm that the quality manual conforms to the requirements of ISO 13485
confirm its implementation status
confirm the scope of certification
check legislative compliance
produce a report that identifies any non-compliance or potential for non-compliance and agree a corrective action plan if required.
produce an assessment plan and confirm a date for the Stage 2 assessment visit.
Stage 2 - the purpose of this visit is to confirm that the quality management system fully conforms to the requirements of ISO 13485 in practice. The assessor will:
undertake sample audits of the processes and activities defined in the scope of assessment
document how the system complies with the standard
- report any non-compliances or potential for non-compliance
produce a surveillance plan and confirm a date for the first surveillance visit
If the assessor identifies any major non-conformance, the organisation cannot be certified until corrective action is taken and verified.
What are the benefits of certification?
Customer satisfaction - through delivery of products that consistently meet
- customer requirements as well as quality, safety and legal requirements
- Reduced operating costs - through continual improvement of processes and resulting operational efficiencies
- Improved stakeholder relationships - including staff, customers and suppliers
- Legal compliance - by understanding how statutory and regulatory requirements impact the organization and its customers
Improved risk management - through greater consistency and traceability of products and use of risk management techniques
- Proven business credentials - through independent verification against recognized standards
- Ability to win more business - particularly where procurement specifications require certification as a condition to supply in a highly regulated sector
Who is ISO 13485 applicable to?
ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.
How to gain registration?
The process of registration follows three simple steps:
Application for registration is made by completing the application questionnaire
Assessment to ISO 13485 is undertaken by NQA - the organisation must be able to demonstrate that its quality management system has been fully operative for a minimum of three months and has been subject of a full cycle of internal audits
Registration is granted by NQA and maintained by the organisation. Maintenance is confirmed through a programme of annual surveillance visits and a three yearly re-certification audit
ISO Riyadh for ISO Certificate and ISO Training in KSA providing ISO 9001 ISO 14001 OHSAS 18001 HACCP ISO 22000 ISO 17025 consulting in As Riyadh Jeddah. ISO Certification Mecca, ISO Certification Dammam, ISO certification Madina, ISO certification Burayda and ISO Certification Al khobar.
ISO consultancy training ,certification against various standards like ISO 9001 Quality Management System, ISO 14001 Environment Management System, OHSAS 18001 Occupational Health Safety Management System, ISO / IEC 17025 Laboratory accreditation management system, ISO 27001 information management system, ISO 20000 IT Service Management System, HACCP ISO 22000 Food Safety Management System etc.
CONTACT US FOR FREE CONSULTATION FOR ISO 9001 /ISO 14001/OHSAS 18001/ISO 27001/HACCP /ISO 22000/ISO 10001/10002
ISO Riyadh for ISO Certificate and ISO Training in KSA providing ISO 9001 ISO 14001 OHSAS 18001 HACCP ISO 22000 ISO 17025 consulting in As Riyadh Jeddah. ISO Certification Mecca, ISO Certification Dammam, ISO certification Madina, ISO certification Burayda and ISO Certification Al khobar,Jubail