Oxebridge Quality Resources - ISO 9001 and AS9100 Implementation

Oxebridge provides medical device manufacturers with Rapid ISO 13485 Implementation, ensuring compliance to the latest international quality system standard for the medical equipment manufacturing industry.

No matter what class of medical device your company manufactures, Oxebridge can assist in implementing the requirements of ISO 13485, using a four-phase implementation program:

• Phase 1 - Information Capture. Oxebridge comes on-site to your facility and conducts interviews with your key management and staff to ascertain the current practices of your company, to see where you already comply with the standard. The notes taken from Phase 1 become the basis for the next phase.
• Phase 2 - Documentation Preparation. Oxebridge Specialists prepare an ISO 13485 compliant manual and supporting procedures, forms and other necessary documents based on the results of the Phase 1 interviews. Your resulting documentation is fully customized, based on the company’s current practices, and only introduces new or modified practices where the company either does not meet a requirement at all, or where current practice deviates from a requirement. Boilerplate documents are not used, and your staff are not assigned any writing duties!
• Phase 3 - Implementation and Training. Oxebridge Specialists return on-site and assist in implementing the resulting systems, train employees and internal auditors, and conduct the first round of required internal audits. We facilitate a QMS management review, including a review of the process objectives and metrics. At the end of Phase 3, your company is ready for third party certification auditing.
• Phase 4 - OPTIONAL - Audit Interfacing. For those clients wishing to be certified by a third party Certification Body (”registrar”), Oxebridge will attend the audit and provide on-site assistance and facilitation of the audit, ensuring a smooth and effective audit by the registrar, and ensuring your registrar’s auditor does not deviate from international accreditation rules, or “make up” requirements that do not exist.

(NOTE: Oxebridge works with your company’s selected registrar, and has no formal relationship with any such certification body, to maintain a process that is free of any conflicts of interest.)

Oxebridge’s ISO 13485 program may be eligible for significant grant reimbursement.

Please call or email Oxebridge for more information on this service, or submit an online quote request right now.