Quality Assurance
Call Us Now on +44 (0)1353 667914
'Quality is everyone's responsibility' - We have a fully trained, in-house Quality Assurance Team to ensure our customers quality expectations are fulfilled.
- Quality Systems approval (various) for over 70 years.
- ISO 13485 (2016) approved since inception of the standard (one of the first 1% of UK Medical Device Businesses to be approved), notified body BSI. - Manufacturer of FDA approved devices (in excess of 60 devices). FDA registered Contractor with Device Listings. - FDA registered site (#8044131) - Certified ISO 14644-1 Class 7 Cleanrooms (2 Rooms) - Quality department of 5 members of staff. - Audited and approved by Japan Focus for export to Japan 2009 & 2011. - Audited by multiple major Notified Bodies in conjunction with CE marking of our Clients products. |
Our Experienced team provide the following quality assurance activities:
- Mature Client Files, Archiving, Supplier Approval (Including supplier audits), Calibration and Internal Auditing Systems.
- CAPA & Change note systems with turnaround measures. - A fully audited Training Matrix system. - The trending of test results. - SPC capabilities. - Validation support. - Installation, Operation and Performance Qualifications (IQs/OQs & PQs). - Risk Assessment and Management . - Document Origination - Standard Operating Procedures, Works Instructions, Controlled Forms/Templates and Batch History Records. |
Telephone: +44 (0)1353 667914
Email: colin@wesleycoe.com Business Hours: Monday - Thursday 7.30AM to 4.30PM Friday 7.30AM to 12.30PM |
© Wesley Coe (Cambridge) Ltd, Gas lane, Ely, Cambs, CB7 4GH, UK.
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Company Registration Number - 00502988
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