Best practice testing at Boddingtons, Med-Tech Innovation exhibitor.
Boddingtons is certified to ISO13485 and ISO9001 Quality Management Systems Requirements.
Award-winning plastics injection moulding manufacturer, Boddingtons returned to the Med-Tech Innovation Expo in April for the third year running. The company presented its manufacturing operations; Class 7 cleanrooms and the testing and inspection services it offers.
Boddingtons is certified to ISO13485 and ISO9001 Quality Management Systems Requirements and is also compliant with FDA 21 CFR Part 820.
Jay Cheema heads up the quality management function at the company. Cheema’s previous experience includes roles in cleanroom medical plastics and device manufacture, including quality management systems (ISO13485), validation (IQ, OQ, PQ), metrology (contact and non-contact) and programming of automated test equipment. He also has the added bonus of leading Six Sigma & NPI projects with cross-functional teams.
Cheema’s wider work experience in other industrial sectors includes quality management system knowledge in AS9100 and TS16949 including core tools (FMEA, SPC, MSA, PPAP, Control Plan.
All of this enables Boddingtons to utilise best practices that have been acquired and adapted from all sectors.
Cheema said: “Boddingtons has invested heavily in new facilities and infrastructure – reinforcing my belief that quality starts with the environment that we work in.”
He pointed out that: “Investment in metrology equipment is critical, since there is little point producing precise mouldings if we cannot measure the parts accurately.”
Boddingtons is therefore currently equipped with contact and non-contact coordinate measuring machines (CMM) and with an array of bespoke measurement and test equipment.
The company is continuing its investments in testing and inspection with the purchase of a second non-contact CMM. This equipment will be commissioned in the coming months and will assist with validation work and in-process control measurements caused by increased demand from the marketplace.
“Quality of people is also a big part of our company recipe – and is essential in the Medical Device manufacturing industry.
Having the right people on-board enables Boddingtons to fulfil our ever-increasing global regulatory requirements and obligations.”
The Quality Team at Boddingtons has 100-plus years combined experience across all quality disciplines such as quality management systems, metrology, validation, auditing, problem solving and continuous improvement techniques.
Cheema added: “The Boddingtons approach of ‘everything is possible’ combined with our added value services offers our medtech customers a very promising manufacturing future.”