Polyco Healthline is certified to ISO 9001:2015, ISO 13485:2016 and ISO 14001:2015. These certifications demonstrate that Polyco Healthline has an integrated management system in place, helping to ensure our processes are effective and enabling us to continually improve to meet customer needs and expectations.
ISO 9001:2015 is the international standard for creating a quality management system. To obtain this Polyco has demonstrated its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
This is a stand alone QMS standard derived from ISO 9001but adapted as a process based model specifically for a regulated medical device manufacturing environment.
ISO 14001:2015 is the international standard for Environmental management systems, designed to help businesses to reduce their environmental impacts. Maintaining this standard helps Polyco understand its environmental impacts and respond accordingly to reduce them by putting appropriate environmental improvements in place.
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