Quality lies at the heart of our process and concerns, from design right through to delivery, as evidenced by the numerous certifications we are granted again each year.
Because our products are designed to make everyday life easier for people of all ages and help them take care of their health, quality is essential. As a result, all Stiplastics employees are trained in Good Manufacturing Practices quality standards and principles, from product design through to delivery.
ISO 9001 management system certification QSE at Stiplastics ensures compliance with ISO standards and regulations throughout the life of the product, by every department in the business. ISO 13485 and ISO 15378 certifications (including GMP) and CE marking for oral drug delivery devices, among others, prove our commitment to meeting quality standards in the pharmaceutical sector.
Our quality standards go well beyond our regulatory obligations. In fact, we have been supplying leading international pharmaceutical firms, with more stringent quality requirements than those imposed by the standards, for over 20 years. These relationships mean that Stiplastics constantly strives for excellence as the business develops.
Whether you are a supplier or a customer, our QSE department is your dedicated point of contact for all quality, safety, environmental and regulatory matters. It listens to your needs in relation to pharmaceutical, hygiene and cleanliness regulations, and provides personalised, up-to-date advice.
By managing your entire product development process, we are able to supply you with a turnkey device, including the regulatory technical documentation required to obtain CE marking. Effectively, we draft all your technical documentation ready for registration, and keep it up to date based on changes in the regulations and/or to the device. By dealing with every aspect of your project, we offer you complete peace of mind.
Our production systems have been driven by a continuous improvement approach to our quality management system for decades, guaranteeing our products’ quality, compliance, safety and hygiene. This approach is embedded in the entire business on a daily basis and evidenced in tangible terms through various certifications, CE marking and registration with the FDA.
The ISO 9001 standard is based on a number of quality management principles, in particular a strong customer focus, management motivation and commitment, a process-oriented approach and continuous improvement.
The ISO 14001 standard offers managers, staff and external stakeholders the assurance that environmental impacts are measured and improved.
The OHSAS 18001 standards defines management system requirements for occupational health and safety.
The ISO 13485 standard sets out requirements for the quality management system, where an organisation has to demonstrate its ability to supply medical devices and associated services on a regular basis, in accordance with customer requirements and the applicable regulatory stipulations.
The ISO 15378 standard stipulates requirements for the quality management system, where an organisation has to demonstrate its ability to supply primary packaging items for medicines that satisfy customer requirements on an ongoing basis, including regulatory requirements and international standards applicable to primary packaging items.
Our MD are compliant with European regulations on medical devices.
Authorised economic operator for simplified customs, security and safety procedures