Certified quality management system

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.

Quality: the heart of our organisation

Spoonbox quality control process

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.

More than just certifications: a management system to meet your needs

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.

Metrological checking by camera
Metrological checking by camera
Metrological checking by camera

Quality culture!

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.

ISO 9001

ISO 9001

Organisation LNE-Gmed

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.

ISO 14001

ISO 14001

Organisation LNE-Gmed

The ISO 14001 standard offers managers, staff and external stakeholders the assurance that environmental impacts are measured and improved.

ISO 18001

OHSAS 18001

Organisation LNE-Gmed

The OHSAS 18001 standards defines management system requirements for occupational health and safety.

ISO 13485

ISO 13485

Organisation LNE-Gmed

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.

ISO 15378

ISO 15378

Organisation LNE-Gmed

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.

CE standard

CE marking

Organisation LNE-Gmed
Link: CE marking

Our MD are compliant with European regulations on medical devices.

AEO authorised economic operator

AEO

Organisation World Customs Organization

Authorised economic operator for simplified customs, security and safety procedures

FDA authorised operator

FDA

Our drug delivery devices are registered with the Food and Drug Administration.