THERMOFORMED packaging supplier Macpac has announced it has achieved ISO 13485:2016 accreditation at the first attempt.
The internationally recognised quality management standard confirms that the manufacturer’s systems meet the stringent requirements needed to support customers within the medical device sector.
The achievement follows successful completion of both Stage 1 and Stage 2 assessments, during which Macpac underwent an audit process designed to measure the effectiveness of its quality management systems, controls, and compliance procedures.
The ISO 13485:2016 accreditation places particular emphasis on risk management, document control, traceability, and continuous improvement.
Alison Griffies, QA manager at Macpac, said, “We are delighted to have achieved ISO 13485:2016 accreditation at the first attempt. This certification gives customers additional confidence that choosing Macpac as their preferred supplier for thermoformed plastic packaging means our processes and controls are aligned with the strict regulatory requirements of the medical device industry.”
