Companies of all sizes must have a robust quality management system (QMS) in place to deliver high-quality, compliant products that meet customer expectations.
Regulatory bodies like the International Organization for Standardization (ISO), International Aerospace Quality Group (IAQG), and International Automotive Task Force (IATF) publish guidelines for establishing and maintaining an effective QMS.
Outside of ISO 13485, which applies to medical device companies, ISO 9001 is the globally recognized quality management standard for most industries. Although it’s not a requirement, many companies adhere to the ISO 9001 guidelines to improve their processes, enhance customer satisfaction, and increase market competitiveness. The IAQG issued the AS9100 standard which is based on the principles of ISO 9001 and provides QMS guidance to organizations manufacturing aerospace and defense products. Similarly, the IATF issued the IATF 16949 standard which provides QMS requirements for companies in the automotive industry.
Arena QMS and Arena PLM for AWS GovCloud provide secure, cloud-native platforms for your internal teams and external partners to easily manage design controls, sourcing, corrective and preventive actions (CAPAs), training, and other quality processes while meeting ISO, AS9100, and IATF 16949 requirements. The ability to collaborate anytime and anywhere keeps everyone on the same page and reduces audit risks.
can demonstrate complete control and traceability through closed-loop quality processes
can readily compile QMS documentation to expedite audits and certifications
gain greater visibility into design changes, nonconformances, and other items that impact product launches
establish strong design controls by linking user needs and requirements directly to design inputs and outputs
can easily manage employee training plans and ensure adherence to SOPs, policies, work instructions, and more
can evaluate performance against targeted business objectives using convenient analytics tools
The key to achieving compliance is maintaining a tight connection between your product and quality information. Arena links quality records and associated change processes to the product bill of materials (BOM). This product-centric approach to quality management enables complete control and visibility throughout the entire NPDI process.
Gain Control of Product and Quality Processes
Expedite Internal Audits and Certifications
Drive Continuous Improvement
Internal audits help organizations uncover deficiencies in processes that impact operational efficiency, product quality, and overall performance. They also help companies monitor their QMS and assess whether it meets regulatory requirements.
Learn tips and best practices for planning and conducting an internal audit of your QMS.
“We needed to demonstrate to our government contract customers that we established a best-practice PLM platform and a QMS that were aligned and working together in support of our ISO 9000 effort.”
Steve Anderson, Vice President of Operations
