QUALITY MANAGEMENT SYSTEM COMPLIANCE

REDUCE AUDIT RISKS WITH A PRODUCT-CENTRIC APPROACH

MEET REGULATORY REQUIREMENTS FOR AN EFFECTIVE QMS

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.

HOW ARENA SIMPLIFIES ISO, AS9100, and IATF 16949 COMPLIANCE

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.

QUALITY

can demonstrate complete control and traceability through closed-loop quality processes

DOCUMENT
CONTROL

can readily compile QMS documentation to expedite audits and certifications

PRODUCT
TEAMS

gain greater visibility into design changes, nonconformances, and other items that impact product launches

ENGINEERING
TEAMS

establish strong design controls by linking user needs and requirements directly to design inputs and outputs

MANAGEMENT
TEAMS

can easily manage employee training plans and ensure adherence to SOPs, policies, work instructions, and more

EXECUTIVE MANAGEMENT

can evaluate performance against targeted business objectives using convenient analytics tools

A PRODUCT-CENTRIC APPROACH TO QUALITY MANAGEMENT

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

Automated change processes and revision controls are applied to documentation for enhanced traceability and accuracy
Teams can identify, analyze, and resolve issues fast to drive closed-loop CAPA process

EXPEDITE INTERNAL AUDITS AND CERTIFICATIONS

Easily document, control, and track compliant processes in Arena
Quickly compile up-to-date SOPs, DHFs, supplier lists, training records, and other compliance evidence

DRIVE
CONTINUOUS
IMPROVEMENT

Readily monitor and track key performance indicators (KPIs) using Arena Analytics
Enhance product and quality performance with actionable insights

Learn how Arena’s connected quality management approach enhances compliance and speeds product development.

READ WHITE PAPER

IMPROVE QUALITY MANAGEMENT WITH INTERNAL AUDITS

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.

READ BEST PRACTICE

“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