// ROBOTICS AND SMART FACTORIES TERM
ISO Certification
ISO Certification means a company has met international standards for its management systems, like quality or environmental management. It shows they follow best practices.
TECHNICAL DEFINITION
ISO Certification signifies an organization's adherence to International Organization for Standardization (ISO) management system standards, such as ISO 9001 for Quality Management Systems (QMS) or ISO 14001 for Environmental Management Systems (EMS), validated by an accredited third-party auditor.
BACKGROUND
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 and EN 46002 (1996), the previously published ISO 13485, and ISO 13488.
READ MORE ON WIKIPEDIASYNONYMS & ALIASES
- ISO Standard
- Certified Quality
- Management System Certification
- International Standard
USAGE NOTE
Achieving ISO certification often enhances market credibility and demonstrates a commitment to operational excellence.
DEVELOPERS
Organizations developing technology related to ISO Certification.
Develops the ETQ Reliance platform, a QMS, EHS, and compliance management software that helps organizations automate processes for achieving and maintaining ISO certifications such as ISO 9001, ISO 14001, and ISO 45001.
Provides a digital quality management system (QMS) platform that automates and manages document control, audits, training, and corrective actions to help companies comply with and maintain various ISO standards, particularly in life sciences.
Offers a highly configurable no-code Quality Management System (QMS) software platform designed to streamline compliance with ISO standards by managing documents, audits, nonconformances, and CAPA processes.
Develops the Veeva Vault Quality Suite, a cloud-based QMS that unifies quality processes, document management, and training for life sciences companies to ensure compliance with industry regulations and standards like ISO 9001 and ISO 13485.
Creates a MedTech-specific Quality Management System (eQMS) designed to help medical device companies streamline documentation, risk management, and design controls to accelerate compliance with standards like ISO 13485.
Develops a cloud-based platform that combines Product Lifecycle Management (PLM) and Quality Management Systems (QMS) to help manufacturers manage quality processes and supply chain compliance required for ISO 9001 and ISO 13485 certification.
Provides integrated software for Governance, Risk, and Compliance (GRC), focusing on Environmental, Health, and Safety (EHS) and quality management. Their technology helps organizations manage and report on activities required for ISO 14001, ISO 45001, and ISO 9001 certification.
Develops a cloud-based electronic quality management system (eQMS) for life sciences companies, simplifying document control, training, and event management to help them achieve and maintain compliance with standards such as ISO 13485.