Join ConQuest 2025 | ComplianceQuest User Conference | April 8–10, Clearwater Beach, FL
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Enable cross-functional collaboration and accelerate your product lifecycle with a cloud-based platform for innovation
Design Process and Quality System Development Tools in Product Lifecycle
Get full visibility over your product design processes and make collaboration easy to get your products to market faster, compliantly
Design Quality: Connecting Design to Documentation
Transform customer complaints to valuable sources of insights for continuous improvement through smart automations and integrated regulatory reporting
Challenges with Triage and Investigation in Complaints Management Process
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Transform quality into an enabler: boost efficiency, increase satisfaction, and trim costs with a fully connected, AI-powered quality management solution
Frost Radar for Quality Management Systems Names ComplianceQuest Leader
Enable risk-based thinking throughout your quality processes with a fully integrated risk management solution
Automation of the Risk Management Lifecycle with AI and Analytics
Increase supplier performance, reduce costs, and streamline your supply chain with integrated supplier quality and collaboration tools
The Ultimate Guide to Next-Generation Supplier Management [e-Book]
Identify and minimize safety events. Prevent accidents, safeguard workers, and ensure their well-being and health
Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
Proactively and accurately monitor and measure your company’s impact on the environment to improve performance and reach your environmental and sustainability targets
Environmental & Sustainability Management
Electronic and Automated Approach to Audit Management
Managing the Tools of the Trade
Manage Operational Risk Tracking, Evaluation, Mitigation and monitoring
Leveraging CAPA for Continuous Improvement
Ensure your laboratory is compliant with systematic and efficient laboratory investigations
Incident Reporting and Management
Organization, Collaboration and Governance for Efficient Changes
Conduct smart management review meetings with a tower of data to improve your quality and safety systems
Gain 360 degree vision into enterprise wide Safety risks
Enhance Safety and Compliance with Smarter Chemical Management
Ensuring Quality across Departments & Locations
Partner With Suppliers And Vendors To Improve Quality And Safety
Create Loyalty by Addressing Customer Complaints Smartly
Bring Consistency to Permit Practices
Make it easy for your people to manage, track and analyze environmental and sustainability metrics
Bring higher quality products to market quicker with design controls, projects & DHF
Streamline Permit Management and Ensure Compliance
When Learning Propels Organizational Growth
Improve efficiency, productivity, and compliance with a solution designed for today's diverse workforce learning styles
Strategically manage the complete lifecycle of your product
Efficient Waste Management for Compliance & Sustainability
Relevant Information within reach - Always.
Assuring Quality Products and Services
ComplianceQuest covers the whole spectrum of customers, industries and regions across the world. Whether it is a small, medium or enterprise sized manufacturer, companies choose ComplianceQuest for its end-to-end Product Lifecycle, Quality, Safety and Supplier Management Solutions.
Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
ComplianceQuest Medical Devices QMS Success Stories eBook
Complaint Handling Process for MedTech and Life Science Companies
Audit Management
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
Unlocking the Value of Complaints
Why You Need to Digitally Transform Your QMS
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Safety Technology Trends to Watch in 2023 (Infographic)
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
American Society of Quality Lean Six Sigma Conference
23 Feb, 2025
Phoenix, AZ
Transform to a fully connected business with a next-generation AI-powered Product Lifecycle, Quality, Safety, and Supplier management platform, built on Salesforce.
Our connected suite of solutions helps businesses of all sizes increase product, quality, safety, and supplier as they bring their products from concept to customer success.
Where Your Career Takes Flight: Join our dynamic team and be part of an innovative, collaborative and rewarding workplace culture.
Impact Through Action: How the ComplianceQuest team supports social causes and community engagement
The Pulse of ComplienceQuest: Our newsroom shares stories of innovation, progress, and change
Stronger Together: How our partnerships drive success and innovation
Today’s competitive business environment has placed tremendous pressure on manufacturing companies to lower operating costs, address complex product design, outsource development and seek global expansion plans. Beyond this pressure there is a major opportunity for companies to build a competitive advantage through an integrated risk and compliance management approach, that ensures all features are working together effectively, enabling superior visibility into the value chain.
Manufacturing processes and supply chain management that were once easy to handle are now much more complex. What used to be controlled and contained within the manufacturing plant is now monitored, run and maintained globally. Given this situation, building an effective risk and quality compliance system that conforms to management standards like ISO 9001 among others, is imperative for companies that want to work efficiently and win over smarter customers.
ISO 9001:2015 is one of the most significant updates in ISO standards. It affects almost every industry and its standards (AS9100D:2016, IATF 16949:2016, etc.,) and every supplier. Instead of creating generic quality management systems that apply to all certified companies, ISO 9001:2015 takes a new approach about an Organization. Organizations are required to design their Quality Management Systems based on the context (Industry) in which they operate. With more than 1 million organizations in more than 170 countries certified in ISO 9001, all were encouraged to transition and upgrade their certificates to ISO 9001:2015 to meet a September 2018 deadline.
Recertifying to comply with ISO 9001:2015 might at first glance appear to be an overwhelming project. However, the new standards make the workflow easier. ISO 9001:2015 matches quality management processes with the current business environment, taking technology, globalization, and other factors into consideration.
While ISO 9001:2015 is still based on the same seven quality principles, there is increased attention to the transformation of business methods over the past decade. ISO 9001:2015 changes the focus from documentation to managing processes with risk-based thinking. The new standards place a heightened emphasis on the importance of formal risk analysis. Companies are now tasked with using risk analysis to identify management challenges in their business processes.
Source: ISO 9001:2015(en)-Clauses 4 to 10 grouped in relation to Plan-Do-Check-Act (PDCA) cycle.
ComplianceQuest – A 100% modern cloud Enterprise Quality & Safety Management System (QHSE) goes above and beyond the requirements for ISO 9001:2015 while automating your entire ISO 9001 Quality Management System requirements. CQ significantly reduces the effort involved in maintaining your ISO 9001:2015 Quality System by making the required processes automated while maintaining full traceability. In addition, it provides a complete view of your organization’s data concerning the performance and effectiveness of your quality and compliance management system.
The ISO 9001:2015 Quality Management System (QMS) is crucial for organizations seeking to enhance overall performance and customer satisfaction.
Establishes a systematic approach to quality, emphasizing customer focus, leadership involvement, and process improvement. ISO 9001:2015 provides a globally recognized framework that helps organizations streamline operations, reduce errors, and consistently deliver products or services that meet or exceed customer expectations.
Certification to this standard signifies a commitment to quality and boosts credibility in the marketplace, opening doors to new business opportunities.
ISO QMS software facilitates risk management, encourages continuous improvement, and ensures legal and regulatory compliance.
ISO 9001:2015 outlines specific requirements for a Quality Management System (QMS) aimed at ensuring organizations consistently provide products or services that meet customer and regulatory requirements. The standard emphasizes a process approach, requiring organizations to define and document their processes, roles, responsibilities, and interactions. Customer focus and leadership involvement are essential, and a robust commitment to continual improvement is mandated. Organizations must establish and maintain a risk-based thinking approach, identifying and addressing potential issues.
The standard demands the monitoring and measurement of processes, products, and customer satisfaction. Documented information, including a quality manual and documented procedures, is required. ISO 9001:2015 also stresses the importance of competent personnel, infrastructure, and a focus on evidence-based decision-making. Certification to ISO 9001:2015 signifies an organization's compliance with these requirements, demonstrating a commitment to quality and customer satisfaction.
The process approach is a fundamental concept within ISO 9001 Quality Management System (QMS) standards, emphasizing the importance of viewing organizational activities as interconnected processes that collectively contribute to the achievement of quality objectives. When applied to quality management software conforming to ISO 9001, this approach entails identifying, documenting, and managing key processes involved in software development, implementation, and maintenance.
Each process is interconnected, with inputs, outputs, and feedback loops. The process approach encourages a systematic and efficient structure for managing software quality, fostering consistency, and enabling continuous improvement. It ensures that the organization focuses on the effectiveness of its processes, leading to enhanced product quality, customer satisfaction, and overall performance in the dynamic and competitive software development landscape.
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