Quality Management Systems (QMS)
M-Files QMS: Meet customer expectations, foster continuous improvement, and sustain the company's reputation.
Why Choose Us for Compliance and QMS
Navigating the complexities of compliance and quality management is a monumental task. We offer a holistic, certified solution that not only makes compliance manageable but turns it into a strategic advantage for your organisation.
Deviations and CAPA Processing: Quick and Effective Solutions
For deviations from set standards, our Corrective and Preventive Actions (CAPA) system quickly sets a plan in motion to bring operations back to compliance.
Customer Feedback Processing: Your Customer's Voice Amplified
Customer feedback is not just data; it's a goldmine of actionable insights. We provide the tools to process this feedback and integrate it into your QMS for ongoing improvements.
Digital Signature: Secure and Compliant
Every action in your QMS can be digitally signed for enhanced security and traceability, in compliance with laws like FDA 21 CFR part 11 and Eudralex Vol 4 Annex 11.
Certified Compliance and Security: ISO and SOC Certifications
We're proud to offer an ISO and SOC certified QMS, compliant with ISO/IEC 27001:2013, SOC 2 and SOC 3, ISO 9001:2015, GDPR, ISO/IEC 27017:2015, ISO/IEC 27018:2014, ISO 22301:2012, and more.
Records Management: Compliance Across the Board
We adhere to international records management standards like SÄHKE2, DoD 5015.2, MoReq2, as well as compliance with FDA 21 CFR part 11, Eudralex Vol 4 Annex 11, HIPAA, SOX-404, and FIPS 140-2 Level 2.
Document Control: The Spine of Compliance
Document control is the cornerstone of any robust QMS. Range IS offer advanced solutions for managing and storing your important documents in a safe, searchable, and regulated environment.
Change Management: Adapt with Confidence
Change is inevitable in every business landscape. Our change management systems ensure a smooth transition, effectively handling scheduling, responsibilities, and impact assessment.
Audits and Findings Follow-Up: Proactive Correction
We take audits seriously. Our system allows you to schedule, perform, and follow-up on audits effortlessly. Critical findings are flagged for immediate attention to ensure compliance and continuous improvement.
Repeating Quality Control Tasks: Consistency is Key
Our system automates the tedious yet crucial tasks in quality control, ensuring that your products or services maintain a consistent high quality.
Quality Manual: Your QMS Bible
Our comprehensive quality manual is your go-to guide for every process, responsibility, and procedure that forms part of your QMS.
External Documents: Integrated Seamlessly
All external documents, whether from suppliers or regulatory bodies, are managed and integrated into your QMS for complete traceability.
Training Documents: Equipping Your Team
Compliance begins with the right education. We provide updated training documents, ensuring that your team is well-equipped to maintain quality and compliance standards.
QMS Validation: Ensuring System Integrity
Our solutions go through rigorous validation procedures to ensure that they meet all industry-specific regulations and standards.
Process Maps: Visualising Success
A picture is worth a thousand words. Our detailed process maps offer a visual representation of your QMS, enhancing understanding and implementation.
