When ISO 9001:2015 is implemented properly, your business will be more efficient, profitable and a happier place to work. Roles are assigned, there is visibility, and continuous improvement is part of the culture.
Implementing ISO 9001 properly is not possible without the right tools.
Our quality management software provides a central system for all your ISO 9001: 2015 system plans, processes and reports.
Documents, risks, competence, external providers and improvement are all managed centrally.
World class performance don’t happen overnight. It takes years of planning, reviewing, learning and monitoring.
EQMS by Qualsys provides a platform for your organisation to make ISO 9001:2015 best practice requirements natural and easy.
Systematic risk-based thinking
ISO 9001:2015 has more rigorous requirements when it comes to managing risks relating to products, suppliers, compliance and innovation. Our software provides a best practice framework for identifying, assessing, managing and recording risk.
Ensure your employees are fully competent
Integrated process management modules help you prioritise training requirements of your employees and even your suppliers.
Schedule audits at your critical control points for new and existing suppliers.
A secure, incorruptible system
Document all feedback and record activity through electronic signatures, audit trails and workflows.
Manage supplier records
Continuously monitor and re-evaluate suppliers' activities to ensure the product meets your business's requirements.
Easy to validate your processes
Our software has been deployed by global pharmaceutical businesses, NHS trusts and other health organisations. The solution has been validated as complying with the requirements of many regulations, including FDA 21CFR Part 11 and the EU Electronic Signatures Directive.
This whitepaper explores how the role of internal auditors is changing due to increasing commercial pressures and time constraints.
Dive into a library of guides, templates and interviews with experts.
How do we manage our ISO 9001 internal audit program?
You can conduct ISO 9001:2015 management system audits, gap analysis and process reviews with the auditing module.
This module is also often used by our customers for a variety of other purposes, such as supplier audits, health and safety site inspections, and on-boarding checklists.
Can we control other documents with Qualsys EQMS?
Our customers use the document control module for to bring their ISO 9001:2015 quality management system to life.
Safeguard your quality processes, policies and procedures by controlling all documentation centrally.
The document control module enables you to control any file, manage retention policies, archival records, and there’s an audit trail for everything.
How do we manage risk and ensure risk based thinking with EQMS?
EQMS ensures risk based thinking is practised throughout your business: from leadership to people on the shop floor. For example, the issue management module enables incidents, near-miss and opportunities to be fed instantly to the people who need to know and the training records management module ensures employees are competent in their roles.
There is also the risk management module which provides a framework for formal risk assessments, setting your risk appetite and change management.
Can we manage other ISO standards / regulations in EQMS?
Most customers use EQMS as their business management system to integrate and unite quality, health and safety, information security, risk, compliance etc. in a simplified tool.
The system has been designed to adopt the Annex SL high level framework to assist your business to achieve certification to multiple standards, and more importantly, to generate efficiency savings, prevent duplication of effort, align the business, prevent costly mistakes, and improve customer satisfaction.