ISO 9001:2015

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.

Best of all, free end users means you can give permission-controlled access to anyone. Leadership have a picture of the business, auditors understand your approach, and customers are confident you have everything under control.

Complex circle

Software for ISO 9001

Use our best practice software and implementation services for your ISO 9001 management system.

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.

Audit trail

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.

Integrated modules to make your ISO 9001:2015 management system.

All our modules work well in isolation and in harmony together.
Document control software
Document control software
Modern technology means we are bombarded with information. The challenge is making sure the right information is viewed by the right person at the right time. Document Manager by Qualsys provides a comprehensive and powerful solution for the distribution and control of all types of crucial documenta...
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Audit management software
Audit management software
Too many businesses hope that when an external auditor is examining their business they don’t uncover any issues. But this approach causes stress, encourages a reactive culture and exposes the business to high levels of risk. A regular and thorough internal auditing programme helps you identify an...
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Accident & incident management software
Accident & incident management software
When an accident or incident occurs, it's important there is an accurate record of events to understand the root cause and prevent it from happening again. Use our accident and incident management software to properly record, communicate and identify trends to prevent it from happening again.
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Equipment maintenance software
Equipment maintenance software
Over 70% of organisations have no formal method for managing how equipment is used, maintained and eventually replaced, or for ensuring there’s a qualified person on-site to operate that equipment. Managing business equipment correctly is crucial if your organisation is to compete in the fast-pace...
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Latest insights

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ISO 9004 overview
ISO 9004 is currently under revision and the draft international standard is now available for public comment. In this article, we spoke to Richard Green, founder of Kingsford Consultancy Services Ltd and former Technical Director at IRCA, who shared what the standard is about and how you can get i...
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ISO 9001:2015 explained: The process approach
While the process approach is by no means a new requirement, anecdotal evidence suggests that it is poorly understood. The process approach was first introduced in ISO 9001:2000. And while the concept of a process-based quality management system has not changed, the requirements in the latest versi...
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Internal auditing challenges: Emerging trends from ISO 9001:2015
Back in July 2014, Richard Green, CQI's former Head of Technical Services, said he believed the upcoming changes to ISO 9001 meant the auditor's role would transition from 'auditor' to 'assessor'. Auditors would increasingly need to deal with "shades of grey" and "new evidence sources would need to ...
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Evolving role of the internal auditor

This whitepaper explores how the role of internal auditors is changing due to increasing commercial pressures and time constraints.

ISO 9001:2015 transition toolkit

Dive into a library of guides, templates and interviews with experts.

Questions about using our software for ISO 9001? Schedule a 15-minute discovery call