ISO 9001 Software

About ISO 9001 Software for Quality Management System

The ISO 9001 standard provides a framework for operating and maintaining a Quality Management system. EtQ's ISO 9001 Software solution is built upon a framework that incorporates the methodologies and processes associated with the ISO 9001 Quality Management System requirements. EtQ ISO 9001 Software contains processes related to Document Control, Corrective and Preventive Action, Audit Management, Employee Training, and the various other processes within the ISO 9001 standard.

As with any ISO related process, ISO 9001 is a framework for operating an effective system, such as Quality Management. EtQ has built a software solution that takes many different processes, including ISO 9001 and others, and incorporates them into the Quality and Compliance Management software solution. EtQ's quality Management software provides ISO 9001 software processes and can easily adapt to different configurations within your ISO 9001 program. This is accomplished through out flexible workflow technology, which provides the business rules and configurations to enable users to configure the workflows, forms, fields, sections, and keywords within the software. This flexibility and ease of use can turn an out of the box ISO 9001 software solution to a company-configured ISO 9001 Software solution, without programming.

EtQ's ISO 9001 software capabilities are just one or many best practices built into the EtQ suite of Quality Management Software solutions. EtQ also has built processes around ISO 14001, OHSAS 18001, ISO 13485, ISO/TS 16949, AS 9000 and many more. EtQ also builds in best practices for all industries, such as Medical Device, Pharmaceutical, discrete and process manufacturing, food and beverage, aviation, health and safety, and many more.

ISO 9001:2015 Management Software

The International Organization for Standardization (ISO) has made updates to the new ISO 9001 Quality Management Systems standard, with the ISO 9001:2015 revision. These updates not only reflect the overall Quality System requirements, but also a company mindset to Quality Management. While the requirements drive the framework and provide details on aligning processes to the standard, the 2015 standard takes a broader stroke in explaining the overall goals and mindset Quality Management should take into companywide operations. It’s not necessarily a change in the requirements, but in the approach that is taken to satisfy them.

ISO 9001:2015

The International Organization for Standardization (ISO) has made updates to the new ISO 9001 Quality Management Systems standard, with the ISO 9001:2015 revision. These updates not only reflect the overall Quality System requirements, but also a company mindset to Quality Management. While the requirements drive the framework and provide details on aligning processes to the standard, the 2015 standard takes a broader stroke in explaining the overall goals and mindset Quality Management should take into companywide operations. It’s not necessarily a change in the requirements, but in the approach that is taken to satisfy them.

The Challenge – Aligning the Entire Business to Quality Management

Quality Management Systems by EtQ

One mindset is in the people and leaders within your organization. There is no specific requirement around a Quality Management Representative, or even a Quality Manual, which is a shift from previous iterations, but it focuses a lot on a companywide commitment around Quality and the leaders within the organization that will drive in line with Quality. So the question becomes, “If we’re all enrolled in the Quality management effort, and we need to collaborate on our own part in the Quality story, then how can we do that in a centralized and common system?”

Another challenge is the notion of applying “risk –based-thinking” to your Quality Management System. Risk-based thinking refers to a coordinated set of activities and methods that organizations use to manage and control the many risks that affect its ability to achieve objectives. Risk-based thinking replaces what the older revisions of ISO 9001 used to call preventive action.

Aligning the business leadership to the Quality Management System around ISO 9001:2015 starts with Risk-Based Thinking. Most leaders in the organization don’t always “speak the language” of Quality, and that can be a disconnect when trying to promote a culture of Quality. What Risk management is able to do is act as a “universal translator” of sorts to Quality events. Leadership may not “Speak Quality” but they will be able to speak risk.

The Solution:

EtQ’s Quality Management System enables you to build a Quality System solution that is centralized, controlled, and fosters a common platform is key. This centralization of a Quality System provides that single, common source for all information. The automation of processes which fosters collaboration within the entire organization and builds greater visibility and control. It also provides a method for creating a risk-based view into Quality Management.

ISO 9001: 2015 Section Summary EtQ's Quality Management System Capabilities
4: Context How you will manage Quality in a process-Based QMS? Flexibility: Needs to meet your unique business processes

Adaptation: Map the solution to YOUR QMS
5: Leadership Quality is a company-wide commitment, driven by many leaders, not just one person Centralization of QMS: Single Holistic Place for managing control/visibility

Document Control: Single source for fostering collaboration on processes
6: Planning Shift to Risk-base-thinking – identification AND control of risks Risk Management and CAPA: leveraging risk methods to identify hazards, but also tools, embedded into the process that assess risk integrate with actions (CAPA, etc.)
7: Support Focus on People and Infrastructure Document Control, Integrated with Employee Training: Link the processes with the training to support the Quality Management System framework
8: Operations Traceability on how you design, source, plan and measure Integrated Processes: Building a seamless, traceable process, with one process integrated to the next.
9: Evaluation Build a feedback loop and track Customer feedback, Audits, and Management Reviews Complaint/Adverse Event Tracking: Recording Feedback from your customers

Auditing: External and internal audits based on processes, with links to Corrective Action

Reporting and Analytics: Robust analytics to generated scheduled and ad-hoc reporting
10: Improvement Fostering a commitment to company-wide improvement Nonconformance Tracking: Build in automatic notifications and workflows to tracking and resolving Nonconformities

Corrective Action: Focus on risk-based thinking for Preventive measures, and Corrective actions that take risk into prioritizing the process

Reporting & Change Management: Build in a Quality LifeCycle that closes the loop with reporting and management of change workflows.

Learn more:

From a requirements perspective, EtQ has the solution that will not only meet the ISO 9001:2015 Quality Management Systems framework, but provide you with the tools to exceed and drive towards true Operational Excellence. To Learn More, contact us at

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