A complete QHSE Management System.
Scalable. Integrated. Easy.

SoluDyne is a complete system with integrated modules and functionality for Quality Management.
Easily track compliance with ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 27001 etc.
Simple solution available on web and handheld device.
Available as Cloud Solution or installed at Customer's location.
Supports Workflows from Work Processes to Automatization of Work Flows.
Configurable Dashboards and Form Designer integrated with Work Flow Designer.
Document management, reporting of improvement proposals and near-misses, management of deviations and claims, preparation of action plans, management of audits, risk assessment as well as maintenance and calibration of equipment, etc.

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Quality Management in SoluDyne and the 7 principles for good quality management as defined in ISO 9001

SoluDyne provides businesses with a complete package to thrive and excel in Quality and Continuous improvement as required by ISO 9001 and the 7 principles of Quality Management. These seven principles serve as a framework for organizations seeking to establish and maintain effective quality management systems in accordance with ISO 9001 standards. They promote a customer-centric approach, employee involvement, and a focus on continual improvement to ensure that products and services consistently meet or exceed customer expectations.

1. Customer Focus: Organizations should be customer-centric, understanding and meeting their current and future needs and expectations. Customer satisfaction is a key driver of business success.

2. Leadership: Effective leadership is essential to establish and maintain a quality management system. Leaders should create a unified vision and mission, set clear objectives, and ensure that everyone in the organization is aligned with quality goals

3. Engagement of People: People at all levels of the organization should be involved and engaged in achieving the organization's quality objectives. This principle emphasizes the importance of empowering and motivating employees to contribute to quality improvement.

4. Process Approach: Quality management should be approached as a series of interconnected processes that collectively create value for the organization and its customers. Understanding and managing these processes is critical to achieving consistent and desired outcomes.

5. Improvement: Continuous improvement is a fundamental principle. Organizations should regularly assess and enhance their processes and products to achieve better performance and customer satisfaction. The use of data and evidence-based decision-making is crucial for improvement.

6. Evidence-Based Decision Making: Decisions should be based on the analysis and evaluation of data and information. This ensures that decisions are rational and can lead to better outcomes and continual improvement.

7. Relationship Management: Building and managing mutually beneficial relationships with suppliers, partners, and other interested parties are essential for success. Collaborative relationships can enhance the organization's ability to deliver value and meet quality objectives.

APOS Process Management

Complete Process Management from Work Process all the way to Work Flow Automation. Achieve a process-based management and quality system. With in-browser modelling tool. Read More

SoluDyne and system alignment with the 7 principles for good quality management - ISO9001

Alignment with ISO 9001 and Work Process vs Work Flow

A Work Process used as governing documentation is a non automated process view illustrating a number of steps to be taken in order to achieve a specific result. A work process clearly defines roles and responsibilities and are ideally combined with governing elements in order for employees to have a clear understanding of the task to be performed and the requirements and risks involved if any. Work Processes are generally used to replace complicated procedures written as documents where the risk of human error is evaluated to be relevant. Many modern organizations manage their whole operation using Work Processes as this ensures higher control and efficiency. Learn more

In conclusion a Work Process in this context means Governing Documentation defining how work is to be performed.
Work Flow is an automated Process assisting with performing the actual task. For example reporting of deviations can be considered an automated process.

Work process software can align with several of the seven principles of ISO 9001, depending on its specific functionality and how it is implemented within an organization. Here are the ISO 9001 principles that work process software can align with:

APOS - WORK PROCESS USED AS GOVERNING DOCUMENTATION

Process Approach: APOS Work Process supports the process approach principle by helping organizations define, control, and manage their Work Processes. It ensures that Work Processes and records are created, reviewed, approved, and distributed as part of a structured workflow, aligning with the overall process-oriented approach of ISO 9001.

Evidence-Based Decision Making: Work Processes when used as governing documentation plays a crucial role in evidence-based decision making. It helps organizations maintain a clear audit trail of process changes, approvals, and revisions. This evidence can be invaluable in making informed decisions related to work process control, compliance, and work process improvements.

Customer Focus: Effective work process management is essential for maintaining customer focus. Good Work Processes ensures that customer requirements and expectations are documented, communicated, and integrated into organizational processes and products or services.

Leadership: Leadership teams often rely on Work Processes to ensure that key governing documentation, policies, and procedures are consistently communicated and followed throughout the organization. It supports the leadership principle by providing a mechanism for top-level management to set expectations and align the organization with quality objectives.

Engagement of People: Work Process Management directly engage people, it provides employees with the tools to access, collaborate on, and contribute to the Work Processes and Continuous Improvement relevant to their roles. This direct engagement supports the engagement of people principle by enabling employees in direct participation, which is very different from managing by Document Management with Procedures, where Roles and Responsibilies of the employees may be clearly defined but may be difficult to deciphre for the employee.

Relationship Management: APOS facilitates collaboration and communication among team members and stakeholders. It helps manage relationships by ensuring that the right people have access to the right Work Process at the right time, supporting effective teamwork and alignment with quality objectives.

Improvement: APOS contributes to continual improvement by providing a structured approach to work process control and management. It helps organizations identify areas for improvement in work-processes and ensures that changes are tracked and documented, aligning with the improvement principle.

APOS - WORK FLOW AUTOMATION

Process Approach: Work Flow software supports organizational processes by enabling consistent and efficient task management, mirroring the process approach principle of achieving desired outcomes.

Improvement: The software offers tools for process analysis, performance tracking, and feedback, fostering continuous improvement in processes, products, and services.

Evidence-Based Decision Making: With its analytics capabilities, Work Flow software facilitates data-driven decisions about process optimization and operational improvements.

Engagement of People: By streamlining task management and collaboration tools, the software indirectly boosts employee engagement.

Customer Focus: Configurations within the software can prioritize tasks impacting customer satisfaction, enhancing customer-centric operations.

Leadership: The software aids leadership in overseeing key organizational processes, aligning with setting objectives and quality management goals.

Relationship Management: Work Flow software supports team collaboration and stakeholder communication, aiding in relationship management.

The software's alignment with ISO 9001 principles hinges on its implementation in an organization's quality system. Effective use can boost process efficiency and quality management, pivotal for ISO 9001 compliance.

Deviation Management & Continuous Improvement

The quality improvement module is designed to handle all types of observations, Improvement proposal, Deviations, Customer Complaints, near misses, Occupational injuries, Audit results. Read More

Alignment with ISO 9001 - 4 of 7 principles:
Process Approach By addressing deviations as part of a structured process, organizations can ensure that non-conformities are managed effectively and that corrective actions are taken in a systematic manner.

Improvement: Continual improvement is a fundamental aspect of ISO 9001, and deviation management supports this principle by enabling organizations to learn from deviations and enhance their processes.

Deviation management relies on collecting and analyzing evidence to determine the root causes of deviations and to make informed decisions about corrective and preventive actions. This aligns with the principle of Evidence-based decision making, as organizations use data and information to guide their actions and improve their processes.

Depending on type of business, by involving Suppliers and Customer's directly into your deviation reporting/continuous improvement process this module can also assist with Relationship Management providing a concrete feedback loop between you and your suppliers and you and your customers.

RISK Management

Complete Risk Management System. Can be used independently and together with the rest of the system, for example in preparation for an audit or to illustrate risk in connection with the execution of a job defined in a work process.
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The Risk Management System aligns with ISO 9001's principles by emphasizing risk-based thinking in quality management. Specifically:

Customer Focus: It manages risks affecting product/service quality to meet customer needs.

Leadership: RISK reflects leadership's proactive commitment to quality, promoting a risk-aware culture.

Engagement of People: It involves employees in risk processes, fostering risk-awareness and responsibility.

Process Approach: RISK systematically identifies, assesses, treats, and reviews risks, mirroring ISO 9001's process-centric view.

Improvement: Addressing risks leads to organizational adaptation and refinement.

Evidence-based Decision Making: RISK offers insights for informed decisions regarding risks.

Relationship Management: It ensures external partners align with the organization's quality and risk standards.

Overall, RISK upholds ISO 9001's principles, underscoring the importance of risk-based thinking.

Audit Management

Plan and Manage internal and external Audits/Revisions. Includes functionality for inlcuding multiple participants and task delegation. Read More

Internal and external audits are essential for ISO 9001 compliance. Audit management software streamlines the audit process, tracks findings, and facilitates corrective actions.

Audit management software is a valuable tool for organizations seeking to align with the seven principles of ISO 9001, a quality management system (QMS) standard. Here's how audit management software can align with these principles:

Customer Focus:
- Audit management software can help organizations gather and analyze customer feedback and complaints, providing valuable insights into customer satisfaction and expectations.
- By conducting customer-focused audits, organizations can identify areas for improvement and take action to meet customer needs more effectively.
Leadership:
- Leaders can use audit management software to set audit objectives, allocate resources, and establish audit policies and procedures.
- They can demonstrate leadership by ensuring that audits are conducted regularly and effectively, promoting a culture of quality within the organization.
Engagement of People:
- Audit management software facilitates collaboration among auditors, auditees, and other stakeholders involved in the audit process.
- It ensures that audit teams are well-trained and engaged in conducting audits and implementing corrective actions.
Process Approach:
- The software supports a systematic and structured approach to audits, from planning and preparation to execution and reporting.
- It helps organizations improve the consistency and effectiveness of their audit processes.
Improvement:
- Audit management software allows organizations to track audit findings, nonconformities, and corrective actions.
- It supports the implementation of corrective and preventive actions (CAPA) based on audit results, leading to continuous improvement in processes and quality.
Evidence-Based Decision Making:
- The software stores audit data and findings, providing evidence for decision-making related to compliance, process improvement, and resource allocation.
- Organizations can use data analytics within the software to make informed decisions about addressing audit findings and improving their QMS.
Relationship Management:
- Audit management software can help organizations manage relationships with auditors, suppliers, and other external stakeholders.
- It tracks audit schedules, findings, and follow-up actions related to external parties, ensuring that they contribute to the organization's quality goals.

In summary, audit management software aligns with the principles of ISO 9001 by providing a structured and systematic approach to audits, compliance, and quality management. It supports organizations in understanding and meeting customer expectations, demonstrating leadership commitment to quality, engaging personnel in the audit process, following a process-oriented approach to audits, driving continuous improvement through findings and corrective actions, making evidence-based decisions, and managing relationships with auditors and external parties. This alignment helps organizations maintain and enhance the quality of their products and services while ensuring compliance with ISO 9001 requirements.

Document Management

Complete and powerful module for managing and handling all types of documents. Includes integrated review process.
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Document Management & ISO 9001 Principles:

Process Approach: The software aids in defining and managing document-related processes, ensuring structured workflows and alignment with ISO 9001's process orientation.

Evidence-Based Decision Making: The software ensures clear audit trails of document changes, supporting informed decisions on control, compliance, and improvements.

Customer Focus: By documenting customer needs and expectations, the software integrates them into organizational processes and offerings.

Leadership: Key documents, policies, and procedures are consistently disseminated, helping leadership align the organization with quality objectives.

Engagement of People: The software allows employees to access, collaborate, and contribute to relevant documents, indirectly fostering engagement.

Relationship Management: Facilitating collaboration, the software ensures timely document access, enhancing teamwork and quality goal alignment.

Improvement: The software promotes continual improvement by streamlining document control, highlighting areas for enhancement, and documenting changes.

By integrating these capabilities, document management software underpins ISO 9001 compliance and quality management principles.

HR and Competence Management

Complete HR and Competency Management System. Measure GAP and plan upskilling of your workforce. Includes Course Management Functionality. Read More

Alignment with ISO 9001:
Competency Management helps manage employee training and development, ensuring that employees are competent and well-trained, which aligns with the "Engagement of People" principle.

Action Plans & Project Management
Complete and powerful project management tool integrated with End-User's Work Queue to delegate tasks and responsibility. Read More

ISO 9001 is a quality management system (QMS) standard that provides a framework for organizations to establish and maintain processes that ensure the consistent delivery of quality products and services. The standard is based on seven key principles of quality management. Action plan software can align with these principles in various ways to support an organization's quality management efforts:

Customer Focus:
- This Module helps organizations gather and analyze customer feedback and requirements to create action plans for improving customer satisfaction.
- It allows organizations to track and prioritize tasks related to addressing customer concerns and needs.
Leadership:
- The Action plan module can be used to assign and track tasks related to leadership responsibilities, such as setting quality objectives, establishing policies, and promoting a quality culture within the organization.
Engagement of People:
- The software can facilitate collaboration and communication among team members, ensuring that everyone is aware of their roles and responsibilities.
- It can help in assigning and tracking training and development activities to ensure that employees have the necessary skills and knowledge to contribute to quality objectives.
Process Approach:
- This module when integrated with the Process Module enables organizations to define and document their processes, including the steps, inputs, outputs, and responsibilities.
- It helps in identifying areas for process improvement and tracks actions taken to enhance process efficiency and effectiveness.
Improvement:
- This Module is seamlessly integrated with Deviation Management and is a valuable tool for creating and managing corrective and preventive action plans (CAPA) to address nonconformities and prevent their recurrence.
- It allows organizations to measure and monitor key performance indicators (KPIs) and initiate improvement actions based on data and trends.
Evidence-Based Decision Making:
- The Action Plan Module stores and provides access to data, evidence, and documentation related to quality management activities, making it easier for organizations to make informed decisions.
- It supports the collection and analysis of data for continuous improvement initiatives.
Relationship Management:
- The Action Plan module helps manage relationships with suppliers and other external stakeholders by tracking and assigning tasks related to supplier performance, audits, and contract management.
- It can assist in maintaining a database of supplier and customer information for effective communication and collaboration.

Action Plans & Project Management

Asset and Maintenance Management. Includes Equipment and Spare Part Management. Read More

The Maintenance Management System, which is used to plan, schedule, and track maintenance activities aligns with the seven principles of ISO 9001, a quality management system (QMS) standard, in the following ways:

Customer Focus:
- Maintenance management software helps ensure that equipment and assets are well-maintained, reducing the risk of product defects or service disruptions that could impact customer satisfaction.
- By preventing equipment failures and downtime, it indirectly contributes to meeting customer requirements and expectations.
Leadership:
- Leaders within an organization can use maintenance management software to set maintenance objectives, allocate resources, and establish policies and procedures for equipment maintenance.
- They can demonstrate leadership by prioritizing maintenance activities that directly affect product quality and safety.
Engagement of People:
- Maintenance management software facilitates collaboration among maintenance teams, operators, and other employees involved in maintenance processes.
- It helps ensure that personnel are adequately trained and engaged in maintaining equipment, contributing to overall product and service quality.
Process Approach:
- The software enables organizations to define and document maintenance processes, including work order creation, scheduling, execution, and follow-up.
- By following a structured process, organizations can improve the consistency and effectiveness of maintenance activities.
Improvement:
- Maintenance management software allows organizations to track equipment performance and maintenance history, helping identify areas for improvement.
- It supports the implementation of preventive maintenance programs, reducing breakdowns and promoting continuous improvement.
Evidence-Based Decision Making:
- The software stores data on equipment maintenance, breakdowns, and repair history, providing evidence for decision-making related to maintenance strategies and resource allocation.
- Organizations can use data analytics within the software to make informed decisions about optimizing maintenance practices.
Relationship Management:
- Maintenance management software can be used to manage relationships with equipment suppliers, maintenance contractors, and other external stakeholders.
- It helps in tracking maintenance contracts, supplier performance, and service agreements, ensuring that external parties contribute to maintaining product quality.

In summary, maintenance management software aligns with the principles of ISO 9001 by providing a systematic approach to equipment maintenance and asset management. It supports organizations in meeting customer requirements, maintaining leadership commitment to quality, engaging employees in maintenance processes, following structured maintenance processes, continuously improving maintenance practices, making evidence-based decisions, and managing relationships with relevant stakeholders. This alignment can help organizations enhance product and service quality, reduce downtime, and ensure compliance with ISO 9001 requirements.

Supplier Follow Up

Follow up Suppliers. Includes Contract Management and Rating.

Alignment with ISO 9001:
Relationship Management: Supplier management is fundamentally about managing relationships with external parties, which is consistent with the ISO 9001 principle of relationship management. Developing strong, mutually beneficial relationships with suppliers is a primary objective of a Supplier Management System

A complete QHSE Management System. Scalable. Integrated. Easy.

SoluDyne is a complete system with integrated modules and functionality for Quality Management.

Easily track compliance with ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 27001 etc.

Simple solution available on web and handheld device.

Available as Cloud Solution or installed at Customer's location.

Supports Workflows from Work Processes to Automatization of Work Flows.

Configurable Dashboards and Form Designer integrated with Work Flow Designer.

Document management, reporting of improvement proposals and near-misses, management of deviations and claims, preparation of action plans, management of audits, risk assessment as well as maintenance and calibration of equipment, etc.

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Supplier Follow Up

A complete QHSE Management System.
Scalable. Integrated. Easy.