Challenges in practice
Audits have long since become more than just mandatory appointments on the calendar. Companies today must continuously comply with a multitude of national and international standards such as ISO 9001, VDA 6.3, and ISO 13485 – and be able to demonstrate this compliance at any time. The requirements are increasing, the audit intervals are shortening, and the expectation of transparency and traceability is constantly growing.
Depending on customer requirements, regulatory specifications, and product-related risks, all areas of the company and its value chain must be audited regularly – from processes and systems to products, suppliers, and other stakeholders.
In practice, this means: significant coordination efforts, decentralized documentation, manual tracking of actions, and a steadily increasing administrative burden. Without structured, software-supported solutions, it is becoming increasingly difficult to plan audits efficiently, conduct them in accordance with standards, and evaluate them effectively.
Solution QS1
In general
QS1 digitally maps the entire audit process seamlessly – from structured planning and standards-compliant execution to detailed evaluations and analyses. Whether supplier audit, product or process audit, or internal system audit: with QS1, you manage all types of audits centrally on a single platform.
For all common norms and standards, predefined question and assessment catalogs as well as proven audit processes are available. These can be flexibly adapted to your individual requirements or defined entirely from scratch – for maximum design freedom while maintaining the highest standards compliance. In addition, freely definable checklists help ensure the smooth execution of your audits.
Planning and controlling
Based on defined rules in the master data – such as classifications, audit intervals, and risk assessments – and taking past audit results into account, QS1 automatically generates suggestions for upcoming audits. A clear overview of upcoming audits is thus presented. This ensures that no audit deadlines are missed and that high-risk areas are prioritized.
Planning and monitoring are conveniently managed via graphical overviews and integrated calendar functions. Audit appointments can be coordinated transparently and, if required, synchronized with the respective auditor's Outlook calendar – for seamless integration into daily workflows.
Execution
QS1 provides flexible and freely configurable workflows for conducting audits. Whether remote audit, document audit, or structured self-assessment – various scenarios can be mapped system-supported and in compliance with standards.
Predefined questionnaires can be customized and supplemented directly within each audit, for example, with content from previous audits or specific customer requirements. This ensures that every audit remains dynamic and practical.
Users are guided intuitively through the entire audit process during feedback – whether via mobile device, the web portal, or offline. Features such as the quick batch answering of questions or question groups ensure efficient processing. Current statuses and assessments are available at any time in real time or afterward.
For external auditors, such as those conducting customer audits, QS1 offers convenient import options as well as a separate, streamlined data entry process for the structured transfer of chapter assessments, deviations, and resulting corrective actions.
Deviations
QS1 supports the structured recording of deviations directly during the ongoing audit – regardless of where in the process they occur. This allows findings to be documented without any media breaks and processed immediately.
Differentiated classification and evaluation criteria are available for each deviation. Supplementary information such as images, documents, references, or evidence can be easily stored. If required, deviations can be seamlessly transferred to the QS1 CAPA processes to ensure systematic root cause analysis and sustainable error prevention.
The defined corrective actions are fully integrated into QS1's corrective action management system. Clear responsibilities, deadline and status monitoring, and documented effectiveness reviews ensure transparency, accountability, and complete traceability until completion.
Supplier Management
QS1 supports the structured recording of deviations directly during the ongoing audit – regardless of where in the process they occur. This allows findings to be documented without any media breaks and processed immediately.
Differentiated classification and evaluation criteria are available for each deviation. Supplementary information such as images, documents, references, or evidence can be easily stored. If required, deviations can be seamlessly transferred to the QS1 CAPA processes to ensure systematic root cause analysis and sustainable error prevention.
The defined corrective actions are fully integrated into QS1's corrective action management system. Clear responsibilities, deadline and status monitoring, and documented effectiveness reviews ensure transparency, accountability, and complete traceability until completion.
QS1 “Self-assessment” – structured feedback using a system
With its self-assessment function, QS1 provides a flexible tool for structured, fillable, and re-importable PDF forms. External partners can conveniently collect information offline or digitally and send it back to you – fully integrated into your existing QS1 processes.
The incoming data is not only documented but also automatically evaluated, analyzed, and transferred into defined workflows. This transforms simple feedback into a solid basis for decision-making – including scoring, status monitoring, and the derivation of action items.
The applications extend far beyond traditional supplier management: Whether customer surveys, compliance checks, risk analyses, marketing surveys, or internal self-assessments – the QS1 self-assessment is a versatile instrument for structured information gathering with direct system impact.
- Standards-compliant: Predefined questionnaires for all common standards
- Flexibility: Freely customizable assessment schemes with configurable calculation methods
- Planning tool: Graphical audit planning with integrated calendar
- Coordination: Invitation and participant management
- Efficiency: Workflow-based audit processing including team, agenda, and checklists
- Access: Conduct audits on mobile devices or via a web portal
- Digital: Support for remote and document audits
- Suppliers: Integrated self-assessment and potential analysis
- Product audits: Conducting and requalifying audits
- Customer audits: Rapid results capture and feedback
- Deviation management: Includes corrective action and CAPA processes
- Transparency: Status tracking and complete history
- Process integration: Integration into supplier evaluation, self-assessment, and audit control
- Insights: Analyzer and knowledge management system for analyses and reports
Does this sound familiar?
- Audits are not simply "appointments," but rather a constant pressure to demonstrate compliance: ISO 9001, VDA 6.3, ISO 13485, and other standards must be demonstrably met at all times, despite increasing requirements and shorter audit intervals.
- The audit landscape is becoming increasingly complex: Processes, systems, products, suppliers, etc., must be audited regularly and based on risk. This is coordination- and planning-intensive, especially given increasing requirements and shorter audit intervals.
- Documentation is decentralized and inconsistent: Questionnaires, assessments, findings, and evidence are scattered; standards are interpreted differently, making comparability across audits difficult.
- While deviations are identified during audits, their implementation often stalls: Corrective actions are tracked manually, responsibilities are unclear, and effectiveness reviews are neglected. As a result, findings reappear in the next audit.
- External audits (customer/supplier) create media breaks: results arrive as PDF/Excel, chapter evaluations and measures have to be laboriously transferred; status and history cannot then be cleanly integrated.
This should be achieved through a robust process
- Digital end-to-end audit process: Planning => Execution => Deviations => Corrective Action/CAPA => Effectiveness Review => Reporting.
- Risk-based audit planning: Intervals, classifications, risk assessments, and results from past audits must be automatically incorporated into planning and prioritization.
- Standardized yet flexible catalogs: Predefined question and assessment catalogs for common standards, adaptable to customer requirements and internal processes.
- Efficient execution in all scenarios: Mobile, web portal, or offline; remote and document audits, self-assessments, and team audits must be reliably implemented.
- Direct access to deviations: Findings must be captured, classified, and documented (documents/images/references) directly during the audit and seamlessly integrated into corrective action and CAPA processes.
- Transparency for management: Dashboards, trends, top findings, corrective action effectiveness, and audit status must be available in real time, including a complete history and learning loop for future audits.
Coverage in QS1
- Digitally maps the entire audit process and centrally manages all types of audits on a single platform: internal system audits, process and product audits, supplier audits, and customer audits.
- Provides predefined question and assessment catalogs for common standards and simultaneously allows for freely definable catalogs and checklists, as well as flexible assessment schemes with configurable calculation methods.
- Automatically generates suggestions for upcoming audits based on master data rules and past audit results, prioritizes high-risk areas, and prevents missed deadlines.
- Supports convenient planning and coordination via graphical overviews, calendar functions, invitation and participant management, and optional synchronization with Outlook calendars.
- Guides users through the audit process (mobile, web portal, offline) including efficient features such as batch responses, real-time progress updates, and dynamic adjustment of catalogs during the actual audit.
- Captures deviations directly during the audit, structured, classified, and supplemented with evidence (documents, images, references); seamlessly transfers findings into CAPA/error analysis and fully manages corrective actions via the integrated action management system, including deadlines, status, escalations, and effectiveness reviews.
- Integrates suppliers into audit and self-assessment processes (web portal or re-importable PDF self-assessments), automatically evaluates incoming data, and links results to supplier evaluations and approval status, up to and including blocking and consequences in downstream processes.
- Consolidates all results, evaluations, deviations, and corrective actions in BI/dashboards, reports, and analyzer functions, creating a learning system: Insights from audits guide the planning, content, and priorities of future audits for continuous improvement.
Your result: Reduced coordination and administrative effort, standards-compliant audits with a complete history, faster processing and effective closure of findings, reliable management transparency regarding risks and trends, and a closed audit control loop that operates across company boundaries.
Your advantages
- Questionnaires: Predefined for all common standards, ready to use immediately
- Evaluation: Customizable evaluation schemes with configurable calculation methods
- Planning: Graphical audit planning with integrated calendar and scheduling
- Checklists: Customizable checklists for easier audit organization.
- Invitations: Convenient management of auditors, participants, and appointments
- Workflow: Structured audit processing including team, agenda, and checklists
- Execution: Flexible via mobile or web portal
- Remote: Support for remote and document audits
- Suppliers: Easily integrated self-assessment and potential analysis
- Products: Securely manage product audits and requalifications
- Customers: Rapid recording of customer audit results
- Deviations: Recording and corrective action management, optionally with CAPA
- Tracking: Status tracking and complete history
- Integration: Integration into QS1 processes such as supplier evaluation, self-assessment, and inspection control
- Analysis: Comprehensive analyzer and knowledge management system
