Challenges in practice
Based on standards such as ISO 9001 VDA 6.3, .ISO 13485, etc., companies are required to constantly monitor the maintenance of various standards in relation to company processes and to address and ultimately eliminate any deviations identified in continuous improvement processes in accordance with the standards.
Depending on your customers' specifications and the risk assessment of your products, all areas of the company & value chain, systems, processes, products, suppliers, customers, etc. must be subject to ongoing auditing. Given the increasing importance and complexity of internal and external audits as part of a QM system, companies need a highly professional, software-based solution that supports the entire audit process in full compliance with the relevant legislation and standards.
In general
QS1 supports the entire audit management process, from planning and implementation through to comprehensive analyses. QS1 provides question catalogues and evaluation catalogues for all common standards and norms as well as predefined processes. These can be easily customised to your requirements and needs.
Planning and controlling
Use QS1 to plan and control the audit process for suppliers, products and all internal management processes.
The system proposes new audits based on rules stored in the master data (classification, frequency, etc.) and the results of previous audits. These audits are planned and monitored on a graphical basis or using the QS1 calendar functions (these allow, among other things, synchronisation with the Outlook calendar of the respective auditor).
Execution
Various freely configurable workflow processes are available for carrying out audits. These include support for remote audits, document audits and self-assessment processes.
Predefined question catalogues can be adapted very easily in individual audits (e.g. addition of questions from previous audits)
In the course of the feedback (which can also be provided via mobile, web portal or offline), QS1 guides the user through the audit process in a convenient way. In addition to functions for quick collective answers to questions and groups, the current (interim) result is available at any time or in real time.
For the recording of results from external auditors (e.g. customer audits), in addition to convenient import functions, a separate process is available for the quick and easy recording of chapter results, deviations and measures.
Deviations
QS1 supports the recording of deviations and measures at all points in the audit process!
In the non-conformities, extensive options are available for error classification and the allocation of supplementary information (images, documents, references, etc.). Deviations can also be analysed further as part of the QS1-CAPA processes.
The measures recorded for a deviation are part of the QS1 measures management and allow extensive options for responsibilities, deadline and status monitoring and effectiveness checks.
Supplier Management
QS1 offers extensive options for supplier management and for the process of analysing potential. This can also be done either by integrating suppliers via a web portal or via PDF documents to be completed (and re-imported) by the supplier.
All audit results of a supplier are included in the supplier evaluation as well as in the supplier's approval status. This also allows the blocking of a supplier (or even individual products) to be mapped. Furthermore, these results can also have an influence on the process of future incoming goods inspections (e.g. adjustment of inspection dynamisation).
- Predefined question catalogue for all common standards
- Freely customisable assessment schemes with configurable calculation methods
- Graphical audit planning with integrated calendar function
- Invitation management
- Workflow-based audit processing (incl. team, agenda and checklists)
- Audit execution optionally via mobile or web portal
- Support for remote and document audits
- Supplier self-assessment and potential analysis
- Product audits and requalification
- Fast results recording of your customer audits
- Deviation and action management (optionally with CAPA support)
- Status tracking and history
- Integration into the QS1 processes supplier evaluation, self-assessment and inspection control
- Analyser and knowledge management system
