Objective
Help organizations to:
- Design and implement a QMS build acc. with ISO 9001 requirements with the final goal of system 3rd party certification (external certification)
- Maintain and continuous improve implemented system after initial certification
Proposed activities:
- Collect and evaluate existing system documentation already available and in place
- Gap Analysis against ISO 9001:2015 requirements to identify the differences that need to be addressed, in order to ensure QMS meets all the new requirements
- Provide appropriate training for process owners involved in QMS design and implementation (Internal trainings on ISO 9001:2015 requirements, Risk Analyze, Quality Tools, Problem Solving Methodologies…)
- QMS Design:
- QMS documentation creation and/or modification based on Gap Analysis results
- Processes Map, Processes definitions/diagrams, Interactions between internal processes, Processes Owners (Responsibilities)
- Support processes from remote/external locations (Interactions with local processes)
- Records for data collection, evaluation and and monitoring
- QMS Implementation
- Processes implementation (Risk Analysis)
- Data collection and evaluation
- Processes monitoring (records implementation, KPIs)
- Internal audits of all defined processes
- Internal audits Programm, Audits Planning, Non-conformities and Audits Reports
- Corrections/Corrective actions implementation based on internal audits findings
- Follow-up audit for CAs effectivenes verification
- Management Review
- Support during external audit
- Support for audit findings closure