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> Audit of quality management system under ISO-11135
Audit of quality management system under ISO-11135
Management Responsibility
1.1* - Has top management demonstrated commitment to the quality management system (QMS)?
1.2* - Has a quality policy been established and communicated?
1.3* - Has a quality objectives plan been developed?
1.4* - Is there evidence of management reviews being conducted?
1.5* - Are responsibilities and authorities defined and communicated?
Resource Management
2.1* - Are resources (human, infrastructure, and financial) adequate for QMS implementation?
2.2* - Are personnel competent and adequately trained for their assigned tasks?
2.3* - Is there a documented training program in place?
2.4* - Are work environment conditions suitable for product realization?
2.5* - Are appropriate monitoring and measuring equipment available and calibrated?
Product Realization
3.1* - Is there a documented process for product realization?
3.2* - Are customer requirements adequately determined and documented?
3.3* - Are product design and development processes controlled?
3.4* - Are purchasing and supplier control procedures in place?
3.5* - Is there a process for identifying, controlling, and disposing of non-conforming products?
Measurement, Analysis, and Improvement
4.1* - Are quality objectives being measured and monitored?
4.2* - Is there a process for collecting and analyzing data related to customer satisfaction?
4.3* - Are internal audits being conducted and documented?
4.4* - Is there a process for corrective and preventive actions?
4.5* - Are management reviews being conducted to evaluate the QMS effectiveness?
Note: This checklist provides a general outline and may need to be customized based on specific requirements and processes related to ISO-11135.
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