Implement the required
processes of Quality Management according to ISO 9001
with reduced investment in external consulting:
1
Content
2
The novelties within
ISO 9001:2015
3
PDCA cycle
4
Main processes of ISO 9001
5
Processes of ISO 9001 in detail
5.1
Process overview
5.2
Process groups of ISO 9001
5.3
Management processes
5.3.1
Quality policy and organisation
5.3.1.1
Interfaces of quality policy and organization
5.3.1.2
Definition of quality policy
5.3.1.3
Operationalization of quality policy
5.3.2
Development and maintenance of the QM-system
5.3.2.1
Interfaces of development and maintenance of the QM-system
5.3.2.2
Definition of medium term maintenance and development activities
5.3.2.3
Management of improvement proposals
5.3.3
Evaluation and optimization of the QM-system
5.3.3.1
Interfaces of evaluation and optimization of the QM-system
5.3.3.2
Maturity evaluation
5.3.3.3
Management review
5.3.3.4
Short term optimization activities
5.3.4
Document and record control
5.3.4.1
Interfaces of document and record control
5.3.4.2
Organization of document and record control
5.3.4.3
Operational document and record control
5.3.5
Quality documentation and reporting
5.3.5.1
Interfaces of quality documentation and reporting
5.3.5.2
Maintenance of the documentation of the quality management system
5.3.5.3
Ensuring the quality documentation
5.3.5.4
Actualization of quality system procedures
5.3.5.5
Quality reporting
5.3.6
Process management
5.3.6.1
Interfaces of process managements
5.3.6.2
Process management review
5.3.6.3
Process coordination
5.3.6.4
Process controlling
5.3.6.5
Implementation of business processes
5.3.6.6
Process review
5.3.6.7
End of life for business processes
5.3.7
Management of conformity risks
5.3.7.1
Interfaces of the management of conformity risks
5.3.7.2
Risk analysis from conformity perspective
5.3.7.3
Risk prevention activities
5.3.7.4
Risk monitoring and reporting
5.3.8
Knowledge Management
5.3.8.1
Interfaces of knowledge managements
5.3.8.2
Gathering know how relevant documents
5.3.8.3
Knowledge review
5.4
Resource processes
5.4.1
Personnel qualification
5.4.1.1
Interfaces of personnel qualification
5.4.1.2
Actualization of qualification requirements
5.4.1.3
Planning of activities for personnel qualification
5.4.1.4
Monitoring of activities for personnel qualification
5.4.2
Infrastructure qualification
5.4.2.1
Interfaces of infrastructure qualification
5.4.2.2
Actualization of infrastructure requirements
5.4.2.3
Planning of activities for infrastructure qualification
5.4.2.4
Monitoring of activities for infrastructure qualification
5.4.3
Budget for quality management
5.4.3.1
Interfaces of budget for quality management
5.4.3.2
Budgeting for quality management
5.4.3.3
Controlling for quality management
5.5
Improvement processes
5.5.1
Supplier audits
5.5.1.1
Interfaces of supplier audits
5.5.1.2
Supplier audit planning
5.5.1.3
Supplier audit execution
5.5.2
Internal audits
5.5.2.1
Interfaces of internal audits
5.5.2.2
Organization of self assessment
5.5.2.3
Self assessment
5.5.2.4
Audit planning
5.5.2.5
Audit execution
5.5.3
Customer satisfaction
5.5.3.1
Interfaces of customer satisfaction
5.5.3.2
Customer satisfaction surveys
5.5.3.3
Customer feedback management
5.5.3.4
Monitoring of customer complaints
5.5.4
Control of defective products and services
5.5.4.1
Interfaces of control of defective products and services
5.5.4.2
Organization of control of defective products and services
5.5.4.3
Control of defective products
5.5.4.4
Control of defective services
5.5.5
Activities for the QM-system
5.5.5.1
Interfaces of the activities for the QM-system
5.5.5.2
Implementation planning of activities for the QM-system
5.5.5.3
Implementation management of activities for the QM-system
5.5.5.4
Corrective and preventive actions
5.5.5.5
Reporting for corrective and preventive actions
5.6
Business processes
5.6.1
Marketing and sales
5.6.2
Planning
5.6.3
Production and service provision
5.6.4
Dispatch and handover
5.6.5
Customer service
5.6.6
Product and service development
5.6.7
Procurement
5.6.8
Logistics
5.6.9
Operational quality assurance
5.6.10
Finance and controlling
5.6.11
IT
5.6.12
Facility management and maintenance
5.6.13
Human resources
5.7
Operational quality management processes
5.7.1
Management of test equipment
5.7.1.1
Interfaces of management of test equipment
5.7.1.2
Organization of management of test equipment
5.7.1.3
Operational management of test equipment
6
Glossary
6.1
Process documents
6.2
Involved roles of quality management
7
Responsibility matrices (RACI)
7.1
Responsibility matrices management processes
7.1.1
Quality policy and -organization
7.1.2
Development and maintenance of the QM system
7.1.3
Evaluation and optimization of the QM system
7.1.4
Document and record control
7.1.5
Quality documentation and reporting
7.1.6
Process management
7.1.7
Management of conformity risks
7.1.8
Knowledge management
7.2
Responsibility matrices resource processes
7.2.1
Personnel qualification
7.2.2
Resource qualification
7.2.3
Budget for quality management
7.3
Responsibility matrices improvement processes
7.3.1
Supplier audits
7.3.2
Internal audits
7.3.3
Customer satisfaction
7.3.4
Control of defective products and services
7.3.5
Activities for the QM system
7.4
Responsibility matrices operational quality management
7.4.1
Management of test equipment |
