The new QM Process Library

Processes Management Resources Improvement Business Operational Quality Management

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1. PDCA Cycle

Positioning of the process groups within the ISO 9001 PDCA cycle referring to the chapters of the standard.

2. Processes

2.1. Management Processes

2.1.1. Quality Policy and Organization

Interfaces Quality Policy and Organization

Integration to other ISO 9001-process groups and main information flows thereto

Definition of Quality Policy

Definition, formulation and documentation of the quality policy

Operationalization of Quality Policy

Operationalization and execution of implementation activities for the quality policy

2.1.2.Development and Maintenance of QM System

Interfaces Development and Maintenance of QM System

Integration to other ISO 9001-process groups and main information flows thereto

Definition of Medium Term Maintenance and Development Activities

Definition of potential medium term activities for the future maintenance and development of the quality management in the company

Management of Improvement Proposals

Intaking of, evaluation of and relevant reaction to improvement proposals including feedback to the proposer

2.1.3. Evaluation and Optimization of QM System

Interfaces Evaluation and Optimization of QM System		Integration to other ISO 9001-process groups and main information flows thereto
Maturity Evaluation		Diagnosis and evaluation of the maturity of the quality management system
Management Review		Definition of a structured portfolio of future developments of the quality management in the company based upon a complete review of the effectivity of the quality management system
Short Term Optimization Activities		Definition of potential short term optimization activities for the quality management in the company and as far as possible immediate implementation

2.1.4. Document and Record Control

Interfaces Document and Record Control

Integration to other ISO 9001-process groups and main information flows thereto

Organization of Document and Record Control

Organization of processes and procedures for the life cycle management of documents and records needed to be controlled:

creation
checking
approval
distribution
cancellation (documents)
archiving period (records)

Operational Document and Record Control

Operational life cycle management of documents and records needed to be controlled:

creation
checking
approval
distribution
cancellation (documents)
archiving period (records)

2.1.5. Quality Documentation and Reporting

Interfaces Quality Documentation and Reporting		Integration to other ISO 9001-process groups and main information flows thereto
Maintenance of Documentation of the QM - System		Permanent actualization and further development of the documentation of the quality management system
Ensuring the Quality Documentation		Ensuring of operational documentation of quality operations
Actualization of Quality System Procedures		Provision of relevant reporting for the quality management
Quality Reporting		Creation of relevant reporting for the quality management

2.1.6. Process Management

Interfaces Process Management		Integration to other ISO 9001-process groups and main information flows thereto
Process Management Review		Continual validation and improvement of the procedures and methodologies of the company wide process management
Process Coordination		Coordination of life cycles of company wide processes and ensuring friction free integration
Process Controlling		Assessment of company wide processes by analysis of their performance indicators and deduction of improvement potentials
Implementation of Business Processes		Design and implementation of new respective modified business processes according to the business requirements based upon the formal requirements of process management
Process Review		Checking the company wide processes for problem areas on regular basis and introduction of necessary activities thereof
End of Life for Business Processes		Controlled shut down of usage of defined business processes

2.1.7. Management of Conformity Risks

Interfaces Management of Conformity Risks		Integration to other ISO 9001-process groups and main information flows thereto
Risk Analysis from Conformity Perspective		Analysis of criticality of products and services from conformity perspective
Risk Prevention Activities		Activities against detected conformity risks including process and responsibilities thereto
Risk Monitoring and Reporting		Management of risk avoiding activities (surveillance, triggering of corrective actions) and reporting thereto

2.1.8. Knowledge Management

Interfaces Knowledge Management

Integration with other ISO 9001-process groups and main information flows thereto

Gathering Know How Relevant Documents

Structured collection and archiving of the knowledge of the (quality-)organization

Knowledge Review

Review of the actuality of the knowledge management database

2.2. Resource Processes

2.2.1. Personnel Qualification

Interfaces Personnel Qualification		Integration to other ISO 9001-process groups and main information flows thereto
Actualization of Qualification Requirements		Review of requirements to personnel qualification and triggering of adequate activities to ensure sufficient qualification in case of changed requirements
Planning of Activities for Personnel Qualification		Planning of adequate activities to ensure sufficient qualification according to the quality requirements
Control of Activities for Personnel Qualification		Control of execution and effectivity of adequate activities to ensure sufficient qualification according to the quality requirements

2.2.2. Infrastructure Qualification

Interfaces Infrastructure Qualification		Integration to other ISO 9001-process groups and main information flows thereto
Actualization of Infrastructure Requirements		Review of requirements to infrastructure and triggering of adequate activities to ensure sufficient infrastructure in case of changed requirements
Planning of Activities for Infrastructure Qualification		Planning of adequate activities to ensure sufficient infrastructure according to the quality requirements
Control of Activities for Infrastructure Qualification		Control of execution and effectivity of adequate activities to ensure sufficient infrastructure according to the quality requirements

2.2.3. Budget for Quality Management

Interfaces Budget for Quality Management

Integration to other ISO 9001-process groups and main information flows thereto

Budgeting for Quality Management

Planning of sufficient financial resources to fulfill the quality requirements and targets

Controlling for Quality Management

Economic control of utilization of financial resources for the quality management

2.3. Improvement Processes

2.3.1. Supplier Audits

Interfaces Supplier Audits

Integration to other ISO 9001-process groups and main information flows thereto

Supplier Audits Planning

Periodical and event triggered planning of supplier audits

Supplier Audits Execution

Execution of scheduled periodical respective event triggered supplier audits according to the supplier audit planning

2.3.2. Internal Audits

Interfaces Internal Audits		Integration to other ISO 9001-process groups and main information flows thereto
Organization of Self Assessments		Organization of the internal evaluation of the quality management system from inside the organization
Self Assessment		Planned and event triggered internal evaluation of the quality management system from inside the organization
Audit Planning		Periodic and event triggered planning of internal audits
Audit Execution		Execution of scheduled periodical respective event triggered internal audits according to the internal audit planning

2.3.3. Customer Satisfaction

Interfaces Customer Satisfaction		Integration to other ISO 9001-process groups and main information flows thereto
Customer Satisfaction Surveys		Proactive collection of information about the satisfaction of the consumers with the supplies of the company and introduction of necessary activities thereof
Customer Feedback Management		Management of feedback (complaints and commendation) from customers and introduction of necessary activities thereof
Monitoring of Customer Complaints		Monitoring of open customer complaints to enable necessary counter activities

2.3.4. Control of Defective Products and Services

Interfaces Control of Defective Products and Services		Integration to other ISO 9001-process groups and main information flows thereto
Organization of Control of Defective Products and Services		Setup of processes, definition of responsibilities and documentation standards for the control of defective products and services
Control of Defective Products		Ensuring that defective products are identified and indicated removed from the further production respective service process subject to a special deviation permit in case of further usage respective rework accordingly documented in all steps of their further treatment analyzed for defect causes undergoing corrective actions with defined responsibilities to avoid recurrence of the detected defects causally
Control of Defective Services		Ensuring that defective services are identified and documented removed from the further production respective service process subject to a special deviation permit in case of further usage respective rework accordingly documented in all steps of their further treatment analyzed for defect causes undergoing corrective actions with defined responsibilities to avoid recurrence of the detected defects causally