SOP System ISO 9001

MIT Gesundheit - SOP System ISO 9001

We develop a tailor-made SOP system for you that meets the requirements of DIN ISO 9001:2015.

An SOP system ISO 9001 describes the quality objectives and processes of a company. Particular attention must be paid to the interfaces and the precise delineation of all responsibilities. Every company is different and therefore no two SOP systems are alike.

SOP System ISO 9001 – Standards

According to the ISO standards, this may include the following points, among others:

  1. Scope
  2. Normative references
  3. Terms
  4. Context of the organization
    4.1 Understanding the organization and its context
    4.2 Understanding the requirements and expectations of interested parties
    4.3 Define the scope of the quality management sysstem
    4.4 Quality management. system and its processes
  5. Leadership
    5.1 Leadership and commitment
    5.2 Quality policy
    5.3 Roles, responsibilities and authorities in the organization
  6. Planning for the quality management system
    6.1 Measures for dealing with risks and opportunities
    6.2 Quality objectives and planning to achieve them
    6.3 Planning for changes
  7. Support
    7.1 Ressources
    7.2 Competence
    7.3 Awareness
    7.4 Communication
    7.5 Documented information
  8. Operation
    8.1 Operational planning and control
    8.2 Requirements for products and services
    8.3 Development of products and services
    8.4 Control of externally provided processes, products and services
    8.6 Release of products and services
    8.7 Control of non-conforming process results, products and services
  9. Performance evaluation
    9.1 Monitoring, measurement, analysis and evaluation
    9.2 Internal audit
    9.3 Management review
  10. Improvement
    10.1 General
    10.2 Non-conformity and corrective action
    10.3 Continuous improvement

In addition we also offer the implementation of other international standards besides ISO 9001:2015 in your quality management system.

Quality Management – Further Services

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