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Quality management system guidance

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Planning

4.0 Organizational context

This is the 'Plan' part of the PDCA process. Establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organizational policies. This is often implemented using stated objectives, work instructions or procedures as required for consistent process output.

  • Identify external and internal issues relevant to the organization's operational purpose and strategic direction. Monitor and review these issues for change.
  • Identify interested parties (stakeholders), their requirements and their impact the quality, environmental or OH&S management system. Monitor and review stakeholder requirements for change.
  • Base the scope of the management system on the external and internal issues - Clause 4.1, stakeholder needs - Clause 4.2, and the types of operational activity that your organization undertakes - Clause 8.1.
  • Define the quality management system's processes, their sequence and interaction, and the quality related performance indicators needed to monitor the process.

How to apply the latest quality management principles

Apply the quality management principles (QMPs) in the context of your business's own particular operations by reviewing and documenting its activities in the context of each quality management principle. The ISO 9000 quality management principles are embodied with in the individual requirements of ISO 9001 and the table below relates these principles to the applicable clauses and requirements:

ISO 9000 Principles ISO 9001 Base Clauses Action & Compliance Summary ISO 9001 Clauses
Process approach and Relationship management 4.4.1 Processes (a, b, & c) Identify external and internal issues relevant to the organization's operational purpose and strategic direction. Monitor and review these issues for change. 4.1 Understanding Context
Relationship management 4.4.1 Processes (a, b, & c) Identify interested parties (stakeholders), their requirements and their impact the management system. Monitor and review stakeholder requirements for change. 4.2 Interested Parties
Process approach 4.4.1 Processes (a, b, & c) Base the scope of the management system on the external and internal issues - 4.1, stakeholder needs - 4.2, and the types of operational activity that your organization undertakes - 8.0. 4.3 Determining Scope
Process approach 4.4.1 Processes (a, b, & c) Define the management system processes, their sequence and interaction, and the quality performance indicators needed to monitor process performance. 4.4 Management System Processes

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ISO Navigator™ is our FREE online training tool that shows you how to apply the principles of PDCA to your operations. We also offer many helpful templates that get you on the road to documenting your management system, please visit the download page.