ISO 9001: Clauses 4 through 6

Section 4: Quality Management System

  • The company must define its processes and show the sequence and interaction of these processes. (This can be done using process mapping or process flow charts.)
  • Determine the testing and documentation needed
  • Documentation is less restrictive and the company can determine most of the documentation they require.
  • Six procedures are required by the standard and about 19 records. You decide the additional documentation and records needed fro your organization.

Section 5: Management Responsibility

  • Top management must provide evidence of its commitment to the development and improvement of the quality management system.
  • Top management is responsible to ensure that customer needs and expectations are determined, converted into requirements, and fulfilled with the aim of achieving customer satisfaction.
  • A quality policy must be established to meet the standard requirements and communicated to all employees.
  • The quality objectives must be established, measurable and consistent with the quality policy and include a commitment to continual improvement.
  • Responsibilities and authorities must be defined and communicated.
  • A management representative must be appointed.
  • The leadership must communicate about the quality management system processes and effectiveness.
  • Management review meetings are required with specific inputs and outputs.

Section 6: Resource Management

  • The organization must determine basic competence for employees, hire to meet the competencies, provide training, and¬†determine effectiveness of training.
  • The organization must identify, provide and maintain the facilities it needs to achieve conformity of product including: workspace and associated facilities; equipment, hardware and software; and supporting services.
  • The organization must identify and manage the work environment with consideration of the human and physical factors needed to achieve conformity of product.

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