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.

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, 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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