New ISO 9000: 2000 Requirements Discussed in the Book:
ISO 9000: 2000 (DIS) New
Requirements, 28 Requirements Checklist and Compliance Guide By: Jack Kanholm
Published by AQA
4 QUALITY MANAGEMENT SYSTEM
4.1 GENERAL REQUIREMENTS - No new requirements.
4.2 GENERAL DOCUMENTATION REQUIREMENTS
Document the quality system as required to ensure the effective operation and control of its processes (elements). (page 14)
5 MANAGEMENT RESPONSIBILITY
5.1 MANAGEMENT COMMITMENT
Demonstrate top management commitment to the development and improvement of the quality system. (page 15)
5.2 CUSTOMER FOCUS
Ensure that customer needs and expectations are determined and converted into specific requirements. (page 16)
5.3 QUALITY POLICY
Ensure that the quality policy includes commitments to meeting requirements and to continual improvement. (page 18)
Ensure that the quality policy provides a framework for establishing and reviewing quality objectives. (page 18)
Periodically review the quality policy for continuing suitability. (page 18)
5.4 PLANNING
5.4.1 Quality Objectives
Establish measurable quality objectives at relevant functions and levels within the organization. (page 20)
5.4.2 Quality Planning
Identify and plan processes and resources required for the quality system and for achieving quality objectives. (page 22)
Update quality plans in response to organizational, process or product changes. (page 22)
5.5 ADMINISTRATION
5.5.1 General
5.5.2 Responsibility and Authority - No new requirements.
5.5.3 Management Representative
Ensure that Management Representative promotes awareness of customer requirements throughout the organization. (page 25)
5.5.4 Internal Communication
Ensure effective internal communication regarding the quality management system. (page 25)
5.5.5 Quality Manual
Identify and justify in the quality manual any exclusions of ISO 9001 requirements. (page 27)
5.5.6 Control of Documents - No new requirements.
5.5.7 Control of Quality Records - No new requirements.
5.6 MANAGEMENT REVIEW
5.6.1 General
Evaluate the need for changes to the quality system, including quality policy and objectives. (page 29)
5.6.2 Review Input
Review improvement opportunities related to customer satisfaction, processes, products, and the quality system. (page 30)
5.6.3 Review Output
Include in the management review output actions related to improvement of the quality system, products, and resource needs. (page 31)
6 RESOURCE MANAGEMENT
6.1 PROVISION OF RESOURCES - No new requirements.
6.2 HUMAN RESOURCES
6.2.1 Assignment of Personnel - No new requirements.
6.2.2 Training, Awareness and Competency
Evaluate the effectiveness of training. (page 33)
Ensure that employees are aware of the importance of their activities and how they contribute to the achievement of quality objectives. (page 33)
6.3 FACILITIES - No new requirements.
6.4 WORK ENVIRONMENT
Determine and manage the work environment as needed to achieve product conformity. (page 35)
7 PRODUCT REALIZATION
7.1 Planning of Realization Processes
Establish documented quality plans for product realization processes and product validation activities. (page 37)
7.2 CUSTOMER-RELATED PROCESSES
7.2.1 Identification of Customer Requirements
Determine customer requirements, to include those that are not specified but are necessary for use or compliance with laws and regulations. (page 39)
7.2.2 Review of Product Requirements - No new requirements.
7.2.3 Customer Communication
Define and implement arrangements for communicating with customers. (page 41)
7.3 DESIGN AND/OR DEVELOPMENT
7.3.1 Design and/or Development Planning
Design and development plans shall include required review, verification and validation activities. (page 42)
7.3.2 Design and/or Development Inputs - No new requirements.
7.3.3 Design and/or Development Outputs - No new requirements.
7.3.4 Design and/or Development Review - No new requirements.
7.3.5 Design and/or Development Verification - No new requirements.
7.3.6 Design and/or Development Validation - No new requirements.
7.3.7 Control of Design and/or Development Changes - No new requirements.
7.4 PURCHASING
7.4.1 Purchasing Control
Establish criteria for initial evaluation and selection of suppliers, and for their periodic re-evaluations. (page 44)
7.4.2 Purchasing Information - No new requirements
7.4.3 Verification of Purchased Products - No new requirements
7.5 PRODUCTION AND SERVICE OPERATIONS
7.5.1 Operations Control - No new requirements
7.5.2 Identification and Traceability - No new requirements
7.5.3 Customer Property - No new requirements
7.5.4 Preservation of Product - No new requirements
7.5.5 Validation of Processes - No new requirements
7.6 CONTROL OF MEASURING AND MONITORING DEVICES
Validate software used for product verification. (page 48)
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1 PLANNING
Define and plan measurement and monitoring activities. (page 49)
8.2 MEASUREMENT AND MONITORING
8.2.1 Customer Satisfaction
Define and implement measures for obtaining and using information on customer satisfaction and dissatisfaction. (page 50)
8.2.2 Internal Audit - No new requirements
8.2.3 Measurement and Monitoring of Processes - No new requirements
8.2.4 Measurement and Monitoring of Product - No new requirements
8.3 CONTROL OF NONCONFORMITY - No new requirements
8.4 ANALYSIS OF DATA
Collect and analyze data to determine the effectiveness of the quality system and for identifying where improvements can be made. (page 53)
8.5 IMPROVEMENT
8.5.1 Planning for Continual Improvement
Plan and manage for continual improvement of the quality system, including the use of quality policy and objectives and quality performance data. (page 54)
8.5.2 Corrective Action - No new requirements
8.5.3 Preventive Action - No new requirements
For more information
about ISO 9000:2000 (DIS) NEW REQUIREMENTS
28 Requirements Checklist and Compliance Guide
By: Jack Kanholm Published by AQA
New ISO 9000: 2000 Requirements