|
ISO 9001:2000 Clauses
|
Summary of Requirements
|
| 4. Quality Management System |
|
| 4.1 General Requirements
|
Implement quality system
and continually improve it |
| 4.2 Documentation Requirements
|
|
| 4.2.1 General |
Include the required
documents and records |
| 4.2.2 Quality Manual
|
Establish
and maintain a quality manual |
| 4.2.3 Control of Documents
|
Ensure documents are
at right status in right places |
| 4.2.4 Control of Records
|
Identify records and
keep as evidence of conformity |
| |
|
| 5. Management Responsibility
|
|
| 5.1 Management Commitment
|
Show evidence of top
management commitment |
| 5.2 Customer Focus |
Meet the requirements
and satisfy your customers |
| 5.3 Quality Policy |
Have top management
express quality intentions |
| 5.4 Planning |
|
| 5.4.1 Quality Objectives
|
Set measurable targets
for products and processes |
| 5.4.2 Quality Management System
Planning |
Carry out plans for
quality system and its processes |
| 5.5 Responsibility, Authority, and
Communication |
|
| 5.5.1 Responsibility and Authority
|
Make sure everyone
knows their duties and roles |
| 5.5.2 Management Representative
|
Appoint a manager as
focal point for quality system |
| 5.5.3 Internal Communications
|
Keep everyone informed
of system effectiveness |
| 5.6 Management Review |
|
| 5.6.1 General |
Review the quality
system at planned intervals |
| 5.6.2 Review Input |
Ensure the required
agenda topics are covered |
| 5.6.3 Review Output |
Record the decisions
and actions from reviews |
| |
|
| 6. Resource Management
|
|
| 6.1 Provision of Resources
|
Provide necessary resources
to meet requirements |
| 6.2 Human Resources |
|
| 6.2.1 General |
Ensure everyone working
in system is competent |
| 6.2.2 Competence, Awareness, and
Training |
Train personnel and
recognize their contributions |
| 6.3 Infrastructure |
Provide facilities,
equipment, and support services |
| 6.4 Work Environment |
Manage combination
of human and physical factors |
| |
|
| 7. Product Realization
|
|
| 7.1 Planning of Product Realization
|
Plan and develop processes for product
realization |
| 7.2 Customer-Related Processes
|
|
| 7.2.1 Determination of Requirements
Related to the Product |
Define customer, regulatory, and
own requirements |
| 7.2.2 Review of Requirements Related
to the Product |
Review requirements before committing
to customer |
| 7.2.3 Customer Communication
|
Talk to customers about products
and complaints |
| 7.3 Design and Development
|
|
| 7.3.1 Design and Development Planning
|
Plan design stages, activities,
and responsibilities |
| 7.3.2 Design and Development Inputs
|
Identify and review input requirements
for design |
| 7.3.3 Design and Development Outputs
|
Prepare design outputs and approve
before release |
| 7.3.4 Design and Development Review
|
Review ability of design results
to meet requirements |
| 7.3.5 Design and Development Verification
|
Verify the design outputs meet input
requirements |
| 7.3.6 Design and Development Validation
|
Validate the product is okay for
application or use |
| 7.3.7 Control of Design and Development
Changes |
Review, verify, and validate any
design changes |
| 7.4 Purchasing |
|
| 7.4.1 Purchasing Process
|
Evaluate, select, monitor, and control
your suppliers |
| 7.4.2 Purchasing Information
|
Create purchase orders describing
supplier products |
| 7.4.3 Verification of Purchased
Products |
Check purchases to ensure they meet
requirements |
| 7.5 Production and Service Provision
|
|
| 7.5.1 Control of Production and
Service Provision |
Plan and control production and
service activities |
| 7.5.2 Validation of Processes for
Production and Service Provision |
Examine the process if you can’t
check the product |
| 7.5.3 Identification and Traceability
|
Identify the product and its inspection
and test status |
| 7.5.4 Customer Property
|
Exercise care with any customer
property |
| 7.5.5 Preservation of Product
|
Handle, store, package, and protect
the product |
| 7.6 Control of Monitoring and Measuring
Devices |
Calibrate measuring equipment for
valid results |
| |
|
| 8. Measurement, Analysis, and
Improvement |
|
| 8.1 General |
Plan, measure, analyze, and improve
processes |
| 8.2 Monitoring and Measurement
|
|
| 8.2.1 Customer Satisfaction
|
Ask customers what they think about
your products |
| 8.2.2 Internal Audit |
Evaluate compliance and effectiveness
of system |
| 8.2.3 Monitoring and Measurement
of Processes |
See if processes are achieving planned
results |
| 8.2.4 Monitoring and Measurement
of Product |
Verify products meet acceptance
criteria |
| 8.3 Control of Nonconforming Product
|
Prevent use or delivery of nonconforming
product |
| 8.4 Analysis of Data |
Analyze effectiveness and identify
improvements |
| 8.5 Improvement |
|
| 8.5.1 Continual Improvement
|
Continually improve effectiveness
of system |
| 8.5.2 Corrective Action
|
Fix problems and prevent recurrence
|
| 8.5.3 Preventive Action
|
Avoid potential problems by preventing
occurrence |
Larry Whittington is President of Whittington & Associates,
a quality system training, consulting, and auditing company located in
Marietta, Georgia. He is an ASQ Certified Software Quality Engineer and
Quality Auditor. Both the RAB and IRCA have certified him as an ISO 9000
Lead Auditor. He is also a trained TickIT Lead Auditor for software systems
and a certified QS-9000 Lead Auditor for the automotive industry. Mr.
Whittington can be contacted at 770-517-7944, or by e-mail
at Larry@WhittingtonAssociates.com.
