Plain English Overview of ISO 9001 2000

ISO 22000 Food Safety Management Standard

OHSAS 18001 Occupational Health and Safety Standard

ISO 13485 2003 Medical Device Management Standard

ISO 14001 2004 Environmental Management Standard

ISO 27001 Information Security Management Standard

ISO 27002 Information Security Management Standard

ISO 90003 Software Quality Management Standard

NFPA 1600 Business Continuity Management Standard

ISO 9001 QUALITY MANAGEMENT STANDARD

4 Systemic Requirements

4.1
Establish your 
quality system

•  Develop your quality management system.

•  Implement your quality management system.

•  Improve your quality management system.

4.2
Document your 
quality system

4.2.1 Develop quality system documents.

4.2.2 Prepare quality system manual.

4.2.3 Control quality system documents.

4.2.4 Maintain quality system records.

ISO 9001 QUALITY MANAGEMENT STANDARD

5 Management Requirements

5.1
Support 
quality

•  Promote the importance of quality.

•  Develop a quality management system.

•  Implement your quality management system.

•  Improve your quality management system.

5.2
Satisfy your
customers

•  Identify customer requirements.

•  Meet your customers' requirements.

•  Enhance customer satisfaction.

5.3
Establish a 
quality policy

•  Define your organization's quality policy.

•  Manage your organization's quality policy.

5.4
Carry out 
quality planning

5.4.1 Formulate your quality objectives.

5.4.2 Plan your quality management system.

5.5
Control your 
quality system

5.5.1 Define responsibilities and authorities.

5.5.2 Appoint management representative.

5.5.3 Support internal communications.

5.6
Perform
management
reviews

5.6.1 Review quality management system.

5.6.2 Examine management review inputs.

5.6.3 Generate management review outputs.

ISO 9001 QUALITY MANAGEMENT STANDARD

6 Resource Requirements

6.1
Provide quality
resources

•  Identify quality resource requirements.

•  Provide quality system resources.

6.2
Provide quality
personnel

6.2.1 Use competent personnel.

6.2.2 Support competence.

6.3
Provide quality
infrastructure

•  Identify infrastructure needs.

•  Provide needed infrastructure.

•  Maintain your infrastructure.

6.4
Provide quality
environment

•  Identify needed work environment.

•  Manage needed work environment.

ISO 9001 QUALITY MANAGEMENT STANDARD

7 Realization Requirements

•  Plan product realization processes.

•  Develop product realization processes.

7.2.1 Identify customers' product requirements.

7.2.2 Review customers' product requirements.

7.2.3 Communicate with your customers.

7.3.1 Plan design and development.

7.3.2 Define design and development inputs.

7.3.3 Generate design and development outputs.

7.3.4 Carry out design and development reviews.

7.3.5 Perform design and development verifications.

7.3.6 Conduct design and development validations.

7.3.7 Manage design and development changes.

7.4.1 Control purchasing process.

7.4.2 Document product purchases.

7.4.3 Verify purchased products.

7.5.1 Control production and service provision.

7.5.2 Validate production and service provision.

7.5.3 Identify and track your products.

7.5.4 Protect property supplied by customers.

7.5.5 Preserve your products and components.

•  Identify monitoring and measuring needs.

•  Select monitoring and measuring devices.

•  Calibrate monitoring and measuring devices.

•  Protect monitoring and measuring devices.

•  Validate monitoring and measuring software.

•  Use monitoring and measuring devices.

ISO 9001 QUALITY MANAGEMENT STANDARD

8 Remedial Requirements

8.1
Perform remedial
processes

•  Plan remedial processes.

•  Implement remedial processes.

8.2
Monitor and
measure quality

8.2.1 Monitor and measure customer satisfaction.

8.2.2 Plan and perform regular internal audits.

8.2.3 Monitor and measure quality processes.

8.2.4 Monitor and measure product characteristics.

8.3
Control
nonconforming
products

•  Develop a procedure to control nonconforming products.

•  Identify and control your nonconforming products.

•  Re-verify nonconforming products that were corrected.

•  Control nonconforming products after delivery or use.

•  Maintain records of nonconforming products.

8.4
Analyze quality
information

•  Define quality management information needs.

•  Collect quality management system data.

•  Provide quality management information.

8.5
Make quality
improvements

8.5.1 Improve quality management system.

8.5.2 Correct actual nonconformities.

8.5.3 Prevent potential nonconformities.

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ISO 9000 2000 Introduction

ISO 9000 2000 Principles