The key differences between ISO 9001:1994 and ISO 9001:2000 are summarized below by ISO 9001:1994 clause number (with the ISO 9001:2000 clause numbers identified).

4.1 Management Responsibility

• Emphasis on top management commitment (5.1)
• Policy on requirements and improvement (5.3.b)
• Measurable objectives at relevant levels (5.4.1)
• Awareness of customer requirements (5.1.a; 5.5.2.c)
• Resources for improvement and satisfaction (6.1.a)
• Requirement for internal communication (5.5.3)
• More duties for management representative (5.5.2)
• Specific topics for management reviews (5.6.2)

4.2 Quality System 

• Measurement and analysis of processes (4.1.e)
• Continual improvement of effectiveness (4.1.f)
• Identification and control of outsourcing (4.1)
• Fewer specific procedures are required (4.2.1)

(see 4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2, and 8.5.3)

• Quality manual with process interaction (4.2.2)
• Expanded planning for quality system (5.4.2)

4.3 Contract Review 

• Now in Customer-Related Processes (7.2)
• No requirement for documented procedure
• Delivery and post-delivery requirements (7.2.1.a)
• Unstated, but necessary requirements (7.2.1.b)
• Statutory and regulatory requirements (7.2.1.c)
• Records kept of actions from reviews (7.2.2)
• Requirement for customer communication (7.2.3)
• Monitoring of customer satisfaction levels (8.2.1)

4.4 Design Control 

• Renamed as Design and Development (7.3)
• No requirement for documented procedure
• Functional and performance requirements (7.3.2.a)
• Previous similar designs considered (7.3.2.c)
• Outputs to purchasing, production, service (7.3.3.b)
• Actions noted from Reviews and Changes (7.3.4; 7.3.7)
• Actions from Verification and Validation (7.3.5; 7.3.6)
• Impact on constituent parts; shipped product (7.3.7)

4.5 Document and Data Control

• Renamed as Control of Documents (4.2.3)
• Document reviews and updates as necessary (4.2.3.b)
• Changes to documents must be identified (4.2.3.c)
• Legible and readily identifiable documents (4.2.3.e)
• Distribution control for external documents (4.2.3.f)

4.6 Purchasing 

• Same title for requirements; new clause (7.4)
• No requirement for documented procedure
• Evaluation, selection, re-evaluation criteria (7.4.1)
• Records of action arising from evaluations (7.4.1)
• Supplier “requirements” on purchase order (7.4.2.a,b,c)
• Receiving inspection addressed in Purchasing (7.4.3)

4.7 Control of Customer-Supplied Product 

• Clause renamed as Customer Property (7.5.4)
• No requirement for documented procedure
• Exercise care while under your “control” (7.5.4)
• Note that may include intellectual property (7.5.4)

4.8 Product Identification and Traceability 

• Renamed Identification and Traceability (7.5.3)
• No requirement for documented procedure
• Includes identifying measurement status (7.5.3)
• Note regarding configuration management (7.5.3)

4.9 Process Control 

• Mostly in Control of Production and Service Provision (7.5.1)
• Documented procedures are still optional
• Product planning in clause 7.1 (system at 5.4.2)
• New, expanded clause for Infrastructure (6.3)
• Separate clause for Work Environment (6.4)
• More required to validate a special process (7.5.2)
• Reference to release, delivery, post-delivery (7.5.1.f)

4.10 Inspection and Testing 

• Now Monitoring and Measurement of Product (8.2.4)
• No requirement for documented procedure
• Less emphasis placed on test requirements (8.2.4)
• More focus on planning and prevention (4.1, 5.4.2, 7.1, 8.1)
• Authority or customer approve NC product release (8.2.4)

4.11 Control of Inspection, Measuring and Test Equipment 

• Renamed Monitoring and Measurement Devices (7.6)
• No requirement for documented procedure
• More simply stated calibration requirements (7.6)
• Action on device/product if invalid results (7.6)

4.12 Inspection and Test Status 

• Now in Identification and Traceability (7.5.3)
• No requirement for documented procedure
• Expressed as status of product measurement (7.5.3)

4.13 Control of Nonconforming Product 

• Same title; now clause number of 8.3
• Newly worded actions for dealing with NC (8.3.a,b,c)
• Records kept of subsequent actions taken (8.3)

4.14 Corrective and Preventive Action 

• Separate corrective (8.5.2) and preventive (8.5.3) clauses
• Preventive action dropped focus on nonconformity history
• Different words, but basically same requirements (8.5.2; 8.5.3)

4.15 Handling, Storage, Packaging, Preservation, and Delivery 

• Primarily in Preservation of Product (7.5.5)
• No requirement for documented procedure
• Protection also applies to constituent parts (7.5.5)

4.16 Control of Quality Records 

• Renamed to Control of Records (4.2.4)
• Words changed, e.g., retrireview versus access (4.2.4)
• Dropped references to subcontractor records

4.17 Internal Quality Audits 

• Section renamed as Internal Audit (8.2.2)
• “Impartial and objective” versus “independent” (8.2.2)
• Audit planning based on prior audit results (8.2.2)
• Defined criteria, scope, frequency, methods (8.2.2)
• Without “undue delay” versus “timely action” (8.2.2)

4.18 Training 

• Now in Competence, Awareness and Training (6.2.2)
• No requirement for documented procedure
• Use of “competence” versus “qualified” (6.2.2.a)
• Evaluation of effectiveness of training (6.2.2.c)
• Awareness of role and important activities (6.2.2.d)
• Contribution to attaining quality objectives (6.2.2.d)
• Records of education, skills, and experience (6.2.2.e)

• No requirement for documented procedure
• Servicing merged with Production (7.5)

4.20 Statistical Techniques 

• Statistical techniques no longer a separate clause
• No requirement for a documented procedure
• Covered as part of measurement planning (8.1)

About the Author

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.