The document discusses the key changes and improvements in the revised ISO 9001 quality management standard, including: 1) Increased emphasis on risk-based thinking throughout all processes and a process-based implementation approach. 2) A requirement for organizations to define their context and plan their quality management system related to their business objectives and risks. 3) Greater flexibility with less prescriptive requirements around documents and more focus on performance and results to improve customer satisfaction. 4) Alignment of the standard with other ISO management system standards using a common framework defined in Annex SL.

1. PHILOSOPHY AND
INTRODUCTION
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2. *
*Maintain relevance in the marketplace
*Integration of management system standards
(common structure, text, terminology) –Annex SL
*Increase variety of business users
(Service industries, office environments)
*Address increased complexity of business environment
*Less emphasis on documents and instead alignment
with ERP systems
*Greater emphasis on results to improve customer
satisfaction; add value; less prescriptive = performance
based
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3. *
*Designed for fully integrated management
systems – based on Annex SL – utilize a
single management system (Appendix 3 of
ISO/IEC Directives, Part 1 Annex SL)
*Risk-based thinking throughout all processes
*PDCA/Process-based implementation
maintained and enhanced
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4. *
Change in numbering structure of the standard
Define the Context of the organization
Plan the QMS (including Risk), related to the business
Leadership emphasis / Leveraging management review
process
Change Management
Knowledge Management
“Documented information” and “Retained information”
No quality manual or Management Representative required
Improved PDCA philosophy
Preventive Action removed and implied with Risk-based
thinking methodology through-out all processes
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5. *
*Customer-related process
*Purchasing process
*Design and Development process
*Resources
*Production and Servicing process
*Calibration
*Corrective action process
*Internal Audit Process
*Nonconforming product process
*Customer Satisfaction
*Analysis and evaluation
*Improvement
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6. *
*Product is now Products and Services
*Purchased product is now Externally
provided product and services
*Supplier is now External provider
*Outsourcing is now External Provision
*Document Control and Record Control is
now Documented information and
Retained information
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7. Quality is Culture
*
*ISO 9000 – Fundamentals and Vocabulary
*ISO 9004 – Managing for sustained success of
an organization - Guidance document
*ISO 31000 – Risk Management Principles and
Guidelines
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8. Quality is Culture 8
*
*Annex A (ISO 9001) – Clarification of new structure, terminology
and concepts
- Structure and Terminology
- Products and Services
- Understanding the needs and expectations of interested parties
- Risk-based thinking
- Applicability
- Documented information
- Organizational knowledge
*Annex B (ISO 9001) – Other International Standards on QMS
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9. *
*New Plan-Do-Check-Act
*Risk-based thinking defined
*Intent is harmonization with other ISO
management systems.
*Appendix 3 of ISO/IEC Directives,
Part 1 Annex SL
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10. Quality is Culture 10
*
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11. Quality is Culture 11
*
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12. *
*Clause 4 – Context of the organization
*Clause 5 – Leadership
*Clause 6 – Planning for the quality management system
*Clause 7 – Support
*Clause 8 – Operation
*Clause 9 – Performance Evaluation
*Clause 10 – Improvement
*See handout Correlation of Clauses previous/new
standard.
*www.iso.prg/tc176/sc02/public
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