Key Changes and Impacts

The new Draft International Standard (DIS) of ISO 9001 maintains the essence of the PDCA cycle and the process approach, reinforcing the integration of risks and opportunities and referring to the new ISO/CD 9000.

1. Scope and Regulatory References

• The purpose and applicability remain unchanged.
• New references: ISO 3534-2 (statistics), ISO/CD 9000, and EN ISO 9001:2015, in addition to ISO 9000:2015.

2. Terms and Definitions

• Some key definitions (organization, interested party, risk, documented information) are now included in the text itself, complementing references to ISO/CD 9000.

3. Organizational Context

• New requirement: determine whether climate change is relevant to the QMS.
• Stakeholders may have requirements related to climate change.
• The scope and processes of the QMS remain aligned with 2015

4. Leadership

• Enhanced focus on customer satisfaction and a culture of quality and ethics.
• The quality policy must be implemented, updated, and aligned with the context.
• Roles and responsibilities remain unchanged, with more explicit wording regarding reporting and integrity of the QMS.

5. Planning

• Separate approach to risks and opportunities in subclauses:
  • 6.1.2 Risks
  • 6.1.3 Opportunities
• Quality objectives maintain measurement and communication requirements, now with greater documentary clarity.

6. Support and Resources

• Structure and content similar to 2015, but harmonized and focused on remote/hybrid work, culture, and ethics.
• Competencies and awareness also apply to subcontractors.
• Organizational knowledge now includes experience, tacit knowledge, and culture.

7. Operation

• No major changes, but with updates:
  • Communication includes emergencies, social media, and disruptions.
  • Design and development recognizes iterative cycles and incomplete inputs at the outset.
  • External providers must communicate with customers and stakeholders.
  • Production and release require clear documentation of activities.
  • Non-compliant outputs also include services provided, with mandatory registration.

8. Performance Evaluation

• Internal audits structured in a formal program (9.2.2); existing requirements.
• Management review includes stakeholder needs and expectations and continuous improvement initiatives.

9. Improvement

• Continuous improvement (10.1) becomes the top clause.
• Nonconformities and corrective actions (10.2) include updating risks/opportunities and reinforcing investigations.

10. Practical Impacts

• Record climate relevance in the QMS and monitor stakeholder requirements.
• Clearly separate risks and opportunities in plans.
• Explain the internal audit program.
• Treat continuous improvement as a priority, keeping the corrective action cycle up to date.
• Greater document flexibility and integration of technology/digitization as an informative guide.

Who is this content intended for?

Quality Managers
Internal and external auditors
Professionals responsible for management systems
Companies that want to ensure continuity and compliance