MAJOR Changes are on the Way with ISO 9001 Revision 2015!

For those already familiar with ISO 9001:2008, here are the latest changes as they appear in the Committee Draft:

SECTION:

• 4: Context of the Organization. Focus on senior management to understand the relationship between risk, challenges, and management systems.
• 4: Process Management. The determination of process risk and the allocation of responsibilities.
• 5: Leadership. Alignment of the company’s direction with quality management, risk identification, assessment, and management from multiple directions.  Focus again on leadership.
• 6: Product Conformity and Customer Satisfaction. Change from preventive action to analysis of risk and opportunity that relate to product conformity and customer satisfaction.
• 7: Efficient Resource Management. Continuous attention to customer needs and satisfaction.
• 8: Contingency Planning for customer communication. Also, design suitability before operations begin.
• 8: Outsourced Activities. Incorporates risk management of outsourced activities.
• 9: Stronger Measuring and Monitoring. Incorporates risk assessment and quality management.
• 10: Continual Improvement Internal Audits are more structured.

These proposed changes bring ISO 9001 more current with the modern world and give it and businesses the tools necessary to anticipate and deal with future changes using risk management techniques.

Currently the process seems to be on or only slightly behind the original schedule outlined below.  NOTE:  It appears new certifications will continue to be in accordance with ISO 9001 2008 until early 2016 and upgrades of existing certifications will begin with surveillance audits in 2016.

According to the draft design specification, the revised ISO 9001:2015 standard should:

• Provide a stable core set of requirements for the next 10 years or more
• Remain generic, and relevant to all sizes and types of organization operating in any sector
• Maintain the current focus on effective process management to produce desired outcomes
• Take account of changes in quality management systems practices and technology since the last major revision in 2000
• Reflect changes in the increasingly complex, demanding and dynamic environments in which organizations operate
• Enhance compatibility and alignment with other ISO management system standards
• Facilitate effective organizational implementation and effective conformity assessment by first, second and third parties
• Use simplified language and writing styles to aid understanding and consistent interpretations of its requirements

 

Seven Significant Changes in ISO 9001 Revision 2015 Committee Draft

1. The term “product” has been replaced by “goods and services”.
2. Two new clauses related to the context of the organization:
   4.1 Understanding the organization and its context
   4.2 Understanding the needs and expectations of interested parties.
3. The requirement to use the “process approach” has been more explicit by adding a new clause.
   4.4.2 Process approach
4. The standard does not include a specific clause for “Preventive Actions”.
5. The terms “document” and “records” have been replaced with the term “documented information”.
6. of external provision of goods and services address all forms of external provisions.
7. The term “continual improvement” has been replaced with “improvement”.

 

ISO 9001 Revision 2015 CD differences from ISO 9001:2008

ISO 9001:2008	ISO Revision 2015 CD	Comment
4.1 General Requirements	4.1 Understanding the organization in its context 4.2 Understanding the needs and expectations of interested parties 4.3 Process approach
4.2.3 Control of documents 4.2.4 Control of records	7.5 Control of documents	Records and documents are identified as “documented information”
5. Management Responsibility	5. Leadership
5.4 Planning	6 Planning
5.5.2 Management Representative		Eliminated
5.6 Management Review	9.3 Management Review
6. Resource Management	7. Support
6.1 Provision of Resources	7.1 Resources
6.2 Human Resources	7.2 Competence
7. Product Realization	8. Operation
7.5.3 Identification & Traceability	8.6.2 Identification & Traceability
7.5.5 Preservation of Product	8.6.4 Preservation of Goods & Services
8. Measurement, Analysis & Improvement	9. Performance Evaluation
8.2.2 Internal Audit	9.2 Internal Audit
8.5 Improvement	10. Improvement
8.5.1 Continual Improvement	10.2 Improvement
8.5.2 Corrective Action	10.1 Nonconformity & Corrective Action
8.5.3 Preventive Action		Eliminated

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