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ISO 9001:2008 vs ISO 9001:2015

What are the differences between ISO 9001:2008 and ISO 9001:2015?


Significant Changes in ISO 9001 Revision 2015 Committee Draft (CD):


1. The term "product" has been replaced by "goods and services". What is your opinion on this?(external link)

2. Two new clauses related 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. Control of external provision of goods and services address all forms of external provisions.

7. The term "continual improvement" has been replaced with "improvement". What is your opinion on this?(external link)

Comparison between ISO 9001:2008 and ISO 9001:2015 Committee Draft (CD)



ISO 9001:2008 ISO 9001:2015 CD Remarks
0. Introduction 0. Introduction
1. Scope 1. Scope
2. Normative references 2. Normative references
3. Terms and definitions 3. Terms and definitions
4. Quality Management System 4. Context of the organization
4.1 General Requirements 4.1 Understanding the organization and its context
4.2 Documentation Requirements
4.2.1 General
4.2.2 Quality Manual - Quality Manual not required(external link)
4.2.3 Control of Documents 7.5 Documented Information Records and Documents are now "Documented Information(external link)"
4.2.4 Control of Records 7.5 Documented Information Records and Documents are now "Documented Information(external link)"
5. Management Responsibility 5. Leadership
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning 6. Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5 Responsibility, Authority, and Communication
5.5.1 Responsibility and Authority
5.5.2 Management Representative MR not required(external link)
5.5.3 Internal Communications
5.6 Management Review 9.3 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
6. Resource Management 7. Support
6.1 Provision of Resources 7.1 Resources
6.2 Human Resources 7.2 Competence
6.2.1 General
6.2.2 Competence, Training, and Awareness
6.3 Infrastructure
6.4 Work Environment
7. Product Realization 8. Operation
7.1 Planning of Product Realization
7.2 Customer-Related Processes
7.2.1 Determination of Requirements Related to the Product
7.2.2 Review of Requirements Related to the Product
7.2.3 Customer Communication
7.3 Design and Development
7.3.1 Design and Development Planning
7.3.2 Design and Development Inputs
7.3.3 Design and Development Outputs
7.3.4 Design and Development Review
7.3.5 Design and Development Verification
7.3.6 Design and Development Validation
7.3.7 Control of Design and Development Changes
7.4 Purchasing
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
7.5.2 Validation of Processes for Production and Service Provision
7.5.3 Identification and Traceability 8.6.2 Identification and traceability
7.5.4 Customer Property
7.5.5 Preservation of Product 8.6.4 Preservation of goods and services
7.6 Control of Monitoring and Measuring Equipment
8. Measurement, Analysis, and Improvement 9. Performance evaluation
8.1 General
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audit 9.2 Internal Audit
8.2.3 Monitoring and Measurement of Processes
8.2.4 Monitoring and Measurement of Product
8.3 Control of Nonconforming Product
8.4 Analysis of Data
8.5 Improvement 10. Improvement
8.5.1 Continual Improvement 10.2 Improvement Continual deleted(external link)
8.5.2 Corrective Action 10.1 Nonconformity and corrective action
8.5.3 Preventive Action - No requirement related to PA(external link)



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References
http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref1633(external link)
http://drafts.bsigroup.com/Home/Details/51222(external link)







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