Standard ISO 9001:2015 DIS 17.2.2015 preview

ISO 9001:2015 DIS

Draft International Standard (DIS). One of the most popular global standards, ISO 9001:2015 Draft International Standard (DIS) was released for public comments.

Automatically translated name:

Draft International Standard ( DIS). One of the most popular world standards ISO 9001 : 2015 Draft International Standard ( DIS) was released for public comment.



STANDARD published on 17.2.2015


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The information about the standard:

Designation standards: ISO 9001:2015 DIS
Publication date standards: 17.2.2015
SKU: NS-586684
The number of pages: 48
Approximate weight : 136 g (0.30 lbs)
Country: International technical standard

The category - similar standards:

Quality management and quality assurance

Annotation of standard text ISO 9001:2015 DIS :

We offer to you unique opportunity to purchase the final draft of international standard (DIS) ISO 9001:2015.

Please note that the document is just a final DRAFT which is to be approved. The final version may differ.

Planned differences between ISO 9001:2008 and ISO 9001:2015.

1. New Structure

The new standard has 10 clauses

  1. SCOPE
  2. When/why should an organization adopt this standard?

  3. NORMATIVE REFERENCES
  4. Blank clause introduced to match with other management system standards.

  5. TERMS AND DEFINITIONS
  6. Definitions of various terms referred in the standard.

  7. CONTEXT OF THE ORGANIZATION
  8. Determine the purpose and the direction of the organization.

  9. LEADERSHIP
  10. Commitment of the top management, quality policy, roles and responsibilities.

  11. PLANNING
  12. Planning to address risks and opportunities and achieving quality objectives.

  13. SUPPORT
  14. People, infrastructure, knowledge , communication, documented information

  15. OPERATION
  16. Finding out customer requirements, designing, delivering, post delivery support.

  17. PERFORMANCE EVALUATION
  18. Customer satisfaction, analysis, internal audits and management review.

  19. IMPROVEMENT
  20. Nonconformity, corrective actions and continual improvement.

ISO is in process of harmonizing all management system standards. For this a harmonized structure (Annex SL) has been developed. Some standards such as ISO 30301:2011 (Information and documentation – Management systems for records), ISO 22301:2012 (Societal security – Business continuity management systems), ISO 20121:2012 (Event sustainability management systems) have already been changed to this new structure and some other are in process of being revised to this new structure.

2. Process Approach

ISO 9001:2015 promotes the process approach beyond the existing requirements of ISO 9001:2008.Clause 4.4 (Quality management system and its processes)of the DIS provides specific requirements for adopting a process approach.

Preventive Action vs Risk Management

One of the key purpose of implementing a quality management system is to act as a preventive tool. As a result the formal requirement related to preventive action is no more existing in the current draft. This is being replaced with risk based approach.

Although it is required by the organization to determine and address risks, there is no requirement for implementing a formal risk management process.

4. Context of the Organization

Two new clauses have been added to the draft standard.

  • 4.1 Understanding the organization and its context
  • 4.2 Understanding the needs and expectations of interested parties.

5. Quality Management Principles

So far the standard was based on eight quality management principles. In this standard the earlier existing eight principles have been reduced to seven quality management principles. (QMP)

  1. QMP 1 - CUSTOMER FOCUS
  2. Meet and exceed customer expectations

  3. QMP 2 - LEADERSHIP
  4. Provide purpose, direction and engagement.

  5. QMP 3 - ENGAGEMENT OF PEOPLE
  6. Recognition, empowerment and enhancement of skills and knowledge.

  7. QMP 4 - PROCESS APPROACH
  8. Understand processes to optimize performance.

  9. QMP 5 - IMPROVEMENT
  10. To maintain current performance and to create new opportunities.

  11. QMP 6 - EVIDENCE-BASED DECISION MAKING
  12. Facts, evidences and data analysis for decision making.

  13. QMP 7 - RELATIONSHIP MANAGEMENT
  14. Manage relationship with interested parties to optimize performance.

6. Products and Services:

In 2008 version of the standard the term "product" was used. This term also included services. In the Committee Draft issued in June 2013, this term was proposed to be changed to "Goods and Services". In this DIS the proposed term is "Products and Services".

7. Documented Information:

2008 version of the standard had two separate terms: "documents" and "records". In the Committee Draft issued earlier it was combined together and called "documented information". The same term is maintained in the recently issued Draft International Standard.

Annex A of the DIS clarifies that where ISO 9001:2008 would have referred to documented procedures, it is now expressed as a requirement to maintain documented information.

Documented procedures in ISO 9001:2008 = Maintain documented information in ISO 9001:2015

8. No Exclusions:

ISO 9001:2008 version allows organizations to exclude the standard requirements under the following conditions:

  • Exclusions are allowed for the requirements which can not be applied due to the nature of the business.
  • Exclusions are limited to clause 7 (Product Realization)of the standard.
  • Such exclusions do not affect the organization's ability to provide products which meet the customer requirements and also the applicable legal requirements.

The new standard does not make any reference to exclusions. However in Annex A, the standard clarifies that the organization can not decide a requirement to be not applicable if it falls under the scope of its QMS. Also non-applicability is not allowed if that could lead to failure to achieve the conformity or to enhance customer satisfaction.

9. Work Environment:

The term "work environment" used in ISO 9001:2008 has been replaced with "Environment for the operation of processes".

10. Purchased Product:

The term "purchased product" has been replaced with "externally provided products and services".

11. Supplier

The term "supplier" has been replaced with "External provider".

This does not meet that organizations would need to change this term in their QMS as well. Organizations can still maintain the term "supplier", "vendor", "contractor", "consultant" etc. as per their own need.

Comparison between ISO 9001:2008 and ISO 9001:2015 Draft International Standard (DIS)

ISO 9001:2008 ISO 9001:2015 DIS Remarks
0. Introduction 0. Introduction
1.1 General 1. Scope
1.2 Application 4.3 Determining the scope of the quality management system
2. Normative references 2. Normative references * There is no normative reference in the DIS.
3. Terms and definitions 3. Terms and definitions * Definitions from ISO 9001:2014 DIS included.
4. Quality Management System 4. Context of the organization
4.1 General Requirements 4.4 Quality management system and its processes
4.2 Documentation Requirements 7.5 Documented information * Reduced requirements for documentation
4.2.1 General 7.5.1 General
4.2.2 Quality Manual - * Quality Manual not required.
4.2.3 Control of Documents 7.5 Documented Information * Records and Documents are now "Documented Information".
4.2.4 Control of Records 7.5 Documented Information * Records and Documents are now "Documented Information".
5. Management Responsibility 5. Leadership
5.1 Management Commitment 5.1.1 Leadership and commitment for the quality management system
5.2 Customer Focus 5.1.2 Customer focus
5.3 Quality Policy 5.2 Quality policy
5.4 Planning 6. Planning for the quality management system
5.4.1 Quality Objectives 6.2 Quality objectives ans planning to achieve them
5.4.2 Quality Management System Planning 6.3 Planning of change
5.5 Responsibility, Authority, and Communication 5.3 Organizational roles, responsibilities and authorities
5.5.1 Responsibility and Authority 5.3 Organizational roles, responsibilities and authorities
5.5.2 Management Representative - * MR not required.
5.5.3 Internal Communications 7.4 Communication
5.6 Management Review 9.3 Management Review
5.6.1 General 9.3.1 Management Review
5.6.2 Review Input 9.3.1 Management Review
5.6.3 Review Output 9.3.2 Management Review
6. Resource Management 7.1 Resources
6.1 Provision of Resources 7.1 Resources
6.2 Human Resources 7.1.2 People
6.2.1 General 7.2 Competence
6.2.2 Competence, Training, and Awareness 7.2 Competence and 7.3 Awareness
6.3 Infrastructure 7.1.4 Infrastructure
6.4 Work Environment 7.1.5 Environment for the operation of processes
7. Product Realization 8. Operation
7.1 Planning of Product Realization 8.1 Operational planning and control
7.2 Customer-Related Processes 8.2 Determination of requirements for products and services
7.2.1 Determination of Requirements Related to the Product 8.2.2 Determination of requirements related to products and services
7.2.2 Review of Requirements Related to the Product 8.2.3 Review of requirements related to products and services
7.2.3 Customer Communication 8.2.1 Customer communication
7.3 Design and Development 8.3 Design and development of products and services
7.3.1 Design and Development Planning 8.3.2 Design and development planning
7.3.2 Design and Development Inputs 8.3.3 Design and development inputs
7.3.3 Design and Development Outputs 8.3.5 Design and development outputs
7.3.4 Design and Development Review 8.3.4 Design and development controls
7.3.5 Design and Development Verification 8.3.4 Design and development controls
7.3.6 Design and Development Validation 8.3.4 Design and development controls
7.3.7 Control of Design and Development Changes 8.3.6 Design and development changes
7.4 Purchasing 8.4 Control of externally provided products and services
7.4.1 Purchasing Process 8.4.1 General
7.4.2 Purchasing Information 8.4.3 Information for external providers
7.4.3 Verification of Purchased Product 8.4.2 Type and extent of control of external provision and 8.6 Release of products and services
7.5 Production and Service Provision 8.5 Production and service provision
7.5.1 Control of Production and Service Provision 8.5.1 Control of production and service provision
7.5.2 Validation of Processes for Production and Service Provision 8.5.1 Control of production and service provision
7.5.3 Identification and Traceability 8.5.2 Identification and traceability
7.5.4 Customer Property 8.5.3 Property belonging to customers or external providers
7.5.5 Preservation of Product 8.5.4 Preservation
7.6 Control of Monitoring and Measuring Equipment 7.1.6 Monitoring and measuring resources
8. Measurement, Analysis, and Improvement 9.1 Monitoring, measurement, analysis and evaluation
8.1 General 9.1.1 General
8.2 Monitoring and Measurement 9.1.1 General
8.2.1 Customer Satisfaction 9.1.2 Customer satisfaction
8.2.2 Internal Audit 9.2 Internal Audit
8.2.3 Monitoring and Measurement of Processes 9.1.3 Analysis and evaluation
8.2.4 Monitoring and Measurement of Product 8.6 Release of products and services
8.3 Control of Nonconforming Product 8.7 Control of nonconforming process outputs, products and services
8.4 Analysis of Data 9.1.3 Analysis and evaluation
8.5 Improvement 10. Improvement
8.5.1 Continual Improvement 10.3 Continual Improvement * Continual deleted in CD, but is back in DIS
8.5.2 Corrective Action 10.2 Nonconformity and corrective action
8.5.3 Preventive Action 6.1 Actions to address risks and opportunities * PA is being replaced with risk based thinking

Source: qualitygurus.net

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