ISO 9001:2015 Draft International Standard (DIS)
ISO 9001:2015 Draft International Standard (DIS) has been issued for comments. Voting on DIS is planned between 10 July 2014 to 10 Oct 2014.
Following are the key changes in this draft:
1. New Structure
The new standard has 10 Clauses.
ISO is in process of harmonizing all management system standards. For this a harmonized structure 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.
3. 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 principals.
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.
And where ISO 9001:2008 would have referred to records this is now expressed as a requirement to retain documented information.
See the list of mandatory documents and records required.
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 | 4.4 Quality management system and its processes | Reduced requirements for documentation |
| 4.2.1 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 | |
| 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 | |
| 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 | |
| 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 | 9.1.3 Analysis and evaluation | |
| 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 Improvement | Continual deleted |
| 8.5.2 Corrective Action | 10.2 Nonconformity and corrective action | |
| 8.5.3 Preventive Action | - | No requirements related to PA |
