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ISO 9001:2015
ISO 9001:2015 was released 23 September 2015.
Following are the key changes in this standard from ISO 9001:2008:
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(DIS)
6. ISO 9001 2008
7. ISO 9001 2015
Revision
8. Quality Improvement
Tools
9. QG's Six Sigma
Handbook
10. History of Quality
Latest Changes
1. History of Quality
2. ISO 9001:2015 Final
Draft International
Standard (FDIS)
3. ISO 9001 2015
Revision
4. ISO 9001:2008 vs ISO
9001:2015
5. 7.5 Documented
information
6. 6.1 Actions to address
risks and opportunities
7. 4.1 Understanding the
organization and its
context
8. ISO 9001 2015
9. Non-conformance vs
Non-compliance
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1. New Structure
The new standard has 10 clauses
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 provides specific requirements for adopting a process approach.
QMS LEAD
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And where ISO 9001:2008 would have referred to records this is now expressed as a requirement to retain
documented information.
Records in ISO 9001:2008 = Retain documented information in ISO 9001:2015
8. No Exclusions:
ISO 9001:2008 version allows organizations to exclude the standard requirements under the following conditions:
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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 nonapplicability 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.
ISO 9001:2015
0. Introduction
0. Introduction
1.1 General
1 Scope
1.2 Application
Remarks
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2. Normative references
2 Normative references
4.2.1 General
7.5.1 General
5. Management Responsibility
5 Leadership
5.2 Policy
5.4 Planning
6 Planning
7.4 Communication
5.6.1 General
9.3.1 General
MR not required
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6. Resource Management
7.1 Resources
7.1 Resources
7.1.2 People
6.2.1 General
7.2 Competence
6.3 Infrastructure
7.1.3 Infrastructure
7. Product Realization
8 Operation
7.3.2 Design and Development Inputs 8.3.3 Design and development inputs
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7.4 Purchasing
8.4.1 General
8.5.4 Preservation
8.1 General
9.1.1 General
9.1.1 General
8.5 Improvement
10 Improvement
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action
8.5.3 Preventive Action
Related content
8.1 Operational planning and control
6.2 Quality objectives and planning to achieve them
5.1.2 Customer focus
ISO 9001 2015 Revision Status
ISO 9001:2015 DIS - No Quality Manual
10.1 General
Annex SL
8.7 Control of nonconforming outputs
8.3.3 Design and development inputs
5.2.2 Communicating the quality policy
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2016
2008 Wasn't the Crash It Was
Only a Tremor Before the
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