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.
View the standard revision timeline here .
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
(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.
Understanding ISO/DIS 9001:2015 Course at Udemy
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 management principles .
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
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
See the list of mandatory documents and records required by clicking here .
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
0. Introduction
1.1 General
1.2 Application

ISO 9001:2015 DIS

0. Introduction
1. Scope
4.3 Determining the scope of the
quality management system

2. Normative references

2. Normative references

3. Terms and definitions

3. Terms and definitions

Remarks

There is no normative
reference in the DIS
Definitions from ISO
9001:2014 DIS included

4. Quality Management System 4. Context of the organization

4.4 Quality management system and
4.1 General Requirements
its processes
4.2 Documentation
Reduced requirements for
7.5 Documented information
Requirements
documentation
4.2.1 General
7.5.1 General
Quality Manual not required
4.2.2 Quality Manual
4.2.3 Control of Documents

7.5 Documented Information

4.2.4 Control of Records

7.5 Documented Information

5. Management Responsibility 5. Leadership

5.1.1 Leadership and commitment
5.1 Management Commitment
for the quality management system
5.2 Customer Focus
5.1.2 Customer focus
5.3 Quality Policy
5.2 Quality policy
6. Planning for the quality
5.4 Planning
management system
6.2 Quality objectives ans planning
5.4.1 Quality Objectives
to achieve them
5.4.2 Quality Management
6.3 Planning of change
System Planning
5.5 Responsibility, Authority, 5.3 Organizational roles,
and Communication
responsibilities and authorities

Records and Documents are

now "Documented
Information "
Records and Documents are
now "Documented
Information "

ISO 9001:2008
5.5.1 Responsibility and
Authority
5.5.2 Management
Representative
5.5.3 Internal Communications
5.6 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
6. Resource Management
6.1 Provision of Resources
6.2 Human Resources
6.2.1 General
6.2.2 Competence, Training,
and Awareness
6.3 Infrastructure
6.4 Work Environment
7. Product Realization
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

ISO 9001:2015 DIS

5.3 Organizational roles,
responsibilities and authorities
7.4 Communication
9.3 Management Review
9.3.1 Management Review
9.3.1 Management Review
9.3.2 Management Review
7.1 Resources
7.1 Resources
7.1.2 People
7.2 Competence
7.2 Competence and 7.3 Awareness
7.1.4 Infrastructure
7.1.5 Environment for the operation
of processes
8. Operation
8.1 Operational planning and control
8.2 Determination of requirements
for products and services
8.2.2 Determination of requirements
related to products and services
8.2.3 Review of requirements related
to products and services
8.2.1 Customer communication

8.3 Design and development of

products and services
7.3.1 Design and Development 8.3.2 Design and development
Planning
planning
7.3.2 Design and Development
8.3.3 Design and development inputs
Inputs
7.3.3 Design and Development 8.3.5 Design and development
Outputs
outputs
7.3.4 Design and Development 8.3.4 Design and development
Review
controls
7.3.5 Design and Development 8.3.4 Design and development
Verification
controls
7.3.6 Design and Development 8.3.4 Design and development
Validation
controls
7.3.7 Control of Design and
8.3.6 Design and development
7.3 Design and Development

Remarks

MR not required

ISO 9001:2008
Development Changes

ISO 9001:2015 DIS

Remarks

changes
8.4 Control of externally provided
7.4 Purchasing
products and services
7.4.1 Purchasing Process
8.4.1 General
8.4.3 Information for external
7.4.2 Purchasing Information
providers
8.4.2 Type and extent of control of
7.4.3 Verification of Purchased
external provision and 8.6 Release of
Product
products and services
7.5 Production and Service
8.5 Production and service provision
Provision
7.5.1 Control of Production and 8.5.1 Control of production and
Service Provision
service provision
7.5.2 Validation of Processes
8.5.1 Control of production and
for Production and Service
service provision
Provision
7.5.3 Identification and
8.5.2 Identification and traceability
Traceability
8.5.3 Property belonging to
7.5.4 Customer Property
customers or external providers
7.5.5 Preservation of Product 8.5.4 Preservation
7.6 Control of Monitoring and 7.1.6 Monitoring and measuring
Measuring Equipment
resources
8. Measurement, Analysis, and 9.1 Monitoring, measurement,
Improvement
analysis and evaluation
8.1 General
9.1.1 General
8.2 Monitoring and
9.1.1 General
Measurement
8.2.1 Customer Satisfaction
9.1.2 Customer satisfaction
8.2.2 Internal Audit
9.2 Internal Audit
8.2.3 Monitoring and
9.1.3 Analysis and evaluation
Measurement of Processes
8.2.4 Monitoring and
8.6 Release of products and services
Measurement of Product
8.7 Control of nonconforming
8.3 Control of Nonconforming
process outputs, products and
Product
services
8.4 Analysis of Data
9.1.3 Analysis and evaluation
8.5 Improvement
10. Improvement
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action

10.3 Continual Improvement

10.2 Nonconformity and corrective
action
6.1 Actions to address risks and
opportunities

Continual deleted in CD, but

is back in DIS

PA is being replaced with

risk based thinking