ISO 9001 - 2015 Draft International Standard - DQS India

ISO 9001:2015 Draft International Standard | DQS India
http://dqsindia.com/news/iso-90012015-draft-international-standard/
(http://www.dqsindia.com/)
Home (/)
CMMI Certification (/cmmi/)
ISO Certifications (/iso-certifications/)
Personnel Certifications (/personnel-certifications/)
1 of 9
About Us (/about-us/)
Compliance (/compliance-services/)
News (/news/)
Specialized Audits (/specialized-audits/)
Contact Us (/contact-us/)
ISO 9001:2015 Draft International Standard
Search for:
Posted June 8th, 2015 by admin (http://dqsindia.com/author/admin-2-2/) & filed under News
(http://dqsindia.com/category/news/).
Search
ISO 9001:2015 Draft International Standard is published. The revised version of the quality
management system standard is due to release in September 2015, by the International
Organization for Standardization (ISO).
Back ground of ISO 9001
(http://dqsindia.com/wp-content/uploads/2015/06/Back-ground-of-ISO-9001.png)
WHY ISO 9001:2015?

As per the policy of ISO all standards needs to be reviewed and revised in every 5 Years and to
incorporate the new High Level Structure as defined in the Annex SL of ISO 17021. ISO new
version main objective is to provide confidence in the organizations ability to consistently provide
customers with conforming goods and services and to enhance customer satisfaction.
New ISO 9001:2015 standard characterize a technical revision compared to 2008 edition. It also
adopts revised clause sequence, quality management principles and addition of new concepts.
Some concepts introduced in new standard are:
Integration of Risk Management
Resource Management
Systematic problem solving and learning
Voice of the customer
Knowledge management
Measures (examples are performance, satisfaction and ROI.)
ISO 9001:2015 REVISION PROCESS
11/26/2015 7:07 PM
2 of 9
(http://dqsindia.com/wp-content/uploads/2015/06/REVISION-PROCESS.png)
QUALITY MANAGEMENT PRINCIPLES used in ISO 9001:2015 DIS

Seven Management System Principles were used in ISO 9001:2015 DIS standard
Customer Focus
Leadership
Engagement of People
Process Approach
Improvement
Evidence based Decision Making
Relationship Management
Major Changes in ISO 9001:2015 DIS

High Level Structure is used in text writing (i.e. clause sequence, common text and
terminology)
New clause sequence is adopted in new version which is consistent with Annex SL, highlighted
in main body of the text (clause 1 to 10).
No specific reference and text for possible exclusions of requirements
No specific requirement and text fordocumentedprocedures and records. Both have been
replaced throughout by the text documented information.
Role ofManagement Representative Now the activities of Management Representative should
be performed by one of group of Senior Management.
No mention of a Quality Manual. Specific word Quality Manual is no-were mentioned in the
Draft Standard.
Quality policy / objectives compatible with strategic direction
Integration of QMS requirements into business processes
Change of tem product to product and services. New term include all output categories i.e.
hardware, services, software and processed materials
Organization needs to determine the knowledge necessary for the operation of the QMS and
its processes and to achieve conformity of process
Risk-based thinking introduced in all clauses
Organization needs to determine the risks to conformity of goods and services and to
customer satisfaction and opportunities in place of preventive action
RISK ADDRESSED IN FOLLOWING CLAUSES OF ISO 9001:2015 DIS
11/26/2015 7:07 PM
3 of 9
Clause 4
Organization is required to determine risks that can affect its ability to meet objectives.
Clause 5
Top management are required to commit to ensuring Clause 4 is followed.
Clause 6
Organization is required to plan and take action to address risks and opportunities.
Clause 8
Organization is required to have processes which identify and address risk in its
operations.
Clause 9
Organization is required to consider risks and opportunities when determining what

needs to be monitored, measured, analyzed and evaluated.
Clause 10
Organization is required to improve by responding to changes in risk and opportunities.
PDCA CYCLE APPROACH IN RISK MANAGEMENT
(http://dqsindia.com/wp-content/uploads/2015/06/PDCA-CYCLE-APPROACH.png)
ISO 9001:2015 DIS CLAUSES

CLAUSE 4: Context of an organization
4.1
Understanding the organization and its context
4.2
Understanding the needs and expectations of interested parties
4.3
Determining the scope of the quality management system
4.4
Quality management system and its processes
CLAUSE 5: Leadership
5.1
Leadership and commitment
5.2
Quality policy
5.3
Organizational roles, responsibilities and authorities
11/26/2015 7:07 PM

CLAUSE 6: Planning for quality management system
4 of 9
6.1
Actions to address risks and opportunities
6.2
Quality objectives and planning to achieve them
6.3
Planning of changes
CLAUSE 7: Support
7.1
Resources
7.2
Competence
7.3
Awareness
7.4
Communications
7.5
Documented information
CLAUSE 8: Operations
8.1
Operational planning and control
8.2
Determination of requirements for products and services
8.3
Design and development of products and services
8.4
Control of externally provided products and services
8.5
Production and service provision
8.6
Release of products and services
8.7
Control of nonconforming process outputs, products and services
CLAUSE 9: Performance Evaluation

9.1
Monitoring, measurement, analysis and evaluation
9.2
Internal audit
9.3
Management review
CLAUSE 10: Improvements

10.1
General
10.2
Nonconformity and corrective action
10.3
Continual improvement
ISO 9001:2008 Standard Mapping with ISO 9001: 2015 DIS

ISO 9001:2008
ISO 9001:2015 DIS
List of
Clauses
Description
List of
Clauses
Description
Scope
1.1
General
Scope
Remarks
11/26/2015 7:07 PM
5 of 9
4.1
Understanding the organization and its

context
New Clause
4.2
Understanding the needs and expectations
New Clause
of interested parties
1.2
Application
4.3
Determining the scope of the quality

management system
Normative Reference
Normative Reference
Terms and Definitions
Terms and Definitions
4.0
Quality Management System
Context of the organization
4.1
General Requirements
4.4
Quality management system and its

processes
Documented
scope required
New
Determination of
risks and
opportunities
4.2
Documentation Requirements
7.5
Documented information
New term
introduced in place
of documents and
records. No
requirement of
documented
procedure.
4.2.1
General
7.5.1
General
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
5.0
Management Responsibility
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 and 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
5.5.3
Internal Communication
7.4
Communication
5.6
Management Review
9.3
Management Review
Responsibilities
are re-defined
New requirements
added and only 7
quality
management
principles
introduced
More specific
requirements
introduced
New requirements
introduced
11/26/2015 7:07 PM
6 of 9
5.6.1
General
9.3.1
Management Review
5.6.2
Review Input
9.3.1
Management Review
5.6.3
Review Output
9.3.1
Management Review
6.0
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, Awareness and
7.2
Competence
7.3
Awareness
New Clause
7.1.6
Monitoring and measuring resources
New Clause
New Clause
Training
6.3
Infrastructure
7.1.4
Infrastructure
6.4
Work environment
7.1.5
Environment for the operation of

processes
7.0
Product realization
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

Planning
8.3.2
Design and development planning
7.3.2

Inputs
8.3.3
Design and development inputs
7.3.3

Outputs
8.3.5
Design and development outputs
7.3.4

Review
8.3.4
Design and development controls
7.3.5

Verification
8.3.4
7.3.6

Validation
8.3.4
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
New Clause
products and
services new term
products and
services new term
11/26/2015 7:07 PM
7 of 9
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
8.6
7.5
Production and service

provision
8.5
Production and service provision
7.5.1
Control of production and
8.5.1
Control of production and service provision
8.5.1
Control of production and service provision
New requirements
introduced
service provision
7.5.2
Validation of processes for

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
7.1.6
Monitoring and measuring resources
measuring Equipment
8.0
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
New Clause
New requirements
introduced
8.2.3

of processes
9.1.3
Analysis and evaluation
8.2.4

of product
8.6
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
10.1
General
8.5.1
Continual improvement
10.3
Continual Improvement
8.5.2
Corrective action
10.2
Nonconformity and corrective action
8.5.3
Preventive action
6.1
Actions to address risks and opportunities
New requirements
introduced
New Clause
You have questions about ISO 9001:2015?

Please contact us for questions about the new standard and your next assessment.
Contact Details
Mr. Rajendra Khare, + 91 9810268573, rkhare@dqsindia.com (mailto:rkhare@dqsindia.com)
Source: Information collected from ISO Website
11/26/2015 7:07 PM

Leave a Reply
Name (required)
Mail (will not be published) (required)
Website
Submit Comment
Notify me of follow-up comments by email.

Notify me of new posts by email.
Our Services
About DQS
ISO Certifications (http://dqsindia.com/iso-certifications/)
History (http://dqsindia.com/about-
Personnel Certifications (http://dqsindia.com/personnel-certifications/)
us/company-history/)
CMMI Certification (http://dqsindia.com/cmmi/)
Newsletter (http://dqsindia.com/about-
Specialized Audits (http://dqsindia.com/specialized-audits/)
us/newsletter/)
Compliance (http://dqsindia.com/compliance-services/)
Organizational Structure
Like
us Consulting
on Facebook
Important Terms
PCI DSS
(http://dqsindia.com/it-security-services/pci-ssc-data-security-standards/)
8 of 9
Contact
DQS India
(http://dqsindia.com/dqs-group
CMMI (/cmmi/) CSBA
Rajendra/organizational-structure/)
Khare, MD
(/personnel-certifications/csba-
(http://in.linkedin.com/in/rajendrakhare)
dqs-certification-certified-software-
DQS Certification India Private Limited
business-analyst/) CSPM (/personnel-
(http://www.dqsindia.com/)
certifications/cspm-dqs-certificationcertified-software-process-manager/)
CSQA (/personnel-certifications/csqadqs-certification-certified-software-
CMMI
Appraisal (/cmmi
/appraisal/) CMMI
Consultant (/cmmi
/consultant/)
quality-analyst/)
USA: +1-703-574-4929,
+1-703-574-4962,
+1-703-466-0248
India: +91-9810268573,
+91-9810895173,
+91-11-27025910
e-mail: rkhare@dqsindia.com
(mailto:rkhare@dqsindia.com)
(https://www.facebook.com
CMMI Templates (/cmmi/toolkit/)
CMMI Training (/cmmi/training/)
/cmmiconsultants)
(https://twitter.com
Customer Satisfaction Survey

(/specialized-audits/customer-
/cmmiconsultant)
11/26/2015 7:07 PM
satisfaction-surveys/) Employee
(http://www.linkedin.com/company
Satisfaction Survey (/specialized-audits

DISCLAIMER: We
have no association with Deutsche Gesellschaft zur Zertifizierung von Managementsystemen (Germany).
/employee-satisfaction-surveys/)
HIPAA
/dqs-certification/)
(/compliance-services/hipaa/) ISO 9001
copyright reserved by DQS Certification India Private Limited
(https://plus.google.com
(/iso-certifications/non-accreditediso-certifications/iso-90012008-qualitymanagement-system/) ISO 14001 (/iso-
/u/0/104240445417004933098/)
(http://pinterest.com/cmmiconsultants/)
certifications/non-accreditediso-certifications/iso-140012004environmental-management-system/)
ISO 18001 (/iso-certifications
(https://www.facebook.com/sharer
/sharer.php?u=http://dqsindia.com/index.php)
/non-accredited-iso-certifications/ohsas180012007-health-and-safety-
(skype:rajendrakhare1?call)
management-system/) ISO 20001 (/isocertifications/non-accreditediso-certifications/iso-20000-12005it-services/) ISO 27001 (/isocertifications/non-accreditediso-certifications/iso-270012005information-security-managementsystem-isms/) Personnel Certifications (/personnelcertifications/)
Mystery Audits (/specialized-
audits/mystery-audits/) SSAE16
(/compliance-services/ssae-16/)
9 of 9
11/26/2015 7:07 PM

ISO 9001 - 2015 Draft International Standard - DQS India

Hochgeladen von

Dokumentinformationen

Originaltitel

Copyright

Verfügbare Formate

Dieses Dokument teilen

Dokument teilen oder einbetten

Freigabeoptionen

Stufen Sie dieses Dokument als nützlich ein?

Sind diese Inhalte unangemessen?

Copyright:

Verfügbare Formate

ISO 9001 - 2015 Draft International Standard - DQS India

Hochgeladen von

Copyright:

Verfügbare Formate

ISO 9001:2015 Draft International Standard | DQS India

CMMI Certification (/cmmi/)

ISO Certifications (/iso-certifications/)

Personnel Certifications (/personnel-certifications/)

Specialized Audits (/specialized-audits/)