A Review ISO 9001:2015

What’s Important to Know

Prepared by
Kunal Bhoir,
Lead Auditor, certified by CQI IRCA
WHY ISO 9001 STANDARDS ARE REQUIRED?
(SCOPE)

ISO 9001:2015 specifies requirements for a quality

management system when an organization:

a) needs to demonstrate its ability to consistently provide

products and services that meet customer and
applicable statutory and regulatory requirements, and

b) aims to enhance customer satisfaction through the

effective application of the system, including processes
for improvement of the system and the assurance of
conformity to customer and applicable statutory and
regulatory requirements.

3/25/14
Timeline to Revision Release and
Client Transition

2013 2014 2015

June 2013 CD
(Committee Draft)

April 2014 DIS

(Draft International Standard)

July 2015 FDIS

(Final Draft International Standard)

September 2015
(Published International Standard)
Timeline to Revision Release and
Client Transition

2015 2016 2017 2018

September 2015
Published International Standard

September 2015 start of 3 years

transition period to September 2018
Objective of Revisions

• Enhance an organization’s ability to satisfy

customers.
• Maintain relevance, provide integrated
approach to organizational management, and
integrate with other management systems.
• Reflect needs of all user groups and
increasingly complex operating environments.
• Set a consistent foundation for next 10 years.
What’s New?
• Risk management is being added with focus on risk-based
thinking. Identification of risk and risk control now a
requirement.

• Standardized core text, structure, definitions enable

organizations with multiple management systems to achieve
improved integration & implementation.

• Major focus on achieving value for organization and its

customers.

• Revisions allow ISO 9001 to be more applicable by “service-

based” organizations.

• Primary focus remains on Customers!

Revision in Terminology;
QMS Structure Re-organized:

4. Context of Organization – addresses needs and expectations

of interested parties, scope of QMS

5. Leadership – addresses management commitment, policy,

roles, responsibility & authority

6. Planning – includes risks, opportunities, objectives and plans

to achieve them, the planning of changes

7. Support – includes resources, competence, awareness,

communication, documented information
Structure Re-organized

8. Operation – includes planning & control, determine

market needs, interaction w/customers, planning process,
control of external provisions of goods/services, production
of goods, provision of services, release of goods/services,
non-conforming goods/services

9. Performance Evaluation – includes monitoring,

measurement, analysis & evaluation, internal audit,
management review.

10. Improvement – addresses non-conformity & corrective

action, improvement
What we offer (for 3 months- 12 sessions) :

•Management Documented Information

•Departmental Format Designing
•One Management Review meeting
•One Internal Audit
•Employee Training
•Audit Preparation session
•Certification Audit presence-
(if required)