ISO 9001:2008 to ISO 9001:2015

Main Changes
This ISO-9001:2015 –is a 4th revision – 5th
Edition was published on 15th September-
2015
• The time period for revision is given for 3
year – i.e. 15/09/2015 to 14/09/2018, if not
revised or up graded your certificate will be
automatically cancelled
 Main Changes
 Now , it’s 7nos management principals instead of
8nos
 Now,10nos.ISO Clauses instead of 8nos.
 The term documented information introduced as
part of common high level structure
(HLS)developed by ISO body to ensure greater
harmonization among its many different
management system standards such as
Environment, Aerospace, Automotive system etc.
 Main Changes
Objectives evidence can be obtain through
observation, measurement , test, records or
other means (like-SPC, Quality tools)

More flexibility in documentation system

Increased leadership requirements and

Involvements
 Main Changes
 No MR post all HOD/ Concern executives are MR now?
a limited role of “facilitator” you can say instead of
MR.!

 Greater emphasis on planning(PDCA),controlling and

achieving desired processes results to improve
customer satisfaction and achieving objectives.

 Management review is aligned to organization result.

 Main Changes
Address supply chain management More
effectively.

New word “context of the organizations”- for

product and services which are delivered to
customer: External & Internal Issues ; Needs
and Expectations of Interested Parties
 Main Changes
External Factors:
Culture , social , political , legal ,regulatory,
financial , technological , economic and
competitive environmental all levels. ( PEST )
Internal Factors:
Corporate culture, governance organizational
structure, technologies , information and
communications system and decision making
process etc.
 Main Changes
 Organizational Knowledge” means gained by
experience , information shared to achieve
Organizations objectives, and purpose to safe
guarding the organization to acquire new
knowledge as its business concept chances.

 “Improvements “word use is broader meaning

break through Improvements , re- engineering
Initiatives or Innovation.
 Main Changes
 “Address risk based thinking” – organization
needs to plan and implement action to address
risk and opportunities establish a basis for
increasing effectiveness of QMS , achieving
improved results and protective negative
effect.(SWOT Analysis)

 Opportunities can be : to attract the customers,

develop new Products and services , reduced
waste or improve productivity.
 Main Changes
Risk Means – uncertainty can have positive or
negative effect

Information for external providers (clause

8.4.3) means to be purchase department.

This standard are develop by TC-176, SC-2

Management System
 FIVE STAGES OF MANAGEMENT
SYSTEM to FOUR STAGES
• 1.ESTABLISHMENT
• 2.DOCUMENTATION – implicit
• 3.IMPLEMENTATION
• 4.AUDITING
• 5. IMPROVEMENTS