HISTORY OF
ISO HEADQUARTERS: GENEVA,
SWITZERLAND
FOUNDED IN
1947, LONDON
VIENNA CONVENTION
23rd MAY 1969
MEMBER COUNTRIES BEGAN
BRITISHWITH
MILITARY
STANDARDS
165 PUBLISHED STANDARDS:
23791+
TECHNICAL
COMMITTES
781
HISTORY OF
ISO
FOUNDERS OF
ISO
ISO 90
01
PROCESS APPROACH
ISO 9001 :2015 Basic Standard
ISO 9001:2015 Quality Management
ISO 9001:2015 System ISO 14001:2015 EMS
Environmental Requirements
+
ISO 9001:2015 Occupational Health &
Safety Requirements ISO 45001:2018 OHSMS
+
ISO 9001:2015 Food Safety
Requirements ISO 22000:2018 FSMS
+
ISO 9001:2015 Information
RequirementsSecurity ISO 27001:2013 ISMS
+
PROCESS APPROACH
PROCESS APPROACH
Verbal Wo
rds
• “shall” indicates a requirement “should”
• indicates a recommendation “may”
•
indicates a permission “can” indicates a
possibility or capability “Note” is
guidance/clarification on
requirements
•
• “Note to entry” additional information
that
supplements the terminology
•
KEY TERMS
KEY TERMS
PROCESS APPROACH
CLAUSE 4 : CONTEXT OF ORGANIZATION
Clause 4.1 The Organization and Its Context
Clause 4.2
Understanding the Needs and Expectations of
interested parties
Clause 4.3 the scope of QMS
Determining
Clause
Quality 4.4
Management System & Its Processes
4.1 Understanding Organization
and its context
4.1 Understanding Organization &
Its Context
CONTEXT ANA
LYSIS
4.2 Understanding Needs & Expectations of In
terested Parties
SOME INTERESTED P
ARTIES
SOME INTERESTED P
ARTIES
4.3 Sc
ope
Clause 4.3 Scope
of QMS • Intended to clarify the
boundaries of QMS
4.3 Determining scope of QMS Consider external and
SCOPE management system •
internal factors
• Requirements of interested
parties
• Work related activities
B C
performed
D E
• AnyExclusions shall be
considered & justification
4.3 Scope State
ments
4.4 QMS & Its Pr
ocess
DETERMINE INPUTS & OUTPUTS
SIPOC
4.4 QMS & Its Pr
ocess
PROCESS SEQUENCE MATRIX : ENSURE COMMUNICATION FLOW
4.4 QMS & Its Pr
ocess
PROCESS SEQUENCE MATRIX : ENSURE COMMUNICATION FLOW
5.1 – Leadership & Com
mitment
5.1 – Leadership & Com
mitment
5.1 – Leadership &Com
mitment
5.2 – QUALITY POLICY
QUALITY POLICY EXAMPLES
5.3 Organizational Roles & Resp
onsibilities
ROLES, RESPONSIBILITIES &
AUTHORITIES
Establish Organization Chart
and Issue Roles,
Responsibilities to all the
Employees including Top
management & Contract
Employees.
Eo
T nagement is responsible to
p
communicated about his roles,
responsibilities & Authorities
Ma
CLAUSE 6 : PLANNING
CLAUSE 6 : PLANNING
CLAUSE 6 : PLANNING
4.2 Understanding Needs & Expectations of In
terested Parties
6.1 Understanding Needs & Expectations of In
terested Parties
6.2 Quality Obje
ctives • What will be done What
•
resources Who will be
responsible When completed
• How measured through
indicators if practicable,
monitored and frequency How
actions will be integrated
• into overall business processes
Maintain and retain
• documented
• information
Establish Plans to Achieve the Established Objectives.
Ensure Organizational and Process Level KPIs/Objectives
are Established
6.2 Quality Obje
ctives
6.3 Planning of C
hanges
6.3 Planning of C
hanges
6.3 Planning of C
hanges
CLAUSE# 7 : SU
PPORT
7.1 Resou
rces
Clause #7 Organizational K
nowledge
Organizational knowledge is the
sum of all knowledge contained
within an organization that can
provide business value. It may be
gained from intellectual property,
product knowledge, lessons of
failure and success, conferences,
or customer communications, just
to name a few sources
7.2 COMPETE
NCE
7.2 COMPETE
NCE
7.3 Awareness
• Made aware of QMS policy,
Objectives
•
Implication of not conforming with
QMS requirements
7.3 Awareness
•
Information and outcomes of
investigations of relevant incidents
•
Risk & Opportunities relevant to
them
• Aware about Positive & Negative
Impacts
7.4
Communication •
Determine the need for internal or
external information and communication
relevant to QMS
7.4 Communication •
What , when, who and when it will inform
and communicate
•
Who – internally, externally with
interested
parties, contractors or visitors to the
•
workplace
how it will received, maintain documented
information and respond to relevant
communications
7.5 Documented
Information
7.5 Documented
information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented
information
• Clause where reference to documented information 4.3, 5.2, 5.3, 6.1.1, [Link],6.1.3,
• 6.2.2, 7.2, 7.4, 7.5.1. 7.5.3, 8.1.1., 8.2, 9.1.1, 9.1.2, 9.2.2,
9.3, 10.1 & 10.2
6.2 Quality Obje
ctives
8.1 OPERATION PLANNING &
CONTROL
8.2 REQUIREMEMTS FOR PRODUCTS
& SERVICES
8.3 DESIGN & DEVELOPMENT OF PRODUC
TS & SERVICES
8.4 CONTROL OF EXTERNALLY PROVIDE
D PROCESSES, PRODUCTS & SERVICES
8.5 PRODUCTION & SERVICE P
ROVISION
4.2 Understanding Needs & Expectations of In
terested Parties
8.5 PRODUCTION & SERVICE PROVISION
8.6 RELEASE OF PRODUCTS &
SERVICES
6.2 Quality Obje
ctives
CLAUSE#9 : PERFORMANCE EV
ALUATION
9.3 : MANAGEMENT REVIEW
6.2 Quality Obje
ctives
CLAUSE#10 – PERFORMANCE EV
ALUATION
–e
10.3 – CONTINUAL IMPRO
VEMENT
•Continually improve the suitability,
adequacy and effectiveness of the
QMS to enhance environmental
performance
