ISO-9001:2015

Objective of the program?

 Tounderstand some key features of the

ISO 9001:2015 system
 Demonstrate organization’s ability to
consistently provide product or service that
meets customer / interested parties, and
applicable statutory and regulatory
requirements.
 Key Feature
 TheISO 9001:2015 quality management
system (QMS) standard is recognised
world wide
ISO - International
Organization for
Standardization.
 Quality Management system (4)

Customer Focus Continual

Improvement
Quality Policy Management

Internal Audit
Review
Quality Quality Quality
RESOURCE

objectivesobjectives objectives

Customer
Customer

Analysis
Monitoring & Measurement Of Data

Operational planning & Control

Internal Audit

RESOURCE
Model of Process-based QMS
showing link to ISO 9001: 2015
 Reasons for ISO certification
 InternalOperational Efficiency
 Lower production Costs
 Access to new Markets
 Some Markets favour companies with ISO
9001 registration.
 Greater quality awareness
 Reduced cost of non-quality
 Risk Based Quality Management System
 Internal Operations Efficiency
 Core process formalised and documented
 Correction system
 Corrective actions system
 Production Monitoring
 Supplier Monitoring
 Continual improvement
 Customer focused objectives and targets
 Lower Production Costs
 Less waste
 More right first time, Less rework
 Efficient processes
 Correct resources identified
 On time in full
Some Markets require ISO 9001
Certification

You will not achieve

preferred supplier
status with some
companies if you are
not certified to
ISO 9001:2015
 Greater Quality Awareness
 Defined parameters
 More right first time, Less rework
 Efficient processes
 Correct resources identified
 Reduced cost of non quality
 Well defined parameters meeting customers
requirement.
 Testing of all parameters at defined
frequency.
 Timely monitoring, measurement, analysis
and evaluation.
 Root cause analysis / corrective action to
eliminates reoccurrence of non-conformity
(NC) (non fulfilment of a specified
requirement).
 Risk Based Thinking

 Risk is effect of uncertainty on an

unexpected result.
 Risk evaluated for all internal and external
issues.
 Risk considered in Establishment,
implementation, maintenance and
continual improvement of QMS.
 Requirements
 A Quality Policy
 A Manual incorporating the 10 elements of
the ISO 9001:2015 system
 Leadership to embrace and be the owner
of the system
 A System Coordinator
 Internal Auditor/s
 Documented Information
 ISO 9001:2015 doesn’t require a
management representative
 Quality
Policy 5.2.1

(Apex Document)
Food safety
Policy
 Company Manual Clauses as per
ISO 9001 :2015 - 10
 Clause 1 – Scope
 Clause 2 – Normative References
 Clause 3 – Terms & Definitions
 Clause 4 – Context of Organization
(Understanding needs and Expectation of
interested parties, QMS and its Scope)
 Clause 5 – Leadership (Leadership &
Commitment, Quality Policy, Roles,
responsibilities and authorities)
 Clause 6 – Planning (Action to address risk and
opportunities, objectives, planning of changes)
 Company Manual Clauses

 Clause 7 Support – Resource, Infrastructure ,

Environment, MMDs, Competence/ Training ,
Awareness, Control of Documents & Records
 Clause 8 – Operation Planning & Control,
Design & Development , external process /
product / service control, Production &
Service , Release of Product, Control of Non
conforming Products
 Clause 9 – Performance Evaluation
 Clause 10 - Improvement
 Leader Ship (5)

 Must provide evidence that it is committed

to installing the Quality Management
System and then continually improving it,
 Must be aware of the importance of
meeting the customers / interested parties
requirements
 Also statutory and regulatory requirements
compliance.
 System Coordinator
 The processes needed for the quality
management system are established and
maintained.
 Report to top management on the
performance of the QMS with any need
for improvement.
 Ensure the promotion of awareness of
customer / interested parties requirements
throughout the organisation.
 Operation (8)

 Identifyprocesses or series of steps

needed to take the raw material to
make a product or offer a service.
 Each step is broken down into
documented processes, procedures
and/or work instructions.
 Customers / interested parties
requirements and special instructions
are formally documented.
 Internal Auditor
 To help improve your companies
performance they can become an asset in
the organisation.
 To make sure that the company is meeting
the requirements
 If non conformances found by the internal
auditor have been addressed, this should
lead to successful external audits.
 Customer Satisfaction 9.1.2

 The demand for companies to provide

quality products and services is not just
from the customer but also the stake /
share holders.
 Features of ISO 9001:2015
 Improved product reliability
 Better process control and flow
 Better “documented information” of process
 Greater employee quality awareness
 Reductions in product scrap, reworks and
rejections.
 Integration with other standards
 Risk Based Thinking.
 The common foundation of
quality management Principles
 Customer Focus
 Leadership
 The involvement of people
 A process approach
 A system approach to management
 Continual improvement
 A factual approach to decision making
 Mutually beneficial supplier / External
provider relationships
 Major Difference between ISO
9001:2008 and ISO 9001:2015
ISO 9001:2008 ISO 9001:2015
Products Products and services
Management representative Not used
(Similar responsibilities and authorities are
assigned but no requirement for a single
management repre- sentative)

Documentation, quality
manual, documented pro- Documented information
cedures, records
Work environment Environment for the operation of processes
Monitoring and measuring Monitoring and measuring resources
equipment
Purchased product Externally provided products and services
Supplier External provider
 Important Information:
 All employees are responsible for proper Implementation of
ISO 9001:2015.
 Means no more one man show.

 Risk based Quality Management System

 CCP – Critical Control Point

 Each CCP has one critical limit

 When Critical limit is exceed, CCP is out of control and a

deviation is formed.
Correction in Record:

Correct
Wrong
Thanks