Professional Documents
Culture Documents
INTEGRATED
MANAGEMENT SYSTEM
Objective of this lecture:
PDCA Cycle
Definition:
“The totality of features and characteristics of a product or service that bear on
its ability to satisfy stated or implied needs.“
In simpler words a product has good quality when it "complies with the
requirements specified by the client“.
II. Function:
To design a bunch of standards for :
Note: The standards are reviewed every five years and revised if required.
Why is ISO certification
required:
Any generic standard such as ISO requires a basic structure ( a basic way of doing
things) containing set of procedures.
This basic structure or the way of implementing these standards is the Management
System.
Based on the area such as product quality improvement, environment quality, and
occupational safety while working ,
Different type of management systems have been designed such “ Quality
Management System (QMS), Environment Management System ( EMS), OHSAS etc.
Management System – In detail
The set of procedures an organization needs to follow in order to meet its objectives.
For some small organizations: "our way of doing things", that is mostly kept in the heads
of the staff.
Larger organization, the more likely that procedures need to be recorded to ensure
everyone is clear on who does what, when and how things are to be done. This process of
systemizing how things are done is known as a management system.
The first step Define organization policy containing clear cut goals and objectives.
Different management systems: QMS , EMS , OHSAS , EnMS & IMS for implementing
different standards.
Implementing any Management System
3
2
The concept:
Recognize the external quality related requirements specified in Licenses to
Trade, guidelines, specified customer requirements, and the chosen
management system standard(s).
Ensure that all requirements have been documented within the
management system in the appropriate location in terms of defined specific
system requirements.
Confirm that employees receive applicable training in the quality system
requirements.
Outline performance processes, where applicable, to the quality system
requirements.
Produce records or evidence that system requirements have been met.
Quality Management System
Execute the audit and analyze the system processes and correct them
when necessary.
Include processes that will help continually to improve the quality system.
How to implement QMS
An External Audit:
Conducted by a person outside your organization such as a customer or
an independent third party organization like a Registrar to verify that you
conform to the applicable requirements
An Internal Audit :
Used to assess conformity, evaluate effectiveness, and identify
opportunities for improvement.
Internal audits also help to prepare for external audits.
During an internal audit quality system against the requirements of the
standard are compared.
A group of internal auditors from within your company to perform the
audits.
Non Conformance to Management
System
What is Non conformance and how it can be rectified:
A non-conformance means a deficiency arising in the system that impairs the effective
implementation of any Management system viz. QMS, EMS, OHSAS.
Examples:
An element of standards such as ISO etc. not implemented.
Procedures not developed or not implemented.
non-conformance can be in service, a product, a process, from a supplier, or in the
system itself. It occurs when something does not meet the specifications or
requirements in some way. Those requirements might be defined by the customer, a
regulatory body such as ISO, or in the internal procedures of the company.
A non-conformance could be identified through customer complaints, internal audits,
external audits, incoming material inspection or simply during normal testing and
inspection activities.
ISO 9001:2008 requires that you document your non-conformance procedure (clause
8.3) and keep records of non-conformance issues you identify and the actions taken.
ISO 9001:2015 no longer requires a documented procedure, but you must still keep
records (“retain documented information”) of the nonconformity and what was
done to correct it, i.e. the corrective actions.
ISO 9001:2015
ISO 9001:2015: Revised and latest version of ISO 9001 ,easier to implement for organizations
using multiple management systems i.e. one or more type of systems integrated or
organizations following integrated management systems ( IMS).
To identify the risks one may have to do Risk Assessment of the process activities involved.
Environment Management System
( The management system required to improve the
quality of environment we work in & implement ISO
14001)
Environment Management System
The most widely used standard which EMS uses is based on is International
Organization for Standardization, ISO 14001. Other relatively lesser known
standards are ISO 14000 & ISO 14004.
Environment Management System
PDCA Cycle
ISO 14001
ISO 14001:2004 , the first revision of ISO 14001 was reviewed and used
till 2015, after which the latest revised version ISO 14001:2015 was issued in
2016.
ISO 14001:2004
It requires an organization to :
Identify the environmental aspects,
Applicable legal and other requirements to which the organization subscribes.
Examine existing environmental management practices and procedures.
Evaluation of previous emergency situations and accidents.
Note: An organization has the freedom and flexibility to choose to implement this
International Standard with respect to the entire organization or to specific operating units of
the organization.
ISO 14001:2004: how it works
What is life cycle thinking : Applying a holistic approach when talking about a
product .
In general life cycle of any product may consist of:
Material processing
Transportation
Distribution
Consumption
Reuse/ recycling
Disposal
What is Hazard:
Source or situation with the potential to cause harm in terms of human injury or ill-health
Risk assessment – The process of evaluating the risk arising from the hazards.
Includes:
The likelihood of a hazardous event or exposure and
the severity of injury or ill health that can be caused by the event of exposure
I Processes, practices,
PROCESS DOCUMENTS responsibilities,
AND PROCEDURES interfaces
II
Detailed instructions
INSTRUCTIONS on how to carry out
III
specific tasks
Out side
SPECS IV documents
ISP 19 -
PROCEDURE OF CONTROL OF INSPECTION ,MEASURING AND TEST EQUIPMENTS
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