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Fundamentals of ISO

Quality
• Quality is Conformance with requirements
• Quality is fitness for purpose
• Quality is fitness for use
• Quality is user dependent

To achieve consistency in output, it is quality of


everything that we do, which can be improved.
Quality

The extent to which a set of inherent


characteristics fulfills
requirements/specifications
Need for Quality
Every organization would like to
improve in different ways i.e.
• Improving customer satisfaction
• In means of operations
• Increasing market share
• driving down costs
• managing risk more effectively.
Core Principles of Quality Management

• Customer Focus.
• Leadership.
• Involvement of People.
• Process Approach.
• System Approach to Management.
• Continual Improvement.
• Factual Approach to decision Making.
• Mutually beneficial supplier relationships.
Quality Management System

A quality management system gives you the


Framework and guidelines you need to
monitor and improve performance in any
given area

• Management System to direct and control


an organization with regard to quality
• Assess the processes and measure the
same
ISO Quality management -key
requirements

• QMS - Document processes necessary to ensure product or service is of


high quality and conforms to customer requirements.

• Management Responsibility - Provide a vision. Show commitment.


Focus on the customer. Define policy. Keep everyone informed.

• Resource Management - Assign the right person to the job. Create and
maintain positive workspace.

• Product Realization - Clearly understand customer, product, legal and


design requirements. Ensure specifications are followed. Check your
suppliers.

• Measurement, Analysis & Improvement - Identify current and


potential problems. Monitor and measure customer satisfaction. Perform
internal audits. Fix problems.
ISO
To address this need of the customers and also to
ensure that organization would improve their
working internally, system standards were
released by ISO, in the year 1987 which have
been revised once in 1994 and latest version
standards have been released in 2000.

ISO stands for “International Organization for


Standardization”
ISO Core Standards

ISO 9000:2000 Series, 1994 family of standards


have been reduced to 4 core standards:

• ISO 9000:2005 - Fundamentals and Vocabulary


• ISO 9001:2000 – Requirements
• ISO 9004:2000 – Guidelines for performance
improvements
• ISO 19011:2002 – Guidelines for Auditing Quality and/ or
Environmental Management Systems Auditing
• ISO 90003: 2004 - Guidelines for the application of ISO
9001:2000 to computer software.
Process
The ISO standards are structured around the
Process Approach concept. Two of the eight quality
management principles are key to understanding
this principle:
• Process Approach - Understand and organize
company resources and activities to optimize how
the organization performs.
• System Approach to Management -
Determine sequence and interaction of processes
and manage them as a total system. Processes
must meet customer requirements.
Work Process
Monitoring and Measurement opportunities before, during and
after the process

Method

INPUT (Includes resources)


Output
PROCESS
Product (Result of Process)
Documentation
Management should define the
documentation, including the relevant
records, needed to establish, implement and
maintain the quality management system
and to support an effective and efficient
operation of the organization’s processes.
Typical Structure of Documentation
• The number and levels may be adjusted to meet the organization’s needs.
• Forms may be applicable at all levels of the hierarchy.

Quality
manual
(Level A)

Quality Management
System Procedures
(Level B)

Work Instructions, Process maps and


other documents for QMS
(Level C)

Forms and Records


(Level D)
Documentation
Quality Manual:
The quality manual gives the management’s directions for
Quality Management system, in which it will define the
departments/ Areas to be covered in the process system.

QMS - Procedures/ SOP:


 Control of Documents
 Control Records
 Internal Audits
 Control of Nonconformity
 Corrective Action
 Preventive Action
ISO clause
Clause4: Quality management system

Clause5: Management responsibility

Clause6: Resource Management

Clause7: Product realization

Clause8: Measurement, analysis and improvement


Audit
• Systematic Approach
• Independent and well documented
• Process for getting evidence
• Evaluating objectively
• Check if the audit criteria is fulfilled
Quality System Audit
An investigation of the intent and the
implementation of selected aspects of the
quality system of an organization.
Types of Audit
• Internal Audits
• External Audits
• Second party audits
• Third party audits
Audit Activities
• Initiating an Audit
• Conducting document review
• Preparing for onsite activities
• Conducting onsite activities
• Preparing, approving and distributing the
audit report
• Complete the audit
• Conducting the audit Follow-up.
Audit Plan Sample Template

Audit Plan
Audit objective
Audit criteria and reference documents
Audit scope - Coverage
Area and aspects
Dates and places for audit activities
Audit meeting Times
Allocation of resources for critical areas.
Audit Template
• Purpose:
• Dept/Function:
• Auditee:
• Auditor:
• Date & Time:
• Remarks/comments:
Types of Checklist

• Bulleted
• specific Question
• "Look AT" and "Look FOR" Model
Sample Template "Look AT" and
"Look FOR" Model

Function : HR Dept - Recruitment Area


Activity : Updating the skills of Employee
Look AT : Employee Details Screen- (SPCG)
Look FOR: Skill Type, Skill Rating, Employee
joining date, Frequency of updating the skill.
Sample size : 10
Time : 30 min
Remarks:
Non conformance
• Not meeting customer requirements
• Not meeting our own defined
processes
• Not meeting management
commitments
Types of Non conformity
• Major Non conformity
• Minor Non Conformity
• Observation
Major Non conformity
• The absence or total breakdown of a system to meet the ISO 9000
requirement.

• A bunch of number of minor nonconformities against one requirement can


represent a total breakdown of the system and thus be considered a major
nonconformity.

• Any noncompliance that would result in the probable shipment of


nonconforming product to the customer.

• A condition that may result in the failure or materially reduce the usability of
the products or services for their intended purpose at customer place

• Anything that can affect the quality system itself


Minor Non Conformity

• A failure in some part of the documented


quality system relative to ISO 9000, or

• A single observed lapse in following one


item of the company's quality system as
an isolated case.
Observation

• An observation is essentially an OPINION.

• Some say you can ignore it while others


expect the Observation to be addressed in
some manner - such as through the
corrective action system.
Audit Finding Template