Fundamentals of ISO

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• Fundamentals of ISO

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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.

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Quality

• The extent to which a set of inherent
  characteristics fulfills requirements/specificatio
  ns

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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.

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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.

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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

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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.

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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

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ISO Core Standards

• ISO 90002000 Series, 1994 family of standards
• have been reduced to 4 core standards
• ISO 90002005 - Fundamentals and Vocabulary
• ISO 90012000 Requirements
• ISO 90042000 Guidelines for performance
  improvements
• ISO 190112002 Guidelines for Auditing Quality
  and/ or Environmental Management Systems Auditing
• ISO 90003 2004 - Guidelines for the application
  of ISO 90012000 to computer software.

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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.

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Work Process

• Monitoring and Measurement opportunities before,
  during and
• after the process

Product (Result of Process)
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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 organizations processes.

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Typical Structure of Documentation

• The number and levels may be adjusted to meet the
  organizations 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)
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Documentation

• Quality Manual
• The quality manual gives the managements
  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

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ISO clause

• Clause4 Quality management system
• Clause5 Management responsibility
• Clause6 Resource Management
• Clause7 Product realization
• Clause8 Measurement, analysis and improvement

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Audit

• Systematic Approach
• Independent and well documented
• Process for getting evidence
• Evaluating objectively
• Check if the audit criteria is fulfilled

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Quality System Audit

• An investigation of the intent and the
• implementation of selected aspects of the quality
  system of an organization.

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Types of Audit

• Internal Audits
• External Audits
• Second party audits
• Third party audits

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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.

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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.

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Audit Template

• Purpose
• Dept/Function
• Auditee
• Auditor
• Date Time
• Remarks/comments

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Types of Checklist

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

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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

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Non conformance

• Not meeting customer requirements
• Not meeting our own defined processes
• Not meeting management commitments

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Types of Non conformity

• Major Non conformity
• Minor Non Conformity
• Observation

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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

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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.

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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.

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Audit Finding Template