1. Fundamentals of ISO

2. 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.

3. Quality
The extent to which a set of inherent characteristics fulfills requirements/specifications

4. 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.

5. 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.

6. 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

7. 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.

8. 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”

9. ISO Core Standards ISO 9000:2000 Series, 1994 family of standards
have been reduced to 4 core standards:
ISO 9000: 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: Guidelines for the application of ISO 9001:2000 to computer software.

10. 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.

11. Work Process
Monitoring and Measurement opportunities before, during and
after the process
Method
INPUT (Includes resources)
PROCESS
Output
Product (Result of Process)

12. 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.

13. 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)

14. 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

15. ISO clause Clause4: Quality management system
Clause5: Management responsibility
Clause6: Resource Management
Clause7: Product realization
Clause8: Measurement, analysis and improvement

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

17. Quality System Audit An investigation of the intent and the
implementation of selected aspects of the quality system of an organization.

18. Types of Audit Internal Audits External Audits Second party audits
Third party audits

19. 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.

20. Audit Plan Sample Template
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.

21. Audit Template Purpose: Dept/Function: Auditee: Auditor: Date & Time:
Remarks/comments:

22. Types of Checklist Bulleted specific Question
"Look AT" and "Look FOR" Model

23. 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:

24. Non conformance Not meeting customer requirements
Not meeting our own defined processes
Not meeting management commitments

25. Types of Non conformity
Major Non conformity
Minor Non Conformity
Observation

26. 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

27. 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.

28. 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.

29. Audit Finding Template