Overview of ISO 9001

Module -2

Technical Training
Topaz Engineering

Technical Training Topaz

Document No: QAQC-2 1
Engineering
 Aim of ISO 9001

An organization
A. Needs to demonstrate its ability to
consistently provide product(product
or service that is intended for or
required by a customer)that meets
. Customer requirements
. Applicable regulatory
requirements
B. Aims to enhance customer
satisfaction through
. Effective implementation of
QMS
. Assurance of conformity to
requirements

Technical Training Topaz

Document No: QAQC-2 2
Engineering
 Supply chain vocabulary

Technical Training Topaz

Document No: QAQC-2 3
Engineering
 Structure of ISO 9001
1. Scope 1.1 General 5. 5.1 Management Commitment
1.2 Application Management 5.2 Customer focus
responsibility 5.3 Quality Policy
5.4 Planning
5.5 Responsibility, Authority and
communication
5.6 Management review
2. Normative 6. Resource 6.1 Provision of resources
reference Management 6.2 Human Resources
6.3 Infrastructure
6.4 Work Environment
3. Terms and 7. Product 7.1 Planning of product realization
definitions Realization 7.2 Customer related processes
7.3 Design and Development
7.4 Purchasing
7.5 Production and Service provision
7.6 Control and Monitoring and
measuring devices
4. Quality 4.1 General 8.Measureme 8.1 General
Management requirements nt, Analysis 8.2 Monitoring and Measurement
System 4.2 and 8.3 Control of Nonconforming
Documentation Improvement product/service
requirements 8.4 Analysis of date
8.5 Improvement
Technical Training Topaz
Document No: QAQC-2 4
Engineering
 General Requirements
QWMS development would begin with writing a quality policy,
manual followed by documented procedures.
But ISO 9001 clause 4.1 emphasize on PDCA and the system
approach.
Identify QMS processes and their application

Determine sequence and interaction of processes

Determine criteria and methods

Ensure availability of resources and information

Monitor, measure and analyze

Achieve planned results and continual improvements

Technical Training Topaz

Document No: QAQC-2 5
Engineering
 Anatomy of a clause

The following extract from ISO 9001 shows a typical clause

4.2 Documentation requirements
4.2.1 General
The quality management system documentation shall
include
Documented statements of a quality policy and quality
objectives
A quality manual
Documented procedures required by this International
Standard
Documents needed by the organization to ensure the
effective planning, operation and control of its processes
and
Records required by this International Standard (see 4.2.4)
Technical Training Topaz
Document No: QAQC-2 6
Note 1 Where the term documented
Engineering procedure appears
 Typical QMS Documentation Structure
Quality Manual
Specifications/Work
Forms/Records
objectives Instructions/ Guidelines

Technical Training Topaz

Document No: QAQC-2 7
Engineering
 Typical QMS Documentation Types of
Documentation
Quality Manual

Describes arrangements specific to a

customer, contract or project

Provides data as evidence of the degree to

which requirements have been met

Technical Training Topaz

Document No: QAQC-2 8
Engineering
 Continual Improvement
Policy
Quality Objectives

Corrective and
Audit Analyze Date
Preventive Action

Management Review

Technical Training Topaz

Document No: QAQC-2 9
Engineering
 The Audit Process
Module - 3

Technical Training
Topaz Engineering

Technical Training Topaz

Document No: QAQC-2 10
Engineering
 Quality System Audit

Audit is defined as
Systematic, independent and documented process for
obtaining audit evidence and evaluating it objectively to
determine the extent to which agreed criteria are fulfilled

Technical Training Topaz

Document No: QAQC-2 11
Engineering
 Quality System Audit

Type Auditor/Audit Focus on

ee
Relationship
First Party Organization
(Internal) audits itself

All Processes
Second Customer
Party audits a
(External) supplier

Contract related Processes

Third Audit by an
Party independent System and
(External) organization processes
Technical Training Topaz
Document No: QAQC-2 12
Engineering
 Typical Audit Objectives

Compliance

Are objectives
achieved?

Technical Training Topaz

Document No: QAQC-2 13
Engineering
 Reasons to audit
First Party

Technical Training Topaz

Document No: QAQC-2 14
Engineering
 Audit Guidelines

TermsActivities
Principles
Managing
Audit
Competence
and of
an
Definitions
and
Auditing
Audit
Evaluation
Program of Auditors

Technical Training Topaz

Document No: QAQC-2 15
Engineering
 The Audit Process

Technical Training Topaz

Document No: QAQC-2 16
Engineering