Professional Documents
Culture Documents
Systems
Chapter 10
Introduction
ISO- International Organization for
Standardization
Founded in 1946, in Geneva, Switzerland
Main function is to promote the
development of standardization of goods
and services, to better accommodate a
world wide market.
ANSI- American National Standards Institute
ANSI represents U.S. in the ISO
ISO Registration
Companies can become registered as
an ISO company
This involves the registrar giving an
assessment of the operations a
company, and then making periodic
surveillance audits
Primary Reason: To give your customer
the comfort of knowing that you have a
quality plan in place, and it is being
monitored by an objective third party
Internal Reasons for Becoming
ISO Registered
100 Italian manufacturing firms were
surveyed to find out what improved
after certification.
Internal quality: less scrap, rework,
nonconformities
Production reliability: less breakdowns, less
time with emergencies, downtime
Time performance: time to market, punctual
deliveries
Externally: less nonconformities
Negatives
Prevention and appraisal costs increased
AS9100-
ISO/TS 16949
TL9000
AS9100
This standard is specifically for the
aerospace industry
Attempt at unifying the requirements
of NASA, DOD, and FAA
At the same time satisfying the
industrys needs
ISO/TS 16949
Standard specifically for automotive
suppliers
Merges supplier quality requirements of U.S.
with German, French, and Italian
automakers
Goal- provide continuous improvement,
defect prevention, reduce variation and
waste
Is assumed that this standard will show 85%
improvement rate in first 5 years
TL9000
Telecommunications Industry
Consolidate various quality systems
requirements
Defines design, development,
production, delivery, installation and
maintenance of telecommunications
Customers receive benefits ,
worldwide competition, benchmarks,
improvement initiatives
TL 9000 continued-
This standard focused on:
1) Scope
2) Normative Reference
3) Terms and Definitions
4) Quality Management Systems
5) Management Responsibility
6) Resource Management
7) Product Realization
8) Measurement Analysis and Improvement
1. Scope
a) Customer Requirement
b) Regulatory Requirements
c) Customers Satisfaction
2. Normative Reference:
Fundamentals and vocabulary
3. Terms and Definitions:
Supplier Organization Customers
4. Quality Management System:
a) General Requirements
b) Documentation
* General Documentation
* Quality Manual
* Control of Documents
* Control of Records
5) Management Responsibility:
a) Management commitment
b) Customer Focus
c) Quality policy
d)Planning
* Quality Objectives
* Quality Management System
Planning
e) Responsibility, Authority, And
Communication
* Responsibility and Authority
* Management Representative
* Internal Communication
f) Management Review
* General Management
* Review Input
* Review Output
6) Resource Management :
a) Provision of Resources
b) Human Resources
* General
* Competence, Awareness and Training
c) Infrastructure
d) Work Environment
7) Product Realization
a) Planning of product Realization
b) Customer Related Processes
* Determination Of Requirement Related to
the Product
* Review Of Requirement Related to the
Product
*Customer Communication
c) Design And Development
* Design And Development Planning
* Design And Development Inputs
* Design And Development Outputs
* Design And Development Review
* Design And Development Verification
* Design And Development Validation
* Control of Design And Development
Changes
d) Purchasing
* Purchasing Process
* Purchasing Information
* Verification Of Purchased Product
e)Production And service Provision
* Control Of Production And service
Provision
* Validation Of Processes For
Production And service Provision
*Identification And Traceability
* Customer Property
* Preservation of Product
f) Control Of Monitoring And Measuring Devices
8) Measurement , Analysis, And
Improvement
a) General
b) Monitoring And Measurement
* Customer Satisfaction
* Internal Audit
* Monitoring And Measurement Of Processes
* Monitoring And Measurement of Product
and Service
c) Control Of Nonconforming Product
d) Analysis Of Data
e) Improvement
* continual improvement
* corrective Action
* preventive Action
IMPLEMENTATION
1) Examination of documents
2) Observation of activates
3) Interviews
Examination of Documents:
The auditor should examine the documents in a
systematic manner
1) Documents are identified with a title, revision
date, and responsible owner.
2) Documents are readily available to users
3) A master list by departments or function for
procedures, work instructions, and records is
appropriately located.
4) There are no obsolete documents at workstations.
5) Changes follow a prescribed procedure.
Observation Activity:
It requires an aptitude for details.
Interviews:
1) Place the auditee in a nonthreathing environment
2) Encourage employees to talk about the process.
3) Focus on the system not on the auditee.
4) Discuss the major issues informally with the
auditee first.
5) Use the appropriate type of questions.
PROCEDURE:
Two parts:
1) Selecting a registrar.
2) The registration process.
SELECTING A REGISTRAR