Quality Management 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

– Only one negative shown in 100 surveys.

– Positives outweigh negatives
– Takes time to implement, but worth it in the long
run
 ISO 9000
• The ISO 9000 series of standards is generic
• It is designed to adapt to fit any industry type
• Three standards of the 9000 series:

– ISO 9000:2000- Fundamentals and vocabulary

– ISO 9001:2000- Requirements
– ISO 9004:2000- Guidelines for performance
improvements
 Sector-specific Standards
• Some industries require special set of ISO
rules; not operated the same as most
• Three other quality systems:

– 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 industry’s
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:

– Hardware Specific Requirements and Measures

– Software Specific Requirements and Measures
– Services Specific Requirements and Measures
 ISO 9001 REQUIREMENTS
• The standard has 8 clauses

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

To provide a product that meets

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) Top Management Commitment

2) Appoint the Management Representative
3) Awareness
4) Appoint an Implementation Team
5) Training
6) Time Schedule
7) Select Element Owners
8) Review the Present System
9) Write the Documents
10) Install the New System
11) Internal Audit
12) Management Review
13) Preassessment
14) Registration
 DOCUMENTATION

States Policy and Objectives for each of

policy the pertinent ISO elements

procedures Departmental Procedures & responsibilities

Work instructions Forms, Work Instructions &

or Equipment Instructions
practices
Records or proof Business supporting documents
POLICY:

• This is a document that defines what will be done

and why.

• A quality policy manual should be written so it is

clear, precise, practical, and easy to understand.
PROCEDURE:

• The procedures define

1) who should perform specific tasks
2) when the task should be done
3) Where documentation will be made
showing that the task was performed.
WORK INSTRUCTIONS:

• Work instructions are usually department, machine,

task, or product oriented and spell out how a job will
be done.

• The writing of a work instruction is best carried out

by the employee who performs the task.
RECORDS:

• Records are a way of documenting that the polices,

procedures, and work instructions have been
followed.

• Records provide data for corrective action and a way

of recalling products.
DOCUMENT DEVELOPMENT:

• To begin creating the documentation system, the

implementation team should gather all the existing
policies, procedures, work instructions, and forms
that are presently in use.

• When the documents have been completed, they

should be formatted in a manner that will allow for
simple and effective document control.
 WRITING THE DOCUMENTS

• When writing the document it should be simple

rather than complex.

• Use flow chart and check sheets where ever possible

wherever possible rather than lengthy verbiage.
 INTERNAL AUDITS
Objectives:
1) Determine that actual performance conforms to
the documented QMS.
2) Initiate corrective action activities in response
deficiencies.
3) Follow up on noncompliance items from previous
audits.
4) Provide continued improvement in the system
through feedback to management.
5) Cause the auditee to think about the process,
thereby encouraging possible improvement.
AUDITOR:

A qualified individual who have received

training in auditing principles and procedures
should perform audits.
TECHNIQUES:

During the audit the auditor should employee three

methods:

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:

• Before the audit takes place an audit plan and check

list should be prepared.

• The audit itself has three parts

1) The preaudit meeting
2) The audit
3) A closing meeting
 REGISTRATION

It is the assessment and audit of a quality system by a

third party, known as a registrar.

Two parts:
1) Selecting a registrar.
2) The registration process.
SELECTING A REGISTRAR

• Qualifications And Experience

• Certificate Recognition
• The Registration Process
• Time And Cost Constraints
• Auditor Qualifications
REGISTRATION PROCESS

The process has six basic steps:

1) Application for registration.
2) Document review.
3) Preassessment
4) Assessment
5) Registration
6) Follow-up surveillance
 CLOSING COMMENTS

• The standards are written for contractual compliance

to the standard.

• Before entering into a contract for registration,

management must be able to justify the cost versus
the potential gains in continued or increased business.