QUALITY MANAGEMENT SYSTEM

QMS

ISO 9000
Mandate
to promote development of international
standards to facilitate the exchange of goods
and services worldwide
Nature & Purpose
1. Advisory
2. Two-Party Contractual Situations
3. Internal Auditing

EC Adoption Universal Acceptance

ISO 9000
Adopted as National Standard by most
member countries
ANSI American National Standard Institute
ASQ American Society for Quality
PSQCA Pakistan Standards & Quality Control
Authority

ISO 9000
Two-Party System
Pre-shipment Inspection
Vendor Audit Multiple, Extremely Costly

Replaced Third-Party Registration System

Assessment
Registrar Interprets the Standard
Periodic Surveillance Audit
Adequacy of Supplier Quality System
Certificate of Registration Quality System in place
and being monitored

ISO 9000
Benefits
Compliance
Process Improvement
Global Deployment of Services/Products
Snowball Effect whole value/supply chain
certification
Commercial Aspects Market Share
Well-documented quality system

ISO 9000
Internal quality improvement - % of scrap,
rework and non-conformance
Production reliability No. of Breakdown
per month , % times dedicated to
emergencies , % downtime per shift
External Quality - Customer Acceptance
without Inspection , claims of nonconformance , returned product

ISO 9000
Time Performance - Time to Market , Ontime delivery
Cost of Poor Quality

ISO 9000
Downside
Prevention Cost
Appraisal Cost

ISO 9000
Scope - Generic:

large or small organization

service or manufacture organization
Construction, Engineering, Healthcare, Legal
Say What you Do; Do What you Say

ISO 9000
Family of Standards
ISO 9000:2005 (Fundamentals & Vocabulary
Definition)
ISO 9001:2008 (Requirement Certification)
ISO 9004:2009 (Continuous Improvement)

Sector Specific Standards Supplier

AS9100 Aerospace Industry
ISO/TS 16949 Automakers
TL 9000 - Telecom

ISO 9000
Clauses
1. Scope
2. Normative Reference
3. Definition
4. Quality Management Systems
5. Management Responsibility
6. Resource Management
7. Product / Service Realization
8. Measurement, Analysis & Improvement
Last 5 Clauses are Requirements

ISO 9000
Implementation Steps
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.

Top Management Commitment

Appoint the Management Representative
Awareness
Appoint an Implementation Team
Training
Time Schedule
Select Element Owners
Review the Present System
Write the document
Install the new system
Internal Audit
Management Review
Pre-assessment
Registration

ISO 9000
Documentation
1.
2.
3.
4.

Policy Why? What will be done?

Procedure Who? When? Where?
Practices Work Instructions How?
Proof Records / Evidence

Starting Point Existing Documentation!

ISO 9000
Internal Audit Objectives
1. Determine the actual performance conforms to the
documents QMS
2. Initiate corrective action activities in response to
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,
encouraging possible improvements

ISO 9000
Document Control
1. Documents are identifiable with a title, revision
date and responsible owner;
2. Documents are readily available to users;
3. A master list by department 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

ISO 9000
Registration assessment & audit of quality
system by a third party / Registrar
Registrar Selection
1. Qualifications & Experience
a.
b.
c.
d.
e.
f.
g.

Interpersonal relations
Value added
Consistent interpretation
Administration
communication
Financial condition / Solvent
Up to date / Accredited

ISO 9000
2. Certificate Recognition
2. Approved by regulatory agency
3. Recognized by existing customers and prospects
4. Prior customer interviews + customer database

ISO 9000
3. Registration Process
a. Structure registration process tailor to organizational
needs
b. Multiple audits environmental, quality, security and
workplace safety
c. Improving quality & productivity
d. Evaluate existing system
e. Identify opportunities for more efficient practices

ISO 9000
4. Time & Cost Constraints
a. Lead time prior actual audit
b. Time & Cost for initial audit and surveillance audit
c. Additional fees

ISO 9000
5. Auditor Qualification ISO 19011
a. Know the standard
b. Know the type of processes, the organization, the
customer
c. Have the knowledge, temperament and experience to
be credible
d. Non-disclosure Policy
e. No conflict of interest
f. Submit proof of qualifications, knowledge, and
experience
g. No Captive Clause

ISO 9000
Registration Process
1.
2.
3.
4.
5.
6.

Application for Registration

Document Review
Pre-assessment
Assessment
Registration
Follow-Up Surveillance