ISO 9001 provides standards for quality management systems. It was originally created for manufacturing but now extends to services. The standards are generic and applicable to all organization sizes. Key aspects of ISO 9001 include quality policies, objectives, processes, resource management, internal audits, corrective actions, management reviews and continual improvement. Following the ISO 9001 standards helps organizations improve quality, meet customer expectations and requirements, and gain prestige.

1. What is ISO ?

2. I ni
S usahkan
O rang?...

3. INTERNATIONAL
ORGANIZATION
for
STANDARDIZATION

4. ISO 9001
(2008 version)

5. QMS
Quality Management System

6. Quality Management System
is a set of interrelated or interacting elements/processes that
organizations use to direct and control how quality policies are
implemented and quality objectives are achieved.
Each process uses resources to transform inputs into outputs.
Since the output of one process becomes the input of another
process, processes interact and are interrelated by means of
such input-output relationships.
These process interactions
create a single process-based QMS.

7. ISO 9001 Timeline
• First published in 1987
• Revised 1994
• Revised in 2000
(Major revision with a focus on continual
improvements and efficiency)
• Revised in 2008
(Minor changes- to give clarity in some points)

8. ISO 9001 (QMS)
14001 (Environmental)
18001 (Safety & Health)
TS16949 (Automotive)
13485 (Medical)
17025 (Calibration & Test Lab)
Etc.
Etc…..

9. Introduction
• QMS originally created for manufacturing
industry.
• Now extending to service industry
– Educational institutes
– Banking service
– Postal service
– Accounting
• Applicable for all sizes
• Standards are Generic
To
improve
service

10. Reason for Implementation QMS
(Instead of saying ISO9001)
• Goal of improving the quality of XXXX services
• Strategy of the XXXX in quality issues
• Need to improve the work systems
• Need to improve the organization
• Prestige of ISO 9001
• Users requirements and expectations
• Requirements of Government body

11. Cl. 6.2
Cl. 7.2.3
Cl. 7.2 Cl. 6.3 Cl. 6.3, 6.4
Cl. 7.4
Cl. 5.3
Cl. 5.2, 5.4, 5.3, 5.5
Cl. 4.2
Cl. 7.5, 7.6, 8.2.3, 8.2.4
Cl. 5.6
Cl. 5.3
Cl. 7.5.3, 7.5.5 Cl. 8.3
Cl. 8.4
Cl. 8.2.2 Cl. 8.5.2
Cl. 8.5.3
Cl. 8.2.1
CUSTOMER
COMPLAINT &
SATISFACTION
INVOICING
DELIVERY
CUSTOMER
HR, TRAINING,
COMPETENCY, SKILL
FACILITIES, MAIN'T
EQUIPMENT, WORK
ENVIRONMENT
PLANNING
OBJECTIVE
MANAGEMENT
REVIEW
QC INSPECTION
PACKING, RE-PROCESS,
OUTSOURCED
DOCUMENTATION &
RECORD CONTROL
CORRECTIVE &
PREVENTIVE ACTION
INTERNAL AUDIT
Cl. 8.5.1
SUPPLIER
CONTINUAL
IMPROVEMENT
CONTROL OF NC
SALES, MARKETING
ORDER PROCESSING
CUSTOMER
REQUIREMENT
PURCHASING,
MERCHANDISING
RECEIVING
WAREHOUSE LOGISTIC
INFORMATION TECH.
QMPerformance
Policy Direction
Policy Direction
ProductProcess Data
Resourcesneeds
QMS Process Flow

12. Inputs Process Outputs
= Satisfy
customer

14. ISO 9001 = “I’m FREE SIZE
I’m wearable
by
anyone”
(2008)

15. But what if… it’s still too big?

16. Or .…it’s too small?

17. Why Design involved
meh...?
需要吗？

18. Clause 7.3
Clause 7.3.1 Design & Development Planning
Clause 7.3.2 D & D Input
Clause 7.3.3 D & D Output
Clause 7.3.4 D & D Review
Clause 7.3.5 D & D Verification
Clause 7.3.6 D & D Validation
Clause 7.3.7 D & D Change

19. What season/theme?
Targeted
market?
Launching date?
Title of theme?
Fabric /
Material used?
Price
points?
Quality & Quantity
requirement?
In-hse? /
Outsource?
Designer
assign?
Standards
requirement?
PLAN & INPUTS
OUTPUTS
VERIFICATION
Meets your inputs?
Printed
artwork
Mock up
sample
Lab dip Marker artwork
Inputs + Outputs = fulfill your needs?
Enough info
for purchases?
Enough info
for prodn?
Prod
acceptance
criterias?
Printing sample
match?
Previous
design?
Competitor
Analysis

20. PLAN & INPUTS
VERIFICATION
VALIDATION
Shipping sample inspection
Worn by consumer - results
OUTPUTS
Review? Change?
Review? Change?
Review? Change?
Review? Change?

21. Inputs Outputs

22. Inputs Outputs

23. Validation

24. Do I need to remember
this clauses?
需要背吗？。。

25. Things to remember & DO!
1) Know your QMS (ISO 9001:2008)
2) Know your company policy
3) Know your job scope and responsibilities
- who is your immediate superior? i.e. who review & approve your work?
- is your skill/ work experiences fully utilized?
- where is your JD ?
4) Update your records
- is your paper filing in proper order?
- are you able to retrieve your file quickly?
- does the form filled has proper approve/review signature?
- is the form you’re using, controlled?
5) Achieve your dept’l objective
- evidence? e.g. summary reports, datas, etc.
6) There are Int. Audit to all depts.

26. Compliance
Comply with customer, statutory & regulatory
requirements & continuous improvement
Affordable
Affordable & Reasonable Pricing
Quality Product
Quality product & customer
satisfaction
Sample Quality Policy：