ISO 9000 SERIES
Baria, John AllenGantioqui, Karlos Ronald Nikkolas
HISTORY
Problem during the World War II, especially differences in: Ammunition Vehicles Unit of measure
First military standard established Industries realized the merit of
standardization but had differences
HISTORY
Common standards focused on the end product, not on the process
The science of quality control evolved from reactive to proactive
Companies were confused of the different standards in different countries
The International Organization for Standards issued the ISO 9000 series
DEFINITION
Not solely a quality control tool but a guideline for design, manufacture, sale and servicing of a product.
Also, meeting the customers expectations and requirements
Increase the level of quality and reliability, productivity and safety while making products and services affordable
Helps facilitate international trade
DEFINITION
“standards for the whole world” Meant to be generic no matter what
the organization’s business More 40,000 companies are
registered; ¾ are in Europe Process takes 12 to 18 months
registration
DEFINITION
ISO = International Organization for Standardization
= promotes worldwide, standards for the improvement of quality, productivity and operating efficiency through a series of standards and guidelines.
EIGHT QUALITY PRINCIPLES
1. A customer focus2. Leadership3. Involvement of people4. A process approach5. A system approach to management6. Continual improvement7. Use of a factual approach to decision
making8. Mutually beneficial supplier
relationships
REQUIREMENT FOR REGISTRATION OF ISO 9000
Company Review Refine Map Functions
Process control Inspection Purchasing Training Packaging Delivery
REQUIREMENT FOR REGISTRATION OF ISO 9000
Must reregistered every 3 years Helpful for companies that do not
currently have a quality management
STEPS IN OBTAINING ISO 9000 CERTIFICATION
Get top management Top management considers ISO 9000
registration Quality steering committee meets to
evaluate process Committee informs top management of
ISO 9000 costs, schedule, etc. Top management commits to pursue ISO
9000 registration
STEPS IN OBTAINING ISO 9000 CERTIFICATION
Train personnel Hold basic quality and ISO 9000training
for all employees Select and train personnel to be internal
auditors
STEPS IN OBTAINING ISO 9000 CERTIFICATION
Prepare quality manual policy Study and understand ISO 9000
requirements as they apply to your company
Write (or re-write) company Vision and Mission statements
Write basic Quality Policy Manual outline Complete first draft of Quality Policy
Manual Send copy of manual to customer
desiring ISO 9000 compliance (if necessary)
STEPS IN OBTAINING ISO 9000 CERTIFICATION
Prepare Operating Procedures Define responsibilities, using Quality
Manual as a guide Have those responsible for functions
outline their procedures Interview managers and fine-tune
procedures Compare Operating Procedures with
Quality Manual for consistency
STEPS IN OBTAINING ISO 9000 CERTIFICATION
Hold internal audit Hold internal audit of ISO 9000 manual
vs. ISO 9000 compliance Implement corrective action items from
audit
STEPS IN OBTAINING ISO 9000 CERTIFICATION
Select registrar Research registrars and their cost Qualify possible registrars Select third party registrar
STEPS IN OBTAINING ISO 9000 CERTIFICATION
Go through registration process Apply for registration and audits Agree to audit process etc. with registrar Hold pre-assessment audit Take any needed corrective action Have ISO 9000 registration audit Take any needed corrective action Re-audit as needed Take any needed corrective action
STEPS IN OBTAINING ISO 9000 CERTIFICATION
Obtain ISO 9000 registration This verifies that you operate your
business in compliance to the ISO 9000 requirements.
ADVANTAGES
Create a more efficient, effective operation
Increase customer satisfaction and retention
Reduce audits Enhance marketing Improve employee motivation,
awareness, and morale Promote international trade Increase profit Reduce waste and increase
productivity.
DISADVANTAGES
The amount of money, time and paperwork required for registration
Company can intend to produce a poor quality product and providing it does so consistently and with the proper documentation can put an ISO 9001 stamp on it
The standard is seen as especially prone to failure when a company is interested in certification before quality
Certifications are in fact often based on customer contractual requirements rather than a desire to actually improve quality
Competition among the numerous certifying bodies, leading to a softer approach to the defects noticed in the operation of the Quality System of a firm
SUMMARY ON HOW TO GET A CERTIFICATION
Get top management commitment Train personnel Prepare Quality Policy Manual Prepare Operating Procedures Hold internal audit Select registrar Go through registration process Obtain ISO 9000 registration
STANDARDS FOR ISO 9000
System Requirements Management Requirements Realization of Requirements Remedial Requirements
4 GENERIC PRODUCT CATEGORIES
HARDWARE SOFTWARE PROCESSED MATERIALS SERVICE
20 ELEMENTS OF ISO 9000 SERIES STANDARDS
Management Responsibilities Quality system Contract review Design control Document and data control Purchasing Control of customer supplied product Product identification and traceability Process control Inspection and testing Control of inspection, measuring, and test equipment Inspection and test status Control of non conforming product Corrective and preventive actions Handling, storage, packaging, preservation and delivery Control of quality records Internal quality audits Training Servicing Statistical techniques
EXAMPLES OF COMPANIES THAT PRACTICES ISO 9000 SERIES
Gushuyuan Coal Mine Jincheng Coal Nining Bureau Jincheng, Shanxi 048000, China Tel 86-356-3648250, Fax 3648003 Standard: ISO 9002 Registrar: QAC Certification Date: 12/96 Certified Scope: washed coal
EXAMPLES OF COMPANIES THAT COMPLIANT OF ISO 9000 SERIES
Littlestown Foundry, Inc. ISO certified manufacturer of aluminum base alloy castings
using green sand molding methods. Castings include aluminum awning & marine hardware & other types of aluminum hardware. Capabilities include castings from 1 oz to 20 lb., machining, finishing & heat treating. Materials meet ASTM, federal & military standards. Testing services including tensile & destructive, spectrographic analysis, metallographic analysis, microphotograpy, Brinell, ultrasonic, pressure & hydrostatic testing are available. ANSI/ASQ Q9001:2000 certified.
ISO certified, ISO 9000 & QS 9000 compliant manufacturer of aluminum castings. Capabilities include castings from 1 oz to 20 lb., machining, finishing & heat treating. Materials meet ASTM, federal & military standards.
EXAMPLES OF COMPANIES THAT COMPLIANT OF ISO 9000 SERIES
Precise Cast Prototypes & Engineering, Inc. Manufacturer of precision parts. Producing aluminum,
magnesium, & zinc casting & machined parts (all materials). Designs that range from simple to complex.
ISO 9000, ISO 9002, QS 9000 & QS 9002 compliant aluminum castings. Plaster & sand castings. Capabilities include design, dimensioning & tolerancing, GD & T questions, 3-D modeling, tooling design, as-cast model design & reverse engineering. Full-dimensional inspection available. Post-manufacturing services such as heat treating, coatings (paint, powder coat, anodize, etc.). Certification & compliance documentation available.
REFERENCE
Stevenson, William J. and Chuong, Sum Chee. Operations Management: An Asian Perspective. McGraw-Hill,(2007).
Randall, Richard C. Randall’s practical guide to ISO 9000: implementation, registration, and beyond. Reading, Mass. Addison-Wesley, (1995).
http://www.school-for-champions.com/iso9000/registration_steps.htm
http://en.wikipedia.org/wiki/ISO_9000#Certification