ISO 9000 series

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