ISO 9000: The Global Quality Standard

ANWAAR SPENCEBRAD BAGLIANATHAN COOKTIMOTHY CARTER

Brief History of ISO

MIL-Q-9858

(1959)

NATO AQAP (1969

)

BS 5750 (1974

)

ISO 9000: 1987

ISO 9000: 1994

ISO 9000: 2000

ISO 9000: 2008

What is the ISO 9000 Family?

ISO 9000 is a family of standards for quality management systems. It is maintained by ISO, the International

Organization for Standardization A set of rules in which to be followed in order

to meet needs (i.e. consumer) A standard in which to conduct business IOS?? - ISO was derived from the greek word

isos meaning equal

ISO 9000 Family ISO 9004:2000 Quality management

systems - Guidelines for performance improvements.

ISO 9000:2005: Quality management

systems - Fundamentals and vocabulary.

ISO 9000 Family ISO 9001:2008

First Published in 1987 Revised in 1994 Revised in 2000 Current revision in the 11/15/2008

Hence it’s called ISO 9001:2008

ISO 9001-2008 Sections 8 Sections total – req. found in 4-8

1.0 Scope 2.0 Normative referenced 3.0 Terms and definitions - ISO

9000:2005

ISO 9001-2008 Sections

4.0 Scope (the way we run our business – structure)

5.0 Management Responsibility (management supports the structure)

6.0 Resource Management (people, buildings, machines, software)

7.0 Product Realization (the way we make our product)

8.0 Measurement, Analysis, & Improvement (product & process)

Why ISO 9000? Ensures that a company has a quality

system in place and is using that system Creates a competitive edge Increases Customer Confidence Foster employee confidence

Why ISO 9000?

Why ISO 9000?Is It Worth It??

ISO 9001 ElementsISO 9001 Elements

1. Management Responsibilities

2. Quality System

3. Contract Review

4. Design Control

5. Document Control

6. Purchasing

7. Control of Customer Supplied Product

8. Product Identification and Traceability

9. Process Control

10. Inspection and Testing

11. Inspection Measuring and Test Equipment

12. Nonconforming Product

13. Corrective and Preventative Action

14. Handling, Storage, Packaging…

15. Control of Quality Records

16. Internal Audits

17. Training

18. Servicing

19. Statistical Techniques

Why ISO 9000?Is It Worth It??

Certification The International Organization of

Standardization does not itself certify companies. Authorized accreditation bodies give

certification by auditing. Accreditation body members must declare their

common intention to join the IAF. International Accreditation Forum has the full

list of accreditors. Fees are involved for this service.

Certification The applying organization is reviewed based

on an extensive appraisal of its sites, functions, products, services, and processes.

A list of problems is made known to the management.

ISO 9001:2008 certificate is issued If the problems are minor, Corrective plan is produced by the

management. An ISO certificate renewal is every three

years.

Certification A company or organization may publicly

state its conformance with ISO 9001:2008. DOs

Certified or Registered DON’Ts

ISO 9000 Accredited

Certification to the ISO 9001:2008 standard applies to the process not the product.

Process for Certification

Applying organization is reviewed based on appraisal of its sites, functions, products,

services, and processes

A list of problems is

made known to the

management

ISO 9001:2008 certification is

awardedIf problems are minor, a resolution plan must be

set in place pre certification

Auditing Two types required:

external certification body internal staff trained in ISO certification

The aim is a continual process of review and assessment in order to: verify the system is working as it should find out where it can improve and to correct or prevent

problems identified.

Internal auditors should audit outside their usual management line, so their judgments are not biased.

Auditing The 2000 standard uses the process approach.

Auditors are expected to decide what is effective, rather

than what was formally prescribed. Under the 1994 version, the question was

broadly "Are you doing what the manual says you should be doing?“

The 2000 version, the question is more "Will this process help you achieve your stated objectives or is there a better way?

Advantages of Standardization

According to ISO.org“Without the international agreement contained in ISO standards on metric quantities and units, shopping and trade would be haphazard, science would be unscientific and technological development would be handicapped.”

According to ISO.org“Standards ensure desirable characteristics of products and services such as quality, environmental friendliness, safety, reliability, efficiency and interchangeability ”

When things work well we tend not to notice…

When standards are absent, we soon notice Products

Poor quality Lack of fit Incompatibility with equipment that we

already have Unreliability Danger!

Some specific examples… Screw Threads

Helps assembly of products Solves repair and maintenance problems

Symbols Provide danger warnings and information

across language barriers Can you match the symbol to the meaning?

ISO9001 - Advantages Creates a more efficient & effective

operation Raises customer satisfaction & retention Enhances marketing Improves employee motivation, awareness,

and morale Promotes international trade Increases profit & productivity Reduces waste

Problems with ISO 9001 Time and Money

Prone to failure when a company is interested in certification before quality

Customer contractual requirements force certifications rather than a desire to improve quality

Certification by an independent auditor is often a problem ISO actually advises ISO 9001 implementation

without certification, simply for the quality benefits that can be achieved

ISO 13485:2003 – Medical devices ISO 13485:2003 - quality management

system for the design and manufacture of medical devices.

In general ISO 13485:2003 is very similar to ISO 9001 but there is one significant difference ISO 9001 requires organizations to

demonstrate continuous improvement ISO 13485 requires the quality system only

demonstrate that it is implemented and maintained.

Current Good manufacturing practices (cGMP) Applied to Medical Devices in 1978 by the FDA GMP governs

Methods Facilities Controls

Used in Medical Device Design Manufacture Packaging Labeling Storage Installation Servicing

Current GMP Versus ISO 9001

Medical device manufactures must comply with the quality system requirements laid down in Current Good Manufacturing Practice (cGMP)

GMP modifications were made by the FDA (in 1997) to bring the standard closer to ISO 9001/13485 requirements but did not exactly mirror it.

Questions?????? NCR video www.youtube.com/watch?v=G8WI2Mgy

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Quality & ISO video http://www.youtube.com/watch?v=y4iIO

9Db5rk&feature=channel http://www.youtube.com/watch?v=0YAy

79hyJII&feature=channel