QUALITY, ISO, AND

YOUJENN SHAFNERBRIAN KROUSECLINT KEHRES

BRIEF HISTORY OF ISOPre ISO 9000 The BS 5750 standard required factories to

document manufacturing procedures.

BS 5750 was known as a management standard because it did not specify what to manufacture, but how to manage manufacturing processes.

In 1987, the British Government persuaded the International Organization for Standardization (ISO) to adopt BS 5750 as an international standard.

BS 5750 therefore became ISO 9000

ISO 9000 FAMILY ISO 9000 is a family of standards for

quality management systems. It is maintained by ISO, the International

Organization for Standardization Administered by accreditation and certification

bodies which monitor processes to ensure they are effective

Some requirements: Keeping adequate records Checking output for defects, with appropriate

corrective action where necessary Regularly reviewing individual processes and the

quality system itself for effectiveness Facilitating continual improvements

ISO 9000 FAMILY ISO 9001:2000: Quality management systems –

Requirements Intended for organizations which designs, develops,

manufactures, installs and/or services any product or provides any form of service.

Provides requirements to achieve customer satisfaction and expectations.

Includes a requirement for the continual improvement of the Quality Management System

The only standard which auditors may grant certification.

ISO 9000 FAMILY ISO 9004:2000 Quality management

systems - Guidelines for performance improvements. Covers continual improvement and gives advice

on how to enhance a mature system. ISO 9000:2005: Quality management

systems - Fundamentals and vocabulary. Covers the basics of what quality management

systems are and contains the language of the ISO 9000 series of standards.

ISO 9001:2000 Most well known standard is ISO 9001:2000

Combined three standards of ISO 9000:1994 (9001, 9002, and 9003) into one.

The 2000 version placed process management front and center. Process management is the monitoring and optimizing of a

company's tasks and activities. Another goal was to improve effectiveness via

process performance metrics Metrics: numerical measurement of the effectiveness of

tasks and activities.

ISO 9001 ELEMENTS

ISO 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

CERTIFICATION The International Organization of Standardization

does not itself certify companies. Authorized accreditation bodies give certification by

auditing those applying for ISO 9001 compliance certification.

Commonly referred to as ISO 9000:2000 certification, the actual standard certified to is ISO 9001:2000.

Both the accreditation bodies and the certification bodies charge fees for this services.

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.

If these problems are minor, an ISO 9001 certificate is issued by the accreditation body for the visted site once a plan explaining how the problems will be resolved is produced by the management.

An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals (3yrs).

CERTIFICATION A company or organization that has been

independently audited and certified to be in conformance with ISO 9001 may publicly state that it is: "ISO 9001 certified“ "ISO 9001 registered."

Certification to an ISO 9000 standard does not guarantee the compliance and therefore the quality of end products and services

Certification attests that consistent business processes are being applied.

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 ISO 9001 ISO 9001 certification could yield the

following advantages:A more efficient, effective operation Increased customer satisfaction and

retention Enhanced marketing Improved employee motivation, awareness,

and morale Promoted international trade Increased profit Reduced waste and increased productivity

PROBLEMS WITH ISO 9001 Timely and costly

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

VERSIONS OF ISO 9000 AS 9000: Aerospace Basic Quality System

Standard

PS 9000: Pharmaceutical Packaging Materials.

QS 9000: is an interpretation agreed upon by major automotive manufacturers

ISO 13485:2003 is the medical industry's equivalent of ISO 9001:2000. Compliance with ISO 13485 does not

necessarily mean compliance with IS0 9001:2000.

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 VERSUS ISO 9001

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

cGMP governs methods, facilities, and controls used in the design, manufacture, packaging, labeling, storage, installation, and servicing of medical devices

cGMP modifications were made by the FDA to bring the standard closer to ISO 9001 requirements but does 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

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