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ISO 9000 Standards Guide

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Outline

Back Ground

QMS

Requirements

Check List

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Back Ground

ISO 9000 is a family of standards for quality management

systems.

ISO 9000 is maintained by ISO, the International

Organization for Standardization

ISO administered by accreditation and certification bodies.

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ISO 9000-QMS

Establish

Document

Implement

Maintain

Improve

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Management Responsibility

The quality policy shall be defined, documented, understood,

implemented and maintained.

Responsibilities and authorities for all personnel specifying,

achieving and monitoring quality shall be defined.

In-house verification resources shall be defined, trained and

funded.

A designated management person sees that the QMS program

is implemented and maintained

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Design Control

The design of project should be planned.

Design input parameters shall be defined.

Design output, including crucial product characteristics

shall be documented.

Design output shall be verified to meet input requirements.

Design changes shall be controlled.

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Process Control

Service processes shall be defined and planned.

Services shall be carried out under controlled conditions:

documented instructions, in-process controls, approval of

processes and equipment, and criteria for workmanship.

Special processes that cannot be verified after the fact

shall be monitored and controlled throughout the

processes.

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Handling & Delivery

Procedures for delivery shall be developed & maintained.

Handling controls shall prevent damage and deterioration.

All the processes shall be controlled.

Quality of the product after final inspection shall be maintained.

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Quality System

Procedures shall be prepared.

Procedures shall be

implemented.

Contract Review

Incoming contracts (and

purchase orders) shall be

reviewed to see whether the

requirements are adequately

defined, agree with the bid and

can be supplied.

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Document Control

Generation of documents shall be controlled.

Distribution of documents shall be controlled.

Changes to documents shall be controlled.

Purchasing

Potential subcontractors and sub-suppliers shall be evaluated for their ability to provide stated requirements.

Requirements shall be clearly defined in contracting data.

Effectiveness of the subcontractor's quality assurance system shall be assessed.

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Customer-Supplied Material

Any customer-supplied material and Information shall be protected against loss or damage

Product Identification & Traceability

The projects shall be identified and traceable by during all stages.

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Inspection and Test Status

Status of inspections and tests shall be maintained for items as they progress through various processing steps.

Records shall show who released conforming product.

Control of Nonconforming Product

Nonconforming product shall be controlled to prevent inadvertent use or installation.

Review and disposition of nonconforming product shall be formalized.

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Corrective Action Problem causes shall be

identified. Specific problems and their

causes shall be corrected. Effectiveness of corrective

actions shall be assessed

Quality Records Quality records shall be

identified, collected, indexed, filed, stored, maintained and dispositional.

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Training

Training needs shall be identified.

Training shall be provided. Some tasks may require

qualified individuals. Records of training shall be

maintained.

Servicing

Servicing activities shall be performed to written procedures.

Servicing activities shall meet requirements

Feedback mechanism should be placed to capture customer commendations and comments

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Check List for ISO 9000

Management Responsibility

Quality System Contract

Review

Design Control    

Document and Data Control

Purchasing  

Control of Customer-Supplied

Product

Product Identification and

Traceability

Process Control  

Control of Nonconforming

Product

Corrective and Preventive

Action

Delivery

Control of Quality Records

Internal Quality Audits

Training

Servicing  

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Thank You Very Much