ISO 9000

Quality System Certification

Employee Handout

© 1997, 2003
Dexter A. Hansen

19091 Chennault Way
Eden Prairie, MN 55346


Index

What is ISO 9000?

Does the company need ISO 9000?

What are the expected benefits?

The Eight Quality Management Principles

Process Model

Elements of ISO 9001

What is Certification?

What does ISO mean to me?

How will we become certified?

Are we finished once we passed?

The Company's Quality Policy


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What is ISO 9000?

ISO 9000 is a series of related international standards for developing quality management systems. It was developed by the International Organization for Standardization in 1987 to harmonize quality management in Europe and he lst revision was in year 2000.

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Does the company need ISO 9000?

Right now, ISO 9000 is voluntary, however, at any time, a customer may require it. The main reasons for pursuing ISO certification are:

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What are the expected benefits?

ISO 9000 certification will

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The Eight Quality Management Principles

Principle 1 - Customer focus: organizations depend on their customers and therefore should understand current and future customer needs; meet customer requirements and strive to exceed customer expectations.

Principle 2 - Leadership: leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives.

Principle 3 - Involvement of people: people at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit.

Principle 4 - Process approach: a desired result is achieved more efficiently when related resources and activities aremanaged as a process.

Principle 5 - System approach to management: identifying, understanding and managing a system of interrelated processes for a given objective improves the organization's effectiveness and efficiency.

Principle 6 - Continual Improvement: continual improvement should be a permanent objective of the organization.

Principle 7 - Factual approach to decision making: effective decisions are based on the analysis of data and information.

Principle 8 - Mutually beneficial supplier relationships: an organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value.

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Process Model

The ISO 9001:2000  Quality Management System Standard is now based on the Process Model.  A graphic model of the processed based management system as shown below.  The previous ISO9001:1994 Standard was made up of 20 elements.  The new standard includes the elements of the previous standard, however, has been revised to be more comprehensive relative to the processes of a company and how processes interact within an organization.

process model

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Elements of ISO 9001

ISO 9001:2000 Clause Requirements
1.0 Scope

1.1 General

1.2 Application

2.0 Normative reference

3.0 Terms and definitions

4.0 Quality Management System

4.1 General Requirement

4.2 Documentation Requirements

4.2.1 General Requirement

4.2.2 Quality Manual

4.2.3 Control of Documents

4.2.4 Control of Quality Records

5.0 Management Responsibility

5.1 Management Commitment

5.2 Customer Focus

5.3 Quality Policy

5.4 Planning

5.4.1 Quality Objectives

5.4.2 Quality Management System Planning

5.5 Responsibility, authority and communication

5.5.1 Responsibility and Authority

5.5.2 Management representative

5.5.3 Internal communication

5.6 Management Review

5.6.1 General

5.6.2 Review Input

5.6.3 Review Output

6.0 Resource Management

6.1 Provision of Resources

6.2 Human Resources

6.2.1 General

6.2.2 Competence, awareness and training

6.3 Infrastructure

6.4 Work Environment

7.0 Product Realisation

7.1 Planning of Product Realisation

7.2 Customer -Related Processes

7.2.1 Determination of requirements related to the product

7.2.2 Review of Requirements related to the Product

7.2.3 Customer Communication

7.3 Design and Development

7.3.1 Design and Development Planning

7.3.2 Design and Development Inputs

7.3.3 Design and Development Outputs

7.3.4 Design and Development Review

7.3.5 Design and Development Verification

7.3.6 Design and Development Validation

7.3.7 Control of Design and Development Changes

7.4 Purchasing

7.4.1 Purchasing Process

7.4.2 Purchasing Information

7.4.3 Verification of Purchased Product

7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision

7.5.2 Validation of Processes for Production and Service Provision

7.5.3 Identification and Traceability

7.5.4 Customer Property

7.5.5 Preservation of product

7.6 Control of monitoring and measuring devices

8.0 Measurement, Analysis and Improvement

8.1 General

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

8.2.2 Internal Audit

8.2.3 Monitoring and Measurement Processes

8.2.4 Monitoring and Measurement of Product

8.3 Control of Non-conforming Product

8.4 Analysis of Data

8.5 Improvement

8.5.1 Continual Improvement

8.5.2 Corrective Action

8.5.3 Preventive Action

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What is Certification?

A formal assessment of our policies, procedures, work instructions, and quality records will be done by an approved registrar. Upon passing the audit, a certificate will be issued stating we meet the minimum requirements for the ISO9001:2000 quality standard.


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What does ISO mean to me?

ISO 9000:2000 represents a major commitment by management at NVE. ISO 9000 means we have documented ISO our policies, procedures, and work instructions.

After documenting, we check (auditing) ourselves against what we claim we did in the policies, procedures, and written instructions. Basically, ISO 9000 :2000 is forced documentation and implementation.

If you work in Purchasing, Design, Sales, Materials, Quality, Manufacturing, Inspection, Test, Marketing, Shipping, Personnel, Service, or work with anyone from the above areas, you will be involved directly or indirectly with the certification and auditing process.

ISO 9000:2000 reflects another step towards company-wide quality for all NVE products and services that translates into a stronger position in the market place and job security.

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How will we become certified?

The following steps are required for certification:

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Are we finished once we passed?

No, we must continue to pass unannounced full annual or biannual partial audits by the registrar to verify continued quality system operation.

The certification is good for three years before another compulsory final audit is required.

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The Company's Quality Policy

"Total customer satisfaction through continuous improvement in product quality".

The fundamental company goal is to completely satisfy our customers needs and expectations, either internally or externally. To help achieve this, it is the company's policy to constantly improve the quality of our products.

To ensure our success, all employees are required to comply with our company policy and strive for the company goal.

The Management


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