ISO 9000:2000 Quality Management System Requirements

Posted on Dec 20, 2024 in Other subjects

Focused Management Processes

The desired outcomes are achieved more efficiently when resources and related activities are managed as a process.

Towards Integrated Management Process

Identifying, understanding, and managing interrelated processes as a system contributes to the effectiveness and efficiency of an organization in achieving its goals.

Continuous Improvement

  • Continuous improvement of the organization and its activities must become a priority and a permanent objective.
  • The Deming Cycle, or PDCA Cycle, is applicable to the continuous improvement of a quality system.

This improvement cycle consists of four activities:

  1. Plan: Define the objectives to be achieved and choose the appropriate methods.
  2. Do: Carry out the work and planned corrective actions from the previous phase.
  3. Check: Verify and evaluate the system to assess actions taken and their effectiveness, and monitor compliance with objectives.
  4. Act: According to the analysis in the previous phase, there may be a few things we need to tweak, improve, or change. This typically consists of fine-tuning the system.

Summary: “If you follow these steps, you will succeed, and if you want more, do more.”

In the process of continuous improvement, ideas should be:

  • Simple and quick to set up, if possible, by the staff themselves.
  • Not too expensive.
  • Implemented with monitoring by the team or group.

Decisions Based on Facts

  • Effective decisions are based on the analysis of data and information.
  • What is not measured is very difficult to improve, and what is not improved eventually worsens.

Improved Relations with Suppliers

There is a clear interdependence between an organization and its suppliers. As relations improve between the two, the ability of both to create value increases.

Requirements of Quality Management System ISO 9000:2000

The company must:

  • Establish
  • Document
  • Implement

and maintain a system of quality management and continuously improve its effectiveness.

Requirements of Quality Management System ISO 9000:2000

The requirements of the rule are structured as follows:

  • Part I: Introduction to the Standard (Parts 1, 2, 3, and 4 of the Standard)
  • Part II: Management Responsibility (Part 5)
  • Part III: Resources Management (Part 6)
  • Part IV: Product Realization (Part 7)
  • Part V: Measurement, Analysis, and Improvement (Part 8)

Part I: Introduction to the Standard

Adopting a quality management system should be a strategic decision of the organization.

This international standard promotes the adoption of a process approach.

This standard is compatible with ISO 14001:1996.

This standard specifies requirements for a system of quality management, where an organization:

  1. Needs to show its ability to provide consistent products that meet customer requirements and applicable regulatory requirements.
  2. Aims to increase customer satisfaction.

All requirements of this standard are generic and are intended to be applicable to all organizations regardless of type, size, and product provided.

General System Requirements for Quality Management

The organization should:

  1. Identify the processes needed for the quality management system and its implementation throughout the organization.
  2. Determine the sequence and interaction of these processes.
  3. Determine criteria and methods needed to ensure that both the operation and control of these processes are effective.
  4. Ensure the availability of resources and information necessary to support the operation and monitoring of these processes.
  5. Conduct monitoring, measurement, and analysis of these processes.
  6. Implement actions necessary to achieve planned results and continual improvement of these processes.

General Requirements for the Control of Documentation

General

The document should include:

  • The documented statements of policy and quality objectives.
  • The quality manual.
  • The procedures and records required by the standard.
  • Documents required by the organization.
Quality Manual

A quality manual should be created and kept updated with the following contents:

  • The scope of the quality management system, with justification for any exclusions.
  • The procedures defined for the system or reference to them.
  • A description that includes the interactions for the processes involved in the management system.
  • Document control procedures and records, internal audits, control of product nonconformance, and corrective and preventive actions.
Control of Documents

A document defining the controls needed to:

  • Approve documents.
  • Review, update, and approve again.
  • Identify the changes and current revision status of documents.