ISO 9001 Implementation Step-by-Step

What is ISO 9000 & ISO 9001?

You need an understanding of the ISO 9000 standards as well as some basics on quality management systems and the implementation process. These should help:

Who is ISO?
What is ISO 9000 & ISO 9001?
Free Tutorial Video: Basics of ISO 9001
Summary of the clauses in the ISO 9001 Standard
What is a Quality Management System (QMS) and the Process Approach?
Why do companies want to become ISO 9001 Certified? What are the Benefits?
Video: "The ISO 9000 Family: Global Management Standards" from ISO.org

Who is ISO?

ISO (International Organization for Standardization) is a network of standards institutes from 159 countries with a central office in Geneva, Switzerland, that coordinates the system.

ISO is a non-governmental organization that forms a bridge between the public and private sectors, and is the largest standards organization in the world.

Many of its member institutes are part of the governmental structure of their countries, or are mandated by their government.
Some members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations.

Therefore, ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society.

What is ISO 9000 and ISO 9001?

The ISO 9000 Family is a series of documents that define requirements for the Quality Management System Standard. There are several documents in the set, and we recommend buying a copy for your facility. These links bring you to Tech Street where you can purchase a download or hard copy of the standard(s):

ISO 9000:2005 Fundamentals and Vocabulary used in the ISO 9000 Standards
ISO 9001:2008 contains the actual requirements an organization must comply with to become ISO 9001 Registered. People often say "ISO 9000" certified, but what they mean is they have met the requirements of the ISO 9001 standard.
- Past (Obsolete) versions of ISO 9000 included:
  - ISO 9001:2000 was revised in the year 2008.
    Compare the 9001:2000 to the 2008 version.
  - ISO 9001:2000 replaced the 1994 version(s):
    - ISO 9001:1994 - Manufacturing with Design & Development
    - ISO 9002:1994 - Production and Installation (No Design)
    - ISO 9003:1994 - Final inspection and test
  - What Changed from 1994 to 2000?
ISO 9004:2000 - Guidelines for Implementation of ISO 9000 Standards

Free tutorial: Basics of ISO 9001

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Online "Basics of ISO 9001" Tutorial

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Understanding ISO 9001 Training is a good idea if you want to learn more about how to implement ISO 9001 in your organziation. More info...

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Summary of the ISO 9001:2008 Standard

Section 1: Scope

Talks about the standard and how it applies to organizations

Section 2: Normative Reference

References another document that should be used along with the standard, ISO 9000:2005, Quality Management Systems-Fundamentals and Vocabulary

Section 3: Terms and Definitions

Gives definitions used in the standard

Section 4: General Requirements

Gives requirements for the overall Quality Management System

Section 5: Management Responsibility

Gives requirements for Management and their role in the Quality Management System

Section 6: Resource Management

Gives requirements for resources including personnel, training, the facility and work environment

Section 7: Product Realisation

Gives requirements for the production of the product or service, including things like planning, customer related processes, design, purchasing and process control

Section 8: Measurement, Analysis and Improvement

Gives requirements on monitoring processes and improving those processes

Use ISO 9001 Presentation Materials to review the complete standard with your organization.

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What is a Quality Management System?

A quality management system (QMS) is a set of policies, processes and procedures required for planning and execution (production / development / service) in the core business area of an organization. (i.e. areas that can impact the organization's ability to meet customer requirements.) Some people generically refer to the group of documents as a QMS, but specifically it refers to the entire system - the documents just describe it.

A QMS integrates the various internal processes within the organization and intends to provide a process approach for project execution. A Process Based QMS enables the organizations to identify, measure, control and improve the various core business processes that will ultimately lead to improved business performance.

If you were a baker...ISO 9000 as applied to making cookies

Our ISO 9001 Workbook and Presentation shows you step-by-step how to create a Quality Management System in your organization. Learn more...

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Why do companies want ISO 9001?

Market Pressure

Many organizations decide to Implement ISO 9001 and obtain registration because it assures customers that the company has a good Quality Management System (QMS) in place. Many organizations require their suppliers to have ISO 9001 Registration.

Internal Effectiveness and Productivity Benefits

Other organizations implement an ISO 9001 QMS because it has proven over the years that it leads companies to better operations, improved performance, and improved profitability.