Change Management Consulting, Inc.

Transforming Businesses Worldwide

 Site Map

Our Approach

Change Management

Organizational Development

Leadership Development

Sarbanes-Oxley

Strategic Planning

ISO 9000 and 14000

Six Sigma and Lean

ISO 9000 Core Standards

An overview of ISO 9000 Standards and focus

Guaranteed Registration

ISO 9000 is an international family of generic quality standards, originally published by ISO (International Organization for Standardization) in 1987, and updated in 1994 and again in 2000.  This international standard has currently been adopted by over one hundred nations.  It specifies elements necessary for the foundation of a Quality Management System (QMS), but does not specify how the requirements are to be implemented.  It does not replace product safety and regulatory standards or requirements.

A QMS refers to the activities you carry out within your organization to satisfy customers and to create customer loyalty.  Complying with the ISO 9001 Standard does not indicate that every product or service meets your customers’ requirements—only that the QMS in use is capable of meeting them.  That is why you must regularly assess customer satisfaction and loyalty, and constantly improve business processes.  Your effort must result in a culture of continuous improvement.

The key standards within the ISO 9000 family of standards (ISO 9001:1994, ISO 9002:1994, and ISO 9003:1994) have been merged into a single ISO Standard - ISO 9001:2008.  There are four core standards.  ISO 9001 is a requirement standard.  ISO 9000, ISO 9004, and ISO 19011 are guidelines.  ISO 9001:2008 describes what must be done to develop a quality management system, not how to set it up.  The core standards are:

► ISO 9000:2000 provides quality management principles and fundamentals, describes what the series is about, and lists basic definitions of terms for use by any organization.

► ISO 9001:2008 states requirements for Quality Management Systems when it is necessary to demonstrate that an organization is capable of effectively meeting customer and regulatory requirements.

► ISO 9004:2000 provides guidance for establishing a Quality Management System that goes beyond ISO 9001 requirements to meet and exceed customer expectations efficiently.

► ISO 19011 provides guidance on planning and conducting quality audits.

What were the Significant Changes to ISO 9001:2000?

The ISO 9001:2000 changes include:

► Easier adaptation to a wider range of organizations

► Focus on a process approach, including a process model

► More consistent terminology

► Reduction in the amount of required documentation

► Enhanced compatibility with ISO 14000

► Less-prescriptive documentation requirements

► Linkage of Quality Management System to organizational processes

► Continual improvement of the Quality Management System

► Significant emphasis on achieving customer satisfaction

The ISO Standard has a new process-oriented structure.  It includes a process model based on the Plan-Do-Check-Act Cycle—a four-step process for quality improvement.  It provides the framework for the product and/or service cycle, including management review and control.

The main change is the structure of ISO 9001.  The 20-point format has been replaced.  The text of the standard is now organized into five primary processes or clauses:

► Section 4.  Quality Management System

► Section 5.  Management Responsibility

► Section 6.  Resource Management

► Section 7.  Product Realization

► Section 8.  Measurement, Analysis, and Improvement

ISO 9001:2000 Requirements and Focus

The processes necessary to determine and meet customer requirements and to create a culture of continuous improvement—are to be planned, resourced, controlled, verified and improved.  Our clients have always done it this way.  The revised Standard emphasizes:

► Greater Focus on the Customer - Organizations must determine customer needs and expectations and, as a new requirement, monitor customer satisfaction.

► Measurable Objectives Must be Established - Increased emphasis is placed on the role of top management to develop and improve the system, integrate legal and regulatory requirements, and establish measurable objectives at appropriate levels.

► Measurement and Continual Improvement is Required - Performance measurement and monitoring are new requirements.  Data must be used to determine the performance of the quality system and to identify improvements.

► Training Effectiveness Must be Evaluated - Evidence that training has been provided will not be enough.  An evaluation of effectiveness is now required.

New ISO 9001:2008 Standard

The ISO 9001:2000 Standard has been revised after eight years. And the buzz is rapidly reaching a crescendo. We continue to receive numerous emails and phone calls regarding the impact of the new release. First, let us dispel any anxiety about the November 15, 2008 official "2008" release. Simply put, the changes to the ISO 9001 amendment will have considerable benefit and minimal impact.

Let's put things into perspective. This fourth version is more an amended version of the previous release, rather than a complete revision. There are no new requirements. The changes are largely interpretive, and focus on terminology clarifications, and better alignment with ISO 14001:2004, the environmental standard. But don't be too quick to dismiss its relevance-there is potential danger and hidden opportunities.

Transitioning to ISO 9001:2008

The International Organization of for Standardization and the International Accreditation Forum have agreed to a smooth transition. Both standards will remain current for two years-until November 15, 2010. Registration of conformity to ISO 9001:2008 will be issued from November 15 on, and after a routine registrar surveillance audit, or a recertification audit against the new version. Also, as of November 15, 2009, all new registrations and recertifications must be to ISO 9001:2008.

Overview of the Changes

The points of clarification focus on outsourcing, documentation, management representative, employee competence, design verification and validation, process monitoring, control of nonconforming product and corrective and preventive action. But bear in mind, no "shalls" (requirements) were added or removed. A complete listing of changes can be found in Annex B of the Standard.

Potential Danger and Hidden Opportunities

Perhaps the greatest potential danger is to dismiss this release, and to rationalize that there is no work to be done. Even though there are minor changes, hidden opportunities abound. This is the ideal time to be proactive, and to reenergize your quality (business) management system.

Ask yourself: Is your QMS integrated with your organization's vision, mission and values? Are your quality objectives aligned with your organization's business objectives? Have you considered the needs of your customers in developing your objectives? Are you using a balanced scorecard to evaluate performance (key performance indicators)?

The Path Forward

This pragmatic path forward can be used as a guide to craft a game plan during the transition. It stresses the basic steps that your organization should consider, regardless of the maturity of your QMS.

►Obtain a copy of the ISO 9001:2008 Standard. Copies can be purchased from your national standards body ANSI in the United States at (www.ansi.org), the International Organization for Standardization (www.iso.org), or from the American Society for Quality (www.asq.org).
Review Annex B, and brief yourself with the changes to the Standard. This Annex (Table B.1) identifies the text changes between the 2000 and 2008 versions. It's a must read.

►Discuss the transition requirements with your registrar and your CMC Account Manager. Remember you have two years to make the transition. We recommend transitioning sooner than later. This is no time to procrastinate.

►Determine whether the changes impact your organization. If nothing else, it will give you and your management team a better understanding of the nuances and underlying reasons for the change.

►Use this opportunity to reenergize your QMS. Remember, "ISO" is a fundamental business model, and it is the foundation from which to build a competitive, customer-centric enterprise.

We recommend that you schedule a meeting with us to assist you with taking your QMS to the next level. We will also explore ways to leverage your certificate to accelerate short- and long-term growth of sales.
 

ISO 9000 Core Standards