ISO 9000 training session.

ISO 9001:2008 Tour

Welcome to the ISO 9001:2008 Tour

The ISO 9000 standard is reviewed periodically. The purpose is to adapt to changing requirements and still maintain the focus on promoting success by the using organization.  In 1994, 20 elements made up the pillars of the ISO standard. In 2000, the standard upgrade is ISO 9001:2008. Certified companies must upgrade by December 2003.

Going from the 1994 to the 2000 version, no requirements were eliminated. Instead, the format was restructured to increase focus on areas of effort of greater importance for the success of a using firm. Also, changes were adapted to be more easily applicable to functions beyond manufacturing operations, such as services. Areas found to be of greater value are emphasized by the new format of the standard.

The following provides major headings of the revision. This indicates the importance of specific functions. Remember this is only a brief outline. Millions of words have been written regarding the standard and one paragraph here can only start to provide perspective. For more complete discussions and application, please contact a member of the CIRAS Quality Systems Team.

ISO 9001:2008 REQUIREMENTS

Section 4. Quality Management System

This includes overall structure of the quality system including requirements for:

(a) Documentation.
(b) Quality manual.
(c) Control of documents.
(d) Control of quality records.

Section 5. Management Responsibility

The role and responsibility of management is to create and support the quality system. Tasks include:

(a) Demonstrating commitment to the creation and support of the QMS.
(b) Committing to a customer focus.
(c) Creating a quality policy.
(d) Implementing, reviewing and revising plans for improving the entire system.
(e) Reviewing the entire system on a periodic basis to ensure all requirements are met.

Section 6. Resource Management

Inputs needed to successfully conduct the planned activities must be determined. Typically the areas that must be controlled are:

(a) Human Resources, including determination of training and it’s effectiveness.
(b) Infrastructure – all of the resource items such as building, equipment and support such as transportation and communication.
(c) Work Environment – This can include safety, contamination and process discharges.

Section 7. Product Realization

All of the steps normally associated with product/service activity are included here. The section covers planning activities, then lists appropriate steps including:

(a) Customer related processes, or sales communication and requirements determination.
(b) Design & Development as they are accomplished by the firm.
(c) Purchasing of all materials related to product, process quality/integrity.
(d) Production and Service – this starts w/plans for how to accomplish all needed to complete processes.
(e) Control of instruments – measurement verification steps must be done with instruments of known, controlled calibration.

Section 8. Measuring Results

On a regular basis, the organization must review all areas that affect the quality/integrity of the product. Areas to review/study include:

(a) Customer satisfaction.
(b) Internal audits.
(c) The success of product and process steps.
(d) Non-conforming Product.
(e) Analysis of Data – use of facts to guide decisions is required.
(f) Improvement – errors in the system, as they are found, must be attended. This includes conditions that will lead to error.

 
 

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Last updated: 8/1/2013