G3 Solutions, Inc.

ISO 9001:2008 - What has changed?

GGogoleski

ISO 9001:2008 will be the fourth edition of the standard which was first published in 1987. The third edition, published in 2000, represented a thorough revision, including new requirements and a sharpened customer focus, reflecting developments in quality management and experience gained since the publication of the initial version.

ISO's rules for the development of standards require their periodic review to decide if they need revising, maintaining or withdrawing. Compared to the 2000 revision, ISO 9001:2008 represents fine-tuning, rather than a thorough overhaul. It introduces clarifications to the requirements existing in ISO 9001:2000, based on user experience over the last eight years, and changes that are intended to improve further compatibility with the ISO 14001:2004 standard for environmental management systems.

To accompany the publication of the new versions, ISO is now working on implementation guidance for ISO 9001:2008, a reference table comparing and contrasting ISO 9001:2000 and ISO 9001:2008 and answers to Frequently Asked Questions. ISO is collaborating with the International Accreditation Forum (IAF) concerning accredited certification.

The AIAG FMEA 4th edition is here! Coming soon: Advance Product Quality Planning 2nd edition!

GGogoleski

Automotive suppliers beware! The 4th edititon of the Failure Mode and Effects Analysis (FMEA) Reference Manual is here! Soon to be released: the second edition Advance Product Quality Planning (APQP) Reference Manual.

If your organization would like an overview of the new changes to these core tools, contact G3 Solutions to arrange for an on-site training session that will help you keep up to date.

Changes near for ISO 9001? Will your quality management system require revisions?

GGogoleski

A top concern for many ISO 9001 registered companies is how any upcoming changes to the standard will affect their quality management system. The good news is that the proposed changes, which are probably a year or two away from happening, will only require very simple additions or revisions to your organizations quality management system.

A new version of ISO 9001 is currently in the working-draft stage, and is expected to be released in 2008/2009. No major changes are anticipated for this revision and are mostly thought as being simple ammendments and clarifications. These amendments will focus on changes that will increase the benefits of ISO 9001 implementation while involving only minor implementation changes. Any major changes will likely be saved for a more comprehensive revision of the standard which will not take place for at least a few years after 2009.

The proposed changes for 2008/2009 will focus on clarification of clauses that have caused confusion for some companies. At the present time, the main areas of clarification include clauses falling under the following ISO 9001 sections:

4.1 General Requirements
4.2 Documentation Requirements
6.2 Human Resources
7.3 Design and Development
7.5 Production and Service Provision
8.2 Measurement and Monitoring
8.5 Improvement

ISO/TS 16949 registration - is your company eligible?

GGogoleski

Even well before the death of QS-9000 in December '06, many automotive OEMs and Tier 1's have been pushing their suppliers into ISO/TS 16949. All types of organizations down the automotive supply chain have been struck with this mandate usually through some type of generic supplier letter sent by their primary customer. The unfortunate thing about this type of general blanket communication is that it almost always includes recipients that are not eligible for ISO/TS 16949 registration.

The standard is very specific as to applicablilty (see ISO/TS 16949 section 1.1 - General) and excludes many suppliers that are key to manufacturing support. We have received many a panic-stricken phone call from numerous quality managers, plant supervisors and sales reps wondering how and why they have received such a letter. It does make you scratch your head when someone from a company that supplies shop cleaning equipment or warehouses after-market parts is asking how to apply SPC or gage R&R studies into their operations.

If this scenario sounds familiar, make sure that your primary customer contact is aware of just what your organization supplies. See if you can have them provide some documented statement that excludes your company from such an impossible task. Most reputable consultants will gladly provide input and be willing to talk to your customer to explain the situation. If needed, see if you can involve someone from the quality department to help examine the requirements and provide the ammo to prove that TS 16949 does not apply. Also, your ISO 9001 registrar may be a good authority that can put in writing your ineligibility for TS registration.

Issues regarding customer oriented processes

GGogoleski

One of the more common items that continually surfaces during implementation is the lack of having well defined processes. This usually stems from a lack of top management involvement in determining the actual core processes of a company. We have seen process maps ranging in size from as little as two key identified processes to process flow charts that look like a wiring diagram for the space shuttle. Complexity of a diagram will not impress any good auditor, especially when no one in the ranks of top management can explain it! Defining key processes is not an exact science since no two companies are exactly alike. An organization should look at the natural boundaries of specific functions and use such inputs as departments, unique products, and special operations/processes to help determine what can be classified as a customer, support or management process.