G3 Solutions, Inc.

ISO 9001:2008 - What has changed?

GGogoleski — 2008-08-24 06:19:18

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.

Internal Audits - can they be done by an outside party?

GGogoleski — 2008-07-08 18:53:31

Many companies are choosing to outsource their internal audit process because of various resource issues within the organization. A number of reasons for this trend are becoming more common throughout many industries.

After spending large sums of money training a pool of good internal auditor candidates, an organization may find that some within that group take on new positions and responsibilities that either do not allow time for conducting internal audits or they are no longer able to audit certain areas because of their new role. Some employees will leave the organization and some will just decide that internal auditing is not for them. This is especially true in companies that are registered to such standards as ISO/TS 16949, AS9100 and other industry specific standards based on ISO 9001. The methods needed for conducting internal audits in these standards can be rather time consuming in terms of preparation.

Another reason is that some companies will use a large pool of internal auditors where most of them may only get a chance to audit one time per year. For small companies with simple processes, this isn't a big deal. For other organizations that have a multitude of key processes and departments, the auditing process can lose its effectiveness because of a lack of auditing experience by the internal auditor.

If your internal audit program has stalled and surveillance audits are approaching, let G3 Solutions show you how to ease the burden of having limited time for a complex schedule. Not only can G3 Solutions auditors pinpoint critical areas and nonconformances, G3 Solutions consultants and auditors can provide expertise in helping your organization develop cost-saving strategies to implement as part of the corrective action.

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

GGogoleski — 2008-07-07 09:31:49

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.

Maintaining the internal audit schedule

GGogoleski — 2007-09-30 20:21:53

If you are having trouble maintaining your internal audit schedule, contact G3 Solutions to discuss the training options for your audit team or to have a G3 auditor conduct your internal audits for you.

Do not wait until your registrar auditor makes the internal audit "issue" a nonconformance. Call us today to find out how G3 can help.

OHSAS 18001-2007 New and Improved!

GGogoleski — 2007-07-16 21:43:07

OHSAS 18001-2007 is now available. Contact us for more info.

Need help? Ask us here first!

GGogoleski — 2007-06-22 11:30:30

Stuck on some quality or environmental issue and don't know what to do? Post it here and we'll ask our team of experts what they think is the answer. Questions can be on anything related to a quality or environmental system, standard, concept, program, etc. - you get the idea. What the heck - its free! Go on and ask. Consultants love to hear themselves talk - or in this case, see themselves write. We're even humble enough to admit you might have a better idea or solution than us! So go on and post it and lets see what happens.

ISO 14001 - Brag about the positives!

GGogoleski — 2007-06-22 10:31:40

Most companies that implement an environmental management system have programs in place to demonstrate how they attempt to minimize negative environmental impacts. What companies often forget is that environmental programs can demonstrate true positive impacts. These types of programs can demonstrate to the surrounding community that enhancing the environment is a company objective! We have seen companies develop adjacent properties into small gardens, forests and miniature "preserves". Not only can this be an environmental positive, but this can also create a positive company impression in the minds of employees who may use such areas to walk/exercise at lunchtime or just sit and enjoy during a break.

When environmental programs like this are initiated, the result can truly be a win/win for all. This is also the type of environmental program that the marketing and sales side of the company can truly get excited about and use to a positive advantage in company promotion.

Implementation of ISO 9001 and other standards - planning is key!

GGogoleski — 2007-06-20 12:17:24

As with any project, having a solid plan to follow will usually be an accurate indicator of whether the project will flounder or finish. Implementation of such standards as ISO 9001, ISO/TS 16949, AS9100, ISO 13485 and others are no exception.

For statrers, key questions must be asked:

Will the project involve one site or will it include multiple facilities?
What types of activities will be covered under the scope?
Do we need to make exclusions for such items as design, servicing and special process verification? Will exclusions be allowed depending on the standard?
Will the implementation team need formal training?
How well are key processes identified?
What company measurables are in place? Are they adequate? Can they be linked to continual improvement?
Do we need some outside expertise?

This is only the beginning. Once these questions are answered, projects and assignments can be distributed to the proper personnel. It is important that key project milestones and activities have realistic due dates and that those dates are monitored.

Most importantly, the involvement of as many employees as possible in the implementation/documentation phase is critical. Employees that are involved and are solicited for input during the project generally take more ownership of policies and procedures. This helps to create a "quality culture" throughout the organization.

ISO 14001 implementation - worth the effort!

GGogoleski — 2007-06-14 21:43:05

Many times we hear comments about all the commonalities between ISO 14001 and ISO 9001 and the expected ease of implementing an EMS because of these common threads. While it is true that such requirements as management review, corrective & preventive action, internal audits and a top level policy statement make the standards similar, it should not be assumed that implementing 14001 for a company that has a quality management system in place is a walk in the park. Just because a company may not have an inventory of hazardous waste, there are still countless ways that an organization can have an impact on its surrounding environment, even if the organization is a small office of nothing more than a few desks and computers.

Identifying all of the potential aspects and impacts of a company can be a very challenging task regardless of the product or service created. It is also the key to success in implementing an effective environmental management system.

Once these items are properly identified, a company can then go forward and implement programs that can be used to minimize any negative impacts on the environment. They may even find out that helping the environment can be a profitable venture! Reductions in waste can very often show up as cost savings in such areas as resources and utilities - and thats a bonus in any type of environment!

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

GGogoleski — 2007-06-08 00:09:48

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