G3 Solutions, Inc.

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ISO 9001:2008 - What has changed?

GGogoleski | 24 August, 2008 06:19

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 | 08 July, 2008 18:53

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 | 07 July, 2008 09:31

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 | 30 September, 2007 20:21

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 | 16 July, 2007 21:43

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

Need help? Ask us here first!

GGogoleski | 22 June, 2007 11:30

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 | 22 June, 2007 10:31

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 | 20 June, 2007 12:17

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 | 14 June, 2007 21:43

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 | 08 June, 2007 00:09

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 | 05 June, 2007 22:46

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.

ISO Consultants - to hire or not to hire. That is the question...

GGogoleski | 30 May, 2007 15:13

When resources are an issue, an experienced consultant can help to minimize the "trial and error" approach to implementation.

Contrary to what some "experts" may tell you (there are a lot of quality "charlatans" looking for work), no company needs to hire a consultant - some companies have implemented standards just fine on their own provided they have a knowledgeable ISO person or staff available. The purpose of hiring a consultant is to help fill in the knowledge and resource gap, especially when it is difficult to allocate and train current personnel because of staffing/resource issues. A good consultant can help your company avoid the pitfalls of improper and excessive documentation and can also be the shortcut needed for timely project completion.

Implementing ISO 9001 - just how long does it take?

GGogoleski | 30 May, 2007 11:42

Management personnel in companies that have little or no experience with ISO-based standards often ask "How long will it take to implement ISO 9001?". The answer to this question is essentially dependent on the level of resources that an organization is willing to commit to the project.

Having a team for implementation will work far better and provide more value than attempting to make it the pet project of one individual. In most cases, that person usually ends up being the quality manager (in manufacturing facilities) or the office manager (in service-based companies). Although it isn't wrong to have those types of folks become the project managers, it is an issue when the top management of an organization treats it as a task that simply needs completion. The upper management team should be the driving force and support of the project to help instill an attitude of commitment and value to ISO 9001 implementation.

With the right determination of resources including outside consulting help, very few companies, regardless of size, need more than a year (that's being very conservative). The timeline for implementation can be cut much shorter than that depending on how the project is handled. This rule of thumb holds true for other standards such as ISO/TS 16949, ISO 14001, AS9100, ISO 13485, etc. (Be careful - some standards may have restrictions on when a company is technically ready for registration.)

In order to expedite the implementation process, a cross functional team from the organization should be brought together to "share the wealth" of tasks that will need to be tackled during the implementation. From there, duties and projects can be assigned to others to help build the employee "buy-in" for the project. When all employees have some type of input into the architecture of the business/quality management system, the result is a system that truly provides a framework for maintaining a quality culture within the organization.

Issues regarding customer oriented processes

GGogoleski | 30 May, 2007 09:13

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.

How many participants can we have in an on-site training session?

GGogoleski | 24 May, 2007 10:17

The number of participants allowed in a training session may vary based on a variety of factors.

For starters, is the facility big enough to allow all participants room to take notes and examine materials? Companies with limited facility resources need to remember that participants will need more than just a chair and notepad. This can become a big issue for small companies with small facilities, and off-site plans may need to become reality. This does not mean than that expensive hotel conference rooms need to be rented. Many free sources exist for companies to conduct off-site training when the company facility is not equiped for training. Local libraries, state employment offices and even local township offices and town halls can be an affordable (if not free) alternative to renting expensive private conference space.

Another consideration is the course subject itself. Is the material and subject matter new for all participants? What is the experience level of the group? Will there be a large amount of questions from the participants? How many group exercises and activities will there be? These questions must be answered before a realistic limit can be put on the number of participants.

Also, If the course is on-site, top management must make it a priority to insure that participants are not pulled out "just for a quick moment" during the session to answer phone calls, pages, and take care of small fires for other employees. Remember that a comfortable environment is the most effect environment for training. Participants that have minimal distractions in a classroom setting have the best retention of material and stay motivated to apply what they have learned.

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