Quite often, the G3 staff is asked to recommend a plan of action for people who find themselves in the position of “being volunteered” to put together an ISO 9001 (or any other ISO 9001-based standard) system for their company. Unfortunately, for employees that have little to no experience with quality standards, this can be an overwhelming task. We recommend the following steps:

Step 1 – Before you can plan what to do, you and the management team need to know what is required. Start with an overview training session on the standard for yourself followed by a session for top management. Strongly emphasize that the standard is process based and highlight the Plan-Do-Check-Act (PDCA) model. All parties involved in the implementation must realize that the standard has a couple of key principles that are referenced all throughout the standard – customer satisfaction and continual improvement. The ultimate goal is to make all customers happy, but the method of getting to that goal is by the continual improvement of your processes. This is where top management needs to make a little paradigm shift – customer satisfaction means more than a reduction in phone calls from the customer yelling about something that wasn’t just right. It certainly means more than assuming a customer is happy if they continue to give orders for more products and services. Remember, customers can multi-task by giving your organization a new purchase order while giving a new supplier the thumbs up for the next order. By the time some realize the customer isn’t happy, it can be too late.

This is where continual improvement comes into play. By knowing what your customers think of the level of service and value they receive from your organization, your company can initiate the proper continual improvement objectives that can reduce or eliminate the problems and issues that can make their way to the customer.

This is why you need to get all of top management involved. Everyone must get a clear view of the big picture. Having a quality management system (QMS) based on the appropriate ISO standard should become the implementation of a quality philosophy and roadmap for doing things right. Stress that it is a quality management system by which the company will operate and oh, by the way, it just happens to comply with the ISO standard. After that, don’t mention the letters “ISO” – just QMS. Companies that implement systems based on the need to meet ISO requirements often find that employees put an emphasis on doing things just to meet the standard as opposed to improving the process.

Additional steps will be discussed in future posts. Visit g3iso.com for more info.

ISO/TS 16949:2009, Quality management systems – Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations, replaces the 2002 edition which has been used by the major automotive manufacturers to provide a baseline quality system for over 35,000 organizations worldwide that produce and supply parts for the automotive industry.

The 2009 edition was initiated to ensure its compatibility with the requirements of ISO 9001:2008, Quality management systems – Requirements. There are no essential changes to the technical requirements. The modifications are mainly clarifications of certain requirements and do not add any additional requirements.

According to the IOS, up to the end of December 2008, at least 39,300 ISO/TS 16949:2002 certificates had been issued in 81 countries and economies. This represents a 12 % increase over 2007.

The IATF has set a transition period of 120 days from date of publication of the new edition – 15 June – for organizations to comply with the standard’s requirements. The details of the plan are given in a communiqué by the IATF Oversight Certification Body.

ISO/TS 16949:2009 was prepared by the International Automotive Task Force (IATF), with the support of ISO technical committee ISO/TC 176, which is responsible for the ISO 9000 family of quality management standards. Copies of the standard can be ordered through iso.org or other groups such as aiag.org – be sure to upgrade your copy today!

For more information on ISO/TS 16949, contact G3 Solutions today!

It was only a matter of time – and the time has arrived.

The Environmental Protection Agency plans to establish a nationwide system for reporting GHG (greenhouse gas) emissions. It is a program that could serve as the basis for a federal cap on the buildup of carbon dioxide and other gases linked to global warming.

The registry plan would cover about 13,000 facilities that account for 85 to 90 percent of the nation’s greenhouse gas output.

The plan will be adopted by the end of the year and greenhouse gas statistics will be available by the end of 2010. The EPA requirements would apply to large industrial sources that emit 25,000 metric tons or more a year, including oil and chemical refineries; cement, glass, pulp and paper plants; manufacturers of motor vehicles and engines; and confined animal-feeding operations. In addition to carbon dioxide, emissions of methane and other greenhouse gases would have to be reported.

The good news is that most small businesses would fall well below the threshold and would not be required to report, EPA officials said.

For more info on GHG reporting, contact the experts at G3 Solutions.

If your organization is working on the implementation of AS9100, AS9110, or AS9120, the OASIS (Online Aerospace Supplier Information System) database resource is essential as an information tool. Maintained by SAE International, the system provides aerospace supplier certification and registration data that includes information on accreditation bodies, the certification bodies accredited for the scheme, auditors approved for the aerospace scheme and certified suppliers.

To use this resource, you must sign up and register. There is no charge to do this – sign up and registration is free. Simply go to www.sae.org/oasis and the on-line instructions are easy.

For more info or help with OASIS, contact the experts at G3 Solutions.

The ISO 9001 standard was developed by the IOS Technical Committee 176. The committee has also been part of the development of many other standards to aid in the implementation and continual improvement of a quality management system. Be sure to look at some of these quality tools. They can help your organization implement an effective quality system that will provide real value in a number of areas.

Current standards from ISO/TC 176 and its subcommittees:

• ISO 9000:2005 Quality management systems – Fundamentals and vocabulary

• ISO 9001:2008 Quality management systems – Requirements

• ISO 9004:2000 Quality management systems – Guidelines for performance improvements

• ISO 10001:2007 Quality management – Customer satisfaction – Guidelines for codes of conduct for organizations

• ISO 10002:2004 Quality management – Customer satisfaction – Guidelines for complaints handling in organizations

• ISO 10003:2007 Quality management – Customer satisfaction – Guidelines for dispute resolution external to the organization

• ISO 10005:2005 Quality management – Guidelines for quality plans

• ISO 10006:2003 Quality management – Guidelines for quality management in projects

• ISO 10007:2003 Quality management – Guidelines for configuration management

• ISO 10012:2003 Measurement management systems – Requirements for measurement processes and measuring equipment

• ISO/TR 10013:2001 Guidelines for quality management system documentation

• ISO 10014:2006 Quality management – Guidelines for realizing financial and economic benefits

• ISO 10015:1999 Quality management – Guidelines for training

• ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000

• ISO 10019:2005 Guidelines for the selection of quality management system consultants and use of their services

• ISO/TS 16949:2002 Quality management systems – Particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations

• ISO 19011:2002 Guidelines for quality and/or environmental management systems auditing

Quite often companies in the implementation phase of ISO 9001 will ask about the two stage process for registration audits. Sometimes the planning strategy for an organization will not take into account the length of time intended for this process.

The practical reason for having a period in between the stage 1 & 2 registration audits is to provide an organization with the time to make final adjustments and resolve potential nonconformances before their stage two audit.

ISO/IEC 17021:2006, 9.2.3.1.3, which provides registrars with rules and guidelines for conducting audits, states: “In determining the interval between stage 1 and stage 2 audits, consideration shall be given to the needs of the client to resolve areas of concern identified during the stage 1 audit. The certification body may also need to revise its arrangements for stage 2.”

This does not, however, negate the possibility of having back to back audits. This can be arranged with the 3rd party certification body (also referred to as a registrar) but this should be the exception and not common practice.

According to a recent bulletin authored by Randy Dougherty, Vice President of the ANAB, the answer is no. The ANAB “Heads Up” bulletin 138 goes on to explain:

“Since ISO/IEC 17021 has been fully implemented by all ANAB-accredited CBs, ANAB has been asked the same question numerous times: ‘Can a CB extend an ANAB-accredited certificate past the three-year certification if all re-certification requirements were not met prior to the certification expiration?’

The answer is No.

Per ISO/IEC 17021 certificate extensions are not allowed, no matter the situation, per several requirements within ISO/IEC 17021:

8.2.3.c states, The certification document(s) shall identify the following…the expiry date or recertification due date consistent with the recertification cycle…

9.1.1 states, …The three-year certification cycle begins with the certification or recertification decision.

9.4.2.2 states, When, during a recertification audit, instances of nonconformity or lack of evidence of conformity are identified, the certification body shall define time limits for correction and corrective actions to be implemented prior to the expiration of certification.

A decision for initial certification or re-certification cannot be granted unless all of the conditions of 9.1.15 are fulfilled, so if the recertification audit has not been conducted, or any nonconformities have not been addressed to the extent required by 9.1.15b or 9.1.15c, then a certification expires until the conditions are fulfilled.”

In order to accommodate the rumored additional changes to ISO 9001:2008, you will need to incorporate the following form into your organizations Corrective and Preventive Action system. It is also rumored that these requirements will affect additional standards such as ISO/TS 16949, ISO 14001, AS9100, ISO 13485, ISO 22000 and various other standards.

The downloadable form was developed by members of the military to facilitate the documentation of key personal issues into a corrective and preventive action format. If you have any questions or require any help in the application or requirements of this form, please contact G3 Solutions. We will do our best to aid in the development of your quality management system and sense of humor.

During ISO 14001 implementation, the most important exercise a company will go through is identifying all possible environmental aspects. Without a proper and thorough examination of all processes, functions and grounds of a facility, the rest of the environmental management system (EMS) is an exercise in meaningless documentation.

Once all aspects are identified, a determination must be made as to what aspects are significant and if they are within the organizations ability to control. This is best conducted through some type of risk analysis format such as a failure mode and effects analysis (FMEA) type review of the aspects.

If the process of identifying all environmental aspects of your company’s activities is becoming a daunting task due to limited or stretched resources, contact the experts at G3 Solutions today!

In Part 2, the definition of objective evidence was clarified and examples were given. The ISO/TC 176 guidance document on ISO 9001:2008 continues to clarify and explain how conformity with the standard can be achieved. It goes on to state:

“Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d) Planning of product realization, and clause 8.2.4 Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.

Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.”

By examining the intent of the standard, it is clear to see that a good amount of flexibility was built in to allow a company to make the standard work for them. A big fear of ISO implementation is the phobia of having to change an organization from top to bottom to have it meet requirements. The guidance document put out by ISO/TC 176 does a great job of putting these fears to rest.

For more help with ISO standards, contact G3 Solutions today!