Posts Tagged ‘ISO 9001:2008’

Top ten reasons why some companies aren’t getting the most out of their ISO 9001 quality system

Wednesday, March 31st, 2010

In the coming weeks, we are going to give you all of our top ten reasons why some ISO 9001 based quality management systems fail to provide some organizations with real process improvement. We may post another topic here and there, so you’ll just have to check back frequently to see our full list. Enough already!! Let’s begin-

#10 – Too many procedures – the company quality system is from a template!

When performing internal audits for companies, we sometimes see quality system documentation that is rather extensive, especially in older systems that were developed before the major ISO 9001 revision in 2000. Systems based on the old twenty element model contained a procedure for almost every requirement, not to mention a handful of work instructions for every procedure. When the revision came along, some companies interpreted it as a simple renumbering scheme and added a process map that looked like a wiring diagram for the Space Shuttle. Having a system today based on a standard from yesterday usually leads to a lot of frustration, minimal user friendliness, and can also become a “Rubik’s Cube” nightmare for document control.

Another reason for over documentation is that some companies have “borrowed” documentation from other organizations and tried to simply insert their name. This can be easy when the size and industry of the companies are identical, but when you try to implement a system from a 300-employee casting facility and your company is a 20 employee plating shop, you’re in for one big mess of a quality system. In a lot of cases, companies that were in a hurry to implement quality systems to please their customers would buy templates from consultants and were tempted to try the “insert name here” approach. Both approaches can diminish or even negate any value from implementing an ISO 9001 system.

The ISO 9001:2008 standard allows for an amazing amount of flexibility in documentation which provides a real opportunity to create a system that is simple, efficient and relative to the operations of an organization. If your system sounds like what has been described earlier in this posting, you may find it a worthwhile endeavor to overhaul your quality manual and procedures. If you’re starting out and are looking for an easy way to get something in place, contact the experts at G3 Solutions today!

Attention all automotive parts suppliers! Don’t miss the new revision to ISO/TS 16949

Friday, July 10th, 2009

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!

New (or maybe rumored) Corrective and Preventive Action requirements! Make sure your system is up to speed!

Friday, May 8th, 2009

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.

Free download: iso-mil-hf-car-par

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.

ISO 9001 – It is time to put the “document nightmare” perception away! (Part 3 of 3)

Saturday, April 25th, 2009

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!

ISO 9001 – It is time to put the “document nightmare” perception away! (Part 2 of 3)

Thursday, April 23rd, 2009

As we stated in Part 1, documentation for ISO 9001 does not need to be complex. With that being said, the next question that we are usually asked is “How do I show conformance to the standard when I don’t have a document for everything?”

In the ISO 9001 guidance document “Introduction and support package: Guidance on the documentation requirements of ISO 9001:2008”, it states the following:

“To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines ‘objective evidence’ as ‘data supporting the existence or variety of something’ and notes that ‘objective evidence may be obtained through observation, measurement, test, or other means.”

This suggestion provides an amazing amount of flexibility in showing conformance to the standard. If you need assistance with your ISO 9001 system, contact the ISO 9001 experts at G3 Solutions today!

ISO 9001 – It is time to put the “document nightmare” perception away! (Part 1 of 3)

Wednesday, April 22nd, 2009

Although it is true that ISO 9001 does require documented evidence for many requirements, this should not be interpreted as needing a new document for everything you do. Many times companies can modify existing documents to provide evidence of conformity to ISO 9001 requirements. Standards such as ISO/TS 16949, AS9100, ISO 13485, ISO 14001 and others have additional requirements for added documents, but the same strategy of modifying existing documents can be used for a majority of those additional demands.

In the ISO 9001 guidance document “Introduction and support package: Guidance on the documentation requirements of ISO 9001:2008 Document: ISO/TC 176/SC 2/N525R2, October 2008″, it states “For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS. Organizations may be able to demonstrate conformity without the need for extensive documentation.

There are other recommendations for document control which we will list in future posts. Just remember that the standard gives you an incredible amount of flexibility in putting together your documentation. If you would like additional ideas on how you can control your ISO documentation, contact the experts at G3 Solutions today!

Records – are you keeping all that you should?

Thursday, April 16th, 2009

Many companies registered to ISO 9001:2000 are now reviewing their quality management system (QMS) along with associated forms and documents to make sure that there is a smooth, trouble free certificate upgrade to ISO 9001:2008. This is a great opportunity to make sure that all records required to maintain the business are kept in such a way to satisfy the ISO 9001 clause 4.2.4, which states “Records shall remain legible, readily identifiable and retrievable.”

Companies should consider every record needed for the business, not just the ones listed for ISO 9001. Having all important records fall under the scope of the control of records procedure helps to provide real value in the QMS. If you have a system that is based on ISO 9001 but includes other requirements (e.g. – ISO/TS 16949, AS9100, ISO 13485, etc.), the list of records for 9001 is just the beginning of what needs to be maintained.

For a complete list of ISO 9001 required records, you can download the following document:
iso-9001-2008-records

If you need additional help with ISO requirements, visit g3iso.com today!

AS9100 Rev C is here – how will it affect you?

Monday, March 9th, 2009

AS9100 rev. C was released this quarter and contains new requirements in addition to the changes introduced in ISO 9001:2008. There will be a 30 month transition from AS9100 rev. B, but the start date for the proposed transition time has not yet been established by the International Aerospace Quality Group (IAQG). The reason for this gap is that supporting standards and sanctioned auditor training are still being developed. Therefore, registration to AS9100 rev. C is currently unavailable at this time.

More info will be posted on AS9100C in the coming weeks. Stayed tuned or ask a question now by logging in. Visit our full website at www.g3iso.com today!

The ISO 9001 Quality Manual – how useful is it?

Friday, March 6th, 2009

It is always amazing to see how many small companies construct a lengthy quality manual and then question whether or not it provides any real value. Unfortunately, this scenario is more common than it should be and the question is quite valid – how useful is it?

The first thing that an organization should realize when constructing a quality manual is that there is no single prescribed way for it to look. The requirements are plainly stated in ISO 9001:2008 clause 4.2.2. According to the “Introduction and support package: Guidance on the documentation requirements of ISO 9001:2008″ (Document: ISO/TC 176/SC 2/N525R2) created by ISO Techincal Committee 176:

Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS (Quality Management System).

A small organization may find it appropriate to include the description, processes and methods of its entire QMS within a single manual, including all the documented procedures required by the standard.

Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.

The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.”

Nowhere in the standard or in the guidance document does it state that the organization must regurgitate the standard and replace the word “shall” with some type of term as “we do…”.

The best quality manuals are always written specifically for the company (NOT templates) and contain the scope of the manual, reference or inclusion of procedures and SIMPLE, employee-friendly process descriptions that clearly show the sequence and interaction of key company processes.

How does your quality manual stack up? Log in and sound off!

Visit our full website at www.g3iso.com today!

Are big changes in store for ISO/TS 16949?

Monday, February 16th, 2009

According to the IATF website (www.iatfglobaloversight.org/), The 2009 version of ISO/TS 16949 will be out sometime during the first quarter following the ballot of the ISO Technical Committee 176. The revision reflects the changes in ISO 9001:2008.

ISO/TS 16949:2009 introduces no new or changed requirements from ISO/TS 16949:2002. ISO 9001:2008 is based on clarifications or amendments to the existing requirements of ISO 9001:2000 and those that are intended to improve consistency with ISO 14001:2004. This should not make ISO/TS 16949 implementation any more difficult for companies looking to take on this standard.

Certification Bodies and Organizations are expected to understand and apply the amendments to ISO/TS 16949:2009. Application of the clarifications related to ISO 9001:2008 requirements in the boxed text of ISO/TS 16949:2009 is effective not later than 120 days after the release of ISO/TS 16949:2009.

For more information or assistance with making sure your system is up to speed, contact G3 Solutions.