Posts Tagged ‘documentation’

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!

Document control – it can be easier than some may think!

Monday, March 29th, 2010

Recently, I was perusing through a quality discussion forum and the question was asked “Is it ever a good idea to organize and name your company’s files, documents, procedures, work instructions, and other items according to the numbering system of ISO/TS requirements?”

I am always horrified when a company starts constructing a quality system based on a standard rather than their own internal processes. Standards such as ISO 9001 or ISO/TS 16949 should be used as a guide for the construction of the quality system and not the reason for its existence. These types of “let’s satisfy ISO first” quality systems have a tendency to become thought of as documentation for “that annoying ISO stuff!”. This can eventually lead to documents being ignored, or worse, rewritten and uncontrolled in order to be thought of as more relevant to their use.

There is no prescriptive method for numbering or naming your quality system documentation. Usually, simple revision date codes or numbers can be used to provide a level of control needed to meet requirements.

Make your documentation easy to use by somehow identifying it with the process they are associated with to provide a more relevant and effective understanding of their use.

For more tips on document control, 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.

Identifying Environmental Aspects for ISO 14001

Tuesday, April 28th, 2009

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!

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!