Posts Tagged ‘strategy’

Does this scenario sound familiar? If so, G3 Solutions can help!

Saturday, April 10th, 2010

Top ten reasons why some quality systems are ineffective -

Reason #8 – The quality system is handled by one person

At G3 Solutions, we often receive calls from companies that are in need of expertise to help with quality system issues shortly before a third-party audit. This is often due to a lack of resources and downsizing from the recent economic nightmare of the past year.

Unfortunately, those employees that fell under the umbrella of “quality” were some of the first to be downsized. Since these employees were in charge of such key systems as internal audits, corrective actions and analysis of quality data, the maintenance of these systems would continually get put off until the last possible minute, if they were done at all. This is not the way a well implemented quality system should work.

Generally, the reason for this type of system meltdown is that most, if not all key functions of the system were handled by one employee whose primary purpose in the company was to be “the ISO person”. They were responsible for making sure all of that ISO 9001 “stuff” got done, and now they are not around – and no one has a clue as to what needs to be maintained.

A well implemented system will almost run by itself, with just minimal oversight by the selected management representative. Key systems should be shared and divided by top management; not handled solely by the quality manager or ISO coordinator. Not only will this shared strategy help maintain key processes, but will also encourage and promote employees to work with and improve the quality system.

For further information on how we can help, contact G3 Solutions today!

Stage 1 and Stage 2 registrar audits – How does this affect your ISO 9001 plans?

Monday, June 1st, 2009

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.

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!