Posts Tagged ‘QMS’

Top ten reasons for an ineffective QMS!

Monday, April 5th, 2010

Reason #9 – Negligence in training employees to properly use the system!

Competence, training and awareness for employees is more than just a simple ISO 9001 requirement – it is a major factor in the difference of having a system that will work as either a) a tool for continual improvement, or b) a worthless set of documents that are not followed.

Many third party auditors will often look at the training records of the oldest and newest employees as well as directly asking them questions as to how they access and utilize their system. It can be a very good barometer of how well the entire quality management system (QMS) is working.

The reason behind this type of audit sampling is that many company “veterans” will often provide candid feedback on portions of the system that are not operating as documented. In some instances, these employees will even reveal ways that the current system is bypassed for efficiency, especially when improvements to processes are not made. With new employees, training effectiveness is easy to assess based on whether the QMS information and training given to them is memorable, and then asking if they can actually demonstrate use of the system.

Training on the quality system for new hires and ongoing training for veteran employees should be a priority for any company looking to get the most out of their QMS.

For some creative ideas on how to get your employees trained as QMS experts, contact the ISO experts at G3 Solutions today!

Congratulations! You are now in charge of creating an ISO 9001 system – now what?

Monday, August 31st, 2009

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 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!

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!