Note worthy facts:

ISO 9001:2008 has been available sense 11/15/08
ISO 17025 is the standard for laboratories
TS 16949:2002 is the automotive standard that replaceed QS 9000
ISO 14001:2004 is the environmental standard

ISO 13485 (CFR 21 Chapter 820.XX) is the standard for Medical Devices

About the new ISO 9001:2008

• The same 172 requirements with notes making the requirements clearer
• The same five sections starting with 4.0
• Process oriented
• Soliciting customer's perception of your performance for them
• Requires minimum of 6 procedures 
• Requires 22 records (our customers normally have 40 to 50)
• Based on 8 principles - if you consider/embrace these you will have effectively implement an effective management system
• Forms are an important "document" and should have revision control
• Quality Objectives are required for your various processes with measurements that verify whether or not you are meeting the objectives set by management and/or the customer 
• If you measure, you will analyze the data with an aim of continuous improvement

For those of you that are just starting the journey towards registration we offer these helpful tips:

1. Your Mission, if you choose to take it...... Develop a quality management system that: identifies training needs, empowers employees to be responsible for the work they do, gives people information about the customer's requirements, confirms that the equipment being used is capable of meeting the customer's requirements, is a system capable of keeping up with change, and is one that can continuously improve. Do you really think that you can effectively accomplish all that from a software package or from attending training courses alone? There are no shortcuts in the development of a quality management system that will effectively work for and add value to your Company. You will need training, understanding, a strong heart, patience, and advice from experienced people that can effectively interpret the Standard against your operation in your industry.

2. Management commitment... The art of getting management to move from lip service to understanding the time and effort required to implement a quality management system can be an impossible mission. Acquiring the management support to keep the implementation program on schedule, applying pressure to the 50% of the population that believes "This Flavor of the Month" will go away, and the ability to free people's time to document the system, is not an easy task even for the strongest willed individual.

3. One of the most difficult problems you will be faced with is getting people to agree on a sensible approach that can be documented in the procedure. Far too often people spend too much time with their head in the standard versus looking at their process and controlling, through documentation, the "things" that are always important to do correctly the first time.

4. Identify and define all of your policies towards the Standard chosen. Record this information in the Quality Manual. Start by setting up an implementation team that represents the experts from the various disciplines of your company's operations, i.e. Sales, Marketing, Scheduling, Manufacturing, Design, Purchasing, etc. Each individual needs to address their policies towards the requirements of the compliance Standard chosen. The policies need to be addressed/defined in the Quality Manual. In other words, you are defining your company's approach towards the requirements of the Standard by using that Standard as a guideline to define "Where and how do we meet those requirements?"

5. Training and Awareness for the Implementation Team. Often staff are not fully aware of the Standard or its implications. A reasonable understanding is important and should be achieved by awareness sessions and seminars for all levels in the organization.

If you consider such training is required, it must be included in the implementation plan discussed in item #6. In addition, it is important that the Quality Management Representative, and any other key individuals are well versed with the Standard and registration process. Consideration should be given to some intensive training, such as a five day Lead Auditor course for these people.

6. The Implementation Plan. In implementing such a wide ranging project, a clearly defined program of work is essential. Such a program ensures that everyone is aware of their role in the implementation process, the action required, and the priorities that exist. In addition, the implementation plan should define the time scale for each activity and the completion date, this will allow progress to be monitored and resources to be allocated as needed. Time scales, in the form of Gantt charts, must be realistic taking into account people's everyday responsibilities.

A review should be made to assess the current state of the organization against the compliance standard desired: ISO 9001, TS 16949, ISO 14001, AS9000, etc. to asses current practices against the compliance documents; to identify what correction is needed to comply with the compliance document.

Typically organizations find that they comply with many of the requirements of the Standard, but there is a lack of controlling documentation.

Where it is identified that changes to current practice are needed or new practices must be introduced, the actions must be agreed with those involved and the implementation plan developed.

A simple Gantt chart detailing the activities, persons responsible, and the time frame is an effective way of presenting this information.

If this information is useful to you, let us know. If you want additional information please contact us (be sure to include your phone number and mailing address so that we may contact you directly).

Good Luck!

Thomas P. Diehl
President