A Plan for the Development of Your ISO 9000 Quality System
Marci L. Crane
April 28, 2008
There is a lot of talk about quality systems, modernized quality systems and quality systems management. There is also plenty of discussion that revolves around the quality system concepts or guidelines comprised in the ISO 9000:2000 family of "regulations." If you are seriously considering the investment for ISO registration and are committed to quality system improvement, then consider the following development plan for your ISO 9000 quality system.1
A Possible Development Plan for Your ISO 9000 Quality System
Before you begin the development of your ISO 9000 quality system it is essential to understand two things:
Those individuals or organizations with more interest in ISO 9001 certification than in actual quality system improvement are generally less successful in terms of ISO compliance and ISO quality system achievement;
Those individuals or organizations interested in the improvement of their quality systems need to be creative and simultaneously willing to manifest some patience, as it isn´t uncommon for quality system processes to be continually tweaked for fairly long periods of time after implementation.
The Development Plan Process
An online article (we will call it the development plan reference) that this author found to be quite useful has divided the ISO 9000 development process into 5 steps, none of which are required by any company but may be of great use to some. These five steps are quoted as follows:
These 5 steps are practical separation stages for your ISO 9000 quality system. The planning stage of your ISO quality system is actually quite simple…at least at first. You may have to take a few steps backwards from time to time and make quality system adjustments but essentially the planning stage is fairly clear cut.
Start by reading over the ISO requirements and any interpretations of these requirements that would be relevant to your industry. You should also refer to the pros and cons of implementing an ISO quality system and talk with others who have done so. Once you have done your research you can decide whether you want to follow an industry specification, model your system after a colleague´s or try something different. Overall, you should have a basic idea of how your quality system (A) will get you to the ISO requirement ends (B).
Step #2: "Deliver Your ISO 9000 Awareness Program"
If there is any step that is more important than any another, it would be the delivery stage. The development plan reference suggests creating an awareness program which (of course) refers to training. It is of the utmost importance that those who be required to conform with the ISO 9000 quality system become friends with the system itself. This may require hours of training and even hours of "informal" communication. Some companies should consider investing in an automated training software (preferably a solution that can be launched from the same platform as other solutions such as document control and quality system management solutions) that will allow the quick release of training tasks when a quality system change is made or when quality system documentation is revised.
Step #3: "Develop Your Own Quality Assurance Program"
The development of a quality assurance program is where you begin to make your ISO 9000 quality system a reality. The development plan reference suggests breaking your quality assurance program into the following 12 categories:
Quality Leadership Program
Quality Design Program
Quality Purchasing Program
Quality Contracts Program
Quality Production Program
Quality Inventory Program
Quality Inspections Program
Quality Nonconformance Program
Quality Measurement Program
Quality Service Program
Quality Audit Program
Quality Training Program
These categories, like the development plan mentioned above, are not required. They are simply a suggestion for companies looking for implementation ideas. If additional industry interpretations seem like a better fit, don´t hesitate to leave these programs in the dust.
At any rate, these programs will require a lot of time, communication, documentation, training, revision, etc.
Step #4: "Implement Your Quality Assurance Program
At this point, you have talked the talk but can you walk the walk? Make sure you have conducted essential training and then implement the quality assurance program. In the beginning, you may require frequent audits and frequent communication and revisions. Contacting a consultative expert in the area of compliance may be useful step at this or any prior stage. If you decide to invest in a consultant, it is essential that references regarding the consultative individual or organization be obtained.
Step #5: "Evaluate and Improve Your Quality System
The evaluation and improvement of your quality system may be directly proportionate with the time you are willing to devote to it. Maintaining quality simply requires time and brainpower. In fact, an online press release expresses the following:
"Proper staffing of quality roles is just one way organizations optimize their quality function and a study by pharmaceutical benchmarking leader Best Practices, LLC found best-in-class companies have a ratio of quality personnel to total manufacturing employees between 1:4 and 1:7."2
Technological solutions can also cut back on unnecessary work positions or on time wasted. Look for a system that can launch document control, training, change control, CAPA, customer complaints and audit solutions from a single platform.
1 http://connect.ab.ca/~praxiom/plan.htm (The ideas expressed in this article have in the majority been paraphrased from this website)
2 http://www.prnewswire.com/cgibin/stories.pl?ACCT=ind_focus.story&STORY=/www/story/04-18-2008/0004795819&EDATE=FRI+Apr+18+2008,+03:15+PM
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to software designed to streamline quality system management processes in environments regulated by ISO 9000 or additional regulatory entities, please feel free to contact a MasterControl representative.
A Possible Development Plan for Your ISO 9000 Quality System
Before you begin the development of your ISO 9000 quality system it is essential to understand two things:
The Development Plan Process
An online article (we will call it the development plan reference) that this author found to be quite useful has divided the ISO 9000 development process into 5 steps, none of which are required by any company but may be of great use to some. These five steps are quoted as follows:
- "Plan your ISO 9000 Development Project"
- "Deliver your ISO 9000 Awareness Program"
- "Develop your own Quality Assurance Program"
- "Implement your Quality Assurance Program"
- "Evaluate and Improve your Quality System"
These 5 steps are practical separation stages for your ISO 9000 quality system. The planning stage of your ISO quality system is actually quite simple…at least at first. You may have to take a few steps backwards from time to time and make quality system adjustments but essentially the planning stage is fairly clear cut.
Start by reading over the ISO requirements and any interpretations of these requirements that would be relevant to your industry. You should also refer to the pros and cons of implementing an ISO quality system and talk with others who have done so. Once you have done your research you can decide whether you want to follow an industry specification, model your system after a colleague´s or try something different. Overall, you should have a basic idea of how your quality system (A) will get you to the ISO requirement ends (B).
Step #2: "Deliver Your ISO 9000 Awareness Program"
If there is any step that is more important than any another, it would be the delivery stage. The development plan reference suggests creating an awareness program which (of course) refers to training. It is of the utmost importance that those who be required to conform with the ISO 9000 quality system become friends with the system itself. This may require hours of training and even hours of "informal" communication. Some companies should consider investing in an automated training software (preferably a solution that can be launched from the same platform as other solutions such as document control and quality system management solutions) that will allow the quick release of training tasks when a quality system change is made or when quality system documentation is revised.
Step #3: "Develop Your Own Quality Assurance Program"
The development of a quality assurance program is where you begin to make your ISO 9000 quality system a reality. The development plan reference suggests breaking your quality assurance program into the following 12 categories:
These categories, like the development plan mentioned above, are not required. They are simply a suggestion for companies looking for implementation ideas. If additional industry interpretations seem like a better fit, don´t hesitate to leave these programs in the dust.
At any rate, these programs will require a lot of time, communication, documentation, training, revision, etc.
Step #4: "Implement Your Quality Assurance Program
At this point, you have talked the talk but can you walk the walk? Make sure you have conducted essential training and then implement the quality assurance program. In the beginning, you may require frequent audits and frequent communication and revisions. Contacting a consultative expert in the area of compliance may be useful step at this or any prior stage. If you decide to invest in a consultant, it is essential that references regarding the consultative individual or organization be obtained.
Step #5: "Evaluate and Improve Your Quality System
The evaluation and improvement of your quality system may be directly proportionate with the time you are willing to devote to it. Maintaining quality simply requires time and brainpower. In fact, an online press release expresses the following:
"Proper staffing of quality roles is just one way organizations optimize their quality function and a study by pharmaceutical benchmarking leader Best Practices, LLC found best-in-class companies have a ratio of quality personnel to total manufacturing employees between 1:4 and 1:7."2
Technological solutions can also cut back on unnecessary work positions or on time wasted. Look for a system that can launch document control, training, change control, CAPA, customer complaints and audit solutions from a single platform.
1 http://connect.ab.ca/~praxiom/plan.htm (The ideas expressed in this article have in the majority been paraphrased from this website)
2 http://www.prnewswire.com/cgibin/stories.pl?ACCT=ind_focus.story&STORY=/www/story/04-18-2008/0004795819&EDATE=FRI+Apr+18+2008,+03:15+PM
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to software designed to streamline quality system management processes in environments regulated by ISO 9000 or additional regulatory entities, please feel free to contact a MasterControl representative.
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