Anova Quality Systems Services Inc.

Assisting Organizations in Quality Improvement Since 1993

Monthly Archives: July 2011

Seven deadly sins of implementing ISO 9001

The Quality Management Standards including ISO 9001, are excellent standards for management of quality, however, there are many who express their concerns towards the idea of having a documented quality management system.
Based on my experience in working with many organizations the following need to be avoided in establishing a quality management system, to enable you to maintain a dynamic system that helps your organization to grow and continually improve

The following are some examples of why companies fail to reap the benefits of ISO 9001 program:
1. Lack of management understanding and support of the QMS;
2. Neglecting the Quality Policy Statement and asking the staff to memorize it;
3. Lack of experience and desire of the Management Representative, assigned to oversee the system;
Note: Whether the Management Representative is the quality manager or someone assigned to carry out the task, she or he must have the experience and be willing to continually hone their skills to manage the QMS.
4. Use of generic design for the quality management system that is foreign to your organization;
5. Assuming that you have to implement certain tasks because the ISO 9001 standard requires it;
Note: if the consultant or other individuals in charge of your QMS program development tells you that you must do this task because it is required,  I am afraid that the suggested program is not for you. The consultant must be able to convince you that this task is important for maintaining your QMS and, you have to be convinced.
6. Creating a QMS that runs in parallel to your daily activities, without being part of your system, for the purpose of maintaining registration;
Note: your quality management system must become part of your daily activities and not a burden to slow down your work.
7. Over documentation and maintaining too many paper records, which are purely kept for presentation to auditors, with no added value.

Paperless QMS

If you quality management system is still based on paper records, or combination of paper and spreadsheets, and your quality manager has piles of unfiled records waiting for review, analysis and filing, I have to tell you that your QMS is obsolete and you are not running an efficient cost effective system.
Due to advances in technology, there are many tools available that can be used to facilitate this transition. Small and medium size companies can take advantage of simpler, more available databases such as MS Access which is available with most Office Suites at reasonable price.
Alternatively you can set your quality management database on Intranet or more elaborate systems that can be integrated with your ERP or other systems.
Whether your quality management system is based on ISO 9001, ISO 13485, ISO 14001 or other management systems, it is paramount for the efficiency of your quality management system to maintain the following records electronically:
– Nonconformance/Corrective Preventive Actions
– Training records
– Calibration records
– Engineering change records
– Audit records
– Management review records
– Receiving records
Using readily available technology will enable you to maintain a dashboard to readily analyze data and evaluate trends for continual improvement.
If you wish to have an evaluation done on the efficiency of your Quality Management System, we can certainly help you in transfer of your paper based system to an efficient database system suited for your organization.