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.