ISO 9001 Some False Interpretations
There are many different interpretations of the ISO 9001 standard (and some are absurd). In an effort to highlight some common misunderstandings we will highlight some of these myths, urban legends or perceptions of different requirements that may still exist.
Perception: Implementing and maintaining ISO 9001 is expensive.
False: it does not have to be expensive at all! Simply document your management system based on what you already do and put in place the programs required to improve upon them and you are pretty much done. The sooner you set up your management system and use it, the more cost savings you will enjoy. The ROI will be very quick!
Perception: The ISO 9001 system is a Quality System (belongs in the quality department or is the responsibility of the quality manager), or many organizations feel they need to hire somebody full time to manage the ISO 9001 system (internal audit coordinator, corrective action coordinator, ISO coordinator, etc.).
False: the ISO 9001 system covers your entire business starting with customer requirements, review and acceptance of those requirements, executing those requirements, measuring and monitoring your processes to ensure you are meeting those requirements and then, ultimately delivery of a product or service that meets those requirements to ensure customer satisfaction. If only the quality department is responsible for ensuring the above, then I suppose everyone in the company should work for the quality department.
See my post at http://parkerquality.blogspot.com/2009/06/12-myths-surrounding-iso-9001.html for these and more mythd about ISO 9001.
The documentation and record keeping for most industries are part of the legal and/or regulatory requirements. Proper documentation assures transperancy within the organisation and eases training requiremnts among other things. Good records provides valuable feedback and lessons learnt that are essential for the continuous improvement process. The benefits of good documentation and good record keeping far outweighs the costs accrued in maintaing them.
As for responsibility for Quality (and the same applies for Safety and Security) is everybody’s responsibility, the Accountable Manager’s undertaking commits every person in the organisation. Primarily it is the Line Managers duty to translate the Quality (Safety and Security) vision into reality. It is their responsibility to set objectives, implement them and verify their implementation. The Quality department is there to verify compliance with the requirements (legal, regulatiry or internal) and that procedures and corrective actions are effective.