ISO 9001 Tips and Advice
After 20 years of auditing, consulting, teaching and explaining the simplicity of the ISO standard it still amazes me how complicated we make it. With that in mind, in each newsletter ICH will hopefully make the ISO standard just a little easier to understand and hopefully your Quality Management System a little easier to live with.
4.2.1 General
The quality management system documentation shall include.....
d) Documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.
What does "determined by the organization to be necessary" mean? The organization needs a procedure on how to change a light bulb or get a bucket of water? Yes, it is a true story I have seen both of these. The question that begs to be asked is why did the organization determine these documents to be necessary? Did we hire individuals that are not competent for the above mentioned tasks?
Organizations have nursing standards rewritten in their entirety within the documents of the Quality Management System, when all they need to do is simply state within their quality management system that all nursing service follow Lippincott standards. Nurses are trained to Lippincott standards during orientation periods. Nursing competency reviews are also based on these standards. The competencies themselves serve as the procedures and if a Nurse does not remember a procedure, simply utilize the charge nurse's standard copy for review.
Some facilities management services say, "We follow the NFPA codes". What really gets me is when they proceed to rewrite the standards word for word into their own hospital policies. Instead, state in their quality management system that all facility management services will follow the relevant version of the NFPA code. Then as both instructional for employees and evidence of compliance, develop facility checklists to reflect everything necessary from the NFPA codes.
Some organizations are certified to the ISO standard and meeting the requirements of the ISO standard for management review. Why-oh-why did they not just stop there? They wrote their quality manual to reflect the ISO standard word for word, specifically management review, and then wrote a management review procedure which again did nothing more than restate the ISO requirements for management review. Then they put together an agenda which mirrored the ISO standard. Lastly they developed a management review meeting minute's template that once again outlined the ISO standards requirements for management review. Stop killing the trees!! Simply follow the ISO standard and maintain the meeting minutes that show objective evidence of compliance.
It drives me insane when people will say that ISO is a "DOCUMENT MONSTER" and yet they do not realize that in many cases they themselves are "DR. FRANKENSTEIN"
Woody Conway
ICH Lead Trainer
RAB Certified Lead Auditor
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