How to start an ISO 9001 Audit of a Medical Centre

[askingaboutQMS]

I am going to conduct ISO certification Audit of a medical centre. Please give me tips where should I start or commonly asked questions.

 

[Duke Okes]

Re: How to start an Audit of a medical centre.

1. Read the relevant ISO standard

2. Identify the requirements you want to verify, and construct questions to have answered through data

3. Get a copy of the organization's quality manual and organization chart

4. Conduct interviews or observe appropriate personnel or review records to determine whether the requirements are being met

 

[Randy]

Are you competent in QMS auditing to ISO 9001:2008? From your question you apparently have no idea and maybe it's less than a wise choice that you do so. There is opportunity formore harm than good.

You would ask the same questions there just as you would a chemical plant or clay pot factory to start things off and I've done both of those as well as what you are expected to do.

 

[somashekar]

I am going to conduct ISO certification Audit of a medical centre. Please give me tips where should I start or commonly asked questions.

Good luck. I just wish to ask how many mandays of audits you have on your account so far and what are the types of organizations that you have audited and certified. Perhaps more valuable inputs can be given after we know your past auditing history.

 

[AndyN]

I am going to conduct ISO certification Audit of a medical centre. Please give me tips where should I start or commonly asked questions.

A CERTIFICATION audit? For a CB? Or are you doing this for some other purpose?

 

[JaneB]

Re: How to start an Audit of a medical centre.

1. Read the relevant ISO standard

2. Identify the requirements you want to verify, and construct questions to have answered through data

3. Get a copy of the organization's quality manual and organization chart

4. Conduct interviews or observe appropriate personnel or review records to determine whether the requirements are being met

Yup, that pretty much covers it in a nutshell. Except you forgot the pre-requisite:
Be a competent auditor (ie, develop the competencies required).

 

[Wes Bucey]

I have an idea the OP did not express his question as clearly as he intended and thus led some readers to jump to conclusions which may or not be warranted.

Since I, personally, am a world-class competitor in leaping to conclusions, I've been considering a fair response which will be helpful to the OP and illuminating to other readers.

I'm a long-time member of the Institute for Healthcare Improvement (http://www.ihi.org/ihi) and I can attest the arrogance of administrators and health care professionals in medical centers, hospitals, nursing homes, clinics, even small practices of individual doctors, can be frustrating to outsiders who come in to audit, regardless if it is to a Standard or even just a financial audit.

Thus my primary suggestion is to establish at the outset to all and sundry that the auditor is NOT there to play "gotcha," but merely to obtain a true picture of whether

1. the written plans for operations are up to a pre-determined (by the auditee) standard of conformance
2. the personnel actually follow the organization's own plans when observed by the auditor.

and finally, to discuss his findings with the folks in charge so they may agree or challenge and make plans for changing those things they agree need changing

Frankly, some folks don't have the personality to establish the necessary rapport. It is a truism that neophytes and others unprepared to perform a thorough and professional audit will encounter lots of resistance from the auditee's personnel.

I hope this begins to answer the real intent of the OP's query.

 

[JJ777]

You will conduct this audit as any other audit. Look at documentation, look at the procedures and as mentioned ask questions from the standard, e.g a typical question maybe from clause 7.6.a Can you show the the relevant calibration certificate for a medical device e.g. thermometer