Procedures and Quality Manual written - Where next?

[Colin]

Re: Procedures and manual written. Where next???

Kev, sounds like you have a good handle on things. Just a couple of thoughts - you will probably need at least 2 people trained as auditors in order to enable a degree of 'objectivity and impartiality' (as clause 8.2.2 requires). The other point is that many CB's require at least some internal audits and a management review done by the time they do the Stage 1 audit.

 

[jkuil]

Re: Procedures and manual written. Where next???

Almost all the senior and middle management and supervisors are aware of what I have been doing mostly during informal discussions to ascertain the current practices etc. I have been trying to get them involved as the procedures have been created so hopefully no-one should be taken aback when formally issued.

Great that you have the involvement of senior and middle management. My question is, who owns the procedures? Are the responsible managers also the owners of the procedures. This means that they sign off on the procedure and maintain the procedure. They should take responsibility for:

• the training of all personnel involved in the execution of the procedures. It is preferred that the responsible procedure owner delivers the training to show (s)he is taking responsibility and is open for feedback
• the handling of any audit observations or other quality issues originating in their proces/procedure
• the approval of any change request to the procedure

BTW involvement of management only is not always adequate. Some managers have no idea what is realy going on at the work floor. Luckily in your case, supervisors were also involved, but my advice (consistent with Jennifer's) is to involve all layers of personnel at the earliest possible stage.
Please be prepared for many questions during training, even some resistance. Involvement of the responsible managers in the training sessions is a minimum. They can adres the questions and have the authority to agree on last minute changes to the procedures, if good feedback comes out of the training session.

 

[al40]

Hi fellow Covers,

Can anyone advise on my next move. I have pretty much written up all the procedures I think I need to. I have written a Quality Manual and created some new forms/templates to be introduced into the organisation.

My thoughts were to roll out the manual etc to all pertinent areas of the organisation to get some feedback on their validity and feelings from the personnel.

All going well do I appoint a CB to come in and carry out the pre-registration audit to check my paperwork then leave it for a period, say 3 months, with the system running and carry out internal audits prior to the 2nd stage audit. I already have some quotes but still to decide who best to approach formally.

Any advice grateful as I feel I have done all I can from the documenting side of things and need to move on to the next phase and get this up and running:mg:.

Directors are pressing me to get this thing in action and get us certified sooner rather then later so we can tick off the box on any PQQs received.

I would perform a gap analysis to see where you are at this point in time.

Also, training where are you on training the organization on ISO this must include all levels of management and employees.

best regards,

al40

 

[somashekar]

Re: Procedures and manual written. Where next???

Hopefully, all going well within the next few months we are certified and move on to bigger and better things.

Can you have some good auditor / management consultant conduct an extensive audit of what you have documented to assess how you have implemented and are maintaining the same ... ?
I say this perticularly from the hurry that your director and yourself seem to be having in getting your company a certificate.
Hats off to your confidence level, however your above said line makes me feel a little uncomfortable about the implementation and effective audit and corrective action systems that you have.
Having a good and robust QMS is much more than getting a certificate on the wall. Can you ask within the organization what the thoughts are ..... ?

 

[AndyN]

I would perform a gap analysis to see where you are at this point in time.

Also, training where are you on training the organization on ISO this must include all levels of management and employees.

best regards,

al40

Gap Analysis = very important!

Training on ISO? Not necessary, especially for employees! Training, per se isn't the issue it used to be under the 'old regime' - it's much better to define 'competencies' and make people 'aware' that you're implementing a QMS to ultimately lead to a certification. But that's not training.