ISO 9001 clause 8.3 Design and customer 'custom' products

[Randy]

Their hours on site is a bit minimal in my opinion anyway,

How many employees do you have?

 

[nagelbh]

How many employees do you have?

Less than 100 at this plant on its own standalone certificate. (There's a second plant with its own separate QMS and procedures due to very different processes with a different registrar.)

I've escalated this above the auditor to get clarification and I haven't heard back further on that yet. We decided it's much better to get it resolved now than to kick the can down the road and do more work sorting it out later.

 

[Randy]

With justifiable reduction for no design (upwards to 30% max duration reduction) valid durations could go down to 1.5 days annual surveillance and 3.5 days for recertification, without any reductions applied you're looking at about 2.5 days annual and 4.5 days for recertification...........Your numbers are between there, correct? None of this is secret mumbo-jumbo, just basic application of IAF MD5.

 

[nagelbh]

Even counting some offsite prep time and desk auiditing they're a bit below those timeframes.

 

[Randy]

Even counting some offsite prep time and desk auiditing they're a bit below those timeframes.

The durations for your audits are longer? Under normal conditions increasing duration requires written justification as does reducing duration. At 100 people MD5 puts total initial duration at 7 days, annual surveillance is normally at 1/3 initial (or factored @ 0.333) and recertification is normally set at 2/3rds initial (or factored @ 0.67) before any reduction or increase (which both must be justified). (This is of course if IAF MD5 is being applied by a Certification Body accredited by ANAB, UKAS, JAS-ANZ, COFRAC, JAB or other similar organizations that are members of the IAF)