Re: Stage 1 audit for ISO 9001
Are non conformance raised during stage 1 audit? I think so. Could any body provide some of your nonconformances found during stage 1 audit?
Thanks
NC for stage 1?
If done correctly a NC will normally be against documentation such as the lack or a procedure or doc control and will normally be gainst Level 2 documents, occasionally level 3. The purpose of the stage 1 is to determine the ability of the MS to successfully go thru Stage 2 by looking at its design
MS auditing is 3 dimensional "intent-implementation-effectiveness"
The audit of the 1st dimension is what we call the stage 1 audit where we look at the system design through the high level documentation (level 1 & 2) and from it we can determine "intent". This audit may be done on-site or off ( desk audit some call it)
The audit of the 2nd dimension occurs during stage 2 where we look at the "implementation" of the design. This is an operational audit where we see how the design is put into action and this will also normally cover the level 3 type documents...This is the audit where the auditors have to get out and "LOOK", interview and experience the design in action. This audit has to be onsite.
The audit of the 3rd dimension takes place concurrently with the 2nd dimension and it looks at the effectiveness of the implementation of the design. Much of the information is gathered through the reviewing of the level 4 documents...records. What is being looked for here is whether the system is able to achieve and is achieving what it was planned to achieve.
If you look, really look at clause 8.2.2 of 9001 you'll see where the 3 dimensions are called out..........
8.2.2 Internal audit
The organization shall conduct internal audits at planned intervals to determine whether the quality management system
a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and
b) is effectively implemented and maintained.
This "new" Stage 1 & Stage 2 approach isn't new at all (at least to Registrars), it has been going on for 12 years or more since ISO 14001 came out and OHSAS 18001 is audited that way as well.
If you think about it as auditors we were all taught to review documentation and then go out and see if procedures were being followed and stuff was happening as planned...No big deal, people are just making it that way.