Records
Significance of the changes is based on individual company needs and the 'exclusions' (if any) that are justified and pursued. My comments are italicized.
From ISO 9000:2000 In a Nutshell
"Clarifications:
Clause 4 - Explicitly requires that records be controlled (4.2.3)
also, the word 'quality' has been removed in conjunction with records"
(which by elimination expands {for most} review of all records to be considered {at least one time function} for inclusion/determination of retention requirements).
"Clause 7 - Organizations must ensure that records provide evidence that the processes and resulting product meet requirements. (7.1)"
"New Requirements:
Clause 6 - The requirement for organizations to keep training records has been broadened to include records of education, experience, training, and skills.
Clause 7 - The following records were included in ISO 9001:1994; however, the requirements to record results and necessary actions has been added:
* Records for contract review must be more explicit. Rather than having a general record requirement, ISO 9001:2000 specifies that the results of the review and sesultant actions must be recorded. (7.2.2)
* Reviews at suitable stages of design and development must be conducted. The results of the design and development reviews and necessary actions must be recorded and maintained. (7.3.4)
* The results of verification and necessary actions must be recorded and maintained. (7.3.5)
* The results of validation and necessary actions must be recorded and maintained. (7.3.6)
* The results of the reivew of change and necessary actions must be recorded and maintained (7.3.7)
* The results of supplier evaluations and necessary actions must be recorded and maintained. (7.4.1)
* The results of calibration and verification must be recorded and maintained. (7.6)
Clause 8 - Records must be kept for preventive action (8.5.3)"
Granted many of these activities are being done, but not necessarily in a standardized format nor necessarily 'captured' in the system records. As for Clause 7 item 7.6 as listed, I don't agree...this has been there the whole time as I interpreted it. Also, for those of us that were 9002...we now have to address areas where previously we left it up to corporate. Since we DO participate with design reivew/development...I'd rather see proper processes/procedures implemented rather than exclusion just because it's easier to point elsewhere.
Other changes - "What's Not Included:
* The requirement for collection, indexing, access, and filing has been removed.
* The requirement for records of nonconformities accepted by the customer is no longer stated.
* The specific reference to subcontractor records in 4.16 has been removed.
* The legibility requirement of records has been removed but is implied in 4.2.3
* The requirement for a suitable environment to prevent damage, deterioration, and prevention of loss has been removed.
* The requirement for making records available to the customer under contract is no longer stated.
* The note that reminds the user that records can be any type of media has been removed, but it's implied in a note in 4.2.1."
"In a Nutshell -
...ISO 9001:2000 requires auditors to look more closely at the results and actions of the activities instead of just at the paperwork."
I have not included the list of "What Remains the Same" from the book.
Now...IMHO:
As many have stated previously...just because something is no longer 'required'; don't just toss it out. Evaluate its value and determine whether or not it's in your best interest to leave in place. And for many that were doing an 'excellent' job in the record retention area...they will make very short work of this.
However, for those of us (my company included) that have to fight and struggle to get any attention/focus in this area...and/or will be expanding our identified records, this will take more time.
I have been here 3.5 yrs and it (record retention system) was sketchy at best when I started, streamlined and more organized when I set it up 3 yrs ago...but has never been 100% (including basic information...like how long something should be kept), and no matter how much I beg, plead, cajole, etc...it isn't a priority...and isn't stressed by mgmt. Top that off with very light reviews in this area by the registrar (because they always look at MY records which are in top-notch order) and in short - I haven't had any support to stress the need/requirement factor.
Maybe I am obsessive/compulsive or anal-retentive...but I like neat, organized, indexed, records! I guess because it was drilled in during my time in both miliary and construction (legal requirements alone make ppwk tracking a MUST) work. Anyone remember the military 'Marks' system for organizing records? and Flour Daniel has (had during the 2 jobs I work for them...and they were only evaluating/starting pursuing ISO 9000 on the second project I was with them on) a numbered and organized filing system similar to military which make record searching a breeze after records are in storage (where some must be kept 20+ yrs).
Okay...this novella has worn out my wrists...maybe I'll try to use the voice activated software next time within the forum? It would have helped if I thought of trying that earlier. Oh well, I'll sleep in my braces tonight and be ready for tomorrow!
PS to my previous post: We were a 1 manday - twice a year audit plan.... but they included 1/2 day for reporting and 1/2 day for travel...so that made total of 2 per audit...4 mandays/yr @ $1,200 + travel & expenses... = appx. $10 - 12 grand annually.
