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Many
people get confused by records versus documents. In general:
- Documents
are the future they tell you what to do or how something is
done.
- Records
are the history of what you have done. Records are the proof
you need to show that you follow your quality system.
Records
need to be legible. As a result you should consider things like
the use of white correction fluid, erasing and crossing out. Use
of these change habits can invalidate the record credibility or
affect the legality of your records. A common best practice is
to put a single line through something you are changing along
with initials and date. If it is a signifcant change a note may
be necessary to indicate why the change was made.
Many
registrars like to have a "records table". This is a
table that tells them which records are available for the different
clauses of the management system standard.
The
ISO 9000 based standards typically require records for the following
items. Each specific standard will require additional records.
-
Management reviews
- Education,
training, skills and experience
- Evidence
that processes and product or service meet requirements
- Review
of customer requirements and any related actions
- Design
and development including: inputs, reviews, verification, validation
and changes
- Results
of supplier evaluations
- Traceability
where it is an industry requirement
- Notification
to customer of damaged or lost property
- Calibration
- Internal
audit
- Product
testing results
- Nonconforming
product and actions taken
- Corrective
action
- Preventive
action
- Records
you need to provide evidence of following your processes.
Record
retention and disposition are up to you. You make keep records
a day or forever with some exceptions. There may be regulatory
requirements for keeping records. Also registrars generally like
to see three to six months of records at the surveillance audits
and they like three years of records for corrective action, preventive
action, management review and internal audits. Check with your
registrar for specific requirements.
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