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Do you think as an interpretation of ISO9001 clause4.2.4, the organisation should prevent the use of pencils and correction fluid? As some may explain record protection as a protection from unauthorized changes. or tractability of records. but does using pencils prevent that? i know that some cases require protection and prevention of using pencils but is it a general rule? your ideas are very welcomed
According to clauses4.2.3 and4.2.4 the organization is not obliged to prevent use of pencils or correction fluids, but the organization is obliged to define in the relevant procedures how the modification or correction in its documents - including records - is controlled. The controls may include the type of acceptable correction method in records, authorization and approval mechanism including traceability of whom made, reviewed and approved the change where applicable, ..etc. Use of pencils and correction fluids might be acceptable in certain records and circumstances at temporarily basis with specific controls until changes are made final. The conclusion: Nobody can claim that according to ISO9001 the pencils and correction fluids are absolutely forbidden. By the way, there is a famous old story about using pencils instead of pens in space flights because gravity troubles the ink flow inside pens :) ð
ISO requires record protection meaning the record is protected against "un-authorised" use or amendment.
This doesnot mean editing can't be done as it breaches the fundamental principle of Quality Improvement.
It is though required by ISO9001:2008, that edits and amendments should be readily identifyable (a pre-formatted correction form could be filled to identify change).
Record control is to assure that the records have facts and actual data, whatever the tools used to fill the forms.
control of the record will be by date of issue and signatures of authorized persons.
Amendment of the data or changes by corrector or pencil should get more signature beside the changes to confirm that the correction has done by the authorised person.
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