“QMS records” as a term has disappeared from ISO 9001 but has remained in ISO 9000. Many companies continue to use this term, especially as records’ management as a procedure and term has been left in other standards with management system requirements.
The photo to the article is a correction of the quality control record. The QMS record is crossed out and corrected to the new one. The signature of the person who made the correction is placed next to it. This correction is in line with the requirements of ISO 9001, as
- it is a “deliberate change”;
- the original, initial corrected version is visible;
- the person who made the change is indicated. So there is someone to ask in case of disputes with the data and its corrections.
If you consider that the employee who made the adjustment will leave the company, it is advisable to enter the regulations and next to the corrector’s name to put:
- an indication of the reason why the change has been made.
All of the above 4 points constitute the requirements for correcting handwritten records. The QMS record in electronic form shall be corrected in two ways:
- by overwriting the information. And then the history of changes can only be recovered by having a backup system in place for long periods of time
- by saving the modified information in a new version of the file. This option retains the ability to see the previous version without having to restore the files from the archive. Correcting a QMS record in a file under a different name is therefore a priority method for historically significant records in the quality management system.
These may include:
- approvals of terms of reference and contracts;
- quality control records;
- records of tests and new product development plans relating to changes in development inputs.
This would seem to be a minor issue in QMS, but can be very troublesome in the absence of clear rules for making changes to QMS records.
More examples and information on our QMS Training.
More free material in our article on QMS documentation.
Quality systems development
QMS documentation. Structure of QMS documentation