Confusion... records versus documents

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. How are these used to keep the history legible and accurate?

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 quality standard.

The ISO 9001 standard specifically requires records for the following items. Other standards 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.

There are approx. 21 records required by ISO 9001:2008, which are as follows:


Clause Record required



5.6.1 Management reviews



6.2.2 (e) Education, training, skills and experience Must maintain records of education, training, skills, and experience; there is a procedure


7.1 (d) Evidence that the realization processes and resulting product fulfill requirements

Records needed to provide evidence that the realiza tion (existing) processes and resulting product (service) meet requirements.


7.2.2 Results of the review of requirements related to the product and actions arising from

the review. The organization shall review the customer requirem ents of the service. This

review must be conducted prior to commitment to cus tomer. Need records of

the results of the review.


7.3.2 Design and development inputs relating to pro duct requirements



7.3.4 Results of design and development reviews and any necessary actions



7.3.5 Results of design and development verification and any necessary actions


7.3.6 Results of design and development validation and any necessary actions

7.3.7 Results of the review of design and development changes and any necessary actions

7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations
Records of evaluating suppliers must be maintained


7.5.2 (d) As required by the organization to demonstrate the validation of processes where the
resulting output cannot be verified by subsequent monitoring or measurement Need records to validate a process where you cannot monitor or measure easily


7.5.3 The unique identification of the product, where traceability is a requirement

7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use
Must maintain records re: customer property issues


7.6 (a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist

7.6 Validity of the previous measuring results when the measuring equipment is found
not to conform to requirements


7.6 Results of calibration and verification of measuring equipment

8.2.2 Internal audit results and follow-up actions

8.2.4 Indication of the person(s) authorizing release of product.
Need a record of how service gets released (approved). This could include daily inspection records, etc.


8.3 Nature of the product nonconformities and any subsequent actions taken, including
concessions obtained

8.5.2 Results of corrective action

8.5.3 Results of preventive action