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Records Required by ISO 9001

by Ron Kurtus

ISO 9000 requires that records be kept of critical operations. Record keeping is the fourth tier of required documentation in ISO 9000, following the Quality Policy Manual, Procedures, and Work Instructions.

Questions you may have include:

This lesson will answer those questions.

What is a record?

Records consist of any historical documentation, such as summaries or meetings and reviews, specifications, invoices, results of tests and such. This is different than procedures and instructions that tell what do to. Instead, a record is the history of what has been done.

Records required

The following lists the records required under ISO 9001 version 2000, along with the referring sub-paragraph number from the standard. ISO 9002 and ISO 9003 would be subsets of this list. Of course, a company may choose to include additional records that they deem important.


Record Required


Management reviews

6.2.2 (e)

Education, training, skills and experience

7.1 (d)

Evidence that the realization processes and resulting product fulfill requirements


Results of the review of the requirements relating to the product and actions arising from the review


Design and development inputs


Results of design and development reviews and any necessary action


Results of design and development verification and any necessary action


Results of design and development validation and any necessary action


Results of the review of design and development changes and any necessary action


Results of supplier evaluations and actions arising from evaluations

7.5.2 (d)

As required by the organization to demonstrate the validation of processes where subsequent monitoring and measurement cannot verify the resulting output


Unique identification of the product, where traceability is a requirement


Customer property that is lost, damaged, or otherwise found to be unsuitable for use

7.6 (a)

Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist


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


Results of calibration or verification of measuring equipment


Internal audit results


Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product


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


Results of corrective actions


Results of preventive actions

Reason for records

The reason to keep records is for future use as a reference in case of questions related to contractual and legal matters, work techniques, verification of work done, and other parts essential to the company running smoothly. The company management should use sound judgment as to what records are non-essential and how long to keep a specific record.


In order to operate a business effectively, you should keep records of essential activities. To become certified under ISO 9001, there is a specific list of records that need to be maintained. Even if your company is not planning on being certified, this is a good list to follow.

Be valuable to your company

Resources and references

Ron Kurtus' Credentials


ISO Online - International Organization for Standardization website

ISO Standards Translated in Plain English - Extensive listing

ISO 9000 Certification Information - Good listing of ISO 9000 resources

ISO 9000 References and Resources


(Notice: The School for Champions may earn commissions from book purchases)

Top-rated books on ISO 9000


Thanks to Mohsin Nishat of Taseer Hadi Khalid & Co., Charted Accountants in Pakistan, which is a member firm of KPMG International, of Karachi, Pakistan for providing the latest version of the ISO 9001 record requirements.

Mr. Nishat is a Textile Engineer, Qualified Lead Quality Auditor for ISO 9000 and Certified Quality Professional in Pakistan which is based on the same body of knowledge as of Certified Quality Manger of ASQ, USA.

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