ISO Documents (Maintained Documented Information) vs Records (Retained Documented Information) — What is the Difference?
Introduction: In the realm of ISO standards, the terms “documents” and “records” are not interchangeable. They represent distinct types of documentation, each serving unique purposes. Recognizing these differences is essential, as ISO-based Quality Management Systems (QMS) have specific requirements for each. TC 176 (the ISO 9001 development committee) realized this in that, even though they desired to take a more generic approach to documentation, they had to create different phases to differentiate documents from records.
“Maintained Documented Information” (Documents): “Maintained documented information” is essentially what we had historically referred to as documents. These are documents that can change, are always subject to review and approvals, are always subject to revision control, but are NOT subject to retention periods and disposition after such periods. Examples of QMS documents (retained documented information) include things as: procedures, work instructions, blank forms, drawings and blueprints, plans, job descriptions, testing protocols, etc.
Retained Documented Information (Records): On the other hand, “retained documented information” constitutes records. They are HISTORY—past tense. Records cannot change; but records can be corrected (Change relates to something being MODIFIED “ to make it different per Webster, whereas Correct relates to something being FIXED to make it right or correct.)“ Records are NEVER subject to revision control, always have retention periods and disposition after such periods are over., etc. Examples of QMS records (retained documented information) include: management review records, meeting minutes, training records, calibration records, design records, inspection records, test results, evidence of completed work like completed travelers/work orders, completed sales orders, completed POs, etc.
The Role of Language and Perspective: While we commonly use the terms “document” and “record” as both nouns and verbs in English, within ISO’s context, they are strictly nouns. For instance, if we record the names of participants in a meeting, we create a record because it serves as evidence of a historical event. However, if we record the names of speakers for an upcoming conference, it becomes a document because this information may change.
Consider blank forms like checklists. Can they change? The answer is yes. Therefore, blank forms, being subject to modification, are documents. However, once a checklist is entirely filled out, it becomes a record because it now provides evidence of a completed task in the past.
Navigating ISO 9001:2015: In ISO 9001:2008, separate clauses governed the control of documents and records, simplifying the understanding of requirements. However, ISO 9001:2015 has combined these requirements into a single set of clauses under 7.5. Some requirements apply to both documents and records, such as legibility, identification & decription, distribution & access, storage, and preservation format. However, certain provisions in 7.5 apply solely to documents, including review & approval, availability at point of use when and where needed, version control and control of changes. Conversely, other requirements in 7.5 pertain exclusively to records, like retrievability, retention periods, and disposition. This necessitates a clear understanding of the type of documentation to determine the applicability of clause 7.5 requirements.
Conclusion: Distinguishing between ISO documents (maintained documented information) and records (retained documented information) is essential for compliance with ISO standards. While ISO 9001:2015 has merged certain requirements, the distinctions between these two types of documentation remain significant. Properly categorizing documents and records ensures adherence to ISO standards and facilitates effective Quality Management Systems. Here is a handy chart you can refer back to: