Part A: Foundations
Introduction to documents and records
Key takeaways
- A document says what should happen and is revised over its life, with only the current revision valid; a record says what did happen and is fixed once created.
- KS ISO 9001:2015 clause 7.5 calls both documented information: documented information to be maintained is a document, and documented information to be retained is a record.
- Document control keeps the current version in use: approval before issue, review and re-approval, identified revision status, availability at the point of use, and no unintended use of obsolete revisions.
- Under ISO 15489 a record must have authenticity, reliability, integrity and usability, which together make it usable as evidence.
- A wrong record is never overwritten: strike the error through with a single line, write the correct entry beside it, and initial and date the correction.
A quality management system makes two claims: that the organisation knows how it works, and that it can prove what it did. Documentation carries the first claim and records carry the second. Confusing the two is the single commonest error in this paper, so the chapter opens by separating them and does not let the distinction go.
What a document is
The documentation hierarchy is conventionally drawn as a pyramid, narrowing from a single statement of intent at the top to the many detailed instructions at the base.
The documentation hierarchy, with records at the base as the evidence layer
| Level | Document | Answers | Typical audience |
|---|---|---|---|
| 1 | Quality policy and, where kept, the quality manual | Why and to what standard | Everyone, plus customers and auditors |
| 2 | Procedures | Who does what, in what sequence, to what criteria | Process owners and supervisors |
| 3 | Work instructions | How a single task is performed at a single station | The person doing the task |
| 4 | Forms, templates, specifications, drawings | What information to capture, to what requirement | The person capturing it |
| Base | Records (completed forms, results, reports) | What actually happened | Auditors, investigators, regulators, courts |
ISO 9001:2015 does not require a quality manual
The 2008 edition required a quality manual and six named documented procedures. The 2015 edition requires documented information only to the extent the organisation determines necessary. Many certified Kenyan organisations keep a manual because customers and tender documents ask for one, but stating that the standard requires it is an error examiners look for.
What a record is
Document and record distinguished
| Attribute | Document | Record |
|---|---|---|
| Tells you | What should happen | What did happen |
| Tense | Prospective | Retrospective |
| Revised? | Yes, and only the current revision is valid | Never; a record is fixed once created |
| Controlled by | Approval, issue, revision, withdrawal | Capture, protection, retention, disposition |
| ISO 9001 term | Documented information to be maintained | Documented information to be retained |
| Example | Blank calibration form QF-11 Rev 3 | Completed calibration certificate for scale S-14 dated 14 March 2026 |
| If it is wrong | Issue a new revision | Do not alter it; add a correcting record and keep both |
The four characteristics a record must have, again from ISO 15489, are what make it usable as evidence, and they are examined regularly.
Never correct a record by overwriting it
A record altered after the event loses integrity, and with it evidential value. The professional correction is a single line through the error, the correct entry beside it, the initials of the person correcting and the date. In an electronic system the equivalent is an audit trail that retains the original value. Tippex on a batch record is a finding in every audit.
Self-check
Distinguish a document from a record, giving three examples of each from a Kenyan food processing plant, and explain how the control applied to each differs. (8 marks)
State and explain the four characteristics of a record under ISO 15489, and for each state one practice that would destroy it. (8 marks)
Show worked answer
Document versus record (8 marks: 2 for the distinction, 3 for the examples, 3 for the controls).
A document states what should happen and is prospective; it is revised over time and only the current revision is valid. A record states what did happen, is retrospective, and is fixed at the moment of creation and never revised.
Documents in a food plant: the hygiene procedure QP-06; the specification for incoming maize setting maximum moisture content; the blank check-weigh form QF-22; the cleaning schedule; the product recipe.
Records in the same plant: the completed check-weigh sheet for Line 2 on 14 June 2026; the calibration certificate for the metal detector; the goods received note for a maize delivery; the internal audit report; the batch release note.
Controls on documents: approval by an authorised person before issue; identification of revision status and date; controlled distribution so the current revision is available at the point of use; review and re-approval on change; and positive withdrawal or marking of obsolete revisions so they cannot be used by mistake.
Controls on records: capture at the time of the event by a person with direct knowledge; protection from alteration, loss and deterioration; indexing so they can be retrieved; a defined retention period derived from legal, contractual and business need; and a controlled disposition at the end of that period, whether destruction, archiving or permanent retention.
Characteristics of a record (8 marks, 2 per characteristic).
Authenticity: the record can be proven to be what it purports to be, made by the purported person at the purported time. Destroyed by: allowing one operator to sign a form on another's behalf, or by shared login credentials in an electronic system, since neither can then evidence who made the entry.
Reliability: the contents can be trusted as a full and accurate representation of the transaction, because they were captured at or near the time by someone with direct knowledge. Destroyed by: completing a day's check sheets from memory at the end of the shift, which produces a plausible document that evidences nothing.
Integrity: the record is complete and unaltered, and any permitted addition is identified and traceable. Destroyed by: overwriting or obliterating an entry, using correction fluid, or an electronic system that permits a value to be edited without retaining the original in an audit trail.
Usability: the record can be located, retrieved, presented and interpreted for as long as it is needed. Destroyed by: storing records without an index, in a format whose software is no longer available, or on media that degrade, so that a record which legally exists cannot in practice be produced.