CQP Foundation Level

Documentation and Records Management for Quality cheat sheet

Every chapter's key points, formulas and definitions on one page, for the last week before the exam. Each heading links to the chapter that explains it.

Introduction to documents and records

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.

Key terms

Document: Recorded information and the medium on which it is contained. In a quality system a document says what should happen: a policy, a procedure, a work instruction, a specification, a drawing, a form before it is filled in.
Documentation: The set of documents an organisation maintains, together with the system that creates, approves, issues, revises and withdraws them.
Documented information: The term KS ISO 9001:2015 uses in clause 7.5 to cover both documents and records, precisely because the two are controlled differently. The standard speaks of documented information to be maintained (documents) and documented information to be retained (records).
Document control: The set of controls ensuring that the current version is the one in use: approval before issue, review and re-approval, identification of changes and revision status, availability at the point of use, legibility, and prevention of the unintended use of obsolete documents.
Version and revision: A document changes over its life, so each issue carries a revision identifier and a date. Only one revision is current at any moment, and superseded revisions are withdrawn or marked obsolete.
Record: Information created, received and maintained as evidence and as an asset by an organisation or person, in pursuance of legal obligations or in the transaction of business. The definition is from ISO 15489, and the operative word is evidence.
Records management: The field of management responsible for the efficient and systematic control of the creation, receipt, maintenance, use and disposition of records, including the processes for capturing and maintaining evidence of and information about business activities and transactions in the form of records.
Archive: Records selected for permanent preservation because of their enduring value, transferred to an archival institution. In Kenya, public archives are held by the Kenya National Archives and Documentation Service.
Vital records: The small proportion of records without which the organisation could not resume operations after a disaster: title deeds, contracts, insurance policies, the shareholder register, the current customer database.
Disposition: The final action taken on a record at the end of its retention period: destruction, transfer to an archive, or permanent retention.
Authenticity: It can be proven to be what it purports to be, created by the person purporting to have created it, at the purported time.
Reliability: Its contents can be trusted as a full and accurate representation of the transaction, because it was created at or near the time by someone with direct knowledge.
Integrity: It is complete and unaltered, and any permitted annotation or addition is itself identified and traceable.
Usability: It can be located, retrieved, presented and interpreted within the period it is needed.

The rest of the sheet covers

Fundamentals of records management
Principles of records management
Legal requirements
Electronic records management
Standards and best practice
Records management systems
Business continuity and disaster recovery planning
New trends
Exam technique and revision
Glossary