The document outlines ISO 9000:2005 guidelines on quality management systems, emphasizing the importance of effective documentation, which includes various formats and must be clear and legible. It specifies required documented procedures for key activities like document control and corrective actions, and mandates regular review and updates of documents. Additionally, it provides detailed instructions on how to maintain records, correction practices, and the proper mediums for documentation.

2.  Guidance ISO 9000:2005 Quality Management Systems-
Fundamentals and vocabulary defines a document as an
information and its supporting medium.
 Medium can be:
◦ magnetic
◦ paper
◦ electronic or optical computer disc
◦ photograph
◦ master sample

3. Documentation is :
 A set of documents (written or graphical procedures,
manuals, policies , instructions, specifications) and
records (recorded information of performed activity).
 A process that involves the systematic interaction of
people, events and documents to create the records.
Quality can not be assured in a regulated industry
without good documentation practices.

4. ISO 9001:2008 specifically requires the organization to have documented
procedures for the following six activities:
 Control of documents
 Control of records
 Internal audit
 Control of nonconforming product
 Corrective action
 Preventive action
Additional needed documents are:
 Quality policy
 Quality objectives
 Quality manual

5.  Approval – specially for work instructions, procedures, manufacturing
specifications.
 Clarity - documents should not be open to misinterpretation by the
users.
 Regular review and update - documents must be kept up-to-date and
distributed in a controlled manner.
 Formal presentation- controlled documents should be prepared in
accordance with a written procedure.
 Records-related to manufacturing or testing operations should be kept
based on record retention policy.

6.  All entries must be clear and legible.
 Never make erasures or write-overs. (Do not turn a 5 to 6, or 9 into 8)
 Any written error must be crossed out in such a manner that the original
information is still legible.
 Do not scribble out or white out entries.
 The crossed out section must be initialed and dated by originator. Corrections
must be made next to the deleted entry. Write reason for correction.
 Use only black or blue permanent ink.
 Pencil is not acceptable, since all entries must be permanent and able to be
photocopied.
 Make the required entries on the record as the work is performed. Do not record
information on a separate piece of paper and enter on the record later.
 No spaces for handwritten entries are left blank - if unused, they are crossed out
or N/A (or similar text) entered.
 Ditto marks or continuation lines are not acceptable.

7. Want to learn more about GDP, its requirements and best
practices to comply with them? ComplianceOnline
webinars and seminars are a great training resource.
Check out the following links:
 How to Comply with GDP Requirements?
 Good Documentation Practices for GXPs
 Introduction to FDA Good Documentation
Practices
 An Easy to Understand Guide to Good
Documentation Practices
 Good Laboratory Practices (GLP):
Documenting Deviations & Unexpected
Circumstances