control of documents and records

D. Keane June 2005 1

Control of Documents and Control of Documents and RecordsRecords

4.3 Document Control

4.13 Quality and Technical Records


ISO 15189 Requirements for Document Control (4.3)

ISO 15189 Requirements for Quality and Technical Records (4.13)

Templates for Meeting Requirements of 4.3 and 4.13


Requirements for Document ControlRequirements for Document Control

1. - Requirement for procedure to control documents that define the Quality Management System.

- Documents defining the Quality Management System can be internal/

external and are called controlled documents. - Internal (e.g. SOPs - External (standards, regulations)



2. - The retention period for controlled documents must be approved by the Laboratory Director.- Controlled documents can be hardcopy/

softcopy.3. Must define the document types and make

up the Quality Management System.e.g. A document may be in hardcopy or electronic format and may consist of any instruction or information including …….



4. Changes to controlled documents must be controlled:-

- Identify change- Review change- Authorise change

5. Procedure must define and control:- - The review and authorisation of

Quality Management System documents

prior to issue to Laboratory personnel.



5. - A master list of controlled documents which identifies:-

Document nameDocument numberVersionEffective date

- A document review history and distribution listing for each identified controlled document.



5. - Removal of obsolete versions of controlled documents from point of use.

- The regular review of controlled documents and their revision if required.

- The labelling of superceded master documents so as to identify them as separate

from the current version. - The circumstances if any that allow hand amendments to be made including the review and authorisation processes.



5. - Procedures must define and control:-Changes to electronic documents e.g. report formats, parameterisation, calculations etc.

6. Controlled documents must be uniquely identified:-- Title of document- Number of document including version- Page number- Name of reviewer/ authoriser- Source- Changes made from last version


Requirements for Quality and Technical Requirements for Quality and Technical RecordsRecords

Quality and technical records

- A quality record provides objective evidence


Require procedure to control Quality RecordsIdentification of quality recordsCollection of quality recordsAccess to quality records (security)Storage of quality records (environment)Maintenance of quality records (pest control

and archiving)Safe disposal (authorisation/ shredding)A defined retention time for each record type



Requirements for Quality and Technical Requirements for Quality and Technical Records - IdentificationRecords - Identification

Patient Request form

Laboratory workbooks

Complaints/ non-conformances

Examination results

Calibration results

Incident/ accident records

Instrument printouts

Equipment workbooks

Staff training

Procedures QC records External quality assessment records


Collection of Quality RecordsMust be legibleMust be completed by trained/ authorised

personnelMust be readily retrievableMust be collected in a certain mannerRecords may be stored on any appropriate

medium i.e. electronic, hardcopy, CD, microfilm



Storage of quality records - current records - old records

Onsite/ off site (usually warehouse)Facility used must:-

- be suitable and prevent damage, deterioration, loss or unauthorised access

Facilities should be alarmed with sensors (fire/ smoke detection)

Facilities for key documents should have fire proof vaults e.g. for validation documents



Water fire retarded systems are destructive, gas retardant systems are acceptable.

Retention times

- Must have documented retention times for each record type (days –

permanently)



What procedures/ manuals do we need to

meet requirements of 4.3 Document Control

and 4.13 Quality and Technical Records?

- Quality Manual

- Procedures

The number of procedures is totally up to you

1 or more.

Templates for Meeting Requirements of 4.3 Templates for Meeting Requirements of 4.3 and 4.13and 4.13


Templates are provided:-Template 1 – Document Numbering System (4.3)Template 2 – Preparation, Style and Format ofStandard Operating Procedures (4.3)Template 3 – Operation of a Controlled Document System (4.3)Template 4 – Completion and Retention of Quality Records (4.13)Template 5 – Procedure for the Control of Quality and Technical Records (4.13)



Document Numbering System (Template 1)Unique Numbering System (made up of composite parts) location/ area of application/ document type/ number and version.

– Attach forms to a procedure (link)– Facility for expansion– Allocation of document numbers, who?– Large documents (break up in sections)– A master list of documents.



Preparation, Style and Format of Standard

Operating Procedures (Template 2)– Fresh fish for sale (short sentences)– Black and white instructions– Method Q-Pulse/ Microsoft Word– Secure access/ password control– Who writes the SOPs? (training)– Consistent headings



Preparation, Style and Format of Standard

Operating Procedures (Template 2)– Who, where, how, what, when, why?– Test method procedures and the role and

control of product inserts– Critical steps/ checks/ corrective actions– Link change control to the procedure



Requirements of Document ControlRequirements of Document Control

Operation of a Controlled DocumentSystem (Template 3)• Why? Prevent inadvertent use of obsolete

Documents• Official, master, information, uncontrolled

documents• Define process for issue, review, revision,

distribution and disposal of controlled documents.

• Write, review, authorise (who?)• Record on the first page



Operation of a Controlled DocumentSystem (Template 3)Role of Document Controller

– Type and make corrections– Information copies for training in advance– Maintain document review history– Distribute copies and record– Withdraw obsolete version and destroy– Control current master and obsolete master

documents



Operation of a Controlled DocumentSystem (Template 3)Role of Document Controller

– Master list of documents– Document Index– Ensure current version of forms are in place– Do not copy copies– Assign document number– Control documents of external origin– Documentation control stamps



Operation of a Controlled DocumentSystem (Template 3)• Training record for procedures• Uncontrolled documents in the laboratory

(common failings)• Laminating key sections of procedures• All documents do not have to be under

document control• Use of books of forms (pre-printed)



Completion of Controlled Documents (Template 4)

– Traceability to the person who completed the

– record– Authorised signature and initials of

personnel– Indelible ink– Concurrent completion of records with task



Completion of Controlled Documents (Template 4)

– Rubber stamps/ ditto marks– Avoid transcription– Correction fluid– Correcting errors.



Procedure for Control of Quality/ Technical Records (Template 5)

– Master list of record types with retention periods

– Consult with Hospital policy on retention of records

– Meet INAB standards– Meet legal requirements (EU Directive)– Control of disposal– Approval by the Laboratory Director