MRF Name / Logo

QP01 Document control

)ection All Initial issue Release*+mendment summary ,ssue 1.0 Date dd/mm/yy

Approved:

Management Representative

Note: Within this manual template, red italic text should be replaced by MRF speci ic in ormation and any !uidance in "te#t bo#es$ should be implemented%

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MRF Name / Logo

1 Purpose

The purpose of this procedure is to describe the process of controlling the issue and changes made to documents in the (ualit% Management )%stem *(M)+. ,ata #ept on an% electronic media is treated as a document.

&

)cope

This procedure contains the following sections: -.1 -.. -./ -.-.2 2 (ualit% s%stem documentation ,ocument change control 0!ternal documents 1omputer securit% 3bsolete documents Related documents

.lossary
4A)A& 5 4ealth 6 )afet% at &or# (7 5 (ualit% 7rocedures MR 5 Management Representative (M 5 (ualit% Manual (M) 5 (ualit% Management )%stem

Procedure

It is the responsibilit% of the Management Representative *MR+ to ensure the appropriate control and issue of (M) documentation. The MR or delegate is responsible for the preparation review authorisation issue and amendment of #e% (M) documents. /%1 Mana!ement system documentation

A Master ,ocument Inde! *M,I+ is used to identif% the latest issue of controlled documents. It is the responsibilit% of the MR to maintain the M,I and controlled document files. While a hard copy of the Quality Manual (QM) and associated procedures may be maintained as a reference copy, the master controlled copy resides in soft copy only. 3nl% the latest issue of an% document is held in the reference or master soft cop% files. (ualit% 7rocedures *(7s+ are prepared b% the MR 8 process owner and formall% approved b% the MR 5 evidenced b% signature on the front page of each procedure. 0ach qualit% s%stem document includes title reference number issue date and page number. The MR shall ensure that all released (M) documents are updated in a controlled manner and superseded documents are withdrawn from the master document folder on the s%stem. ,ocument change is carried out in accordance with section -... The MR maintains the M,I identif%ing the issue status of procedures and related controlled documents. /%& Document chan!e control

9pon the need to ma#e an amendment the document is revised accordingl% b% the MR and the issue level of the document raised to the ne!t sequential number. Amendments are shown bold and underlined *as this e#ample+ to give a visual indication of the amendments from the previous issue. A deleted paragraph is shown as: 2.: ,eleted. The document revision table is then completed detailing the date of amendment the new issue status and brief details of the change including page and 8 or section references. The standard requires changes to be identified however alternative methods of identification can be used e.g. vertical line in margin coloured te!t or the "trac# changes$ facilit% in Microsoft &ord a "best fit$ method should be selected b% the MR'.

The revised document is then electronicall% approved b% the MR the obsolete copies withdrawn and replaced b% the updated version in the master document folder on the s%stem; the M,I is also electronicall% updated. 3n subsequent updates the previous amendment is "accepted$ *changed to standard te!t+ so onl% new amendments are highlighted.

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MRF Name / Logo

/%0#ternal Documents

0!ternal publications ma% be documents industrial standards and specifications which include I)3 <001:.00= RR) 1ode of 7ractice 4A)A& and other publications as relevant. These documents are chec#ed annuall% via the Internet to ensure the latest version is in use. 0!ternal documents such as )tandards or 1odes of 7ractice are also listed on the M,I where appropriate. 1ustomer supplied documentation is reviewed on receipt and is maintained in accordance with section :.2.- of the (M *1ustomer 7ropert%+. /%/ 1omputer )ecurity

Key office computer information resides on a shared server which is backed up on to tape. !he back up is carried out daily and current back up is stored onsite in the company fire proof safe for security. An anti5virus program and Internet securit% is installed to protect all incoming data from corruption and unauthorised access. An% dis#s of e!ternal origin are virus chec#ed before use in the compan% s%stems. /%2 3bsolete Documents

3bsolete documents are depending on t%pe either retained for the lifetime of the related product 8 service *ta#ing into account regulator% requirements and record retention periods+ or promptl% removed from use b% the MR and deleted. Retained obsolete documents are clearl% identified as >obsolete? by electronic stora"e location / access restriction or physical markin", as appropriate to prevent inadvertent use.

Related Documents
All controlled (M) documents. Master document inde!.

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MRF Name / Logo

+ppendi# 1 Ne4 and e#ternal controlled document lo4 chart

@ew controlled document identified

Is new document of e!ternal originA

@
,ocument produced in format as described in -.1

Requirement for new 8 updated e!ternal document identified

,ocument chec#ed for accurac% b% process owner8 MR and approved

@ew cop% of e!ternal document obtained

,ocument forwarded to MR for entr% on to master document inde!

9pdated master document inde!

)uperseded document mar#ed as >obsolete? if retained

1ontrolled copies of new document released to relevant areas

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MRF Name / Logo

+ppendi# & Document chan!e and obsolescence lo4 chart

Requirement for change to controlled document identified

,ocument changed b% MR *or delegate+ accordingl%

Amendments indicated in te!t b% bold underlined (or alternative)

,ocument revision table updated to include new issue status and summar% of change

1ontrolled copies of new document released to relevant areas

Master document inde! updated to reflect new issue status

9pdated master document inde!

3bsolete document removed and either destro%ed or if retained mar#ed as >obsolete?

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