This Policy summarises the procedure for the preparation, authorisation, issue and amending controlled documents within the Organisation’s Quality System. This Policy is a requirement of clause 4.2.3 of ISO 9001:2008:

1. This Policy will apply to the following types of documentation used at the Home:

• Policies and Procedures, including Job Descriptions

• Record Forms

• Record Books & Wall-charts

• The Quality Manual

• External Publications and Standards for reference purposes

2. POLICIES, PROCEDURES & JOB DESCRIPTIONS:

2.1 All policies, procedures and job descriptions will be prepared in electronic format and stored in password- protected directories on the Organisation’s central computer system.

2.2 For each document there is provision to record the following:

2.2.1 The Document Number (next sequential number from the master index).

2.2.2 Version Number (or Issue Number).

2.2.3 Person within the Home authorising the document for use (Manager or delegate)

2.2.4 Date the document was authorised.

2.2.5 Date the document was last up-dated (as relevant). For new documents this will be above.

2.2 The Document Number, Version Number and Date of Last Up-date / authorisation will be typed directly into thes paces provided in the electronic files.

2.3 A “hard copy” (paper copy) will be printed off and the person authorising the document for use will sign and date the “Authorised” and “Date” boxes respectively. This becomes the “master copy”.

2.4 The master copy will be included in the Policy Manual which will be held centrally by the Domiciliary Care Services Manager for staff reference purposes. This master Policy Manual will be the “Controlled Copy” and will be the only copy in use at the Organisation.

2.5 Copying of any policies from a master or controlled copy manual is NOT permitted without the express authorisation of the Domiciliary Care Services Manager. Any copies that are made for third party reference purposes will be taken to be “uncontrolled copies” i.e. will not be subject to future up-dates, changes or amendments.

2.6 Changes to any policy, procedure or job description are initiated and approved through the same mechanism as original documents, reference clauses 2.1 through 2.6 above. A “rolling” record of up-dates and changes made will be kept on Form No 2-200 - Policy Up-date Record.

2.7 A policy will refer to any relevant record form or book (see sections 3 and 4) used for recording data. Such references are found at the end of the policy document.

3. RECORD FORMS & CHARTS:

3.1 All record forms will be prepared in electronic format and stored in password-protected directories on the

Organisation’s central computer system.

3.2 For each form there is provision to record the following:

3.2.1 The Document Number (next sequential number from the master index).

3.2.2 Version Number (or Issue Number).

3.2.3 Date the document was prepared (as “Last Up-dated”).

3.2 The Document Number, Version Number and Date of Last Up-date / authorisation will be typed directly into the

spaces provided in the electronic files.

3.3 A “hard copy” (paper copy) will be printed off as the “master copy”. For Record Forms it is not considered

necessary to include a provision for authorisation signing and dating.

3.4 The master copy will be included in the Forms Library which will be held centrally by the Domiciliary Care

Services Manager for staff reference purposes. The master Forms Library will be the “Controlled Copy” and will be the only copy in use at the Organisation.

3.5 Copying of any form from a master or controlled copy manual is NOT permitted without the express authorisation

of the Domiciliary Care Services Manager. Any copies that are made for third party reference purposes will be taken to be “uncontrolled copies” i.e. will not be subject to future up-dates, changes or amendments.

3.6 Changes to any form are initiated and approved through the same mechanism as original documents, reference

clauses 3.1 through 3.6 above. A “rolling” record of up-dates and changes made will be kept on Form No 2-201 - Record Forms Up-date Record.

4. RECORD BOOKS & WALL-CHARTS:

4.1 These will include bound record books instead of individual forms that are used to record data (e.g. Complaints

Log), and wall-charts that may give instructions (e.g. washing machine instructions, pictorial cleaning and sanitising procedures that can be employed at the service user’s home).

4.2 For purposes of Document Control, these record books and charts will be referred to as “Forms”. As such:

4.2.1 They will be included on the master index of forms contained in the Forms Library.

4.2.2 Each will be assigned a “Form Number” taken from the sequential master index.

4.2.3 Each will be stamped with the appropriate Form Number.

4.2.4 The master index will identify the locations where these record books and wall-charts may be found at

the Organisation’s premises.

4.2 The on-going validity and currency of all wall-charts on the master index will be reviewed on a yearly

basis at Quality Management Review Meetings.

5. THE QUALITY MANUAL:

5.1 A Master Copy of the Quality Manual will be prepared in electronic format by the Domiciliary Care Services

Manager or designate, ensuring that each page is completed with the following information:

5.1.1 Version Number

5.1.2 Date Prepared / Issue Date

5.1.3 Page Number

5.2 A copy will be printed in “hard copy” format, and each page completed with the signature(s) of persons preparing

and authorising the Quality Manual.

5.3 Additionally, each page will have the words “MASTER COPY” in the copy status grid ticked in RED ink (this will

appear black on subsequent photocopies).

5.4 The “Revision History” page will be completed with details of original Version Number and Issue date, and the

Domiciliary Care Services Manager will sign in the space provided.

5.5 The Quality Manual is a single master document. Copies may be made but in each case, according to need, one

of the following boxes in the copy status grid will be ticked on each page:

5.5.1 “Controlled Copy” (with a Copy Reference Number)

5.5.2 “Uncontrolled Copy - will not be up-dated”

It is the Policy of the Organisation to restrict the number of Controlled Copies to an absolute minimum.

5.6 Amendments to the Quality Manual will be made in exactly the same way as for policies (see section 2) but using

the Manual’s Revision History Sheet as a rolling log of changes in place of Form No 2-200.

6. EXTERNAL PUBLICATIONS & STANDARDS:

6.1 A Master Index will be maintained of all published / external standards used for reference purposes within the

Organisation. For each standard or publication this index will identify the name of the publication, latest edition date in use and the location within the Organisation where the publication may normally be found.

6.2 Each publication will be stamped “Published Standard - Controlled Copy. To be used for reference purposes

only” in RED ink.

6.3 Copies may not be made due to liability of copyright infringement.

6.3 The on-going validity and currency of all published standards on the master index will be reviewed on a yearly

basis at Quality Management Review Meetings. Form No 2-100 applies.

FORMS REFERENCES:

Form No: 2-100 Review of Publications and Standards

Form No: 2-106 Staff Management Review Meetings (Minutes & Action Plan Structure)

Form No: 2-200 Policy Up-date Record

Form No: 2-201 Record Forms Up-date Record