Doc Control sample ISO 9000

12
Document: QMS_OP1 Procedure for Document Control Version: Draft Issue: 1 Page 1 “Company Name” Purpose To establish a documented Quality Management System (QMS) as a means of ensuring that the services provided to customers conform to specific requirements. Approval All documents within the QMS are reviewed and approved by the person responsible for that area. The approved documents are controlled by the Business Standards Manager (BSM). All documents contain reference to Document ID, Version and Issue Number. All documents have in the footer Uncontrolled when Printed. 1. Quality Manual The Department Manager is responsible for the approval of the Quality Manual. This is indicated by an approval date being entered into the approval section at the back of the document and a digital signature on the document, although it will not be visible in the content of the document. This digital signature is used to protect the authenticity and integrity of the document and will lock the document to prevent any further editing. 2. Operating Procedures and Processes The Department Manager is responsible for the approval of the Operating Procedures in conjunction with the Business Standards Manager (BSM). Again, this is indicated by an approval date and digital signature as per the Quality Manual. Processes are written where the absence of such would affect the quality of the service and to ensure effective control and operation of the process involved. A process owner from each area has been allocated who is responsible UNCONTROLLED WHEN PRINTED

description

sample doc control for ISO 9000 2000

Transcript of Doc Control sample ISO 9000

Page 1: Doc Control sample ISO 9000

Document: QMS_OP1 Procedure for Document ControlVersion: DraftIssue: 1 Page 1 “Company Name”

Purpose

To establish a documented Quality Management System (QMS) as a means of ensuring that the services provided to customers conform to specific requirements.

Approval

All documents within the QMS are reviewed and approved by the person responsible for that area. The approved documents are controlled by the Business Standards Manager (BSM). All documents contain reference to Document ID, Version and Issue Number. All documents have in the footer Uncontrolled when Printed.

1. Quality Manual

The Department Manager is responsible for the approval of the Quality Manual. This is indicated by an approval date being entered into the approval section at the back of the document and a digital signature on the document, although it will not be visible in the content of the document. This digital signature is used to protect the authenticity and integrity of the document and will lock the document to prevent any further editing.

2. Operating Procedures and Processes

The Department Manager is responsible for the approval of the Operating Procedures in conjunction with the Business Standards Manager (BSM). Again, this is indicated by an approval date and digital signature as per the Quality Manual.

Processes are written where the absence of such would affect the quality of the service and to ensure effective control and operation of the process involved. A process owner from each area has been allocated who is responsible for ensuring the process is up to date and approval is shown by an approval date being entered onto the document.

3. Documents

All staff has the opportunity to write documentation that will be of relevance to the QMS. Approval of this document will be given by their line manager. Approval is indicated by an approval date from both the author and their line manager.

4. Forms

Each Form has been allocated an Owner. Approval of the form has been given verbally to the BSM.

UNCONTROLLED WHEN PRINTED

Page 2: Doc Control sample ISO 9000

Document: QMS_OP1 Procedure for Document ControlVersion: DraftIssue: 1 Page 2 “Company Name”

5. Work Instructions

The Technical Manager for Branch and (insert in here name/ title for desktops) are responsible for the approval of Work Instructions. This is indicated by the approved work instructions being emailed to the BSM and once verified uploaded to Sharepoint.

A Branch and Desktop Work Instruction Master Register is maintained by the BSM. It contains the identification of all current work instructions uploaded to Sharepoint.

Regional and Team Managers are responsible for assigning staff to tasks that affect the quality of the service. Staff must be trained, competent, and aware of the importance of meeting customer requirements. Competency of staff is documented in their training records as per Competence, Awareness and Training Procedure (insert hyperlink in here once written).

The BSM reviews all documents and going forward in this procedure, documents in this context means the Quality Manual, Operating Procedures, Processes, Forms, Work Instructions and shows her approval by saving the document onto the master share, uploading the document onto Sharepoint and entering all details into the QMS Document Master Register. Enter in here link to the preparation and issue of QMS Document Process)

Executive Management is responsible for the overall structure of the QMS.

Structure and Location

Each controlled quality document is issued a unique number for identification purposes. Allocation of a number by the BSM indicates that the document has undergone an approval process.

1. Master Share and Numbering

All quality documents that are not confidential in nature are located on \\pratechvf\wg_esolutions_qms\ISO 9001 QMS\QMS. This share is restricted only to the Business Standards Team.

Documents that are at the top level of the QMS are prefixed with QMS. For example: QMS_Quality Manual. Within the QMS are folders which reference but are not limited to: Operating Procedures, Processes, Forms, Records, Documents, Templates and Work Instructions.

UNCONTROLLED WHEN PRINTED

Page 3: Doc Control sample ISO 9000

Document: QMS_OP1 Procedure for Document ControlVersion: DraftIssue: 1 Page 3 “Company Name”

Depending on the nature of the document, it will be placed into the relevant folder. If the document is generic to both Branch and Desktops it will sit in the root of the folder. If the document is specific to either Branch or Desktops then it will go into the Branch folder for example.

Therefore a Process that is specific to Branch will be referenced as QMS_P_B and the next sequential numeric number.

Documents that are not confidential in nature have been uploaded to Sharepoint which has restricted read only permissions. This is the location that staff will be directed towards for QMS documentation and not the master share.

2. Confidential and HR Related Documents

These documents are kept in the following areas for Branch and Desktop teams:

Branch: \\pratechvf\wg_esol_branch_hr\

Desktop: \\pratechvf\wg_esolmgt\

All of these documents are filed in an orderly, well indexed and logical fashion that facilitates easy retrieval in a normal office working environment. All quality documents are legible and identifiable

Are there any other documents that hasn’t been captured but are stored elsewhere – if there is then I need to know what they are and where they are located.

UNCONTROLLED WHEN PRINTED

Page 4: Doc Control sample ISO 9000

Document: QMS_OP1 Procedure for Document ControlVersion: DraftIssue: 1 Page 4 “Company Name”

3. Sharepoint Structure

The structure detailed below indicates the location of QMS related documentation that is relevant to staff.

UNCONTROLLED WHEN PRINTED

Page 5: Doc Control sample ISO 9000

Document: QMS_OP1 Procedure for Document ControlVersion: DraftIssue: 1 Page 5

“Company Name”

Backups

1. \\Pratechvf\wg_esolutions_qms\

2. Sharepoint – DC2PRXBLDP

Backups are currently performed manually on a daily basis at 4pm. The location of the backup is \\Pratechvf\wg_esol_sp.

3. \\Pratechvf\applications

4. \\Pratechvf\wg_esolmgt

5. \\pratechvf\wg_esol_branch_hr

Revision

Any documents requiring revision must go through the QMS Change Request Process (insert in here the change request process). All staff has the responsibility to recommend the development of new documentation, improvements, and / or revisions to existing documentation that are utilised in their respective areas of work.

A Change Request Form needs to be completed to change any document held in the QMS. Records of revisions are maintained in the Change Request Log and the QMS Document Master Register.

Typographical corrections, changes to “Company Name” organisational chart and minor editorial changes are not considered as “Changes” for the purpose of this procedure. However, all amendments are documented within the version history on Sharepoint irrespective of the completion of a Change Request Form.

Documents are re-issued after a significant change. Minor changes may be made to a document which will alter the version number. The changes are recorded on the QMS Change Request Form and this Form is referenced in the version history when the document is uploaded to Sharepoint. The uploading of a document to Sharepoint signifies that the document has been approved by the BSM.

UNCONTROLLED WHEN PRINTED

Page 6: Doc Control sample ISO 9000

Document: QMS_OP1 Procedure for Document ControlVersion: DraftIssue: 1 Page 6

“Company Name”

Where changes are being made to a document, those persons making the change shall have access to any pertinent background information required on which to base their review and approval.

Once a document is approved and the version incremented, the previous version of the document will be removed from Sharepoint and archived in the Master Share. Only one archived version of the document will be retained. If a document is considered to be obsolete it will be removed from point of use and moved into the obsolete folder in the Master Share. If a document is to be kept for reference it is marked as obsolete or otherwise destroyed. All obsolete documents will be retained for a minimum retention period of 3 years.

A QMS Document Master Register is maintained by the BSM. It contains the identification of all current issues of quality related documentation. This does not relieve other employees from the responsibility of ensuring that the BSM records the correct data on the Master Register as revisions are made.

Quality related documents uploaded to Sharepoint or filed on the documented network shares are recognised as the most up-to-date versions.

Regional and Desktop Team Managers are responsible for ensuring that relevant versions of applicable documents are available at points of use where operations essential to the effective functioning of the QMS are performed. Branch Managers will use an Engineering Manual Distribution Form to receive verification from staff that they are now using the most up to date version of the document and the previous version has now been destroyed.

Desktop Team Managers – Server and hard disk process needs to be put in here.

External Documents

The QMS includes, where necessary, externally generated documentation such as Technical Services Builds or HR generated procedures. Such documentation is uploaded to Sharepoint as external documentation and the link to these documents have been provided by the external department and it is their responsibility should these links fail. A copy of each document resides on \\pratechvf\wg_esolutions_qms\ISO 9001 QMS\QMS.

Are we having an HR manual for staff?

The results of the Management Review are used to make changes, which continue to improve the quality of the services provided.

Documented procedures and documents may be in any form or type of medium.

UNCONTROLLED WHEN PRINTED

Page 7: Doc Control sample ISO 9000

Document: QMS_OP1 Procedure for Document ControlVersion: DraftIssue: 1 Page 7

“Company Name”

Quality records generated by this process are controlled according to QMS_OP2, Procedure for Record Control.

Further Reference

Branch Work Instruction Master Register

Desktop Work Instruction Master Register

Procedure Competence, Awareness and Training

QMS Change Request Process

QMS Change Request Form

QMS Change Request Log

QMS Document Master Register

Engineering Manual Distribution Form

Procedure for Record Control - QMS_OP2

Revision History

Date: Version: Description of Revision CR No.

1 Initial Document Release

Approvals

This document requires the following approvals:

Name Title Date:

UNCONTROLLED WHEN PRINTED

Page 8: Doc Control sample ISO 9000

Document: QMS_OP1 Procedure for Document ControlVersion: DraftIssue: 1 Page 8

“Company Name”

Rob Lennox Department Manager

Susan Crawshaw Business Standards Manager

Approval is shown by a digital signature on this procedure although it will not be visible in the content of the document. This digital signature will lock the document to prevent any further editing.

UNCONTROLLED WHEN PRINTED