PRO - Control of Documents
PRO - Control of Documents
System: LYRA (PVT) LIMITED Quality Management System
Table of Contents
- PRO - Control of Documents
- Purpose
- Scope
- Related Documents
- Terms and Definitions
- Responsibilities
- Procedure
- General Considerations
- Identification
- Contents
- Creation, Review, Approval and Control of Documents
- Control of the Records
- External Documents
- Distribution of Printed Documents
- Records
Purpose
This procedure sets out the requirement to ensure authority, accuracy and currency of all the Quality Management System documents.
Scope
This procedure applies to all documents created, distributed and retained for information and action in the QMS.
Related Documents
- ISO 9001:2008 Standard
- ISO 9000:2005 Standard
- Quality Management System (QMS) Manual
- Document Data Control List (Annex-A)
- Documents Distribution Log
- Quality Record List
Terms and Definitions
- Document: information and its supporting medium.
- External document: document of external origin determined by the organization to be necessary for QMS.
- QMS: Quality Management System.
- Record: document stating results achieved or providing evidence of activities performed.
- Revision: a number that indicates the level of updating the contents of a document
- PRO: Procedure, document that establish the requirements to fulfill.
- Specification: document stating requirements.
- System Manual: document that establishes and describes the management system.
- Template: supporting medium used for the introduction of specific type of information.
- Issue: number that indicates the level of updating the format of a document (Optional).
- WI: Work instructions, document that define how to do an activity.
Responsibilities
Management Representative Abdul Samad is required to:
- Verify that all documents comply with the requirements defined in this procedure before final approval.
- Control the distribution of documents within the organization.
All managers required to:
- Review the documents applicable to their departments and begin to update them when necessary.
- Approve the documents from their department and ensure that they remain current.
Procedure
General Considerations
- All the documents of the QMS are housed in CompanyCertification® Compliance Management Solution (CC-CMS) and alternatively a hardcopy is also maintained at MR Office. Which is accessible and available to all authorized employees.
- Whenever the format of a document is modified, it will assign a new revision date . If the content of a document is modified, it will also assign a new revision date. In both cases, only the current document could be accessed to operate. All document are modified online by initiating "Document Change Task" at CompanyCertification® Compliance Management Solution.
Identification
All QMS documents are controlled according to the following rule:
- Primary by Title Name of the document.
- Type: MAN (Manual), PRO (Procedure), WI (Work Instruction), REC (Record), TS (Technical Specification), JD (Job Description), FC (Flow Chart), ED (External Document).
- Title. Example: Control of Nonconforming Product Procedure
- Coding is optional and can be document type followed by sequential number. Example "PRO-01". Note to print Barcode avoid using "/" as a separator.
The manual, PROs and WI include:
- The company document title, code(optional), name of approver and date of issue
- Table of contents
- Page Number
Contents
The content is adjusted in each case to the requirements of reference standards and criteria of those responsible for its approval.
Creation, Review, Approval and Control of Documents
Each document must have defined who will approve it. The approver must be a different person than the author. It's recommended to have an optional reviewer role.
All Documents are Created at CompanyCertification® Compliance Management Solution (CC-CMS) by initiating Create Document Task inside the Document Center.
The following documents have already defined the document management roles, according to this matrix:
Document |
Author |
Reviewer (Optional) |
Approver |
MAN: Manual (System) |
Management Representative |
Director |
|
PRO: Procedure |
Department Head |
Department Responsible |
Department Manager / Responsible |
WI: Work Instruction |
Department Head |
Department Responsible |
Department Manager / Responsible |
REC: Record |
Department Head |
Department Responsible |
Department Manager / Responsible |
JD: Job Description |
Department Head |
Department Responsible |
Department Manager / Responsible |
FC: Flow Charts |
Department Head |
Department Responsible |
Department Manager / Responsible |
ED: External Document |
Department Head |
Department Responsible |
Department Manager / Responsible |
TS: Technical Specification |
Department Head |
Department Responsible |
Department Manager / Responsible |
SMF: System Master File |
Director |
Director |
Director |
The Department employee or responsible for Quality PROs and WIs is Abdul Samad.
The process of creation, review and approval of documents is carried out as detailed in the following flowchart at CompanyCertification® Compliance Management Solution (CC-CMS) Document Center:
Control of the Records
As indicated in this procedure, a record is a document stating results achieved or providing evidence of activities performed. When the need arises to create a new record form, or modify an existing one, each Department responsible will define each record policy:
- Title.
- Responsible: owner of the record
- Archive: Records can be in any kind of support, both paper and electronic media and should be saved in facilities that provide environmental conditions that prevent their damage or deterioration and prevent its loss.
- Order: Each sector defines the way in which these records are sorted, so that they can be easily found when requested.
- Retention: Time record is retained, taking into account the existence of standards or legal requirements, contractual and / or stakeholders in general.
- Disposition: indicates how to dispose of the record at the end of time conservation.
Every record must have defined who approves it, if necessary. Some records can be updated directly without an instance of approval.
Document |
Author |
Approver |
RECORD |
Management Representative / Department employee |
Director |
The new record form will be sent to the Management Representative , who will upload the form at CompanyCertification® Compliance Management Solution (CC-CMS) and update the Quality Record List. The Department responsible will communicate the record update.Record policies are included in the last paragraph of each procedure (Records).
External Documents
All records and documents of external origin are sealed with the date of entry. They are distributed according to the Distribution of Documents.
Distribution of Printed Documents
Whenever necessary to distribute printed controlled copies or external documents, the Management Representative will do it, according the Document Distribution Logs and will update at (CC-CMS) Printed Document Distribution field at the Document Center CompanyCertification® Compliance Management Solution (CC-CMS)
Records
Title |
Responsible |
Archive |
Order |
Retention |
Disposition |
Documents Distribution Record / Logs (DDC-Log) |
Management Representative |
[Archive] |
By date |
Permanent |
Not applicable |
Document Data Control List (Annex-A) |
Management Representative |
[Archive] |
By date |
Permanent |
Not applicable |
Quality Record List (Annex-C) |
Management Representative |
[Archive] |
By date |
Permanent |
Not applicable |