What is an ISO 9001 Document Control Procedure?
An ISO 9001 document control procedure outlines the process and methods for the administration, development and maintenance of documents. This is an ISO 9001 requirement of compliance with quality management systems. The objective of a document control procedure is to ensure that all relevant ‘documented information’ and its associated organizational knowledge is reviewed and approved by authorized personnel before issue. Some typical documents that are controlled by a document control procedure can include, but are not limited to:
- ISO quality management system (QMS), quality manuals, procedures, work instructions and related forms.
- Formalized ‘documented information’.
- Operational procedures, reports and forms.
- Management review documents and meeting minutes.
- Specifications, designs and drawings, etc.
- Formal electronic communications.
What is Document Control and Record Management?
Document control refers to a defined management process to ensure that:
- A released document is the latest version of the document.
- A released document has the relevant approvals and revision status.
Generally, controlled documents can be temporarily amended by authorized personnel. The amendments should be initialed or otherwise identified and dated by an authorized person.
Record management specifies the requirements for the identification, storage, security, recovery and retention time of records. The process can apply to all records that are defined within a company’s document register, or other record management system. It is important that a company creates, captures and maintains full and accurate records of its activities, including outsourced, contracted or internet-based activities. Good record management plays a critical role in:
An effective record management process will ensure that:
- All electronic critical quality documents will be maintained and backed up.
- All hardcopy records will be protected from damage by storage in suitable compartments.
- An established documented quality assurance system is enabled.
- Records subjected to regulated timeframes must be kept for the required period to enable an audit trail.
- All archived records stored offsite will be maintained in a secure, suitable location.
- Discarded records will be permanently destroyed/disposed of after retention periods have elapsed.
Note: Records should be situated for easy retrieval in case a backup is needed or a request for viewing by a nominated party.
Electronic Record Management
A company’s electronic records should be maintained within a record management system protocol and/or a recording database to prevent unauthorized access, destruction, alteration or removal and to provide easy access. A company’s network drives, storage media and related technologies and practices for maintaining electronic records must be designed, operated, regulated and maintained in such a way that records cannot be altered without approval or authorization.
Availability, Traceability and Storage of Documents
The records of any reputable company should be legible, identifiable and traceable to the activity, product or service involved.
Key management system documentation should contain:
- An issue date (and revision date where appropriate).
- A standardized documented version number.
- The type of QMS documentation.
- The name of the approver of the document.
No changes, amendments, inclusions or additions to current management system documentation, should be made valid unless authorized by management. Documents should always remain legible when document revisions occur.
Disposal of Documents and Records
Generally, there are two different methods of disposal for documents and records:
- Restricted access or confidential – i.e. records that contain information about individuals, the information given in confidence, or records related to investigations. At the point of disposal, these sensitive records should be shredded.
- Open access or normal records – these records can be destroyed using the usual methods of white paper recycling.
An organization’s management is responsible for ensuring that outdated or redundant documents are removed from all points of issue. Obsolete documentation requiring retention for legal, system evaluation or reference purposes should be identified and appropriately stored (archived) and managed. Records should always be stored in areas that guarantee, as far as is reasonably practicable, protection against any disaster such as fire or flood.
Contents of this ISO 9001 Document Control Procedure
- Document Approval.
- Purpose.
- Scope.
- Terms and Definitions.
- Roles and Responsibilities.
- Documented Procedures.
- Document Reviews and Approval.
- Manage Document Systems and Record Management Processes.
- Document Needed to be Controlled.
- Customer Satisfaction Systems and Processes.
- Record Management.
- Correspondence Protocol.
- Letter Templates.
- Emails.
- Email Use.
- Traceability, Storage and Availability.
- Organizing Files by Date.
- Electronic Records.
- Required Document Control Processes.
- Document Control Process.
- External Origin Documents.
- Storage and Retention.
- General Retention Period for Records.
- Disposal Authority.
- Information Technology.
- Authorized User.
- Electronic Data Backup.
- General Maintenance of Individual Computers.
- Shut Down of Workstations by Users.
- Electronic Virus Control.
- Related Procedures, Forms and Documents.
- Review Criteria.
- Record Management.
- References.
Why Choose to Buy this ISO 9001 Document Control Procedure?
This 14-page ISO 9001 document control system procedure can provide you with a range of methods for the administration, development and maintenance of documents, all in compliance with the ISO 9001 standard.
The procedure can also assist you to meet the international standard ISO 9001 certification requirements of ISO 9001 2015 Quality Management Systems.
After purchasing this template you will be able to:
- Very easily edit and customize the template to create your own robust document control procedure.
- Apply your own style, format and brand to the procedure.
- Use it in any industry or sector regardless of the size or type of organization.
Availability and Use of this ISO 9001 Document Control Procedure
- This document control procedure is accessible to you right now by clicking the ‘Buy Now’ button.
- The procedure will be delivered to you in fully editable Microsoft Word format for immediate and full use in your business.
- There are no subscriptions, contracts or ongoing costs.
