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ISO |
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Meet ISO Document Control Requirements Using Document Control Software
Two ISO Quality System Standards Have Been Released
The ISO 9001:2000 “Quality Management Systems-Requirements” standard is an update of the ISO 9000 series. ISO/TS 16949 is a new international standard.
Document Control Principles
Document control has been and continues to be a key element in the new ISO quality management system (QMS) standards. Without reliable control of procedures and records, a company’s QMS integrity will fail – as a practical business matter and as an auditable compliant system.>
What Documentation is Required?
The updated ISO 9001:2000 standard specifically requires a Quality Policy and Quality Objectives, a Quality Manual, and Documented Procedures. Documented procedures include specific documents identified in the ISO 9001:2000 standard and other documents needed to ensure effective Process Planning, Operation and Control (Element 4.2.1).
To determine what additional documents are needed, the new standard emphasizes a “process approach” and a “system approach” to documenting and managing the QMS.
Needed QMS documentation should be appropriate for the size and type of the organization, the complexity and interaction of processes and the competence of personnel.
Documentation and Record Requirement Examples:
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DOCUMENTATION |
RECORD |
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Planning (5.4) |
Contract Review (7.2.2) |
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Management Review (5.5.3) |
Design Change (7.3.7) |
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Training (6.2.2) |
Supplier Evaluation (7.3.8) |
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Customer related Processes (7.2) |
“Special Process” Validation (7.5.2) |
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Purchasing (7.4) |
Product Approval Criteria (8.2.4) |
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Validation of Processes (7.2) |
Calibration (7.6) |
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Customer Property (7.5.4) |
Design Verification (7.3.5) |
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Internal Audit (8.2.2) |
Design Output Review (7.3.6) |
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Continuous Improvement (8.5.2) |
Corrective Action (8.5.2) |
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Standards requirement |
Preventive Action (8.5.3) |
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Resource Management (6) |
Product Planning (7.1) |
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Plant Layout evaluations (6.3.1) |
Design Input (7.3.2) |
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Change Control (7.1.4) |
Supplier Evaluation (7.3.8) |
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Customer waivers (8.3.4) |
Customer Property (7.5.4) |
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Re-work instructions (8.3.2) |
Product Approval Release (8.2.4) |
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Enterprise Document Management Solutions
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Basic Electronic Systems
Most companies begin developing basic electronic document control systems using network locations and email systems. A hard-copy document control system will usually begin to become “electronic” by establishing directories or folders of documents usually by Department (Quality, Manufacturing, Engineering, etc.) or Document Type (Procedures, Work Instructions, Forms, Drawings, etc.). Network administrators will often control access and security to documents by defining network location “rights” such as “write” and “read-only” to specified employees. Companies may even begin “routing” documents as attachments in email to reviewers and approvers. However, electronic storage and sending documents through email does not necessarily mean documents are controlled and routed effectively.
A company will soon find that storing files in network directories and sending email with attachments as a “routing” to reviewers and approvers in basic electronic document control system has many limitations. Network storage still means that document control is a manually intensive funnel through which all changes must be initiated and tracked.
Even though files are sent electronically through an email system, the sequence of review/approval still has to be monitored manually. Also, electronic signoff can only be used by assuming that signoff through email is allowable and secure. The FDA has released a standard for electronic signatures (21 CFR Part 11).
System administrators must manually track, update, and communicate the review and approval feedback they receive (open loop system) even if documents are sent through email. Administrators must still manually remind the “bottlenecks” to signoff and notify change initiators of the approval status and notify those affected when the change becomes effective – the routing of documents continues to be a manually intensive process in a basic electronic system.
Traditional Document Control Processes
Document control and/or Engineering Change administrators typically receive change information in redlined hard-copy form. They become involved in creating a “change package” that contains the changed document/s, any required form/s, and the “routing” information.
“Routes” are the pre-defined steps and people that the “change package” will be sent or given to for review or approval. Significant time and resources are spent in preparing and routing the change documents for review and approval. Bottlenecks include the time spent copying and distributing change packages, manually tracking and reporting status, waiting for key personnel to sign-off, communication changes, and ensuring training is performed after approvals are received.
Other processes require routing of documents besides basic Document and Engineering Change processes. For example, Corrective Action Process requires constant review and updating to ensure all activities are being completed. The administration of these Corrective Action process is manually intensive.
Documentation related to Supply Chain Management is another process that requires routing. One example is the review and approval of requirements and changes made to product/processes. This process requires significant investment in time and resources.
Advanced Electronic Document Control
Most of the document control solutions available, whether add-on options or dedicated solutions, will have some form of electronic document routing and email notification capability.
Document control software can be used to store QMS documents like the Quality Manual, Procedures, Drawings, Work Instructions, Forms, Records, etc. QMS documentation can be securely stored and controlled in document control software.
- How documents are approved prior to issue.
- How documents are reviewed, updated, and re-approved.
- How changes and revision status are identified.
- How the correct version is made available.
- How documents are made legible and identifiable.
- How external documents are identified and controlled.
- How obsolete documents are identified and controlled.
Controlled Web Access
Users can be given controlled access to the document control system over the Internet with document searching and viewing capabilities. Remote users can participate in collaboration and approval processes. Traveling or off-site employees can stay involved and keep the document control and change management process moving effectively.
Benefits of Document Control Software Solutions
There are many benefits that can be achieved by implementing an electronic document control and change management system. Some of the benefits received are:
- Labor hours reduced
- Reduced supply costs
- Elimination of meetings to approve document changes
- Cycle time reduction
- Improvement in overall processes
Conclusion
Document control software can be used as a tool to help meet the requirements of ISO 9001:2000 and ISO/TS 16949:2002. An increasing number of companies are moving from hard copy and basic electronic systems to advanced document control software solutions.
One of the advantages of using document control software include increased security and rights-based access, improved searchability, reduced hardcopy storage requirements, and reduced change process cycle-time and automatic electronic distribution of current documents and removal of obsolete documents. Other advantages include remote access and platform independence.
What Next?
Contact us to discuss how we can help reduce your document related expenses.
Call: 1.888.427.5663
Email: sales@cstoneindy.com
Click here for specific information about how Cornerstone's Document Control Software can help your company meet the ISO 9001:2000 standards.
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