Document Control with an effective document management system is critical to standards compliance.
Becoming ISO or API certified is just the beginning of a journey. Maintaining the certification is the most challenging aspect of the certification process. Remaining certified entails not only following the processes and procedures that were set in place, but it also requires that you improve your processes and that you record the evidence of such by keeping up with your documentation, updating procedures when the processes change, revising work instructions when more efficient methods are discovered, filling out inspection forms, filling out training records when training was done, and much much more. In essence, ensuring the availability of up to date documentation and the timely availability of records will allow you to provide evidence that you are maintaining your document management system in check.
Documentation can vary from company to company, depending on the size of the company, complexity of the processes and standard or specification. Here are a few examples of documents required to be maintained. For sake of clarity, we have divided them by typical frequency of update, however updates may happen more or less often:
- Management Review Agendas, Reports, Meeting Minutes and Action Items
- Internal Audits Agendas, Reports, Nonconformities
- External Audits Agendas, Reports, Nonconformities
- Customer Satisfaction Survey results
- Risk Assessment
- Contingency Plans
- Emergency Plans
- Work Instructions
- Inspection Test Plans (ITPs), Test Methods
- Forms, Checklist
- Records Retention Matrix
- Company Terms and Definitions
Typically Updated as Often as Necessary
- Training Records
- Training Certificates
- Approved Supplier or Vendor List (ASL or AVL)
- List of Legal Requirements
- Job Descriptions
- Organizational Charts
Document Control Software Examples
- Organization sends redlined procedure to Mireaux
- Mireaux Document Control Specialist updates procedure and sends back for review.
- Organization sends feedback, ready for final review
- Mireaux Document Control Speciaist updates procedure.
- Mireaux Document Control Specialist submits procedure through Master Documents Application for final approval.
- Designated person gets email and approves procedure.
- Updated procedure available to all immediately. Subscribers to the procedure get notification of updates.
- Organization sends internal audit agenda to Mireaux.
- Mireaux Document Control Specialist creates adds agenda in the Internal Audit page.
- Organization conducts Internal Audit and sends report to Mireaux.
- Mireaux Document Control Specialist updates Internal Audit page with the report.
- Mireaux Document Control Specialist enters all nonconformities in the Continual Improvement Program (CIP) Application.
- Organization’s designated person gets email alerting him/her of the need to coordinated new CIPs.
- Organization assigns CIPs to most appropriate employees for root cause analysis and corrective action.
- The CIP application process a CIP from one stage to the other sending emails and routing it through personnel as appropriate.
- Organization sends reviewed and scanned calibration certificate to Mireaux.
- Mireaux Document Control Specialist uploads certificate in the Calibration Application.
- Calibration certificate available to all immediately.
- Calibration KPIs updated instantly.
- Calibration Application sends email reminders to organization’s designated Calibration Techs and Calibration Admins whenever the equipment is due for calibration again.
- Organization sends a new training requirement for a specific job title to Mireaux.
- Mireaux Document Control Specialist creates a new course in the E-Learning Application.
- Mireaux Document Control Specialist formulates questions, answer key, test parameters and passing grade.
- Mireaux Document Control submits to organization for review.
- Organizations review, and approves or request updates.
- Mireaux Document Control Specialist updates and uploads test, answer key, test paramaters and passing grade to E-Learning Application and assigns test to designated job title.
- Test available to designated job title immediately.
- Training records updated as soon as user passes the test.
Mireaux’s Consulting Solution
Organizations who use our Web QMS Electronic Management System can see significant reduction in documentation upkeep, communication efforts as well record retrieval. Our Document Control personnel can serve as your virtual Document Control Specialist, updating your documents and records and making the updates live on your Web QMS and available to you immediately. Are you ready to achieve a streamlined Document Management System? Contact us today.