The Business EdgeISO 9001 Compliant

 

  • Maintaining Measuring Devices and Calibration Schedules/History – When your QA Manager logs into The Business Edge, they are immediately warned if any measuring devices are coming due for calibration. You can calibrate the device yourself (and record the in/out measurements) or use an outside vendor to do the calibration and you simply record that it was done.
  • Inspections / First Article Inspections – This is where you can save the most time. You can setup each product with its own specification (which are created, reviewed, and when revised, the revisions are maintained for ISO compliance). When a first article inspection is needed, you can simply pull the product, record the dimensions and analysis in The Business Edge and then print out the first article inspection. The best part is that since it is in the system, you can easily find the last time one was one on a product.
  • Problem Documents – You can easily record customer complaints, non-conformances, corrective actions and preventive actions. The system is used for both in-house corrective and preventive actions, vendor answers to their problems. You are able to link the documents to Vendors, Products, Purchase Orders, Processing POs, Customers, and Customer Orders. You also can group the problems into different categories and run a Pareto Analysis of the problems you are having. You can then focus on your largest problems. Another benefit is that your QA manager gets a list of all documents that need attention so that you don’t accidentally forget to close a document or review it after the solution has been implemented.
  • Scorecard Reports – We have new customer on-time shipment reports that give you a great summary of how well you are satisfying your customer needs. The Vendor Scorecard reports help you analyze your vendors on-time delivery performance along with what problems are on-going at the vendor.
  • Maintenance Schedules and Logs – The Business Edge helps you plan and record maintenance events of your machines. Your maintenance staff (and their supervisor) are informed on a daily basis of what machines are due for maintenance.

Requirements

  • ✓   4.2.3 – Control of documents
  • ✓   4.2.4 – Control of records
  • ✓   5.6 – Management Review
  • ✓   6.3 – Infrastructure
  • ✓   7.1 – Planning of Product Realization
  • ✓   7.2.1 – Determination of requirements related to the product
  • ✓   7.2.2 – Review of requirements related to the product
  • ✓   7.2.3 – Customer communication
  • ✓   7.4.1 – Purchasing Process
  • ✓   7.4.2 – Purchasing Information
  • ✓   7.4.3 – Verification of purchased product
  • ✓   7.5 – Product and service provision
  • ✓   7.6 – Control of monitoring and measuring devices
  • ✓   8.2.1 – Customer Satisfaction
  • ✓   8.2.3 – Monitoring and measurement of processes
  • ✓   8.2.4 – Monitoring and measurement of product
  • ✓   8.3 – Control of nonconforming product
  • ✓   8.4 – Analysis of data
  • ✓   8.5.1 – Continual Improvement
  • ✓   8.5.2 – Corrective Action
  • ✓   4.2.4 – Control of records
  • ✓   8.5.3 – Preventive Action