Brigid Glass is a Quality Management Systems consultant who resides in New Zealand. She is a lively and passionate trainer who specializes in coaching smaller medical device companies to build Quality Management Systems (QMS) for compliance with ISO 13485, ISO 14971, the 21 CFR 820 (FDA QSR), and other international regulatory requirements.
Her approach gives them a sense of ownership in their documentation, a QMS that supports their business objectives and the skills required to maintain effectiveness. She has 18 years of medical device experience. This experience includes senior positions in Quality and Regulatory Affairs. To learn more about her, please connect with Brigid on LinkedIn: http://www.linkedin.com/in/brigidglass or visit her website – brigidglassassociates.net
Brigid Glass-QMS Consultant
The following excerpt below is from Brigid’s blog, “Implementing ISO 13485: Dealing with Delays.”
“ISO 13485 Implementation: If Your Project Falls Behind Schedule
If you find yourself lagging seriously behind in your project, the following steps will assist you in recovering sufficiently to still be able to attain certification.
- Enlist management support when you need it, especially if you need them to free up resources.
- Prioritize. Before the Stage 1 audit, ensure that those procedures which are required by ISO 13485 are released (there are 19). There’s always room for improvement, but leave some of it for the second revision, instead of delaying certification.
- Ensure that you have at least a few examples of all the required records. Your auditor will be unable to tick off his checklist if a record is absent. Make it easy for the auditor.
- If there is a sizeable gap that you won’t be able to close before certification (i.e., – you have a validation procedure, but validations have not been completed), write a CAPA outlining your action plan to address the gap. During the audit, act confidently when you are questioned about the gap. Many auditors will give you credit for identifying the problem yourself.
- Don’t panic. The worst the auditor can do is to identify a nonconformity you will have to address with a CAPA plan before you can be recommended for certification. At most, this will result in a delay of a few weeks.
- Throughout your certification preparations, and during the certification audits, you will identify issues you may not have time to resolve before the certification process is complete. If you are planning to revise procedures, and make other corrections, make sure you track these issues as CAPAs, or with some other tool (e.g., – an action item list). You want to address each issue prior to the first surveillance audit (no more than 12 months from the date of the Stage 2 audit).”