A clever tool for assigning record numbers is to incorporate a year or date into the control number. For example, 2022-097 could represent the 97th record for 2022. This built-in semi-intelligent system is simple and efficient, especially in companies that have been in business for several years. Having the year embedded in the number is […]
Author: Annette Schaps
Reinforcing Regulatory Requirement Training
Perhaps you have already trained everyone on a new standard or requirement. But how do you periodically reinforce the knowledge? One idea is to create a deck of requirement flashcards. Each card lists a regulatory requirement on one side and then a fun fact or information on the other. Put them in the lunchroom or […]
Documentation
One of the most essential aspects of conformance is documentation and it is essential to how the documentation is structured. What is the outline structure of your documentation? For most organizations, it is best described as a pyramid where the quality manual is the top tier (apex) with procedures and then working documents below. Records […]
ISO 13485: Selecting Suppliers and staying compliant
Nothing is simple in the beginning for a supplier and selecting a supplier is one of them. The organization must establish criteria for the evaluation and selection of suppliers. For a start-up company with an innovative product, this can be problematic as choices for suppliers may be limited. Parts may only be available from a […]
ISO 13485: Selecting Suppliers and staying compliant
Nothing is simple in the beginning for a supplier and selecting a supplier is one of them. The organization must establish criteria for the evaluation and selection of suppliers. For a start-up company with an innovative product, this can be problematic as choices for suppliers may be limited. Parts may only be available from a […]
What are Clinical Evaluations and how they may affect your business?
A Clinical Evaluation is an assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer. A Clinical Evaluation is required for all medical devices to be marketed in Europe. Alternative treatment options including no treatment should be […]
How many procedures are too many or too few?
When companies begin their quest for an ISO 9001 or ISO 13485 certification, they often wonder how many procedures do they need to satisfy certification requirements? It seems that there is a perception that if the number is too big, then the quality system will be too burdensome. If the number is too small, then […]
MDD (Medical Device Directive) and Medical Device Regulation (MDR) Transitional Provisions
If you have CE marked products in Europe, you may already be aware of the change from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR). Currently, the MDD is no longer but if you have products that are CE marked under the MDD, Article 120 of the MDR may allow you to […]
Quality System Process Changes
Continuing with the Quality Management discussion that I started in my last blog, let’s talk about how changes may occur within a predefined process. Perhaps your company has a software development process that it has been using for some time. Someone at your company thinks that the process is too burdensome and would like “streamline” […]
Quality System Processes
A Quality Management System (QMS) is a system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. ISO 9001:2015 defined approach to QMS is the most commonly used. However, not all processes defined by ISO 9001:2015 may be pertinent to your organization. So, the question is: What are the processes needed for […]