Achieving ISO 13485 certification is an important step for manufacturers of medical devices and service providers as it helps an organization design a quality management system that establishes and maintains the effectiveness of its processes. More importantly, it shows a strong commitment to continual improvement, to provide safe and effective products, and to fulfill customer…

Step 1: Gap Analysis Our custom gap analysis is a useful tool to clearly identify the differences between your current practices and the standard requirements. Our consultant evaluates any current quality system procedures, documentation, and the overall identification and implementation of key processes against the requirements of the standard and other best practices. The objective…

To be registered to the ISO 41001 standard, your company must be audited by an external certification body. Before that takes place, you want to do everything necessary to ensure you are prepared. To help with the certification process, simpleQuE’s consultants will work with you, using our collective experience and expertise along with our tools…

To be registered to the ISO 45001 standard, your company will be audited by an external certification body. Before that takes place, you want to do everything necessary to ensure you are prepared. SimpleQuE believes in a simple, customized approach that begins with a gap analysis, then defines an action plan to prepare you for…

To be registered to the IATF 16949® standard, your company must be audited by an external certification body. Before that takes place, you want to do everything necessary to ensure you are prepared. SimpleQuE believes in a simple, customized approach that begins with a gap analysis, then defines an action plan to prepare you for…

Conformance to MAQMSR helps a lower-tiered supplier transition to IATF 16949® by allowing many of the key automotive requirements to be met while developing the remainder of the QMS. The ultimate goal of the supplier development process is to achieve 3rd party registration to IATF 16949®.  It is important to note that the customer determines…

To be registered to the AS9100 standard, your company must be audited by an external certification body. Before that takes place, you want to do everything necessary to ensure you are prepared. SimpleQuE believes in a simple, customized approach that begins with a gap analysis, then defines an action plan to prepare you for certification,…

To be registered to the AS9110 standard, your company must be audited by an external certification body. Before that takes place, you want to do everything necessary to ensure you are prepared. SimpleQuE believes in a simple, customized approach that begins with a gap analysis, then defines an action plan to prepare you for certification, and…

To be registered to the AS9120 standard, your company must be audited by an external certification body. Before that takes place, you want to do everything necessary to ensure you are prepared. SimpleQuE believes in a simple, customized approach that begins with a gap analysis, then defines an action plan to prepare you for certification, and…

Small volume manufacturers often don’t have formal quality management systems and don’t meet all the requirements of AS9100, or even ISO 9001. The Department of Defense (DoD/DCMA), NASA Lockheed Martin, and Northrop Grumman are a few of the companies that allow compliance evidence to AS9003 in lieu of AS9100 or ISO 9001 in their contracts…