Maintaining Your ISO 13485 Quality Management System

Sometimes, companies are certified but struggle to maintain and improve their quality management system or just need to update the knowledge and skills of the quality team.  SimpleQuE can help with consulting resources and continuous improvement initiatives.  In addition, outsourcing internal audits provides a fresh perspective that not only gives opportunities for improvement but also…

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Prepare for ISO 13485 Certification

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…

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Incorporating AS13100 into your Quality Management System

AS13100 is intended to simplify supplier quality requirements by harmonizing about 60% of these four-engine manufacturer’s supplier requirements. There is an industry desire to have the first-tier suppliers in compliance by the end of 2022, and all of the aero engine makers have communicated the requirements and timeline to their suppliers. Note: AS13100 is not…

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SimpleQuE’s 4-Step Approach

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…

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Prepare For ISO 41001 Certification

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…

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Maintaining Your ISO 41001 Quality Management System

Now that your company has been certified, it’s imperative that you maintain your ISO 41001 Quality Management System through ongoing audits, continual process improvements, and training courses. SimpleQuE can provide the assistance you need to ensure that your certification continues to meet the established standards. Our Audit and Gap Analysis can identify any areas where…

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Maintaining Your ASA-100 Quality Management System

Sometimes companies are certified but struggle to maintain and improve their ASA-100 quality management system, or just need to update the knowledge and skills of the quality team.  SimpleQuE can help with customized training, resources and continuous improvement initiatives.  In addition, outsourcing internal audits provides a fresh perspective that not only gives opportunities for improvement,…

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Maintaining Your AS9003 Compliance

Now that your company has been certified, it’s imperative that you maintain your AS9003 Quality Management System through ongoing audits, continual process improvements, and training courses. simpleQuE can provide the assistance you need to ensure that your certification continues to meet the established standards. Our Audit and Gap Analysis can identify any areas where improvement…

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Maintaining Your AS9120 Quality Management System

Sometimes distributors are certified but struggle to maintain and improve their AS9120 quality management system, or just need to update the knowledge and skills of the quality team.  SimpleQuE can help with customized training, resources and continuous improvement initiatives.  In addition, outsourcing internal audits provides a fresh perspective that not only gives opportunities for improvement,…

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Maintaining Your AS9110 Quality Management System

Sometimes companies are certified but struggle to maintain and improve their AS9110 quality management system, or just need to update the knowledge and skills of the quality team.  SimpleQuE can help with customized training, resources and continuous improvement initiatives.  In addition, outsourcing internal audits provides a fresh perspective that not only gives opportunities for improvement…

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