Internal Auditing:
Internal Audits are almost a universal regulatory requirement across the healthcare industry. Some of the top reasons our clients say they contracted us to conduct some of all of their internal audit includes:
- Internal Resource Constraints: Whether you’ve lost key employees in your Quality Department or your internal staff is working on other priorities, we make it easy to ensure you meet your annual internal audit obligations.
- Lack of Expertise: Auditing is a very specialized skill and research has found that many small organizations find it more cost effective to outsource their internal audit than expend the time and money to train auditors internally.
- Insight into Industry Trends: We perform hundreds of audits per year and our auditors are able to advise clients on changes in the regulatory environment and best practices that are otherwise challenging to keep up with.
- Conflicts of Interest: Many small organizations are unable to conduct internal audits without breaching the requirement that auditors are impartial/independent of the areas that are being audited. In larger organizations, we are sometimes brought in to eliminate potential political challenges that can be distracting in an audit.
Regardless of the reason, Quality Auditing LLC is well equipped to assist you with an internal audit of your QMS. The scope of the audit will be tailored specifically to your needs and requirements.
Supplier Auditing:
Auditing of suppliers to Medical Device, Pharmaceutical, and Biotechnology companies can be a daunting task. Quality Auditing LLC can conduct on-site supplier audits on your behalf to ensure that the activities you have contracted them for are being executed according to your requirements and applicable regulations. Due to the size of our company and network we do not charge travels costs!
Our Supplier Auditing Program helps to provide systematic and constant monitoring of your suppliers to mitigate potential supply chain risk and drive continual improvement activities. The scope of our supplier auditing services ranges from a single audit to the complete management of an entire supplier auditing program, from scheduling the audits, to closure of audit nonconformances. The proximity of our auditors to your suppliers anywhere in the world ensures that these audits can be with executed quickly, with local experts who literally speak the language of your suppliers and know the culture.
Training & Compliance Consulting:
We provide QMS Implementation, Training, and Consulting to organizations interested in improving performance, minimizing risk, and avoiding the costly consequences of poor quality. We focus primarily on Quality Systems training & consulting but also offer customized training solutions for a wide variety of conformance and improvement methodologies such as Six Sigma, Lean, performance excellence, medical device quality and regulatory requirements, pharmaceutical quality and regulatory requirements, to relevant standards such as ISO 13485, GMP, FDA QSRs, and the MDSAP Audit Model.
Standards:
While we have auditors & consultants with experience in a wide variety of industries, the most common standards/regulations we work in daily are below:
Customer Satisfaction
