Quality Auditing
Reviews and Complaints

We are a full-service manufacturing plant that engineers, designs, and manufactures automated, aseptic filling machines for the pharmaceutical and animal health industries. We came across Quality Auditing in 2018 while looking for someone to perform an internal audit before our registrar ISO 9001:2015 transition audit. We are so glad that we decided to use Quality Auditing - even though we had already completed our QMS document update to ISO 9001:2015 when we first started working with QA, the auditor really helped inform us on some of the things we had missed. Fast forward to this year, we continue to be very satisfied with the QA auditor's experience and expertise. He is always extremely helpful and we really appreciate his diligence when it comes to our internal audits as he does a great job of preparing us for our annual registrar audit. Our auditor is always very responsive to post-audit questions. We look forward to having Quality Auditing back next year.

We are a combination medical product company located near Seattle, Washington. Quality Auditing has supported our company with a variety of onsite and remote QMS audit solutions for over 10 years, whether it has been our annual medical device/MDSAP internal audits at our Seattle facility, or audits of suppliers located across the U.S. Our 2021 internal audit was going to be a little different in my new role as the Director of Quality! As expected, the MDSAP internal audit went well, I enjoyed working with QA's auditor -they were thorough, detailed, professional, and pleasant to work with. Once again, we received a detailed report that allowed us to address the noted compliance gaps. We followed it up by retaining QA to perform a GLP/21 CFR Part 58 gap assessment of our in-house research lab in preparation for plans to perform our own non-clinical tests. We appreciate the service Quality Auditing has provided to our company over the years and look forward to continuing to work with them!

We are a medical device manufacturer located in Pleasanton, CA manufacturing devices that are classified as Risk Class II in the US and Risk Class I in the EU, Australia, and Canada. We usually have our internal audits performed by an external auditor annually to make sure we are compliant in all areas of the QMS, and receive feedback and OFIs. We do not like an internal resource to perform an audit to avoid conflict of interest. I reached out to Quality Auditing looking for a 3-day audit to cover ISO 13485:2016, 21 CFR Part 820, Canadian regulations, and Australian regulations under the MDSAP scheme. We required an auditor with the relevant certifications and training (e.g. Exemplar Global card etc.), so QA shared the resume, ASQ Biomedical Auditor certificate, and MDSAP training as evidence for the qualified auditor assigned to our audit so we could approve as part of our ASL procedure. QA's auditor worked out great. He is very experienced and knowledgeable, and completed our internal audit successfully!

We are a metal forming solutions manufacturing facility certified to AS9100D and have been working with Quality Auditing LLC since 2015. Over the years, they have helped us in many ways with transitioning to new standards and completing our internal audits. Their coordinator has been instrumental in scheduling our internal audits and we have come to rely on her and her ability to find qualified auditors that can meet our sometimes difficult scheduling needs. She is proactive in contacting me to get the internal audits setup and is a pleasure to work with. The auditors have done a fantastic job performing our internal audits. They are helpful, insightful and thorough in their auditing technique and approach. After the audits, we are left with solid, valid findings and opportunities for improvement that once corrected/implemented will put us in a good position going into our AS9100D Surveillance and Recertification Audits. We really value Quality Auditing for everything they do to help us stay compliant to AS9100.

We are a medical device contract manufacturer located in Portland OR. This is our 2nd year working with Quality Auditing and my first as the newest QA Manager for our company. This year we expanded our audit duration to a 5-day ISO 9001, ISO 13485 & 21 CFR 820 full systems internal audit, from a 2-day partial systems audit in 2019. To overcome any safety concerns resulting from a COVID-19 summer surge, we determined it best to switch to a remote audit. The QA team was very hands-on during every step of the remote audit coordination - from setting up conference calls to discuss audit roll-out, setting up Dropbox file share to facilitate documents & records review, and even walking through a quick tutorial on what to expect when using Zoom during the actual remote audit. The audit went quite well and we were pleased with both the audit process and the level of the auditor's expertise. She was very detailed and provided valuable input to how we can keep our QMS efficient while still meeting the ISO and 21 CFR 820 requirements.

I am the Quality Supervisor responsible for the ISO 9001:2015 certified QMS at our Los Angeles facility of a global automotive components manufacturer. I started working with Quality Auditing team back in 2018 when I needed a qualified local auditor to perform between 8-10 non-consecutive audit days scheduled regularly throughout our fiscal year. Access to QA's local network ensured there were no travel costs, and QA went a step further by offering us a bulk-auditing discount pricing that eased pressure on my annual budget. Prior to kick-off of our first audit in 2018 I defined our business processes and asked QA to utilize their process-based audit expertise. The QA team also helped me become more comfortable with Process Auditing and provided feedback and recommendations for creating our own PEAR form which we rolled out to document the audits. Fiscal year [protected] will be the third consecutive year of QA assisting with our internal audit plan. I've also referred Quality Auditing to my Quality Supervisor colleague at a sister site in the LA area.

We are a medical technology company headquartered in the San Francisco Bay Area with a new facility located in Tijuana Mexico. I reached out to Quality Auditing looking for help with our ISO 13485:2016, 21 CFR Part 820, CMDR & EU MDD internal audit, and to get an objective view of our systems. QA assigned a great credentialed auditor who was local to NorCal that could complete a facility tour on-site and perform the remainder of the audit remotely over 5 audit days. The auditor was very thorough and we loved his openness to provide feedback beyond findings and use them as a learning opportunity. We also requested the QA team document the audit on our own report templates, and they delivered the final report just a week after the audit was completed! Their quick responses throughout the 2020 engagement and how quickly they finalized our report was appreciated! I've already scheduled our 2021 internal audit with QA again, and also introduced them to our Supplier Quality Manager to kick-off discussions on leveraging QA's network to fulfill our supplier auditing needs as well.

Our company has had almost a 10-year long relationship with the team at Quality Auditing. We are a global manufacturer of precision engineered metal components for the automotive, consumer electronic, and healthcare industries with our plant in Southern California. Since 2012, we have utilized QA's expertise annually to support our QMS & EMS needs with internal audits of our IATF16949 and ISO 14001 systems. In 2017, QA also assisted with our transition from TS to IATF16949 with their consultants updating QMS documents including the Quality Manual, almost 30+ procedures, and work instructions etc. While we are in the process of pursuing a strategic initiative to develop our own IATF-trained internal audit team this year, I would like to reiterate that I feel QA and their auditors & consultants have been an absolute asset to us over the years including most recently when QA's IATF auditor came through and performed our 2020 audit â€" I would absolutely want him back if we do decide we need more help and would wholeheartedly recommend him to others. We will continue to work with QA to fulfill our ISO 14001, and future QMS needs.

We are a Seattle-based biotechnology company that has utilized Quality Auditing's internal and supplier auditing services since 2011. So far this year we've use Quality Auditing to conduct a 5-day internal MDSAP audit at our Seattle office, along with a 210/211 supplier audit of a Pennsylvania-based supplier. During our MDSAP internal audit, we also requested QA to perform an assessment against the new EU MDR 2017/745 regulation. From my point of view as the VP Engineering & Ops, the audit went very well. QA's auditor was very competent with a thorough knowledge of all the relevant country regulations. He was collegial while focused on the serious task of performing a deep-dive into our QMS. He also conducted one of the most thorough closing meetings I've ever been a part of which will help us prepare for our upcoming registrar audit. Separately, QA performed a 1-day Part 210/211 audit of one of our suppliers located in Pennsylvania using one of their auditors local to the area, saving us a trip (and the associated costs) to the East Coast. We are presently in the planning stages for another GMP supplier audit. We plan to use QA services further this year and beyond.

The Quality Auditing team already performs internal audits across our sites located on the West Coast. With my recent promotion to cover all Quality Assurance & Regulatory Affairs aspects for our company, I took this as a great opportunity to utilize their QA's expertise to perform a SURPRISE Mock FDA Readiness Inspection at one of our manufacturing facilities in Dallas, TX. I was interested in observing our team's response to this scenario â€" how would they handle the “notification" of the surprise mock inspection, could they find documents related to open complaints, CAPA, any reportable events etc. and ultimately identify any opportunities for improvement to our current system. Over the course of a 3-day onsite, I observed QA's local FDA expert perform the inspection following the same path an actual FDA inspector would, including focus on specific products we manufacture, as requested. The inspection was definitely a very useful exercise and fulfilled our needs! The QA “Inspector" was very thorough and helpful â€" very insightful to our team. Definitely 10 out of 10! The findings and OFIs listed in the final report will only help us improve and prepare for eventuality of an actual inspection.

Having worked with Quality Auditing at a previous role and had a great experience, I reached out to the QA team again for help to complete a 21 CFR Part 820 internal audit at our Mountain View CA based Med Device company. We decided to utilize a remote audit due to the pandemic and throughout the planning process QA's Program Coordinator answered my questions timely and satisfactorily, and they helped get everything we needed prepared. Even though it was a remote audit, our auditor "dug deep" on the areas we requested, we found this to be very helpful. He was patient but thorough. We also informed QA that we had an urgency to receive the report quickly and the QA team managed to provide our report within a week! Following a successful internal audit, we retained QA to support an ISO 13485:2016 & Part 820 supplier audit of an Ohio based supplier on our behalf. I introduced the QA team to our supplier and they handled the rest! QA was very responsive throughout the process and made the necessary arrangements with appropriate follow ups. On top of that, the auditor completed everything according to plan and the report was comprehensive. Both of our audits with Quality Auditing this year were great!

Since March, our company has utilized Quality Auditing's global network of local auditors to complete ISO 13485, and ISO 9001 audits of our suppliers located both in the U.S. and internationally outside. As a Senior Manager of Quality for our San Francisco Bay Area-based medical device company, we were looking to supplement our internal resources to share the burden of auditing 20+ suppliers across our global supply chain. Fortunately, as we'd already had an existing internal auditing relationship with QA, I was able to quickly be introduced to the QA team. Subsequent planning discussions progressed very quickly as in many cases QA's auditor network was located close to supplier sites and would help us successfully achieve our 2021 supplier audit goals. The QA team provided our team with weekly updates on the various stages of each audit, and in some cases facilitated our attendance in select Opening & Closing meetings via conference call or videoconferencing to observe those audit activities. QA auditors were able to comply with our internal certification and training requirements. The expertise, responsiveness, and professionalism of QA auditors and service staff has been of great value to our organization.

I am the QA Manager and CEO of a Small Medical Device Company. We have been using the team over at Quality Auditing to assist us with our MDSAP global medical device audit compliance, and other needs such as software validation requirements for the last two years. We needed to complete or 2020 Internal Audits, and we had to execute this even through these challenging Covid-19 times. We decided for safety reasons to complete our 2-day mock MDSAP audit remotely as we are located in the San Francisco Bay Area. As a small medical device manufacturer, with 33 years of business, we maintain a fair number of documents as hard copies. The QA team worked with me to identify relevant QMS documents that would be requested and to have available, plus during audit we were able to scan electronically and share via Dropbox. The audit was a bit more labor-intensive, but, despite the challenges our QA auditor conducted a very in-depth audit - while drawing upon his prior knowledge of our systems and facility. The auditors facility with various digital sharing platforms as well as virtual meeting platforms made the audit fluid and comprehensive. If fact, this years audit I felt was richer than the last year. . I am very happy with the results!

In my role as the Quality Assurance Manager for a Southern California-based Aerospace Manufacturer primarily focused in the Commercial Space Transportation Industry, I worked extensively with Quality Auditing to upgrade and implement a more robust AS9100D compliant QMS. Over the course of the 6-month consulting engagement, QA performed a variety of "focused-audit" type assessments which involved a deep dive into all our dedicated Engineering groups, and Shared Services. The assessments provided us with a clearer understanding of the interaction of our various Core and Supporting Processes and helped identify important Quality KPIs. Utilizing these results, QA worked closely with our team to implement AS9100D best-practices and other improvements such as updating our Quality Manual, Supplier Quality Requirements Manual, procurement procedures, and even developing SMART Task templates, & a variety of QMS Awareness training resources for the benefit of our employees. Our QA support team consisted of a dedicated Project Manager and a team of Consultants who held scheduled calls with me throughout the engagement for regular progress updates on project tasks & activities until everything was completed. I will happily recommend Quality Auditing to any organization looking to implement or improve their AS9100 QMS.

I am the VP of Quality and Regulatory affairs for an Antimicrobial wound care products in the Los Angeles area. We began working with Quality auditing back in 2016 to support our ISO 13485:2003 internal audits, they then helped us through our transition from ISO 13485:2003 to ISO 13485:2016 and 21 CFR Part 820 in 2018 by performing a gap assessment and internal audit. In 2019 we expanded to the MDSAP model covering chapters 1-7 and regulations for US and Canada. This year due to COVID-19 we were able to navigate the disruptions and keep our scheduled audit on track by completing it remotely. The team at Quality Auditing was very helpful and worked with me to prepare for the 5-day audit. We conducted two test calls utilizing GoTo Meeting to better familiarize with the program, and our auditor even offered to use her premium account and set up meetings to take some of the preparations off my plate. QA set up a secure shared Dropbox folder to be used throughout the audit and with a document log we provided, our auditor was able to request the documents and records that would be needed for the audit so I could have them ready and scanned in ahead of time. The number of documents requested for the 5-day audit was a bit overwhelming, but the auditor and program coordinator took the time to help ease my concerns and walk me through the steps. I also took videos of our facility ahead of time and we used my tablet for a live facility tour to give the auditor a better look into our facility. In the end, the audit went very well. The auditor was great and she completed a very thorough review!

We are a medical device component manufacturer in Southern California certified and operating to ISO 13485:2016. We have enlisted the services of Quality Auditing, to perform our internal audit needs for 2020. We decided to go with them again, since they did such an excellent job for us last year. This was their second consecutive year they have provided auditing services for us. This year was completely different, though. Due to the Covid-19 virus “Lockdown-Stay-Home" orders, we had to hold our internal audit “offsite". This was the first “remote" internal audit that I was involved in. Scary… Unclear on how the audit was going to turn out, I was completely surprised on how Quality Auditing guided us through it. Simple and easy. As for the audit schedule, the auditor kept everything on track. The auditor was great and really knows her stuff. Prior to the audit taking place, I felt “totally in the dark", not knowing how a “remote" audit works I reached out to them for assurance and guidance. The QA team comprising of the Lead Auditor, and Program Coordinator took time out to ensure I was comfortable. They took the time to explain to me the various methods they use to conduct an “offsite" audit. One suggestion for face to face teleconferencing they suggested using "Zoom" video conference technology and they used todays software methods, to engage with the documentation aspects of the audit. They even set up a “pre-audit run through" so, I could understand how it works and not be so worried. All in all, the audit results were very good and I am looking forward to working with Quality Auditing again next year. Hey, with a team like that, it's sure to be another success.