Get a professional, remote or local GMP auditor that's experienced in your industry, at a price you can afford.

“We have engaged Quality Auditing LLC for 3 consecutive years, auditing to ISO 13485. The two auditors they’ve sent have excellent credentials and are very knowledgeable of the standard applying it fairly and pragmatically. Registrar auditors have often commented positively as to the quality and content of the internal audit performed. We shall be engaging them again next year."

— M. Truman, QA Director

How it works:

“We are a manufacturer out here in Chatsworth, California. We make medical device components for our customers under the ISO 13485:2016 standards. QA’s Lead Auditor was very nice, professional and very thorough and was "on the ball". She spotted the "grey" areas that were previously missed. Kudos to Quality Auditing. I'm looking forward to working with them again next year.”

— John B., QA Manager

We make it easy for you.

We understand the importance of industry knowledge—it’s the heart of our business. Our deep experience working across different sectors, standards, and regulations enable us to understand your challenges in the compliance landscape but also provide strategic insights and current market intelligence to help you achieve excellence.

Ready to get started?

Simply click the button below, fill out the quick form and we’ll get in touch ASAP to get you a quote.

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We’ll handle your GMP audit remotely.
So you can run your business.

The Gold Standard of Auditing

Or Give us a call: (612) 208-7845

We work with companies big & small.
We can help you, too.

We know GMP standards.

We’ve honed our expertise working with organizations that range from globally recognized brands to small, family-owned companies in more than 25 countries. Start-ups and established multinationals choose Quality Auditing as their partner to achieve and maintain compliance with global standards & regulations. This positions us to provide unique insights that you can’t find anywhere else.

Safety & quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service & delivery. We help organizations in the industry demonstrate their quality management processes and ensure best practice in everything they do.

1. Get a quote

2. Schedule your audit

3. We audit for you

Auditor credentials provided

Industry references available

Get a quote in 30-mins

Competitively priced

Frequently Asked Questions

Or Give us a call: (612) 208-7845

Let's be honest: COVID-19 is challenging enough to deal with and you need solutions to keep audits on track with minimal distraction.

We’re the leader in remote GMP auditing. Our professional auditors have experience performing thousands of audits. We can conduct remote audits without exposing your personnel to unnecessary risk and reducing your workload of hosting audits.

Let us take auditing off your hands—so you can focus on what matters most.

How are your auditors trained?

Our Auditors all have experience in the industry and training to the specific standard/regulations in which they are auditing. Resumes and credentials are provided as part of the quotation package.

What is Remote Auditing?

A remote audit is an audit that is conducted partially or completely off-site. The audit will use technology solutions to audit everything that is typically covered during an on-site audit.  Remote audits are typically the same duration as an on-site audit and will require a similar level of support from the auditee throughout the audit.

Are Remote Audits acceptable to the industry? Are they common?

The IAF released a statement endorsing remote auditing for accreditation bodies and certification bodies. Nearly all CBs we have surveyed have implemented remote auditing techniques to help clients maintain certification.

The COVID-19 pandemic certainly has accelerated the use of remote audits but it is not a new tool. In fact, remote auditing guidance is included in ISO 19011 Guidelines for Auditing Management Systems and remote audits have been used as part of certification schemes for years.

Why switch to Remote Audits now? Can I just delay my regular on-site audit?

The health and safety of our auditors, clients, and communities are of the utmost importance. Site visits are often not possible or appropriate in the current environment. The decision to conduct audits remotely is the best and often the only realistic option for most clients.

Furthermore, businesses are the most challenged and therefore at the greatest risk in times of crisis.  Audits provided the oversight that is needed now. Certification bodies are not putting client assessments on pause but instead switching to remote audits.  We’re strongly encouraging our clients to follow this lead and maintain their management system commitment to conduct audits. Remote auditing is the new normal and even the best experts aren’t sure how long we’ll be operating in this new environment of social distancing, reduced travel, and stay at home orders.

How are remote audits different?

They will require additional planning to discussing information-sharing methods, familiarize everyone with the technology tools that will be used, and review the audit logistics in general. We recognize this is a learning experience for most clients and we’ve developed tools that will help guide you through the process. Contact us today to learn more.

How much is it going to cost?

Our flat-rate pricing ensures budgeting is easy and you can be assured there will never be additional or unexpected fees. It’s always fair & transparent. 

When can you perform the work?

Typically 6 weeks or less. Audits of a longer nature may require some additional time to schedule.

What does the report look like?

We have fantastic reporting. Let us know if you'd like to see one and we'll show you. We are also happy to customize our report format to meet your needs or work with something you already have.

How soon can we start?

Right away. Click here or Give us a call: (612) 208-7845