Quality Management Systems

What Is Quality Management?

ISO 9001 is a standard related to quality management systems and is designed to help organizations ensure that they meet the needs of their customers while maintaining compliance to any statutory or regulatory requirements related to the product.

ISO 9001 was originally based on a Department of Defense MIL-Q-9858 standard from 1959. Several iterations to the standard were made and it eventually became the BS 5750 series of standards from British Standards Institute (BSI). BS 5750 was eventually proposed to the International Organization for Standardization (ISO) in 1979 and first published in 1987. ISO 9001 has been revised several times, with the most recent being ISO 9001:2015, which was released in September 2015.

Certifications for ISO 9001 began in 1978 by BSI and 1,666,172 sites are certificated throughout the world as of according to the ISO Survey of Certifications.  While ISO 9001 is the most common QMS standard, we support nearly all of the commonly recognized quality standards across industries, including:  

ISO 9001
ISO 13485
AS9100
IATF 16949
21 CFR 210/211
ISO 17025
Food Safety
Nuclear

Auditors

Our auditors & consultants have achieved the highest levels of certification and recognition in the industry. For our clients, this translates to the best, most up-to-date knowledge of industry best practices and guidance on compliance requirements.
QA-Los-Angeles

Worldwide Auditor Network

Our specialized network of QMS experts allows us to provide our clients with local auditors. This is a distinguishing feature of our service. We know our clients prefer a local auditor/consultant because it allows mutually beneficial long term relationships and helps us reduce our lead time when scheduling audits. Perhaps most importantly, we know you’d rather spend your limited resources hiring the most qualified experts, not paying for travel expenses.

QA-Commitment

Proven Expertise

Our Auditors & Consultants have robust credentials from industry leading organizations including ASQ, Exemplar Global, IRCA, Certus, Probitas, & more. They also have a broad range of real-world experience, education, and backgrounds. We utilize a proprietary system for qualifying auditors and monitoring performance to ensure that you always receive the highest level of service. You tell us what you’re looking for and we’ll match you with an auditor who meets your specific needs. 

QA-Mission

Guaranteed Satisfaction

We’re so confident in our ability to meet your needs that we offer a 100% satisfaction guarantee. Simply put, if you aren’t happy with the service we provide, give us one chance to make it right. If we can’t get it right the next time – we will refund your money. Plain and simple.

Services

We provide world-class QMS auditing services to improve efficiencies, mitigate risks, and increase compliance with industry regulation.

Internal Auditing

Supplier Auditing

Training

Compliance Consulting

Internal Auditing

We provide companies with an objective assessment of their own Quality Management System relative the requirements of the standard and industry best practices. The scope all internal audits are tailored to specific our client’s needs and requirements. Organizations contract us to perform their internal audit program for many reasons, but the top 4 reasons are:

  • Better Resource Utilization: Everyone is trying to do more with less these days and we understand your have key personnel working on competing priorities. Internal Auditing is an area that is easy to outsource to free up internal resources and it is not particularly costly.
  • Identification of Best Practices: Our auditors have seen QMS implementations at hundreds of companies and the knowledge we’ve amassed in house is a powerful tool we provide to our clients to improve their systems.
  • Access to Expertise: It is expensive and time consuming to become a QMS expert and almost a full time job to keep abreast of industry trends. Many clients tell us their employees already wear too many hats and outsourcing internal audits is one way to let employees focus on other duties. For small organizations, this is an even bigger challenge – as they may entirely lack the expertise. Our auditors are ISO 9001 experts who can impart their knowledge on your organization and help drive continuous improvement efforts.
  • Guaranteed Impartiality: Section 9.2 of ISO 9001 requires that auditors are objective and impartial of the areas being audited which is can often be a challenge. Engaging our certified auditors to perform your internal audit removes any potential doubts about auditor impartiality.

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Supplier Auditing

We are supplier auditing experts. We conduct on-site supplier audits on your behalf to ensure that the activities you have contracted your suppliers to perform for are being executed according to your requirements and applicable regulations. 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

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Training and Compliance Consulting

We provide QMS training to organizations interested in improving performance, minimizing risk, and avoiding the costly consequences of poor quality. We focus primarily on Quality Systems training 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, nuclear regulatory fundamentals, ISO 9001, ISO 13485, MDSAP, AS9100, ISO 14001, IATF16949, ISO 17025, etc.

We provide clients with consulting to support the needs of your company. We are well suited to collaborate with you to ensure that we deliver marked improvements to your existing processes and exceed your expectations. We are available for work on projects of all sizes and look forward to the opportunity to develop a long term strategic partnership.

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Trusted By

AkzoNobel
Albemarle
Ametek
Borgwarner
BP
Danfoss
Eaton
Exide
GM
IDEX
Kawasaki
Kennametal
3M
Seimens
ParkerHannifin

An industry-leading audit process customized for you​

We have developed and refined a systematic, phased approach for outsourced auditing to ensure the best audit results and we look forward to working with you to tailor this process to your specific requirements.

We have found the key to successful partnerships is communication and flexibility throughout the process. The typical process we follow looks like this:

quality-auditing-process

Want to talk to us directly?
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Please call us at 612-208-7845

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Quality Auditing LLC is the Gold Standard of Auditing.

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Quality Auditing, LLC

Corporate HQ:
225 South 6th St. Suite 3900
Minneapolis, MN 55402

612-208-7845
support@qualityauditing.com

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