QMS Certification Programs

There are a growing number of QMS (Quality Management System) Certifications available, but which one is best for your business? Ultimately, it's all about what your customer wants.

The following is a list of QMS Certification programs that I am aware of. However, as more companies become dissatisfied with ISO, we should expect to see this number grow.

ISO 9001 (Quality Management System Standard)
By far the most popular general (generic) quality standard is ISO 9001. In the words of Nigel H. Croft (ISO/TC 176/SC 2 Chair), ISO 9001 is an “entry point” quality management system standard. ¹⁾ And, according to Maria Lazarte (Team Leader - Media and Engagement at ISO), “ISO 9001:2015 is even less prescriptive than its predecessor.”²⁾

Consequently, ISO 9001 is NOT intended to be a standard for excellence, or even a mid-level standard, but rather a very basic, minimalist, quality management system standard that appeals to the largest possible base (i.e., the lowest common denominator).

While ISO (International Organization for Standardization) does not operate any sort of certification program, there are literally hundreds of ISO 9001 registrars throughout the world. And because there is no common database for all ISO 9001 certifications, it is impossible to determine the exact number issued. However, as of 2017, ISO estimates that there are approximately 1 million certifications worldwide. It is important to note, of that number, approximately 1/3 (350,000) of these certifications were issued to companies located in China. After reaching a high point of approximately 40,000 certifications issued in the USA, this number has now fallen to approximately 25,000.

While there are several reasons for the decline of ISO 9001 registered companies in the USA, a major consideration is the minimalist nature of ISO 9001, coupled with superior competing industry standards.

SAE AS9100 — “Quality Management Systems - Requirements for Aviation, Space, and Defense Organizations”
After a great deal of debate, the committee for AS 9100 decided to continue to use ISO 9001:2015 as the foundation document for AS 9100:2016 (Rev. D), with further requirements added to make the standard more robust.

While many in the aerospace industry recognized the problems inherent in ISO 9001:2015, opposition to the continued marriage between ISO 9001:2015 & AS9100:2016 was futile, because the IAQG AS9100:2016 IDR (Industry Document Representative) Team Leader, Alan Daniels (Manager of Quality Management System Strategies and Industry Standards at Boeing Co.), had also been appointed Chair of the US TAG 176 Strategic Planning Committee (SPC) during the development of ISO 9001:2015. Under the direction of the chair and vice-chair of the U.S. TAG to ISO/TC 176, the SPC charts the future direction of the TAG and deals with strategic TAG issues. This standing committee consists of the TAG Chair, TAG Vice-Chairs, TAG Secretary, the ASQ Administrator, two to four TAG participating members, and at the discretion of the TAG Chair, liaison members from related organizations (such as the U.S. TAG to ISO/TC 207). Mr. Daniels is now Chair ISO TC176 SC1 - Chair IAQG 9100 Team.

The AS9100 certification process is managed by the IAQG (International Aerospace Quality Group).

According to IAQG, AS9100 “standardizes quality management system requirements to the greatest extent possible and can be used at all levels of the supply chain by organizations around the world. Its use should result in improved quality, schedule and cost performance by the reduction or elimination of organization-unique requirements and wider application of good practice. While primarily developed for the aviation, space and defense industry, this standard can also be used in other industry sectors where a quality management system with additional requirements over an ISO 9001 system is needed.”

Not everyone agrees with the above statement… or that AS 9100:2016 has delivered on any of the performance results IAQG expected. And it certainly has not reduced or eliminated organization-unique requirements or promoted wider application of good practices. In fact, several major aerospace companies have independently decided to issue comprehensive “Supplier Quality Requirements” to supplement (i.e., strengthen) AS9100:2016. This means that the level of QMS sophistication of AS 9100 certified companies varies significantly depending upon which customers they serve.

ASA-100 — Distributor Accreditation Program
The ASA Accreditation Program (ASAAP) is a 36 month audit program based on the ASA-100 Standard. The standard was created to comply with the FAA Advisory Circular (AC) 00-56, the Voluntary Industry Distributor Accreditation Program. ASA-100 emphasizes issues such as impartiality, competence, and reliability - all specific to the regulated needs of the aerospace industry.

While ASA-100 competes with AS 9120, many distributors serve multiple industries - and therefore choose the broader AS 9120 in order to capture the ISO 9001:2015 certification which accompanies AS 9120.

While ASA-100 is more specific for distributors, it contains many antiquated and traditional non-value added requirements. For example, it requires a documented “Quality Manual”, it fails to adequately address a metrological confirmation (aka calibration) system - and requires calibrations to be “traceable” to an international or national measurement standard for all measuring and test equipment (when applicable)“. Apparently, the authors of both ASA-100 & AS 9120 have still not heard the news about SI units.

SAE AS 9120 — Quality Management Systems - Aerospace Requirements for Stockist Distributors
If you're a distributor serving both aerospace and non-aerospace industries, AS 9120 may be a good choice for you. While AS 9120 will force your business to also comply with ISO 9001:2015, at least AS 9120 addresses “risk”. While the language in AS 9120 & ASA-100 is ambiguous on the topic, both allow you to determine whether nonconformities are “common cause” (with no assignable root cause) vs. “special cause” (with an assignable root cause) variations.

Published by the Transportation Technology Center, Inc. (a wholly-owned subsidiary of the ” Association of American Railroads“), the dominant Quality Management System Standard for the railway industry is ” AAR Manual of Standards and Recommended Practices - Section J - Specification for Quality Assurance, M-1003“. This standard is typically referred to as simply “AAR M-1003”.

While ”Section J - Specification for Quality Assurance, M-1003“ contains general requirements, it will reference and incorporate other sections of ”AAR Manual of Standards and Recommended Practices“ based upon the specific type(s) of product being produced. This makes “AAR M-1003” a fairly robust QMS Standard, despite being antiquated in some areas.

The certification process is managed by the AAR QA Program Coordinator.

Unlike ISO 9001, there is an online database listing ALL of the AAR M1003 companies at: https://aar.com/standards/M-1003_registry.html

When it comes to food and agricultural products, quality and safety are much more closely linked than many manufactured items.

FSSC 22000 (Food Safety System Certification)
https://www.fssc22000.com
With over 20,500 certificates issued worldwide (in 154 countries), certification to the FSSC 22000 standard is designed for companies that process or manufacture animal products, perishable plant products, products with a long shelf-life, and food ingredients (e.g., additives, vitamins, bio-cultures, etc). Like many of the ISO standards, the ISO/TS 22000 series is inadequate for meaningful certification. However, FSSC 22000 uses ISO/TS 22000 standards as the “foundation” upon which further requirements were added to create a “robust” standard.

Brand Reputation through Compliance Global Standards (BRCGS Certification)
https://www.brcgs.com
BRCGS is a leading brand and consumer protection organization, used by over 28,000 certificated suppliers in more than 130 countries, with certification issued through a global network of accredited certification bodies. BRCGS' Standards guarantee the standardization of quality, safety, and operational criteria and ensure that manufacturers fulfil their legal obligations and provide protection for the end consumer. Certification to BRCGS' Standards is now often a fundamental requirement of leading retailers, manufacturers and foodservice organizations.

GAFTA (Grain and Feed Trade Association) Certification
GAFTA offers certification in 3 main areas:

1. Grain and Feed Superintending (ISO 9001 registration is NOT accepted or recognized as equivalent. However, ISO 17020 Accreditation IS recognized as equivalent)
2. Fumigation of Vessels and storage facilities (ISO 9001 registration is NOT accepted or recognized as equivalent)
3. Laboratory Analysis (ISO 17025 Accredited Laboratories ARE recognized as equivalent)

API Spec Q1 Certification
API Spec Q1 is a quality management system specification, published by the American Petroleum Institute (API), specifically written for organizations that manufacture products for the petroleum and natural gas industry, also known as the oil and gas industry. If your organization manufactures parts for the oil and gas industry, implementing and obtaining certification of compliance with API Spec Q1 (from API Quality Registration) is probably what your customers would prefer. The ninth edition of API Spec Q1, was published in June-2013 and represented a major change for the industry. The revision to the standard came after the Deepwater Horizon disaster, which occurred on April 20, 2010. The specification was introduced to help the industry improve risk assessment and management of their processes employed to produce its products.

API Spec Q2 Certification
API Spec Q2 is a quality management system specification, published by the American Petroleum Institute (API), specifically written for organizations that supply services for the petroleum and natural gas industry, also known as the oil and gas industry. If your organization supplies services for the oil and gas industry, implementing and obtaining certification of compliance with API Spec Q2 (from API Quality Registration) is probably what your customers would prefer.

IDEA-QMS-9090
The ” IDEA-QMS-9090: Quality Management System Standard for Independent Distributors of Electronics Association Members“ was developed to establish specific requirements and practices Independent Distributors of electronic components can use to help ensure that they satisfy their customers’ requirements. These requirements and practices serve to address many of the unique aspects of the Independent Distribution of Electronics Industry which are not addressed in other QMS standards.

In order to assess the Independent Distributor’s ability to meet customer requirements applicable to the service that the Independent Distributor provides, certification to this Standard is mandatory for all Independent Distributors that are Members of IDEA. Conversely, only Independent Distributors who are Members of IDEA or have been conditionally approved for Membership by meeting all requirements within the application policies and process may qualify and become certified to IDEA-QMS-9090.

IDEA-QMS-9090 is supported with IDEA-STD-1010: "Acceptability of Electronic Components Distributed in the Open Market" is the first and leading quality standard for the visual inspection of electronic components and was designed as a technical resource to serve the electronic component industry regarding the detection of substandard and counterfeit components.

AS6081
SAE AS6081 - ”Fraudulent/Counterfeit Electronic Parts: Avoidance, Detection, Mitigation, and Disposition - Distributors“, is intended for distributors to help avoid Counterfeit Electronic Parts.

A growing number of fraudulent/counterfeit electronic parts are entering the supply chain, especially when purchasing parts not from the Original Component Manufacturers (OCMs), or their authorized agents.

The AS6081 standard was created in response to a significant and increasing volume of fraudulent/counterfeit electronic parts entering the aerospace supply chain, posing significant performance, reliability, and safety risks. The AS6081 standard establishes requirements and practices for distributors to mitigate the risk of buying, receiving, and selling fraudulent/counterfeit parts, thus enhancing confidence in the electronics supply chain.

When comparing SAE AS6081 and IDEA-QMS-9090; SAE AS6081 has a narrow scope focused on detecting and avoiding fraudulent/counterfeit electronic parts. In contrast, the scope of IDEA-QMS-9090 is much more comprehensive and robust. And it also addresses fraudulent/counterfeit electronic parts.