Featured Product
This Week in Quality Digest Live
Health Care Features
Edmund Andrews
Dealing with health insurance administrators costs billions in wasted work time and productivity
Graham Freeman
No matter how small an organization is, it’s contributing to a resilient, responsible, and sustainable global community
Gleb Tsipursky
The problem is a lot more complex than you think
Rita Men
A survey shows people tend to trust their employers more than governments or the media
Sharona Hoffman
Here’s how to promote algorithmic fairness

More Features

Health Care News
Free education source for global medical device community
Extended validation of Thermo Scientific Salmonella Precis Method simplifies workflows and encompasses challenging food matrices
‘Completely new diagnostic platform’ could prove to be a valuable clinical tool for detecting exposure to multiple viruses
Provides improved thermal stability for stored materials, risk mitigation advantages, and processes that are documented and repeatable
Patient safety is a key focus in update of ISO 14155, the industry reference for good practice in clinical trials.
Despite being far from campus because of the pandemic, some students are engineering a creative way to stay connected
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Stereotactic robot helps identify target and deliver electrodes to target with submillimetric accuracy

More News

Ryan E. Day

Health Care

Should You Be Certified to ISO Standards?

That depends on your intentions and perception of value

Published: Monday, March 22, 2021 - 12:03

In an article published by Quality Digest, Julias DeSilva addresses recent declines in ISO certification and poses the question, “Does quality matter anymore?” His conclusion is that even if you don’t get certified, you will still gain from a well-implemented management system. But what do manufacturing companies think?

Many certifications are never seen by consumers. Compliance with standards like UL, ENERGY STAR, and USDA Organic are routinely displayed on consumer products, but ISO/IEC 17025, ISO 45001, and NSF/ANSI 173 standards... not so much. These might be considered B2B standards.

So, what’s the ROI for the considerable investment of time and money to certify to these standards? Let’s look at what it means for one of the world’s leading nutritional product manufacturers in the world.

Herbalife Nutrition operates five innovation and manufacturing facilities around the globe and more than 12 working labs where research, quality assurance, or product testing occur. The company’s first innovation and manufacturing facility, in Lake Forest, California, is home to a proton nuclear magnetic resonance spectrometer and gene sequencer—state-of-the-art instruments used to analyze the identity and composition of ingredients and usually only found in research facilities.

The Winston-Salem, North Carolina, facility, which opened in 2014, is an 800,000 sq ft manufacturing facility that is roughly the size of 14 football fields, with more than 750 team members who produce approximately 400,000 units per day.

Spoiler alert

So, what do manufacturing leaders think about standards certification? The nutshell answer from Herbalife is, “Yes.” Herbalife is certified to ISO/IEC 17025, ISO 45001, and three different NSF standards. You could say they’re committed.

Mark Schissel
Mark Schissel

I was able to get Mark Schissel, executive vice president of worldwide operations at Herbalife Nutrition to take a break long enough to give us a peek into his view of the value of standards certification.

ISO 45001

Ryan Day: How does ISO 45001 certification relate to OSHA compliance?

Mark Schissel: ISO 45001 certification, like other ISO certifications, demonstrates a drive to do better and be better. OSHA standards are the minimum you are required to do, but taking an organization and company to a higher level is an investment over and above the standards of OSHA, providing what we believe to be a safe environment for our employees. Meanwhile, the ISO 45001 certification gives our manufacturing facilities the distinction and recognition of being among the safest facilities in the world.

RD: Does certification to ISO 45001 and ISO 17025 standards help open doors to international markets?

MS: ISO certifications signify we are committed to transparency and meet globally recognized standards. We market products in 95 countries, and our ISO 17025 accreditation helps us register our products in those where premarket registration is required. In some cases, government and regulatory bodies will only accept test results from an ISO 17025-accredited laboratory.

A true measure of our commitment to industry-leading quality is the pursuit and attainment of the ISO 17025 accreditation at each of our seven laboratories as well as for 207 methods—which include testing for organoleptic, physical, chemical, microbiological, genomic, heavy metals, pesticides, and contaminants—which represent 70 percent of our tests by volume globally.

ISO/IEC 17025

RD: Herbalife’s quality control laboratory maintains ISO/IEC 17025 accreditation. Can a wellness/supplement company operate without this certification?

MS: Earning ISO accreditation demonstrates a commitment to quality standards that every company should strive for, on behalf of its own high standards and those of its customers. By committing to these standards, we earn our customer’s trust.

ISO accreditation reinforces the fact that a company is following proper laboratory procedures, and employees are properly trained to analyze products in a very consistent manner. However, ISO accreditation is not a regulatory requirement for a company to operate.

Why bother?

RD: We all know how demanding the ISO certification process is. Why does Herbalife do it? Do you feel certification distinguishes you from your competition? Does it open new doors of opportunity?

MS: In addition to certifications for its facilities and laboratory procedures, the company also holds certifications for many of its products, including the NSF/ANSI 173 standard, the only U.S. national standard for dietary supplements, and for NSF’s Certified for Sport program, which verifies that products do not contain unsafe levels of contaminants, prohibited substances, or masking agents.

This is the third certification for both facilities from NSF International, an independent global laboratory. Both facilities operate in accordance with U.S. Good Manufacturing Practices [GMP] and regulatory standards for dietary supplements, acidified foods, and food products. The GMP registration demonstrates that the company follows industry best practices for product content and labeling accuracy.

Herbalife Nutrition labratory

The company’s quality control laboratory also maintains the highly regarded ISO/IEC 17025 accreditation through the American Association for Laboratory Accreditation, so each team member must be dedicated to the pursuit of quality and safety. By achieving ISO 45001 certification, we demonstrate our continued commitment to excellence and best practices to support a healthy and safer work environment.

One of the greatest benefits of ISO certification is the transparency it creates that helps build consumer trust. These standards are a daily commitment and a relentless pursuit by all of us to ensure the uninterrupted production and delivery of the high-quality products our members want, expect, and deserve, while keeping our workplaces safe for our employees.

ISO 45001 helps bring better safety awareness for everyone. This standard challenges us to evaluate our conditions and surroundings every day. This drives the team to seek out safety hazards before they become a problem, and resolve them in a timely manner. This doesn’t just affect our full-time employees, but also the temporary employees, independent contractors, consultants, and visitors to our facilities.

Getting the most out of an investment

RD: Should organizations take a “what is the minimum effort to certify” stance or a “what is the maximum benefit we can extract from certification?” approach?

MS: Since our founding, our ultimate goal has been to earn and foster consumer trust in our products and our company. We achieve this by leading the industry in quality, setting the high standards for our raw materials, our science, our manufacturing, our products, and the customer experience. The high standards we set for ourselves, often exceed those common in the industry and the expectations of regulators.

The company has invested more than $300 million into scientific research and development, manufacturing facilities, and technology. Some of the company’s investments in technology include purchasing advanced testing equipment that is not commonly used by the industry, including nuclear magnetic resonance (NMR) equipment, mass spectrometry high-performance liquid chromatography equipment (LCMS), and next-generation sequencing (NGS) equipment. The recent investment in these sequencing technologies has diversified the company’s genomic/DNA laboratory to improve DNA analytical techniques for processed botanicals, including extracts, making it one of the few nutrition companies in the world to have its own comprehensive program to completely characterize botanical ingredients.

Additionally, we believe it is imperative that private industry, academia, and government partner for the greater good and benefit of the consumer. Those who can have an obligation to the industry and consumers to commit to scientific research, transparency, and accountability.

For that reason, Herbalife Nutrition helped found The Research Alliance, a partnership with the University of Guelph, a comprehensive public research university in Canada and a leader in food science investigation. The Research Alliance is designed to develop new, mutually agreed standards for the industry, including:
• Creating new industry standards for botanical species ingredient authentication, because current standards rely on testing protocols that identify chemicals, not necessarily species in the ingredients
• Developing the standard biological reference materials (SBRM) library for natural ingredients
• Producing a portable molecular diagnostic tool that can be used onsite by industry stakeholders, thus reducing the costs associated with species testing

We are constantly innovating to make better and safer products that we believe raises the bar for the industry and helps to increase consumer trust and use of nutritional products.

RD: Can you point out some specific benefits tied to specific parts of the standards?

MS: The standards promote more participation and consultation among all workers. This gives them a sense of ownership and engagement in creating and sustaining a safer environment. Safety risk assessments are performed continuously to emphasize hazards that are found in the workplace, and a proven path of corrective actions is taken to address and eliminate the hazards. Roles and responsibilities are a huge part of the ISO standards, in that accountability and ownership are defined and accepted by individuals, groups, or departments. There are stakeholders and interested parties such as employees, customers, visitors, contractors, third-parties, neighbors, and regulatory agencies that have needs and expectations that we are required to meet.

The journey to earn the ISO 45001 certification for our U.S. manufacturing sites began in October of 2017 and after a lot of work, we were awarded our manufacturing certifications for both HIM Winston-Salem and HIM Lake Forest in October and December 2020, respectively. However, the journey doesn’t end with certification; we are committed to the safety of our facilities and will be routinely audited to ensure we maintain the standards expected as per ISO 45001.

The ISO 17025 accreditation standard has allowed us to harmonize our laboratory practices across seven different Herbalife Nutrition laboratories to ensure the quality and integrity of our test data. The ISO 17025 accreditation means that Herbalife Nutrition laboratories are routinely audited by independent auditors to demonstrate our adherence to strict standards for the technical competency of laboratory scientific personnel; the accuracy of our microbiology, genomic (DNA), and chemistry testing methods; and the validation of analytical equipment.

Discuss

About The Author

Ryan E. Day’s picture

Ryan E. Day

Ryan E. Day is Quality Digest’s project manager and senior editor for solution-based reporting, which brings together those seeking business improvement solutions and solution providers. Day has spent the last decade researching and interviewing top business leaders and continuous improvement experts at companies like Sakor, Ford, Merchandize Liquidators, Olympus, 3D Systems, Hexagon, Intertek, InfinityQS, Johnson Controls, FARO, and Eckel Industries. Most of his reporting is done with the help of his 20-lb tabby cat at his side.

Comments

Should you be certified to ISO standards?

You should make the distinction between certification and accreditation. ISO/IEC 17025:2017 laboratories are accredited. This particular standard is standard where the accredited laboratory is required to demonstrate competence not merely compliance.

Should You be Certified to ISO?

Nice interview Ryan Day.

The comment that ISO certification is more common among 'business to business' suppliers, rather than 'manufacturers to consumers' is revealing. If a provider of products direct to consumers performs poorly, the customers disqualify the provider; they don't require a third party auditor to measure the suppier's quality. Since the origin of ISO 9001 in 1987, very few consumer products companies have embraced ISO 9001 certification. Interesting that the Herbalife executive did not reference ISO 9001 during your interview. 

In the past several year's, 'business to business' suppliers have also recognized that their customers' evaluation of their performance is demonstrated by the consistent quality of products provided- independent of whether or not the supplier holds ISO 9001 certification.

Currently, only 21,000 US manucturers hold ISO certification, representing only 8% of the approximately 250,000 manufacturers in the US. The 'customers' have spoken; ISO 9001 certification is losing its relevance.

I was pleased to see Herbalife certified to ISO 45001 to support their employees' safety. I believe both ISO 45001 (OH&S) and ISO 14001 (environmental) certification can be  important components of the business management system of companies of all types.

Note: I have been a third party auditor, trainer, and consultant for over twenty years for ISO 9001; ISO 14001 and OHSAS 18001.

Certify to ISO Standards???

The article by Julias DiSilva summarizing an interview/story about Herbalife was textbook rationale FOR registration.....right out of a registrar's PR manual, or in this case, someone who must reenforce the 'vast value' it brings to the company at a significant and real expenditure of time, labor and dollars. It seemed, however, to miss the target it promised to take aim at in the opening paragraph.... "But what do manufacturing companies think?"  I have 'driven' ISO regestration in several comapnies since the 9000:1987 standard. I am a proponent of standardized registrations for numerous reasons including helping to keep an organization on 'the straight and narrow' of good quality, customer focused service, and cost savings by reducing waste in manufacturing and duplicated/redundant auditing of suppliers. So what do real companies think????? Sales/Marketing sees registration as an advertising checkmark that someone else is responsible for. Engineering sees it as a potential list of hard rules that should apply to those 'sloppy' production operations. Manufactuing sees it as another program to endure, thrown at them by a CEO and enforced by the Quality department. The Quality department is saddled with 'making registration happen' but wonders why other departments feel they are exempt just because the word 'quality' isn't in their title.  Administration just wants it to 'happen' without any added resources or distractions. Finance....what's ISO?

For almost 35 of my 45 years in industry, I have led companies (kicking and screaming) into registration with the added burden of trying to educate them on the real value.  Though still generally misunderstood and constantly abused, ISO and similar registrations can have a net positive effect to a company's bottom line as well as its culture. Some of us know that it supports Business 101