ISO/TS Standards Exclusions

Checklist, Conformity, Go/No Go

Question

I have a question regarding exclusions from the ISO/TS standards.

The majority of our business is the design and manufacture of enclosure hardware. Recently though, a small portion of our business has become the sole North American Distributor for an Italian company. Their product lines are similar to ours. However, we procure their products and simply resell/distribute to their customers stateside, to Canada and Mexico. We do not have Design or Process Control for these items; they are pass-through product.

Therefore, my question is related to permissible exclusions from the ISO standard. Should we seek exclusions regarding certain clauses of Clause 7 of the standard, for this certain “supplier”, and/or for certain product groups that are sold on their behalf?

Any assistance you could provide would be helpful.

Answer

Hello,

At first, your question seemed relatively uncomplicated and I am inclined to say that you can simply sell or provide the products in question with a disclaimer or something identifying the fact that your company is not the designer/manufacturer of the product. My company occasionally has purchased parts inserted into or added to the products made (like bushings or threaded inserts, etc). We don’t have to add anything to our QMS for those as long as those items meet regulatory and statutory requirements.

However, I should mention, the standards make it clear that exclusions are permissible if “such exclusions do not affect the organization’s ability or responsibility to consistently provide product that meets customer and applicable statutory and regulatory requirements.”

Therefore, stepping away from the initial ‘simple’ answer, I would say that such exclusions would not be permissible. This is due to the fact that your organization is ultimately responsible for meeting customer requirements. Although you do not design or manufacture that specific product, you provide, and are responsible for what the customer requests.

You are also responsible for seeing to it that the OEM is meeting customer as well as any statutory or regulatory requirements. This would be of particular importance if these are electrical enclosures or intended for hazardous services, such as NEMA 7 (explosion proof enclosures).

Since you already design and manufacture your own products and have the Clause 7 included in your QMS, it would be counterproductive to add more documentation to exclude what you have mentioned. It would be wise to notify customers up-front, in the sales/purchase order process, that the product you are distributing is from a separate company.

Thanks much for this good question.

Bud Salsbury
ASQ Senior Member, CQT, CQI

Can We Require ISO 9001 Certification?

Suppliers, supplier management

Q: My company has bought another company in Canada and we are outsourcing to them. They are not certified to ISO/ANSI/ASQ 9001:2008 Quality management systems–Requirements.  Do we have the legal right to require them to get certified since we are?

A: Thank you for contacting the ASQ Ask the Experts Program.  With regard to your question, there is no requirement in ISO 9001 that requires any organization or their suppliers to be certified by a third-party. Certification is only needed if it’s required by a customer contract/purchase order, or if an organization has opted to be ISO 9001 certified.

However, as an ISO 9001 certified organization, your quality management system must include controls to maintain control over outsourced processes. This requirement is stated in clause 4.1. The control over outsourced processes may include all or any of the following:

1.    Use of an approved suppliers list (see clause 7.4.1)

2.    An onsite supplier quality audit (see clause 7.4.3)

3.    Review and approval of equipment, processes, procedures, methods, and personnel qualifications for processes that require validation such as welding, nondestructive testing, heat treatment or others (see clause 7.5.2).

In summary, ISO 9001 certification is a management decision and not a requirement.  Organizations that follow the ISO 9001 requirements and have outsourced processes should have controls in place to manage those processes.

I hope this helps.

Bill Aston
ASQ Senior Member
Managing Director of Aston Technical Consulting Services
Kingwood, TX
www.astontechconsult.com

Related Content:

Imaging Core Lab Takes Quality Beyond Regulatory Requirements With ISO 9001, ASQ Knowledge Center case study, open access

Medical Metrics Inc. (MMI), had an existing quality management system structured to meet FDA regulations, but it was missing a framework to help drive organizationwide improvement. MMI worked with an external consultant to create an integrated management system—a fusion of regulatory requirements with the ISO 9001 framework—and received certification to the standard in less than seven months. Read More.

Sarbanes-Oxley And ISO 9000, Quality Progress, open access

Critics say ISO 9000 doesn’t compare favorably to quality programs such as the Baldrige criteria, lean and Six Sigma. But ISO 9001’s emphasis on documentation is a major asset from a legal perspective. Quality professionals can help companies comply with Sarbanes-Oxley while enhancing their organizational status. Read More.

Explore the ASQ Knowledge Center for more case studies, articles, benchmarking reports, and more.

Browse articles from ASQ magazines and journals here.

Outsourcing and Quality

About ASQ's Ask the Standards Expert program and blog

Q: The company I work for has outsourced its manufacturing processes and will possibly be outsourcing some of its other processes (including its core quality operations) in the near future.  I am interested in ASQ articles that relate to the outsourcing of core company operations or how quality is affected overall by outsourcing.

A: Outsourcing can be defined as a “strategy to relieve an organization of processes and tasks in order to reduce cost, improve quality, reduce cycle times, reduce the need for specialized skill, and increase efficiency” (taken from The Quality Improvement Glossary by Donald L. Siebels).

The ASQ Knowledge Center has over 30 articles and case studies that specifically focus on the topic of outsourcing.  I have listed some below that I think relate most to your question:

“Quality 3.0”, Quality Progress, Feb. 2010
Abstract: In the era of globalization, the focus of some organizations has shifted from quality to cost savings. The resulting outsourcing of activities created problems with solutions that, thus far, have been short term. Some experts believe better answers are available as long as quality leaders emphasize innovation.

“Reversing Course?”, Quality Progress, July 2011
Abstract: In a recent survey, almost all responding organizations indicated they outsource functions, but most have not met or achieved service, quality and productivity goals.  For outsourced functions, internal service levels were frequently disappointing.  A more holistic approach with less emphasis on cost savings may lead to fewer outsourcing failures.

“Out of Sight…Out of Mind”, Quality Progress, Feb. 2009
Abstract: Quality often takes a hit when a company outsources any process with direct customer impact.  Those changes can leave customers feeling alienated from a company they previously had confidence in.  Holding the outside vendor to a standard of performance can ensure effective oversight and improved customer satisfaction.

“Managing Quality in Outsourced Production: Construct Development and Measurement Validation”, Quality Management Journal, April 2011
Abstract: There is surprisingly little literature on the subject of managing the quality of outsourced production. This paper develops and evaluates the necessary scales of measurement for studying production management of contract manufacturers. To the extent possible these scales are derived from existing literature on in-house production management. These scales are refined through a rigorous item-sorting process and formally assessed using data collected from buyers and contract managers.

“In the Know”, Quality Progress, August 2008 (online-only content)
Abstract: A body of knowledge dedicated to quality in outsourcing will strengthen processes and help companies exceed expectations in today’s global economy. Careful consideration of six knowledge areas can lead to a repeatable, scalable and sustainable outsourcing process based on solid quality fundamentals.

You may also want to take a look at the “Expert Answers” column from the March 2008 issue of Quality Progress.  It contains an answer to a question regarding working on processes related to outsourced products and services.

I hope that this information is helpful.  Please visit the ASQ Knowledge Center if you would like to search or browse for more resources.  Feel free to contact me if you have additional questions.

Best regards,

ASQ Research Librarian
Milwaukee, WI