Already accepted in manufacturing circles, the ISO system of process quality is being embraced by a variety of healthcare technology service and support organizations, including in-house clinical engineering departments. Is the substantial investment of both time and money required to achieve ISO registration the best defense against market threats, both foreign and domestic?
On the basis of identical acronyms* alone, ISO registration seems a good match for the the independent service organization (ISO). Linguistic aerobatics aside, what is this thing called ISO 9002 registration and its application to the biomed service community?
What does it signify?
What is required to achieve ISO registration?
How long does it take?
Is it expensive?
And really … why bother?
Briefly, ISO 9000 refers to 20 voluntary, market-driven, 1994-issue standards for quality management and quality assurance (QA). Developed through international consensus involving experts in the industrial, technical and business sectors, the ISO 9000 family of standards (9001, 9002 and the lesser-known 9003) relate to the making of product, including hardware, software, processed materials and services. The designation is not a product quality label.
New ISO 2000 standards — 6 elements down from the original 20 — are expected to be published later this year.
“I’ve been in this business for 28 years and the most difficult survey of my life was when the ISO auditors came in,” declares Wayne Morse. “I’ve worked for medical device manufacturers, I have worked with hospitals with their accreditation processes, and I’ve never had such a thorough, detailed experience in my life.
“But I’m not sorry I did it.”
Morse, president and CEO, founded Morse Medical (Seattle, Wash.) in 1995 as an educational company, producing written materials and videotapes for biomeds working toward certification. During its second year in business, Morse Medical switched its focus to service. Two years ago, in an effort to organize its existing protocols and processes, the company went after ISO 9002. It has held the registration for nine months now.
“What are the factors you care about when you get something serviced?” Morse asked as a way of explaining the ISO 9002-service connection. “In simplistic terms, I believe the customer cares that it is taken care of the first time and that it is done at a reasonable price. So the processes within an organization fine tune that.”
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