Your step-by-step guide to implementation
Here are the 20 International Organization for Standardization (ISO) 9000 elements, or quality system requirements, with comments on how they relate to health care. Suggestions on adapting the elements to health care are provided by Kathleen Stillwell, RN, MPA, HSA, president of Stillwell & Associates in Seal Beach, CA, and by consultant and certified lead ISO auditor Karen Brink, president of Quality Paradigms Training and Consulting Inc. in Columbia, NJ. Brink's comments come from guidelines she put together during a recent hospital audit.
1. Management responsibility. "Management is the key," Stillwell says. "You have to have responsibility for the administrative and the clinical. I disagree with the argument that the Joint Commission [on Accreditation of Healthcare Organizations] focuses on the clinical and ISO doesn't. For the clinical, who you let in to do what is the key."
"Executive management sets the quality policy, provides organization and resources, and reviews the system," notes Brink.
2. Quality system. "You have to have a system for checking and balancing," Stillwell says. "Are we doing what we're supposed to be doing? This includes the performance improvement program."
"Make quality plans," says Brink. "Have a documented system, including policy manual, procedures, and instructions."
3. Contract review. "All parties must understand and agree what services will take place," Brink says. "Someone reviews and approves."
"This means having a system in place for reviewing contracts you're going to enter into," says Stillwell. "As a risk manager, I've seen health care systems that were the victim of not having this review, of the right hand not knowing what the left hand is doing. When you enter into a contract with an insurer, you may be at risk if there's no one to oversee the contract."
Contract review may be even more important in health care than in engineering or manufacturing, she adds. "[Health care organizations] are starting to do better at getting [contracting] centralized, but it's still often done by different departments."
4. Design control. This can be physical design or program design, Stillwell says. "It could have to do with designing a plan to control the flow of patients, or when you design an ambulatory services area, if it's [Americans with Disabilities Act] ADA-compliant. Design control won't let you fail there, or at least says there's a standard."
5. Document and data control. "The right documents/data are available to the appropriate people, indexed so they are accessible," Brink says. "Obsolete documents are clearly marked or removed."
6. Purchasing. The Joint Commission doesn't have a standard regarding purchasing, Stillwell points out. "It's not only who you hire and what you let them handle, it's also what products you buy and use on people - all the way from medical equipment to pharmaceuticals. After health care benefits for employees, purchasing is usually fighting for the No. 2 position in capital expenditure [for health care providers].
"Evaluate vendors, document accurately, review orders before they go out," adds Brink.
7. Control of customer-supplied product. "Items that are not hospital property but used in the delivery of services are identified and controlled," Brink says. "This also includes control of personal belongings."
Stillwell says she found the best examples of quality in the automotive and aviation industries. She was told by the director of product development and research for a large manufacturer of bearings that if you split a hair a thousand times, the bearings his company makes wouldn't tolerate that margin of error.
That same demand for quality is beginning to move into the health care industry, which has the same incestuous mix of internal and external customers, she says. "Why do we accept such a variation in the delivery of service from someone who's going to take your loved one in for surgery?"
8. Product identification and traceability. This standard deals with tracing product inventory and equipment, with determining, for example, what lot a product was from, she says. "Health care already has procedures in place to do this but is not doing a great job of control."
Brink adapts the standard further for health care, noting, "All patients, records, and activities related to a particular patient are identified with unique patient ID numbers."
9. Process control. "All processes are documented and performed in accordance with the procedures," Brink says. "Personnel are qualified for their positions." Written procedures, she adds, must accurately describe the way things are done.
10. Inspection and testing. This is about quality checks, Brink points out. "That includes assessments, inspections, and various tests at all stages - of processes from admission through discharge of patients and verification of supplies, goods, and services."
11. Control of inspection, measuring and test equipment. " Instruments used for testing are identified, calibrated, and handled properly," Brink notes. For example, spectrometers in the lab have an instrument number and are calibrated. A sticker on each instrument identifies the calibration date.
12. Inspection and test status. This has to do, Brink says, with "the ability to determine [verify] what assessments, inspections, and tests have been performed." This means, for example, that a patient's medical record shows which lab tests and assessments have been taken to date, she adds
13. Control of nonconforming product. "What do you do about things that are not working right?" Stillwell says. "This could be a computer, a broken chair, something that's a problem in the environment."
"What happens when things don't go as expected?" asks Brink. "[It's about] documentation, disposition, and control."
14. Corrective and preventive action. "In all areas, you must have a procedure to correct problems," Stillwell says. "In the patient registration area, if there's a problem with the computer, you don't just leave it for the next shift."
"Suggestions for improvement are documented and followed up on to see that they are effective," Brink adds.
15. Handling, storage, packaging, preservation, and delivery. This can be as simple as leaving the box of tissue out of the patient admission kit, Stillwell notes. Another example, says Brink, is that universal precautions are required when patient contact is necessary.
16. Control of quality records. This differs from No. 5 in that it concerns records on the organization's quality program, Stillwell says. "Do the findings get to the senior management of the company, or is it, 'Don't ask, don't tell?'"
Records related to quality are identified, indexed, and safely stored for a specified time," adds Brink.
17. Internal quality audits. "The quality system is audited regularly," Brink says, and "internal audit schedules and reports exist."
This can be a first-party or second-party audit, Stillwell says, with the first-party audit done by staff themselves or maybe by a quality improvement person assigned to a department or process. An outside consultant might come in to do a second-party audit. "You can't be ISO-registered without a third-party audit, which must be done by the ISO 'registrar,' such as Lloyds of London, or in health care, [Flemington, NJ-based] Kemper Registrar Services."
18. Training. This is about training in quality, not about training in ISO, Stillwell points out. "It has to do with making sure you have the skills to do your job, about staff development. In health care, this is the first thing to get cut in a financial crisis, but you must have a training budget."
"Internal auditors [should] have certificates of training in their files," adds Brink.
19. Servicing. This can be servicing equipment or serving customers - being an internal supplier, Stillwell says.
20. Statistical techniques. "What data helps to control your processing and outcome measures?" asks Brink. "Control its collection and use."
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