Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Del Williams
Options to address the risk of combustible dust explosions for NFPA 61 compliance
Doug Folsom
Unpatched vulnerabilities will become increasingly susceptible to cyberattacks
Del Williams
Mitigate risk, prevent safety issues by utilizing closed conveyor systems designed with sanitation in mind
Dirk Dusharme @ Quality Digest
Companies say they plan to pull some or all of their devices
Dirk Dusharme @ Quality Digest
First step, migrate your QMS to a cloud-based electronic quality management system

More Features

FDA Compliance News
Company’s first funding round will be used to accelerate product development for its QMS and MES SaaS offerings
Showcasing tech, solutions, and services at Gulfood Manufacturing 2022
Easy, reliable leak testing with methylene blue
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth

More News

Quality Digest

FDA Compliance

ISO Publishes Guidance for Health Care Sector

Published: Monday, November 21, 2005 - 22:00

The International Organization for Standardization recently published a new version of International Workshop Agreement 1, which provides additional guidance for the health care sector. IWA 1:2005 has been made more user-friendly by incorporating improvements suggested by health care providers since the original guidance document was published in 2001. The new guidelines include much of the text of ISO 9004:2000, supplemented by text specifically aimed at assisting health care organizations to implement quality management systems—regardless of whether they pursue registration to ISO 9001. The objective of the guidance document is systematic process improvement, the prevention of error and other adverse outcomes, and the reduction of variation and organizational waste.

Principal improvements to the new version of IWA 1 include:

  • The translation of quality-related terminology into language and situations readily understood by health care professionals
  • The addition, after the description of many ISO 9004 requirements, of related advice on “what to look for” and other examples

Mickey Christensen, chair of the committee that developed the original proposal for IWA 1, cites the case of Southern Pharmaceutical Corp. as an example of the benefits of ISO 9001 implementation, supplemented by guidance from IWA 1. The Gulfport, Mississippi-based company, which delivers medicines and vital medical equipment to patients at their homes, was severely damaged by Hurricane Katrina.

“The owner stated that because of their ISO 9001 system and having planned for disasters with documented procedures, they were back in business within a matter of hours, providing the home-care patients the service they needed,” Christensen says.

For more information, visit www.iso.org.

Discuss

About The Author

Quality Digest’s picture

Quality Digest

For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.