International IT Regulations and Compliance
Quality Standards in the Pharmaceutical and Regulated Industries
Chapter One
Quality Standards
This chapter discusses the following:
What quality is
Which mandatory and voluntary quality standards various industries use
What these standards say about IT systems
1.1 What Quality Is
Quality is defined in the International Organization for Standardization (ISO) standard
8402 as 'The totality of features and characteristics of a product or service that bear on
its ability to satisfy stated or implied needs.'
Quality is defined in the Concise Oxford Dictionary as 'possessing high degree of
excellence, concerned with maintenance of high quality (Quality Control).'
There will always be subjectivity involved when defining whether something has good,
not so good, or bad quality. As ISO states, it also has something to do with 'implied
needs,' which definitely will change over time. Forty years ago, a quality car had good
seats, a working en ... read full excerpt from International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated Industries ebook
