'Accountable' may be a more appropriate word, as you suggested; however, the main point here is that a company must established independence.
Here's an excerpt from the Preamble:
"56. Some comments stated that requiring ``individuals who do not have direct responsibility for the matters being audited'' to conduct the audits is impractical and burdensome, particularly for small manufacturers.
FDA disagrees with the comments. Both small and large manufacturers have been subject to the identical requirement since 1978 and FDA knows of no hardship, on small or large manufacturers, as a result. Small manufacturers must generally establish independence, even if it means hiring outside auditors, because the failure to have an independent auditor could result in an ineffective audit.
Manufacturers must realize that conducting effective quality audits is crucial. Without the feedback provided by the quality audit and other information sources, such as complaints and service records, manufacturers operate in an open loop system with no assurance that the process used to design and produce devices is operating in a state of control. ISO 9001:1994 has the same requirement for independence from the activity being audited."
With that, in my opinion, you would have a very difficult time trying to justify having the CEO audit the production facility.
