This article proposes to summarize the High Level Structure for management system standards
The 5S method was formalized in the industrial workshops of Toyota, to allow improving the organization of a workspace.
Principles and calculations for process validation: capability coefficients, standard deviation, centering, error, number of samples required, etc.
Quality manual template for medical device manufacturers, according to ISO 13485 and Regulation (EU) 2017/745
Review of Amendment A11 to EN ISO 13485:2016, containing Annexes ZA and ZB for regulations 2017/745 and 2017/746.