ISO 13485

HLS: High Level Structure for management system standards

By Guillaume Promé
Jan. 25, 2022 ISO 13485

This article proposes to summarize the High Level Structure for management system standards

5s

5S method

By Guillaume Promé
Jan. 19, 2022 ISO 13485

The 5S method was formalized in the industrial workshops of Toyota, to allow improving the organization of a workspace.

Production Process validation: Cp, Cpk, standard deviation… statistical methods

By Guillaume Promé
Jan. 4, 2022 ISO 13485

Principles and calculations for process validation: capability coefficients, standard deviation, centering, error, number of samples required, etc.

Quality manual for medical device manufacturer

Quality manual, ISO 13485 and MDR, free template

By Guillaume Promé
Sep. 24, 2021 ISO 13485, Regulation (EU) 2017/745

Quality manual template for medical device manufacturers, according to ISO 13485 and Regulation (EU) 2017/745

ISO 13485:2016+A11:2021

EN ISO 13485/A11: Annex ZA and ZB for regulations 2017/745 and 2017/746

By Guillaume Promé
Sep. 23, 2021 ISO 13485, 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.