8.1 The Architecture of Compliance (ISO 9001 / 13485)

A Quality Management System (QMS) acts as the organization's engineered operating logic, not merely a repository of documents. Its primary function is to decouple product quality from individual human effort, ensuring that reliability is a systemic output rather than a result of heroic intervention. For electronics manufacturing services (EMS), the QMS must satisfy the dual mandates of commercial efficiency (ISO 9001) and patient/user safety (ISO 13485), creating a "defense in depth" against defect propagation.

8.1.1 The Context & Risk-Based Approach 

ISO 9001:2015 and ISO 13485:2016 mandate that the organization determine its "Context"—the specific internal and external variables that threaten quality.

• Risk-Based Thinking: Every process map must feature an integrated risk assessment. In PCBA manufacturing, this requires identifying failure modes such as supply chain volatility (counterfeit component risk), process drift (reflow oven profile changes), and regulatory obsolescence (RoHS exemptions expiring).
• The Medical Device File (MDF): For ISO 13485 compliance, a specific MDF must be maintained for each device family. This file acts as the "DNA" of the product, linking the physical assembly to its validated process parameters. If a parameter (e.g., torque setting, solder paste type) is not explicitly defined in the MDF, it is unauthorized for production use.

8.1.2 Management Responsibility & Review 

Quality is not solely the domain of the Quality Department; it is a leadership deliverable.

• Management Review: Top management must analyze QMS metrics—Yield, Customer Complaints, CAPA aging, and Supplier Performance—at defined intervals (e.g., quarterly) to resource the system adequately.
• Resource Provision: Leadership is obligated to provide the specific infrastructure (cleanrooms, ESD flooring, calibrated tools) required to achieve product conformity. Failure to provide these resources constitutes a major non-conformance.

Final Checklist