QMSR Suppliers Control

QMSR Suppliers Control Requirements

Our previous post discussed the Applicable Regulatory requirements for the Quality Management System Regulation (QMSR). This post will focus on QMSR suppliers’ control requirements. The final QMSR rule can be seen here.

Supplier Control Procedure

We advise medical device companies to establish a procedure for Supplier Control. To this end, manufacturers should carefully review ISO 13485 Clause 7.4 Purchasing, including 7.4.1 Purchasing process, 7.4.2 Purchasing information, and 7.4.3 Verification of purchased product.

In the Supplier Control SOP, companies should define the nature and extent of control for products and services provided by their suppliers. A finished medical device manufacturer should have sufficient control over suppliers. It is usually good practice to have a quality agreement with the major suppliers to define mutual obligations as well as individual and joint responsibilities towards the relevant regulatory authorities.

Evaluate Suppliers’ Ability & Performance

A manufacturer may audit critical suppliers or, if audits are not practical, continuously evaluate the supplier’s ability and performance via periodic (usually annual) questionnaires or another type of assessment. Please note that the FDA didn’t include “critical supplier” in the QMSR. As for consultants, the FDA said that QMSR requires that a manufacturer determine what regulatory requirements must be met and then assess whether the consultant can adequately meet those needs.

In the past, many manufacturers relied on supplier quality certification (e.g., ISO 9001) as sufficient and often only proof of supplier quality. However, in the new QMSR, FDA clarifies that “certification may not provide adequate assurances of supplier quality without further evaluation.”  In any case, manufacturers must control their suppliers to the extent proportionate to the risk associated with them, be it products or services.

Management Review and Supplier Audit Reports 

One of the significant changes in the new QMSR is the lack of an exception for management reviews and supplier audit reports, which were previously exempted from the FDA review under QS regulation (21 CFR 820.180(c)). From the FDA perspective, the primary motive for including these documents under the review was a general intention to align QMSR with other regulatory frameworks where such exceptions are not available to manufacturers when audited or inspected by other entities (e.g., MDSAP; MDR, IVDR—Notified Bodies).

In addition, the FDA considers it would not be a large burden to the manufacturers to make these records available, as such records are maintained in the regular course of business. Also, FDA inspectors have already had access under QS to data such as nonconformances, complaints, and any corrective actions resulting from internal and supplier audits.
FDA stressed the importance of robust management review and internal and supplier audit programs and intends to modify its inspectional processes consistent with these higher expectations.

BioReg Services

Don’t hesitate to contact us for assistance with FDA QMSR supplier control procedures, management reviews, supplier audits, or QS—QMSR Gap Analysis. Our team can provide cost-effective help with all ISO 13485 Transitions or other Quality and regulatory Consulting tasks.

BioRegards,

Daniel