Quality management system
4.1 General requirements
4.1.1 The organizationshall document a quality management system and maintain its effectiveness in accordancewith the requirements of this International Standard and applicable regulatoryrequirements.
The organizationshall establish, implement and maintain any requirement, procedure, activity orarrangement required to be documented by this International Standard orapplicable regulatory requirements.
The organizationshall document the role(s) undertaken by the organization under the applicable regulatoryrequirements.
NOTE Rolesundertaken by the organization can include manufacturer, authorized representative,importer or distributor.
4.1.2 The organizationshall£º
a) determine theprocesses needed for the quality management system and the application of theseprocesses throughout the organization taking into account the roles undertakenby the organization;
b) apply a riskbased approach to the control of the appropriate processes needed for thequality management system;
c) determine thesequence and interaction of these processes.
4.1.3 For each qualitymanagement system process, the organization shall:
a) determine criteria and methods needed toensure that both the operation and control of these processes are effective;
b) ensure the availability of resources andinformation necessary to support the operation and monitoring of these processes;
c) implement actions necessary to achieveplanned results and maintain the effectiveness of these processes;
d) monitor, measure as appropriate, and analysethese processes;
e) establish and maintain records needed todemonstrate conformance to this International Standard and compliance withapplicable regulatory requirements (see 4.2.5).
4.1.4 The organizationshall manage these quality management system processes in accordance with therequirements of this International Standard and applicable regulatoryrequirements. Changes to be made to these processes shall be:
a) evaluated fortheir impact on the quality management system;
b) evaluated for their impact on themedical devices produced under this quality management system;
c) controlled inaccordance with the requirements of this International Standard and applicable regulatoryrequirements.
4.1.5 When theorganization chooses to outsource any process that affects product conformityto requirements, it shall monitor and ensure control over such processes. The organizationshall retain responsibility of conformity to this International Standard and tocustomer and applicable regulatory requirements for outsourced processes. Thecontrols shall be proportionate to the risk involved and the ability of theexternal party to meet the requirements in accordance with 7.4. The controlsshall include written quality agreements.
4.1.6 The organizationshall document procedures for the validation of the application of computer softwareused in the quality management system. Such software applications shall bevalidated prior to initial use and, as appropriate, after changes to suchsoftware or its application.
The specificapproach and activities associated with software validation and revalidationshall be proportionate to the risk associated with the use of the software.
Records of such activities shall bemaintained (see 4.2.5).
