This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
The organization shall establish, document, implement and maintain a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard.
5.1 Management commitment
6.1 Provision of resources
The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).
7.2.1 Determination of requirements related to the product
The organization shall establish documented procedures for design and development.
Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include
The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.
At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1)
Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4).
Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. Validation shall be completed prior to the delivery or implementation of the product (see Note [...]
Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already [...]
7.4.1 Purchasing process
184.108.40.206 General requirements
Validation of processes for production and service provision of ISO 13485
The organization shall exercise care with customer property while it is under the organization’s control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to [...]
The organization shall establish documented procedures or documented work instructions for preserving the conformity of product during internal processing and delivery to the intended destination.
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1).
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed
As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to whether the organization has met customer requirements.
The organization shall conduct internal audits at planned intervals to determine whether the quality management system
The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to [...]
220.127.116.11 General requirements
The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.
The organization shall establish documented procedures to determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate if improvement of the effectiveness of the quality management system can be made.
The organization shall identify and implement any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.