ISO 13485 standard
Scope of ISO 13485
Clause 1.0
1.1 General
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.
Normative reference
Clause 2.0
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.
General requirements
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.
Documentation requirements
Clause 4.2
4.2.1 General
Management responsibility
Clause 5.0
5.1 Management commitment
Resource management
Clause 60
6.1 Provision of resources
Planning of product realization
Clause 7.1
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).
Customer-related processes
Clause 7.2
7.2.1 Determination of requirements related to the product
Design and development planning
Clause 7.3.1
The organization shall establish documented procedures for design and development.
Design and development inputs
Clause 7.3.2
Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include
Design and development outputs
Clause 7.3.3
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.
Design and development review
Clause 7.3.4
At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1)
Design and development verification
Clause 7.3.5
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
Clause 7.3.6
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 [...]
Control of design and development changes
Clause 7.3.7
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 [...]
Purchasing management
Clause 7.4
7.4.1 Purchasing process
Control of production and service provision
Clause 7.5.1
7.5.1.1 General requirements
Validation of processes for production and service provision
Validation of processes for production and service provision of ISO 13485
Clause 7.5.2
Identification and traceability
Clause 7.5.3
Customer property
Clause 7.5.4
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 [...]
Preservation of product
Clause 7.5.5
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.
Control of monitoring and measuring devices
Clause 7.6
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).
General measurement, analysis and improvement
Clause 8.1
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed
Feedback in ISO 13485
Clause 8.2.1
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.
Internal audit
Clause 8.2.2
The organization shall conduct internal audits at planned intervals to determine whether the quality management system
Monitoring and measurement of processes
Clause 8.2.3
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 [...]
Monitoring and measurement of product
Clause 8.2.4
8.2.4.1 General requirements
Control of nonconforming product
Clause 8.3
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.
Analysis of data of ISO 13485
Clause 8.4
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.
Improvement activities
Clause 8.5
8.5.1 General
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.
Verstions:
ISO 13485:2003
ISO 13485:1996
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