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BS EN ISO 13485:2016+A11:2021

BS EN ISO 13485:2016+A11:2021

$215.11

Medical devices. Quality management systems. Requirements for regulatory purposes

Published By Publication Date Number of Pages
BSI 2021 90
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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 and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements of this International Standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

The processes required by this International Standard that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to this International Standard reflect any exclusion of design and development controls.

If any requirement in Clauses 6, 7 or 8 of this International Standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.

PDF Catalog

PDF Pages PDF Title
2 undefined
35 Foreword
36 Introduction
39 1 Scope
2 Normative references
3 Terms and definitions
44 4 Quality management system
4.1 General requirements
45 4.2 Documentation requirements
4.2.1 General
4.2.2 Quality manual
4.2.3 Medical device file
46 4.2.4 Control of documents
4.2.5 Control of records
47 5 Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.4.1 Quality objectives
5.4.2 Quality management system planning
48 5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal communication
5.6 Management review
5.6.1 General
5.6.2 Review input
49 5.6.3 Review output
6 Resource management
6.1 Provision of resources
6.2 Human resources
50 6.3 Infrastructure
6.4 Work environment and contamination control
6.4.1 Work environment
6.4.2 Contamination control
7 Product realization
7.1 Planning of product realization
51 7.2 Customer-related processes
7.2.1 Determination of requirements related to product
7.2.2 Review of requirements related to product
52 7.2.3 Communication
7.3 Design and development
7.3.1 General
7.3.2 Design and development planning
7.3.3 Design and development inputs
53 7.3.4 Design and development outputs
7.3.5 Design and development review
7.3.6 Design and development verification
7.3.7 Design and development validation
54 7.3.8 Design and development transfer
7.3.9 Control of design and development changes
7.3.10 Design and development files
55 7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
56 7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.2 Cleanliness of product
7.5.3 Installation activities
57 7.5.4 Servicing activities
7.5.5 Particular requirements for sterile medical devices
7.5.6 Validation of processes for production and service provision
7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems
58 7.5.8 Identification
7.5.9 Traceability
7.5.10 Customer property
7.5.11 Preservation of product
59 7.6 Control of monitoring and measuring equipment
60 8 Measurement, analysis and improvement
8.1 General
8.2 Monitoring and measurement
8.2.1 Feedback
8.2.2 Complaint handling
61 8.2.3 Reporting to regulatory authorities
8.2.4 Internal audit
8.2.5 Monitoring and measurement of processes
8.2.6 Monitoring and measurement of product
62 8.3 Control of nonconforming product
8.3.1 General
8.3.2 Actions in response to nonconforming product detected before delivery
8.3.3 Actions in response to nonconforming product detected after delivery
8.3.4 Rework
8.4 Analysis of data
63 8.5 Improvement
8.5.1 General
8.5.2 Corrective action
8.5.3 Preventive action
65 Annex A (informative) Comparison of content between ISO 13485:2003 and ISO 13485:2016
68 Annex B (informative) Correspondence between ISO 13485:2016 and ISO 9001:2015
74 Bibliography

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BS EN ISO 13485:2016+A11:2021
$215.11