BS EN ISO,Medical Devices—Quality Management Systems—Requirements For Regulatory Purposes (British Standard) BS EN ISO PDF can be downloaded free of charge on this website.BS EN ISO replaces BS EN ISO. This International Standard. STANDARD ISO 13485 Third edition 2016-03-01 Reference number ISO (E) Licensed to Red Star Contract Mfg / Barry Leffers (barry@redstarcontractmfg.com) ISO Store Order: OP-125087 / Downloaded: 2016-02-29 Single user licence only, copying and networking prohibited.
Looking for the text of ISO 13485:2016?
You will need to purchase a copy of the standard to reach certification (sometimes multiple standards are required). Due to copyright restrictions, we are not able to include these with our products. So, we have partnered with Techstreet, an authorized seller of ISO Standards. We have sorted each standard into Needed, Recommended, and Additional Related Standards. Each has a link to purchase through Techstreet.
Needed for ISO 13485 Certification:
ISO 13485:2016 –Medical devices – Quality management systems – Requirements for regulatory purposes
ISO 14971:2019– Medical devices – Application of risk management to medical devices
Recommended for ISO 13485 Certification:
- ISO Guide 73:2009 – Risk management – Vocabulary
Additional Related Standards:
- ISO 19011:2018 – Guidelines for Auditing Management Systems
ISO 9001 Family
- ISO 9000:2015 – Quality Management Systems – Fundamentals and Vocabulary
- ISO 9001:2015 – Quality Management Systems – Requirements
- ISO 9002:2016 – Guidelines for the application of ISO 9001:2015
- ISO 9004:2018 – Quality Management – Quality of an organization – Guidance to achieve sustained success
Medical Device Software
- IEC 62304 Ed. 1.1 b:2015 – Medical device software – Software life cycle processes – Consolidated Edition
- IEC/TR 80002-1 2009 – Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software
- ISO/TR 80002-2:2017 – Medical device software – Part 2: Validation of software for medical device quality systems
- ISO 31000:2018 – Risk Management Guidelines
These standards are sold by the Techstreet website, a reseller of ISO Standards that includes ISO, SAE, IATF, and other standards. Many standards are available to download in pdf format. Purchase transactions are conducted on Techstreet’s secure site and are not combined with a purchase from 13485Store.
The book is organized like the standard itself, the table of contents is identical to the ISO 13485 Standards table of contents making it user friendly, familiar, and unintimidating. Each chapter contains the information, explanations, interpretations and examples regarding the requirements stated in the parallel standard clause.
Iso 13485 2016 Standard
The book is 900 pages long. Are you going to read them all? Off course not. I know I would not. This is why I wrote it like the ISO 13485:2016 Standard- Table of contents. When you have a specific answer regarding a topic – you just browse to the specific section and find the solution to your answer.
Iso 13485 2016 Free Download
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
4.1 General requirements
4.1.1
4.1.2
4.1.3
4.1.4
4.1.5
4.1.6
4.2 Documentation requirements
4.2.1 General
4.2.2 Quality manual
4.2.3 Medical device file
4.2.4 Control of documents
4.2.5 Control of records
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
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
5.6.3 Review output
6 Resource management
6.1 Provision of resources
6.2 Human resources
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
7.2 Customer-related processes
7.2.1 Determination of requirements related to product
7.2.2 Review of requirements related to product
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
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
7.3.8 Design and development transfer
7.3.9 Control of design and development changes
7.3.10 Design and development files
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
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
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
7.5.8 Identification
7.5.9 Traceability
7.5.9.1 General
7.5.9.1 Particular requirements for implantable medical devices
7.5.10 Customer property
7.5.11 Preservation of product
7.6 Control of monitoring and measuring equipment
8 Measurement, analysis and improvement
8.1 General
8.2 Monitoring and measurement
8.2.1 Feedback
8.2.2 Complaint handling
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
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
8.5 Improvement
8.5.1 General
8.5.2 Corrective action
8.5.3 Preventive action
Iso 13485 Download Free
Purchase it here: