The terms of the ISO 13485:2016 compare the changes in the content of the ISO 13485: 2003
Preface describes the impact of the third edition of this international standard.
Introduction
0.1 in general, it essentially covers more detailed information about the organizational nature of the international standard requirements and the life cycle stages of medical devices.
It shows that the supplier or the external evaluation organization can use this requirement voluntarily or in accordance with the contractual arrangements.
• remind organizations of responsibilities related to the requirements of the regulations of the quality management system.
• remind organizations of the differences in the definition of local laws and regulations and have a responsibility to understand how these definitions affect their quality management system.
• increasing the organization's responsibilities to meet the requirements of its own quality management system.
Special emphasis is placed on the necessity of "meeting the safety and performance requirements of customers and applicable laws and regulations".
Emphasis on the importance of product safety and performance related requirements.
• two factors that affect the nature of the quality management system have been added to the original list.
It shows that the organization's document formation does not need to follow the framework of this international standard.
The elaboration of the 0.2 concept has added two additional criteria related to the appropriate requirements of the description:
- compliance with the requirements of the laws and regulations;
- requires organization to manage risk.
The term "risk" is applied to the safety or performance requirements of medical devices, or in conformity with the applicable regulatory requirements
It shows that the term "forming document" includes the preparation, implementation and maintenance of the term.
It shows that the term "product" applies to the output expected to be used for customer or customer needs, or any expected output produced in the process of product implementation.
The interpretation of the process method of the 0.3 process method expansion
The relationship between 0.4 and ISO 9001 declares the relationship between ISO 13485:2016 and ISO 9001.
• point out that the relationship between ISO 13485:2016 and ISO 9001: 2015 is described in Appendix B.
The italics used to indicate the difference between the standard and the ISO 9001: 2008 have been cleared.
1 scope. It shows that this international standard is applicable to one or more stages of the life cycle of medical devices.
• explain the international standard that can be used by suppliers or the foreign parties to provide products, including the quality management system related services provided to the medical device organization.
Special emphasis is placed on monitoring, maintaining and controlling the responsibility of the outsourcing process.
Detailed description of the requirements that do not apply to Clause sixth and eighth.
It indicates that the term "regulatory requirements" includes laws, regulations, regulations, directives, and defines the scope of "applicable regulatory requirements" for the quality management system and safety performance requirements of medical devices.
3 terms and definitions - add some new definitions and redefine some of the existing definitions.
4 quality management system
4.1 General requirements: the new requirements for the formation of the members of the organization.
• the process of "considering the organization of the involved members" is required.
The use of "risk - based control methods for the appropriate process of the quality management system" is required.
Increase the related requirements of process changes.
The application of the computer software used in the quality management system confirms the new requirements.
4.2 document requirements include record control within the scope of file control requirements.
List the documents included in the medical instrument document.
New requirements for the protection of confidential health information.
New requirements for damage and loss of documents.
5.6, management review includes requirements for forming one or more management review procedures, as well as requirements for management review in the time interval of the written plan.
• expansion of the input and output list of management reviews.
6.2 human resources - build up the training capacity, provide the required training and ensure the new requirements of the employees' awareness of the process.
6.3 infrastructure increases the requirements of the infrastructure to prevent the mix of products and ensure the orderly processing of the products.
The information system is added to the list of support services.
6.4 new requirements for working environment and pollution control work environment documents.
New requirements related to the pollution control of microorganisms or particulate matter in aseptic medical devices.
7.1 product implementation planning / list added requirements.
7.2 the customer related process list added requirements.
Contact the new requirements of the competent authorities.
7.3.2 design and development planning - a list of new requirements. Traceability Method for designing output to design input
• delete the requirements of interface management between different groups in the process of design and development.
The 7.3.3 design and development of the input list added requirements.
• require additional requirements that should be verified or confirmed.
The 7.3.5 design and development review increases the details of the record.
7.3.6 design and development validation - has increased the requirements for verification planning and the interaction of other medical devices with consideration of factors that should form a document.
• verification of the new requirements of the record.
7.3.7 design and development validation, confirmation, planning, document requirements for the formation of identified products and consideration factors for interactive use.
• confirm the new requirements of the record.
7.3.8 design and development conversion - new sub clause.
7.3.9 design and development of control of changes increases the requirements for the impact of evaluation changes on the output of product, risk management, and product implementation process.
The details of the importance of determining the importance of designing and developing changes are added.
7.3.10 design and development documents - new sub terms.
7.4.1 procurement process: supplier selection criteria focus on the impact of suppliers on the quality of medical devices, the risks associated with medical devices, and the products that meet the applicable regulatory requirements.
• increasing the requirements for monitoring and reassessing suppliers and measures that do not meet the requirements of the procurement requirements
• provide additional details related to the record.
7.4.2 procurement information to add new requirements including notification of purchase product changes.
7.4.3 the validation of the procurement products, the scope of the validation activities, and the new requirements for the measures taken when any changes in the purchase product have been found.
7.5.1 production and service control. Increase the details of the control of production and service.
The cleanliness list of 7.5.2 products has been added.
7.5.4 service activity - the new requirements for the analysis of service activity records.
The 7.5.6 production and service delivery process confirmation list added requirements.
• additional details of the requirements for the confirmation process are added.
The specific methods of software validation should be related to the risks used by the software.
• confirm the new requirements for the record.
7.5.7 sterilization process identification and the special requirements of the aseptic barrier system - new requirements for the aseptic barrier system.
7.5.8 identifier - only new requirements for device identification.
Product identification, as well as new requirements for the written procedure for identification and product status marking in the production process.
7.5.11 product protection to increase the details of how to implement product protection.
8.2.1 feedback indicates that feedback should be derived from activities after production and production.
• increase the full use of feedback in the risk management process to monitor and maintain product requirements.
8.2.2 complaint handling - new sub clause.
8.2.3 reports to the competent authorities.
The monitoring and measurement of 8.2.6 products increases the requirements for identifying the testing equipment used for measurement activities.
8.3 the control of unqualified products increases the relevant details of the various controls that should be formed.
The requirements for the reasons for any research and decision making are outlined.
• increase the concession related requirements.
Pre delivery test, post inspection and feedback of the disqualification requirements respectively.
New requirements for the issuance of the relevant records of the notification.
8.4 data analysis - new requirements include identifying appropriate methods, including data statistics technology and their scope of use.
Increase the details of the input list.
8.5.2 corrective measures increase the requirement that the verification corrective measures do not have adverse effects.
• increase the demand for timely corrective action.
8.5.3 preventive measures increase the requirement that the prevention measures do not have adverse effects.