ISO 13485 Implementation Consulting ( ISO 13485 Consulting )
Obtaining ISO certification related to any standard is required to implement that standard.
How to provide ISO 13485 consulting services to businesses and companies
The purpose of providing ISO 13485 consulting services is to train and implement the requirements of this standard.
Services related to ISO 13485 after signing a contract with the relevant organization and company and through the dispatch of expert consultants and includes several steps that are described below.
Steps of consulting and implementation of ISO 13485
Step 1 : Examine the organization in terms of volume and type of process, in other words, identify the organization and, if necessary, perform a diagnosis
Step 2 : In-house training to get acquainted with the requirements of ISO 13485 – Description of tasks and how to implement the project in the organization
Step 3 : Document the system and standard of ISO 13485, including the implementation of methods – forms and instructions based on the latest version of ISO 13485
Step 4 : Review and monitor the deployed system of ISO 13485
Step 5 : Internal audit to review and find small and large defects
Step 6 : External and final audit by the issuing authority with the approach of obtaining valid ISO 13485 certification
For which centers is it possible to obtain ISO 13485 certification?
According to ISO 13485 standard, consulting to implement and obtain ISO 13485 certification is applicable to all organizations and companies producing medical equipment, instruments, surgery and drug supply chain. All relevant organizations, companies and guilds can apply for this important and widely used standard.
Familiarity with the standard and the importance of implementing ISO 13485
ISO 13485 is an important and practical standard published by the ISO International Organization for Standardization.
ISO 13485 (ISO 13485) is an international standard based on the ISO 9001 process approach. ISO 13485 is a management system standard that is specifically designed for the production of medical devices and devices.
This standard includes specific requirements for the production, installation, and maintenance of the following:
- Implement a quality management system with several features
- Risk management for product development and product realization
- Validity of processes
- Compliance with legal and regulatory requirements
- Ability to track products and systems
ISO 13485 is a tool for organizations that effectively develop and maintain their processes. Organizations that strive for continuous improvement will benefit from this standard and can provide safe medical devices and gain customer trust.
The ISO 13485 standard includes a set of policies, processes, procedures and records. These documents set out a set of rules based on how the quality of medical devices is managed.
Implementing ISO 13485 is one of the best proven methods to raise the quality level. Implementing ISO 13485 is one of the least expensive methods and shows your commitment to help the company, ensure continuous improvement and better work processes.
Rose Calibration Company in Melbourne, Australia with over ten years of experience provides all calibration, maintenance, and repair services throughout Australia. If you live in Sydney, Melbourne, Adelaide, Perth, Geelong, and Brisbane, you can receive your quote in less than two hours by fill-up the form via the “Booking” link.