ISO 13485 Consulting Program customized to meet your organizational, operational, resource and budgetary needs.
Saferlife Quality Team can help you understand and apply management and quality system requirements while ensuring that your program proceeds smoothly. Our consultants will create a custom Quality Management System that is structured around your business, not the ISO 13485 standard. We provide a guaranteed, comprehensive, fixed-rate program.
The key to a successful program is understanding how much of what you do needs to be documented. We offer three different consulting programs to suit organization size, complexity and needs:
ISO 13485 Required
The ISO 13485 Standard requires certain procedures and records have to be documented as mandatory. We can assist you develop a system that meets these minimum requirements. This is particularly good for small organizations, those that are operationally straightforward and those whose processes are well understood and followed.
In addition to the procedures and records that the ISO 13485 Standard requires we would assist you document processes that can have the greatest impact on increasing revenue or reducing costs. This is appropriate for organizations that are a little larger and are experiencing some difficulty with consistency of practices leading to errors (process non-conformances).
We would assist you document all of your processes. This is most appropriate for complex organizations experiencing issues with consistency of practices and errors (process non-conformances) in many different areas and where operational processes are not well defined or understood costing the company significant amounts of time and money.
Now you know what ISO 13485 consulting program approach you want to take, you need to decide what role you want your consultant to play.
Do you have the resources internally to write documents?
Do you have someone who is organizationally knowledgeable that can manage and drive the process?
We offer three different levels of ISO 13485 consulting support to meet your resource and time constraints:
In this role we would be responsible for writing all of your documents with input from your processes owners and handing off responsibility for the documented ISO 13485 system prior to implementation. This option is attractive to smaller organizations and those with limited resources.
As the project manager, we would drive the process, this includes monitoring and guiding documentation and implementation activities against the implementation plan, coordinating with all of your people and being responsible for achieving ISO 13485 registration on time and to budget.
Support and Mentor
In this role we would support your Management Representative/ISO Coordinator as they manage your team and drive the process, offering ISO 13485 consulting support as needed and determined by this person.
Hundreds of organizations have already used our consulting guidance to design, develop and deploy cost-effective, profit-enhancing management systems.
ISO 13485:2003 an international standard designed to orient quality management systems toward the design, development, production, and installation of medical devices and related services. Medical Devices are products designed to cope with disease, treat injuries, investigate and augment human functions and they also are made up of a host of other apparatuses and appliances. The European medical device quality system standard as of this writing is EN ISO 13485:2003. ISO 13485:2003 will replace current harmonized standards EN ISO 13485:2013
A successful implementation will demonstrate a company's ability to supply medical devices and related services to customers that comply with regulatory requirements. ISO 13485 is not just product focused, but it focuses instead on the processes used to develop medical devices. Keep in mind that you also need to comply with all relevant product and service oriented technical standards and regulations in this area of expertise. Although ISO 13485:2003 is based on ISO 9001:2008 quality management standard and uses the same numbering system, ISO 13485 doesn't include the ISO 9001 requirements related to continual improvement and customer satisfaction. ISO 13485 also focuses more on how procedures regulate and control activity and process performance.