ISO 13485 Compliance

The Problems

Medical device manufacturers face pressures from all sides today more than ever. Highly-publicized device failures have increased scrutiny from the regulatory authorities and the media. Competitors are going toe-to-toe daily for the same market share in winner-take-all matches of strategy and execution. Customers are demanding price reductions at an alarming rate and are willing to switch vendors over a few cents difference in price. Now more than ever it is essential that organizations have a well-defined quality management system that is effectively implemented throughout their organization so that team members are all on the same page headed toward the same goals and objectives.

The medical device industry requires that an organization meet both customer requirements and regulatory requirements for their products and services. The ISO 13485 standard (Medical Device Quality Management System Requirements for Regulatory Purposes), based upon the ISO 9001 quality management system standard, includes additional requirements to meet these regulatory needs, and removes some of the ISO 9001 standard that are not applicable. It can be challenging to develop the necessary documentation and evidence needed to achieve your registration goal.

Do these problem sound familiar ?

I am not ready to pass an ISO13485 audit.
I can’t find the correct documentation when I need it.
It is too difficult to develop the right document.
My document does not meet the requirements of the ISO 13485 standard.
My company spends too much money on compliance efforts.
My company is not able to keep up with changes to documents.
I need to bring my documentation up to the current version of the standard.

The Needs

Organizations seeking registration to ISO 13485 must be able to must successfully execute the following:

Development of “audit ready” documentation – Solid documentation must include a policy manual, procedures and instructions covering the requirements in the standards with traceability to the stated requirements and objective evidence to support that the documentation is being followed.
Enforce document control – Successful document control means that you can do the following things well: Revision control, document access, routing, approval and change impact analysis. Besides control, a document must be easy to find and retrieve by the intended user of its contents.
Provide evidence of lab testing competence - Since most medical device manfacturers have extensive laboratory testing facilities, registering your lab with the ISO/IEC 17025 standard is a way to show testing competence to your customers.