The criticality of auditing to the field of medical devices can never be understated, because medical devices play a direct role in human safety. Supplier and internal auditing are separate, but related aspects of the supply chain and quality aspects of medical devices. It is a common practice in the industry to have medical devices from other companies, or what are called suppliers, by agreeing to the required specification and other terms. It is also common to use already manufactured devices from other companies. Sometimes, pharmaceutical and life sciences industries use their own devices. In all these scenarios, auditing is the key, because whichever of these pathways an organization may choose; it is bound by the same rules of compliance as set out by the regulatory authorities.
Need to keep up to prescribed standards
In order to meet regulatory requirements; medical device and related businesses need to keep a few important parameters in mind in order to ensure that supplier and internal auditing are up to prescribed standards.
The following are the important factors for carrying out internal auditing:
• To assess the current and potential risks in any process being undertaken by the organization;
• To bring about improvement in the business processes and practices;
• To help meet regulatory demands;
• To help them understand the changes in the marketplace and other external factors that affect the business.
Benefits of a supplier auditing program
Somewhat allied to this is the supplier auditing program. This is a means for ensuring that devices from external vendors or suppliers meet set standards and specifications.
These may be considered the important benefits of a good supplier audit program:
• It helps to implement an overall quality system in the organization
• It helps establish documentation and business record control
• Helps in the control of the company or its business operations
• Paves the way for business management review
• Helps identify non-conforming product control
• Calibration control and contract review can be achieved.