Using BS EN ISO 13485 to build market trust
MCS Medical is a Worcestershire-based business that manufactures surgical implants and medical components such as bone screws and pins. The company was set up as an offshoot of automotive precision engineers Machined Component Systems. Sales director Warren Gray explains why BS EN ISO 13485:2003 continues to be important in gaining credibility in the marketplace. Benefits to the company include:
- increased access to markets
- stronger product differentiation
- heightened credibility in a highly specialized and demanding field.
How has BS EN ISO 13485 certification opened doors for MCS Medical?
Compliance with relevant standards is increasingly becoming a necessity in many areas of business. Customers and business partners often require that the companies with which they do business demonstrate the level of commitment that standards require.
- Warren Gray says:
“The standard itself is all about inspiring confidence. It allows anyone who buys from us to see an audit trail that shows where each part has come from. It shows where we bought it, where it was made and from which material. It there is a problem with a particular part, we can trace where this has happened.”
Read more about compliance and the supply chain.
Did MCS Medical find the cost of BS EN ISO 13485 to be prohibitive?
When a business is considering implementing standards, it is helpful to examine the established benefits along with the costs. Business support organisations exist to help with these assessments, and funding is sometimes available.
- Warren Gray says:
“Although buying the standard and becoming registered required quite an investment on our part, we felt it was necessary. We also got some funding from our local Business Link, which amounted to about £4000. We got the financial support because we were diversifying into a new area of business and the government is currently keen to encourage diversification into the medical sector.”
What kind of research did MCS Medical undertake before deciding on BS EN ISO 13485?
When entering a new business field, it is important for a company to firmly establish its competence, commitment and credentials. Standards represent a key identifying force in this.
- Warren Gray says:
“When our parent company - Machine Component Systems - was in the process of diversifying, we carried out a lot of research. One thing we realised was that we needed more of a medical profile. We also realised that, without the medical devices standard, we might not be able to attract the type of customers we wanted to reach. I am confident that they wouldn’t even sit down at the table with us if we didn’t have the standard.”
