New quality system brings higher trust for precision engineering firm

Owning a precision engineering company had always been Mr Royston Lim's dream, ever since he was studying engineering at Singapore Polytechnic in the 1970s.

In August 1990, he and a partner started Cragar Industries, with a staff strength of about five, producing electronic goods such as hard-disk drives.

Fast forward to 2014, and the company of 38 employees now specialises in making parts for medical equipment such as surgical microscopes.

In February this year, when Cragar adopted the ISO 13485:2003, it saw a business edge emerge, as less than 10 per cent of its competitors have this certification.

Mr Lim, 58, says: "People trust us more now because we have this standard."

One vital aspect of the standard was to implement new systems to enable traceability, which is the ability to trace the materials used in each batch of products.

"This is especially important in the medical industry because if the end product fails, the client needs to know what went wrong." To the management, the need to adopt this additional standard was obvious; but convincing his staff was not so easy. Initially, they did not accept the idea because it meant more work.

"They asked, 'Why must we trace the materials?'. The machine operators also needed to understand, so they could be more alert and filter out rejects properly," says Mr Lim.

So Cragar hired a consultant to explain the need to its staff and demonstrate the industry's best practices for these new systems, which the company then adopted.

Encouragement from Spring Singapore also helped the company to adopt this standard.

In addition, Spring funded about 70 per cent of the total cost, including the costs of consultancy, implementation and auditing.

Mr Lim says the financial support helped Cragar to make the investment decision and commit to renewing the certification, which costs about $8,000 a year.

While the renewal cost may appear high, Mr Lim says it is more than offset by the better business prospects that his company enjoys by having adopted the standard.

ISO 13485:2003 Quality system for medical device components

What it is: A standard that regulates the manufacture of parts or products for the medical industry

This article was first published on August 6, 2014.
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