Quality is central to Romar Engineering’s diverse manufacturing capability that includes medical device manufacturing, silicone, elastomers and state of the art additive manufacturing.
Our industry-leading team has the expertise to deliver fully compliant, scalable and robust manufacturing solutions, and with ISO certification, our manufacturing always meets International Standards.
ISO Standards are a key part of the manufacturing process and a client’s assurance that your manufacturing partner is certified for safety, reliability and consistency.
A Standards overview
Standards are published documents that set out guidelines and procedures for quality control across sectors including manufacturing, construction, the environment and essential services.
Standards organisations implement Standards based on latest scientific, technological and industrial knowledge and processes. For optimum effectiveness, Standards are regularly adapted in line with new technologies.
There are three types of standards:
- International Standards – developed and approved by an international Standards Development Organisation (SDO)
- Regional Standards – covering specific regions such as the European Union
- National Standards – implemented by national Standards bodies including Standards Australia, our peak non-government, not-for-profit standards organisation
Understanding ISO Certification
The primary international SDO’s are The International Electrotechnical Commission (IEC), the International Organization for Standardization (ISO) and the International Telecommunications Union (ITU). National and Regional Standards bodies generally adopt or modify International Standards.
There are thousands of Standards, numbered by industry and grouped into ‘families’.
For manufacturing, the applicable Standard is ISO 9001: 2015.
The ISO 9000 family of standards includes ISO 9001 and 9000.
Some other common Standards include:
- ISO 13485: Medical devices and equipment
- ISO 14000: Environmental management
- ISO/TS 29001: Gas and oil industry
- ISO/IEC 90003: Software engineering
- ISO 5001:Occupational health and safety
- ISO 27001: Information security
Romar ISO certification
To gain certification, specialist third-party certifying agencies assess a company’s services, products and processes. In 2018, DQS, an international Standards certifier, audited our facilities and processes and awarded us with ISO 13485 (2016) and ISO 9001 (2015). This re-certification is essential to assure our clients that we are certified to the latest industry Standards.
With ISO 13485, we are certified to provide medical devices and related services that consistently meet customer and applicable regulatory requirements, including management of risk-based decisions related to purchasing, design, development, manufacturing and production control.
We produce our medical device manufacturing, medical grade silicone and other manufacturing in our ISO Class 8 clean room, a state-of-the-art facility certified to ISO 13485 which ensures a low level of environmental pollutants.
ISO 9001 is the world’s most commonly used Standard for quality management systems. Our ISO 9001 certification ensures we manufacture products and services of consistent quality that meet customer requirements, adhere to our internal standards and comply with required legislation.
Expertise for exceptional manufacturing
Romar is a leader in multiple strands of manufacturing including advanced manufacturing, medical grade silicone and micromolding, thanks to our advanced technology, facilities and world-class engineering experts.
We also provide tailored manufacturing solutions across sectors including aerospace, mining and defence.
For high quality manufacturing and expert industry knowledge, please contact us.
Ready to Step into the Future of Manufacturing?
Contact Romar today to start the conversation.
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