Dynamic Controls manufacture to exacting standards supported by well-designed and controlled management and production systems. Our process and quality systems exceed the highest international regulatory standards, including the FDA (US), and CE (Europe).
Global quality standards
Dynamic Controls is certified to ISO 13485:2003, which is the international standard for quality system design within the medical device manufacturing industry.
ISO 13485:2003 is harmonized with the ISO 9001:2000 standard and includes within it, additional requirements specific to medical device manufacture. The standard encompasses all areas of quality assurance, including design, development, production, installation and servicing. Consequently Dynamic Controls are also certified to ISO 9001:2000
Europe
Dynamic Controls quality systems comply with CE requirements, as detailed in the Medical Devices Directive, 93/42/EEC.
United States
Dynamic Controls manufacturing systems comply with the FDA's requirements of 'Current Good Manufacturing Practice', Quality System Regulation (QSR) reference 21CFR, section 820. This standard is auditable, with our most recent audit being successfully conducted in December 2006.
Rigorous manufacturing audits
We have undergone successful supplier audits conducted by global players in the telecommunications and automotive industries, each with sales in excess of USD 3 billion.
Corrective Actions
A robust corrective and preventative action process exists, which has been designed to exceed the requirements of the ISO Standards and ensure that Dynamic Controls is a proactive "improvement" based organisation, constantly striving for product and process improvement.
The principles of 8D containment are applied, including root cause identification, corrective action and validation of the effectiveness of any counter-measures applied.
A parallel process of managing service returns including fault identification and service repair can also be provided. In addition, the company operates an effective database analysis tool used to identify and react to any trends, which may affect the long-term integrity of products.
Trainings
Dynamic Controls employs a training philosophy and program which not only meets the requirements of the ISO 9001 and ISO 13485 standards, but also empowers employees to improve their knowledge of both their own task but also the culture and business fundamentals of Dynamic Controls. This ensures that the workforce is competent and capable of performing their role, but also that they are committed to achieving the company's objectives.
Traceability
Dynamic Controls provides traceability of parts from receipt through to completion of finished product. Full lot traceability can be provided if required.
Through utilising bar-coding technology the receipt and movement of materials can be effectively tracked throughout the business.
Reporting
Dynamic Controls employs a thorough analyses and reporting system which allows the company to effectively monitor it's key operations. Such monitoring, not only ensures that product specification is mainlined but it is also a fundamental part of the company's business improvement ethos.
Continuous improvement
Continuous improvement is achieved through a number of initiatives. These initiatives include, but are not restricted to,
- Internal Quality Auditing.
- The daily review of manufacturing quality performance, including any occurrence of non-conformance.
- The weekly review of manufacturing cell quality performance.
- Ongoing training in improvement skills and techniques which are provided to all employees throughout the business.
