Quality Management Systems
UL
Our team can assist with your design efforts, help troubleshoot tough problems, and provide up-to-date and unbiased guidance on domestic and international regulations that may apply to your product.
Our team will help you get your product to market faster other UL consultant companies. With our help, you can get from submittal to certification report in as little as 4 weeks.
When the engineering evaluation is completed, your evaluation plan will be developed. With the proper planning, your product will pass the tests. If there is a test failure, we know how to help correct the problem. The engineers at our company have a tremendous relationship with their UL counterparts. It truly is a successful partnership.
FDA
Our experience helps our clients with professional service to register your company with US FDA, classify and list your products and serve as US Agent. We provide efficient and personal service to you in complying with the registration requirements of the US FDA. Our Team gets you into compliance with the law so your products can be used in the US.
We handle FDA registrations: we register your food or medical device with the FDA and advise of your mandatory FDA Registration Number;
We serve as your mandatory ” Agent” for foreign food or medical device facilities;
We monitor the registration laws and regulations and keeps you advised of any changes to them that might affect your US FDA registration;
We interact between the FDA and you as your agent for all alerts, notices and communications to comply with the Laws
We CONFIDENTIALLY transmit all legally required notices and communications between the FDA and your food facility;
FCC
The Federal Communications Commission (FCC) is an independent United States government agency. The FCC was established by the Communications Act of 1934 and is charged with regulating interstate and international communications by radio, television, wire, satellite and cable. The FCC’s jurisdiction covers the 50 states, the District of Columbia, and U.S. possessions.
Our FCC Services include electromagnetic compatibility, regulatory compliance, qualification, environmental, FCC Compliance services. We assist our clients to be FCC compliance which includes all Military, Consumer and commercial FCC compliance.
ISO
Our company can provide you with the support you need to achieve and maintain ISO certification for your organization. Based on your company’s needs, O&A will assemble a team of experts that can guide you through the steps required to implement a simple, streamlined quality management system that meets ISO requirements and continually improves your business performance.
We assist many small- and medium-sized businesses in working towards ISO certification. Our clients enjoy our flexibility in organizing the process to fit their needs and view us as their partner. Our team is committed to delivering high-quality service. Our consulting services include assistance in all phases of ISO certification: From ISO preparation to ISO documentation, implementation and execution and finally to ISO maintenance. Examples of our services are:
ISO Planning & Project Management
ISO Pre-certification/Pre-Assessment
Gap Analysis
Internal Audit, Maintenance Audits
Document Control System Development
Non-conforming Documents Correction
ISO Implementation & Execution Assistance
Continuous Improvement Implementation
Calibration Processes Analysis
Strategic Quality Plan Development
EMC
Our company transforms information into business results.
Our consultants bring a unique mix of industry, business, and technology expertise to solve today’s toughest challenges.
We help organizations create innovative user experience and designs that transform information into consumable and personalized views.
With expertise in the retail, finance, entertainment, telco and utilities sectors, we have industry-leading capabilities in developing digital applications.
Services we offer includes filter designs, product reviews, EMC test plans and EMC training seminars tailored to customer products and industry requirements.
Our area of expertise includes new product designs and product retrofits that require EMC regulatory compliance or functional needs for:
All types of motors (AC or DC, brushed commutated or electrically commutated)
Printed circuit boards
Connectors
Integrated circuits
Component evaluation and characterization
Complex electro-mechanical assemblies
CE
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives.
Often customers will look for CE marking on a product as an indication of conformance to laid down minimum standards, and therefore a minimum level of quality that other products may lack.
If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the members states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.
Product Directives contains the “essential requirements” and/or “performance levels” and “Harmonized Standards” to which the products must conform. Harmonized Standards are the technical specifications (European Standards or Harmonization Documents) which are established by several European standards agencies (CEN, CENELEC, etc).
Six Sigma
Six Sigma is a rigorous and a systematic methodology that utilizes information (management by facts) and statistical analysis to measure and improve a company’s operational performance, practices and systems by identifying and preventing ‘defects’ in manufacturing and service-related processes in order to anticipate and exceed expectations of all stakeholders to accomplish effectiveness.
Our Practice works closely with clients to assist in the definition and introduction of rapid, optimized processes tailored for specific business needs. We work with client organizations through ongoing training, mentoring, and management assistance to ensure successful introduction of new methods – and achieve the best possible results. The goal of Six Sigma is to increase profits by eliminating variability, defects and waste that undermine customer loyalty.
Six Sigma at many organizations simply means a measure of quality that strives for near perfection. Six Sigma is a disciplined, data-driven approach and methodology for eliminating defects in any process – from manufacturing to transactional and from product to service.
Six Sigma can be understood/perceived at three levels: Metric, Methodology and Philosophy.