January 2018
This Manual details Biodata's Quality Management System: its business and management processes and its documented procedures.
Biodata Ltd produces data acquisition and logging systems for product testing, fault recording and event logging. Many systems are individual with specific functions designed and produced for individual customers.
We liase closely with customers prior to accepting an order, and provide effective long term technical support to our customers. We aim to achieve continued improvement in products and services by setting and reviewing quality objectives, and monitoring performance, as illustrated in the Management Process diagram.
The Company has established procedures, instructions and associated documentation which ensures that products and processes conform to specified requirements as defined in ISO 9001:2015.
It is recognised that the quality function requires the total support of management and effectiveness of the system depends upon the commitment of everybody in the company. With a small workforce we involve all our staff in developing our QMS system, so everyone understands what needs to be done to consistently operate and maintain it.
The organisation considers business risks - including legal, technological, competitive and those of the economic environment both nationally and internationally. We review risks, opportunities and the quality process at each management review meeting, which all managers attend. The results of their discussion helps determine the strategic direction of the company and identify improvements which can be made to the quality system and our processes.
Biodata Ltd has adopted the process approach and the 10 clauses defined by ISO 9000 to improve the effectiveness of the QMS, to enhance customer satisfaction and meet customer requirements.
The process model used is the plan-do-check-act method (PDCA) and describes the sequence and interactions of the processes.
Our management system includes all elements of ISO 9001:2015.
Interested parties which are considered in the Quality Management System include customers, suppliers, employees and regulatory bodies. Their needs and expectations are considered at each management review meeting.
Customers
Customer satisfaction is considered throughout the Quality System, especially in Requirement Review, Quotation, Order Review, Customer Feedback and Corrective and Preventative Action. Their needs and expectations are assessed, met and documented through several possible means: sales calls, emails and visits, the Requirement Review process (Work Instructions 7.3 refers), Customer Satisfaction Surveys, technical support enquiries, customer complaints, customer visits to the factory and customer visits to suppliers.
Suppliers
Suppliers' expectations are assessed during Requirement Review and Purchasing, for example in the order format they require and the payment terms.
Employees
Personnel, skills, training requirements and wages are covered in the Quality and Strategic Reviews. Other requests from employees are made to the Managing Director. We are a small company and it is important to us that our employees are well looked after and their needs met.
Regulatory Bodies
Regulatory Bodies require compliance with their standards and regulations. We adhere to ISO9001, WEEE and CE marking – providing the regulatory bodies with the information that they need. The management review meeting considers whether statutory and standards regulations are being met.
Contractors
Very rarely does Biodata have outsourced processes. If they do do use contractors they are first trained in the Quality system and as appropriate for the job.
Biodata has established and maintains this Quality Manual which meets the requirements of ISO 9001:2015. There are no exclusions.
The Quality Manual comprises authorised, controlled, documented procedures and processes, describing the interaction between the processes. It is held in html format on the Microlink web server and is available at http://www.microlink.co.uk/quality/
When printed this Manual become unauthorised and uncontrolled.
Processes described in this Quality Manual are assessed and improvements considered at the Quality Management Review Meeting.
Biodata adopts the definitions provided in ISO 9000: Quality Management - Fundamentals and Vocabulary.