ISO 9001 – Opritech Summary Statement
4.1 General Requirements
At Opritech quality underpins every aspect of our business and our quality systems enable us to deliver the finest products and services to you – every time, on time, the first time.
Opritech takes an integrated approach to Quality management, Health and Safety and sustainable business management. Opritech maintains an Integrated Management System (IMS) manual that details our procedures and operating systems and explains simply how we assure quality manage general business systems.
Opritech has adopted the European Standard ISO 9001 & 13485- Quality Management System and 14001 Environmental Standard.
4.2 Document Requirements
Opritech’s quality management system includes documents such as our quality policy, quality manual (IMS Manual) and records required to show compliance with quality requirements.
4.2.2 Quality Manual
Opritech has established and maintains a quality manual (IMS Manual) which describes all aspects of our quality management system.
4.2.3 Control of Documents
Opritech controls certain documents, approves these documents for adequacy prior to issue and undertakes reviews as required to ensure continued suitability to our business and business processes.
Printed documents apart from the master copy held by the IMS manager should be treated as reference documents only and electronic copies of current documents are stored on our M-files server.
4.2.4 Control of Records
Opritech retains all documents in electronic format within our M-files server. This system tracks all changes to documents, provides access control and is backed up externally to prevent the loss of records in the event of a disaster.
5.2 Management Responsibility
5.2.1 Management Commitment
Opritech upper management provides evidence of its support of our drive for quality by actively being involved with the development and reviewing of quality systems and policies. Management has a very strong view that our quality systems are how we operate our business, not our business trying to operate to a quality standard – that’s how we know we are complying.
5.2.2 Customer Focus
The whole endeavour of our quality systems is to ensure you as our customer receive total support and satisfaction from our products and services and that your experience with Opritech is a long term partnership.
5.2.3 Quality Policy
Opritech upper management actively implements and reviews the Opritech quality policy to ensure it provides an adequate framework in which to operate our business from and ensures its goals and vision are communicated to all staff.
5.4.1 Quality Objectives
Opritech upper management ensures that our quality objectives are set in the form of KPI’s which are generated from CRM and customer feedback and AID (Accident, Incident, Event) forms are relevant and measured and consistent with our policy.
5.4.2 Quality Management System Planning
Opritech upper management holds regular planning meetings to ensure our quality targets are relevant and in keeping with on-going changes to our business environment.
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority
Opritech upper management delegates responsibilities to staff members – responsibilities are noted on the staff organisation chart and positions described in our IMS manual.
5.5.2 Management Representative
Opritech has appointed a representative – the IMS manager – to ensure systems are established, performance is maintained and systems adapted to suit the current requirements of the business and customers. This delegation is depicted on the staff organisation chart.
5.5.3 Internal Communication
Upper management ensures internal communications are appropriate and organised. Communications are largely self-monitored within CRM and our IMS system by automatically implemented work flows along with daily and weekly staff meetings, email and phone communications.
5.6 Management Review
Upper Management at Opritech undertakes regular documented system reviews and records findings in our annual management review plan. Where improvements and changes are required, these are documented and changes made as required to manuals and policies as required.
6 Resource Management
Opritech manages its resources including human, infrastructure and work environment in accordance with our policies. Opritech determines staff competencies and provides training and awareness and documents this on the staff competency matrix.
Opritech maintains crucial infrastructure and our work environment to a high standard to ensure we deliver to the high expectations of our customers.
7.2 Customer Related Processes
Opritech designates staff to the position of account managers to manage customer accounts and ensure that the customer is experiencing the delivery of quality product and services. Documents relating to the management of customer processes are stores on our M-files server and are available to applicable staff.
Customer contacts are maintained by account managers via visits, phone, email and mail messages.
Opritech controls its purchasing via our CRM system. This work flows every sale from the quotation through to the after sales back up and support.
The purchasing officer and marketing manager are responsible to maintain communications with suppliers to ensure products arrive according to specification and are delivered in a timely and suitable condition. Opritech’s accounting system traces every sale and item to the customer and the equipment’s service history is recorded against this customer item.
8 Measure, Analysis and Improvement
Opritech monitors its products and services and report and non-compliances via its events system. Non-conformances are investigated and measures and controls implemented to ensure no re-occurrence of the event.
Suppliers and contractors are evaluated and rated for the quality and performance and high achieving suppliers are promoted with the company.
Opritech’s quality systems are about measure, test and improvement – this is a continuous cycle in delivering quality to our customers.