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Services ISO Certification Quality
ISO 9001:2008 - Quality Management Systems
ISO 9001:2008 standard is one of the most popular models which can be applied to all types of enterprises and organizations irrespective of size and activity. ISO 9001:2008 aims at organizing and creating an operating framework for the company to provide products and / or services based on customer needs. The model is based on the Deming cycle and the concept of continuous improvement methodology known as «Plan-Do-Check-Act».
The standard is being implemented as follows:
Each company defines its core processes and control points in order to provide products and / or services that comply with legal and regulatory requirements and meet customer requirements. In addition, the company monitors and measures the performance of these processes, defines specific indicators and targets which are under constant review and determines actions in case of departing.
The implementation steps taken by THOMAS POUTAS developing a Quality Management System ISO 9001:2008 are:
Diagnostic Study. At this stage the current situation is determined. Weaknesses and points of improvement are identified.
Setting Policy, Quality objectives and Organizational structure. At this stage the important documents of the system are being defined, in cooperation with the management. Also the organizational structure if does not exist is, at this stage and the term "quality" is defined.
Development Process.
At this stage the existing procedures are being written down, via interviews with personnel. Based on the standard and best practices the procedures are improved. Also new procedures are being developed. All, the procedures are finalized and approved by management.
At this stage the existing procedures are being written down, via interviews with personnel. Based on the standard and best practices the procedures are improved. Also new procedures are being developed. All, the procedures are finalized and approved by management.
Application Training.
At this stage the staff is trained in quality management system and changes in the business are identified.
At this stage the staff is trained in quality management system and changes in the business are identified.
Test Application Period. At this stage, the Quality Management System is applied for a specific time. In addition, internal audits are contacted and improvement actions are taken based on the audit findings
Certification.
An independent certification body chosen by the business certifies the Quality Management System.
An independent certification body chosen by the business certifies the Quality Management System.
Moreover, THOMAS POUTAS supports the operation after certification by conducting internal audits and providing consulting services.
In addition, THOMAS POUTAS provides its own software e-Qual/QS which allow the electronic management of quality system as it is designed to meet all the requirements of the standard.
ISO 13485 - Quality Management System for Medical Devices
ELOT EN ISO 13485:2003 contains the requirements for implementing quality management system for products of medical use. It involves companies that design, produce and distribute medical products. The standard follows the philosophy and structure of ISO 9001 incorporating by requirement the best practices that should be applied in the specific area. The main differences from the ISO 9001 are discussed below. Specifically, the company must:
- Maintain a file for each medical product that contains the product specifications and requirements related to the quality management system.
- Set a specific time period for keeping the quality system records.
- Set a written procedure for facilities maintenance.
- Set a written procedure for the working environment.
- Set a written procedure for risk management.
- Include the stage of clinical testing in the design and development of new products as defined by law.
- Put great emphasis on product traceability.
- Set specific requirements for the production that include.
- Set a written procedure for providing services (such as technical support, maintenance, repair) associated with the medical product and its specifications.
- Comply with current legislation
- Set a written procedure on product sterilization during production
- Set a written procedure to validate the sterilization process of the product.
- Monitor the condition of the product during production.
- Set a written procedure for monitoring production and quality controls
- Set a written procedure for receiving feedback from the customer which must include the update of the company from using the test product when required by law.
- Define a written procedure for informing stakeholders in case of identifying a problem.
CE – Marking Technical File
In a globalized environment there is a need to establish minimum requirements for the production and marketing of those products that safety is especially critical.
The European Union has adopted a series of European Directives which lay down standards for specific product categories and make mandatory the CE Mark to release these products in the European Economic Area, either the manufacturer is located inside or outside E.U.
But what is the CE Mark? It is a statement made by a manufacturer that the product complies with European Union standards for safety and health of consumers or the environment, as defined in the relevant European Directives.
Some of products requiring CE marking under the European legislation are listed below:
- Low Voltage Equipment
- Simple pressure vessels
- Games
- Construction Products
- Electromagnetic Compatibility
- Personal Protective Equipment
- Instrumentation
- Medical Equipment
- Appliances burning gaseous fuels
- Hot water boilers with liquid or gaseous fuels
- Explosives for civil use
- Pleasure crafts
- Elevators
- Cameras
- Diagnostic medical devices in vitro
- Radio and Telecommunications Terminal Equipment
- People Transport facilities moving with cables
- Environmentally friendly design of products that consume energy
But how can a manufacturer obtain the right to mark his products with the CE Mark? The general steps followed are:
1. Recognition of European Directives related to the product.
2. Recognition of the product category in accordance with the criteria specified in the relevant European Directives.
3. Tests on product samples.
4. Compose technical documentation to prove compliance by the manufacturer with the requirements of European Directives.
5. Depending on the type of product, inspection by the "Notified Body" which will certify the adequacy of technical documentation and proper implementation may be required.
6. Application to the "Competent Authority" for inclusion on the register of manufacturers, after which the manufacturer has the right use the CE Mark.
7. Periodic reassessment of the manufacturer to retain the right to use the CE Mark.
ISO 20000 - Information Technology Services Management
The international standard ISO 20000:2005 aims at an integrated process approach to provide IT services achieving complete conformity to both customer requirements and business requirements. Through the standard implementation overall monitoring and control of services is achieved ranging from planning and implementation of services according to customer needs, to the release and delivery of the service, and addressing potential problems and changes needed.
The main processes considered in the implementation of ISO 20000 are:
- Services
- Managing quality level and characteristics
- Monitoring and reporting
- Ensuring continuity and availability
- Financial monitoring
- Managing the resources
- Information Security Management
- Business relationship Management
- Relationship Management between provider and client
- Relationship Management with suppliers
- Emergency response
- Managing incidents of non-quality service recipients
- Problem Management
- Monitoring the service implementation
- Manage the design and individual components of the service
- Change Management
- Release Management
For all these processes, the service management system creates a solid framework for measuring and monitoring performance on specific quality objectives and enables continuous services improvement, the delivery mechanisms as well as the efficient handling of faults.
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