http://www.risk-technologies.comhttp://www.risk-technologies.comhttp://www.eu-vri.euhttp://www.steinbeis.de
 
 
  
 

Standard requirements

ISO 9001:2015 text for reference

 

10 Improvement

10.1 General

The organization shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.

These shall include:

a) improving products and services to meet requirements as well as to address future needs and expectations;

b) correcting, preventing or reducing undesired effects;

c) improving the performance and effectiveness of the quality management system.

NOTE Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation and re-organization.

10.2 Nonconformity and corrective action

10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall:

a) react to the nonconformity and, as applicable:

1) take action to control and correct it; 2) deal with the consequences;

b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:

1) reviewing and analysing the nonconformity; 2) determining the causes of the nonconformity; 3) determining if similar nonconformities exist, or could potentially occur;

c) implement any action needed;

d) review the effectiveness of any corrective action taken;

e) update risks and opportunities determined during planning, if necessary;

f) make changes to the quality management system, if necessary.

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

10.2.2 The organization shall retain documented information as evidence of:

a) the nature of the nonconformities and any subsequent actions taken;

b) the results of any corrective action.

10.3 Continual improvement

The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system.

The organization shall consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement.

 
   
 
 
10.1 General
 
 

Customer focus

Management and employees of R-Tech/EU-VRi are focused on meeting customer requirements. Procedures are provided and implemented to determine customer requirements in contracting phase, to fulfill these requirements by proper planning of product/service realization and to enhance level of satisfaction by monitoring customer satisfaction and initiating preventive and improvement actions. The management ensures that customer requirements are communicated and provided as agreed upon. The responsible project manager (PM) have the primary responsibilities for determining and defining customer needs, expectations, and software / product / service requirements. R-Tech/EU-VRi management is committed to establishing and maintaining effective relationships with its customers and continuously improving customer satisfaction.

After completion of major projects R-Tech/EU-VRi R-Tech conducts surveys on customer satisfaction. This feedback is available in form of letters from customers and is filed in corresponding project maps. 

Product

R-Tech/EU-VRi implements inspection and test points to ensure product requirements are met. PM work from detailed work procedures. Records are maintained on all inspection and testing activities.

R-Tech/EU-VRi performs functional and final testing according to the test planning procedureInspection and test records are recorded by the performing function and maintained electronically on the R-Tech/EU-VRi internal network. Records include, but are not limited to: product identification, quantity of product inspected, inspection procedures followed, person performing the test and inspection, date of inspection and/or test, number, type, and severity of defects found.
Product re-qualification / retesting of released product is accomplished by QMG on a periodic basis. “Retesting” is conducted in a more robust environment than the original acceptance test.

Provision of Resources
R-Tech/EU-VRi management determines and provides the resources needed to implement and maintain the QMS, and continually improve its effectiveness, and to enhance customer satisfaction by meeting or exceeding customer requirements.

Customer Related Processes
R-Tech/EU-VRi is dedicated to determine and review the customer and product requirements. All affected employees within R-Tech/EU-VRi review each non-standard contract and amendments to contracts to assure the capability and ambition to meet or exceed the customer requirements. Any exceptions are communicated and negotiated with the customer to resolve or obtain the most favorable terms prior to contract signing and execution. The CEO and/or other members of the management are authorized to finalize contract negotiations with unresolved issues if an impasse occurs that could jeopardize the pending business relationship. Records of each contract review are maintained and a copy of the executed contract is distributed to the employees involved in the project for the reference purposes. 
R-Tech/EU-VRi communicates with its customers on product information, contracts, order handling, amendments, customer feedback, including customer complaints. R-Tech/EU-VRi maintains a documented customer notification process to ensure that customers are notified of any product problems or changes that may affect them. 
The warranty period and any special handling requirements are outlined in the repair warranty agreement or customer contract. 
R-Tech/EU-VRi maintains a dedicated Technical Service function whose responsibilities include: providing answers to technical and application questions, assisting in resolution of problems, and Marketing for product training. Product training is available for R-Tech/EU-VRi personnel and customers.
Documented procedures have been developed and implemented defining processes for notifying the customer of reported problems, resolution of customer reported problems and providing the customer with feedback. Documented procedures are in place for assigning severity level to customer reported problems to ensure timely resolution.

Customer satisfaction
Methods have been established to collect data from customers concerning their satisfaction with R-Tech/EU-VRi software, products and services. This data is reviewed continuously during management reviews of the QMS.
R-Tech/EU-VRi collects data on delivery and customer response times. This data is reviewed annually and/or monthly by the responsible management and during Management Review.

 

Related Documents:

 
   
 
 
10.2 Nonconformity and corrective action
 
 

Control of nonconforming products 

Nonconforming products are identified and controlled using procedure Control of nonconforming product which defines activities and responsibilities for dealing with nonconforming product. 

The analysis of detected nonconformity is conducted in order to define the measure to eliminate the nonconformity. Nonconformity can be resolved by repairing and in some cases by using non-conforming product but under concession (to be agreed with the customer or authorities if applicable).

Repaired product (e.g. software) is subjected to the re-verification procedure as defined by product realization procedure and test planning before delivery take place.

If nonconforming product can not be repaired or used as it is, it is marked as non-conforming.

Records related to the nature of the nonconformity and actions taken are maintained.

Corrective Measures
The R-Tech/EU-VRi corrective measures procedure define the means by which an issue which causes or may/can cause a quality-related problem will be reported, identified and systematically tackled. The originator of the procedure PM defines the problem and QMG assigns the responsible for resolution. Corrective Action Requests are documented in the QMS Records on the R-Tech/EU-VRi portal and maintained for a minimum of one year. The originator of the procedure is responsible for verifying the effectiveness of measures and the QMG periodically audits for the same. All forms of customer complaints (SPS-TR) are captured and maintained within the R-Tech/EU-VRi corrective measures process to assure effective actions are taken and responses provided.

Preventive Measures
Management reviews product and process data identifying potential problems, their causes and determining the action required to eliminate the possibility of occurrence. Preventative measures are documented utilizing R-Tech/EU-VRi’s documented Corrective and Preventive Measues procedure.

All R-Tech/EU-VRi associates are encouraged to analyze the need for preventative action when implementing or changing actions or functions.

MANL: Measurements, Analysis & Improvement

Related Documents:

 
   
 
 
10.3 Continual improvement
 
 

Analysis of Data
Data and information recorded in quality records are compiled and analyzed periodically to determine trends in the performance and effectiveness of the quality system and to identify opportunities for improvement Some data utilized in this process comes from, but is not limited to, the following:

 

Continuous Improvement

R-Tech/EU-VRi maintains a documented quality improvement to promote continuous improvement of customer satisfaction, products, services, and processes within R-Tech/EU-VRi. 

MANL: Measurements, Analysis & Improvement

 

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