Standard requirements

ISO 9001:2015 text for reference

 

9 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

The organization shall determine:

a) what needs to be monitored and measured;

b) the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results;

c) when the monitoring and measuring shall be performed;

d) when the results from monitoring and measurement shall be analysed and evaluated.

The organization shall evaluate the performance and the effectiveness of the quality management system.

The organization shall retain appropriate documented information as evidence of the results.

9.1.2 Customer satisfaction

The organization shall monitor customers' perceptions of the degree to which their needs and expectations have been fulfilled. The organization shall determine the methods for obtaining, monitoring and reviewing this information.

NOTE Examples of monitoring customer perceptions can include customer surveys, customer feedback on delivered products and services, meetings with customers, market-share analysis, compliments, warranty claims and dealer reports.

9.1.3 Analysis and evaluation

The organization shall analyse and evaluate appropriate data and information arising from monitoring and measurement.

The results of analysis shall be used to evaluate:

a) conformity of products and services;

b) the degree of customer satisfaction;

c) the performance and effectiveness of the quality management system;

d) if planning has been implemented effectively;

e) the effectiveness of actions taken to address risks and opportunities;

f) the performance of external providers;

g) the need for improvements to the quality management system.

NOTE Methods to analyse data can include statistical techniques.

9.2 Internal audit

9.2.1 The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system:

a) conforms to:

1) the organization's own requirements for its quality management system; 2) the requirements of this International Standard;

b) is effectively implemented and maintained.

9.2.2 The organization shall:

a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning require-ments and reporting, which shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits;

b) define the audit criteria and scope for each audit;

c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;

d) ensure that the results of the audits are reported to relevant management;

e) take appropriate correction and corrective actions without undue delay;

f) retain documented information as evidence of the implementation of the audit programme and the audit results.

NOTE See ISO 19011 for guidance.

9.3 Management review

9.3.1 General

Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.

9.3.2 Management review inputs

The management review shall be planned and carried out taking into consideration:

a) the status of actions from previous management reviews;

b) changes in external and internal issues that are relevant to the quality management system;

c) information on the performance and effectiveness of the quality management system, including trends in: 1) customer satisfaction and feedback from relevant interested parties; 2) the extent to which quality objectives have been met; 3) process performance and conformity of products and services;

4) nonconformities and corrective actions; 5) monitoring and measurement results; 6) audit results; 7) the performance of external providers;

d) the adequacy of resources;

e) the effectiveness of actions taken to address risks and opportunities (see 6.1);

f) opportunities for improvement.

9.3.3 Management review outputs

The outputs of the management review shall include decisions and actions related to:

a) opportunities for improvement;

b) any need for changes to the quality management system;

c) resource needs.

The organization shall retain documented information as evidence of the results of management reviews. 
 
   
 
 
9.1 Monitoring, measurement, analysis and evaluation
 
 

As declared in R-Tech/EU-VRi's quality policy, the company is committed to providing its customers with dependable, cost effective, state-of-the-art products and services delivered according to stated specification and applicable quality standards. In the case of EU-VRi, customers include Founding Members and Associate Members of the grouping, some of them being involved in projects coordinated by EU-VRi. The main aim of the policy is achieving full and measurable satisfaction of respective customer(s) and ensuring continuous/continual improvement of the products, services and internal processes of R-Tech/EU-VRi.  

R-Tech/EU-VRi considers meeting its and its customers' quality objectives as a high priority and therefore strives to ensure that processes and product development/delivery are measured and monitored in a structured manner:

PROC-GP: Measurements of Products and Processes details the requirements for measuring and monitoring, including the method and frequency per sub-process (e.g. offer/proposal preparation, software tests and validation, etc.)

The results of the ongoing QM evaluation are assessed on case basis in real-time and are re-evaluated during the internal audit.

 

Customer satisfaction

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 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.

As customer satisfaction is a key issue for R-Tech/EU-VRi, management involves itself directly in any and all cases where customer satisfaction may prove to become either a risk or an opportunity. Customer feedback is collected, assessed and acted upon in real-time by management. 

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. 

 

Relevant processes and documents:

PROC-ENG: Customer-Related Processes

Customer feedback

Customer satisfaction indicators

Customer satisfaction survey

MANL: Management Responsibility

MANL: Resource Management

 

Analysis and evaluation

Advanced Risk Technologies Group and EU-VRi have established their documented Quality Management System (QMS) to ensure control and continuous improvement of the QMS processes. The QMS is set forth in this handbook and is detailed in the quality procedures. The procedures also define elements such as products, customer communication, documentation requirements, internal auditing, manufacturing procedures, supplier evaluation and control, performance measurements and implementing corrective and preventive measures.

A separate set of procedures is provided for:

  • Project Management
  • Product realization
  • Analysis / Improvement
  • Quality improvement

The QMS applies to interactions between different activities such as Project Acquisition & Management, Research, Development, Education, Supporting activities, Training, Purchasing, Subcontracting, Technical activities, Engineering, Contracts/Project Management

Statistical techniques and team tools are used throughout R-Tech/EU-VRi processes to assure process controls and continuous improvement, as well as verification of results. This data is reviewed regularly to determine appropriate changes required to cause consistent improvement.  

 

MANL: Quality Function Flowchart of Product Realization

MANL: Measurements, Analysis & Improvement

 

 
   
 
 
9.2 Internal audit
 
 

R-Tech/EU-VRi maintains an audit program in order to ensure conformity with management's quality requirements and objectives as well as the requirements presented by ISO 9001:2015 standard.

For this purpose, R-Tech/EU-VRi has established a strict internal audit procedure which defines the following:

  1. the audit's scope
  2. responsibilities
  3. schedules
  4. proper conduct of the internal audit
  5. control of measures to be taken
  6. report
  7. document

Related documents and procedures:

PROC-GP: Overview of the Overall Organization of Internal Audit and Management Review

PROC-GP: Internal Audit

PROC-GP: Corrective and Preventive Measures

PROC-GP: Document Management

QMS-CHK02: Checklist Internal Audit 

PROC-GP: Control of Non-Conforming Products

PROC-SW: Software / Product / Service Development Issue Reporting Procedure

Management reviews

 

 

 
   
 
 
9.3 Management review
 
 

Management Commitment

R-Tech/EU-VRi is committed to developing and implementing of QMS and its continuous improving. The management of R-Tech/EU-VRi is communicating to the employees the importance of meeting customers as well as statutory and regulatory requirements. It has established the quality policy and defined quality objectives. In order to ensure the quality of the products and performance, management conducts management reviews and ensures the availability of resources. 

Therefore, management follows a strict management review procedure to ensure a consistent and sustainable high quality and control over the performance of the company in light of past project management and customer feedback.

 

Inputs:

The management review is commissioned from the QMG by the management. The QMG plans the schedule for a series of meetings with the office employees culminating in the Internal audit report.

Internal audit checklist

QMS audits

Previous management reviews

Management review checklist

QMS indicators

 

Outputs:

The management review culminates in an executive meeting where the internal audit and other inputs are presented. 

Management assess the controlled period and re-evaluates its environment, risk analysis, goals and resulting strategy; review outcomes are QM instructions are recorded in the management review checklist.

 

PROC-GP: Overview of the Overall Organization of Internal Audit and Management Review

MANL: Management Responsibility