http://www.risk-technologies.comhttp://www.risk-technologies.comhttp://www.eu-vri.euhttp://www.steinbeis.de
 
 
5.1.1 Leadership and commitment: General
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5630
Last Update by: Katarzyna Tetlak, 24/Oct/17

As from the standard:

"5 Leadership

5.1 Leadership and commitment

5.1.1 General

Top management shall demonstrate leadership and commitment with respect to the quality management system by:

a) taking accountability for the effectiveness of the quality management system;
b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization;
c) ensuring the integration of the quality management system requirements into the organization's business processes;
d) promoting the use of the process approach and risk-based thinking;
e) ensuring that the resources needed for the quality management system are available;
f) communicating the importance of effective quality management and of conforming to the quality management system requirements;
g) ensuring that the quality management system achieves its intended results; h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;
i) promoting improvement;
j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

NOTE: Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization's existence, whether the organization is public, private, for profit or not for profit.

 
   
 
 
5.1.1 Leadership and commitment: General - practical implementation in R-Tech/EU-VRi
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5631
Last Update by: Katarzyna Tetlak, 24/Oct/17

The R-Tech/EU-VRi top management defines, develops and implements the quality management system per Management Review Responsibilities.
Top management demonstrates leadership and ensures that employees at all levels within the organization understand the goals and objectives of The R-Tech/EU-VRi quality management system.
The R-Tech/EU-VRi conducts regular Management Review Meetings and discusses the importance of meeting the following:

  • Customer requirements.
  • Quality objectives / Quality Policy.
  • Statutory, legal, and regulatory requirements.
  • Continuous improvement goals.
  • Availability of resources.
  • Risk analysis
  • Interested parties

The relevant entries can be found under the following links:

Quality Policy - https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2548&pag=601&nr=2#bl1052 ),

2.1 GEN: Quality objectives https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2548&pag=601&nr=2#bl3580 ),

III. 15.1 PROC-ENG: Planning of Product Realization; https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2585&pag=627&nr=15#bl1168).

II.9.5 MANL: Management Responsibility: https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2563&pag=194&nr=9#bl1055).

III.10.1 Internal Audit and Management Review https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2573&pag=548&nr=10#bl4835 / https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2573&pag=548&nr=10#bl965)

III.10.3 Management Review: https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2573&pag=548&nr=10#bl953)

II.9.1 MANL Scope: https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2563&pag=194&nr=9#bl998)

 
   
 
 
5.1.2 Leadership and commitment: Customer focus
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5743
Last Update by: Katarzyna Tetlak, 24/Oct/17

As from the standard:

"5.1.2 Customer focus

Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:
a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met;
b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;
c) the focus on enhancing customer satisfaction is maintained."

 
   
 
 
5.1.2 Customer focus - practical implementation in R-Tech/EU-VRi
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5744
Last Update by: Katarzyna Tetlak, 24/Oct/17

R-Tech/EU-VRi adopts a customer-first approach which ensures that customer needs and expectations are determined, converted into requirements and are met with the aim of enhancing customer satisfaction.

This is accomplished by assuring:

a)    customer and applicable statutory and regulatory requirements are determined, understood and consistently met;
b)    the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;
c)     the focus on enhancing customer satisfaction is maintained.

 

The relevant entries can be found under the following links:

I.2.2 Quality Objectives: https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2548&pag=601&nr=2#bl3580

II.9 MANL Measurements, Analysis & Improvement: https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2563&pag=194&nr=9#bl891

 
   
 
 
5.2.1 Policy: Establishing the quality policy
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5745
Last Update by: Katarzyna Tetlak, 24/Oct/17

as from the standard:

"5.2 Policy

 5.2.1 Establishing the quality policy

Top management shall establish, implement and maintain a quality policy that:

a) is appropriate to the purpose and context of the organization and supports its strategic direction;
b) provides a framework for setting quality objectives;
c) includes a commitment to satisfy applicable requirements;
d) includes a commitment to continual improvement of the quality management system."

 

 
   
 
 
5.2.1 Establishing the quality policy - practical implementation in R-Tech/EU-VRi
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5746
Last Update by: Katarzyna Tetlak, 24/Oct/17

R-Tech/EU-VRi 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. The quality policy acts as a compass by providing the direction and framework for establishing key corporate level performance measures, as well as related objectives and targets. Top management ensures that corporate policies are established and documented, and that the policies are available to all interested parties via our website.

The policy is reviewed at least annually, as part of the management review programme or at a frequency determined by:

1. The changing needs and expectations of relevant interested parties

2.The risks and opportunities that are presented through the risk management process

The relevant entries can be found under the following links:

Quality Policy: https://www.risk-technologies.com/home.aspx?lan=230&pag=601#bl1052

Quality Objectives: https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2548&pag=601&nr=2#bl3580

II.9.1 Scope: https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2563&pag=194&nr=9#bl998
 
   
 
 
5.2.2 Policy: Communicating the quality policy
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5747
Last Update by: Katarzyna Tetlak, 24/Oct/17

as from the standard:

"5.2.2 Communicating the quality policy

The quality policy shall:
a) be available and be maintained as documented information;
b) be communicated, understood and applied within the organization;
c) be available to relevant interested parties, as appropriate."

 

 
   
 
 
5.2.2 Communicating the quality policy- practical implementation in R-Tech/EU-VRi
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5749
Last Update by: Katarzyna Tetlak, 24/Oct/17

Management Board as well as QMG at The R-Tech/EU-VRi  is responsible for assuring the quality policy is understood, implemented, and maintained at all levels. This is accomplished through one-on-one and/or group training of all employees. The quality policy describes R-Tech/EU-VRi overall intentions and directions with regard to quality. Postings of this policy can be found throughout all facilities, e.g. e-mails, direct communication, team meetings, etc. The quality policy is communicated to all employees at all levels also throughout training (see regular internal communications and reinforcement during annual employee performance (CDD) reviews.

The relevant entry can be found under the following link:

CDD - https://www.risk-technologies.com/home.aspx?lan=230&pag=1545#bl4300

 
   
 
 
5.3 Organizational roles, responsibilities and authorities
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5750
Last Update by: Katarzyna Tetlak, 24/Oct/17

as from the standard:

"5.3 Organizational roles, responsibilities and authorities

Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization.

Top management shall assign the responsibility and authority for:
a) ensuring that the quality management system conforms to the requirements of this International Standard;
b) ensuring that the processes are delivering their intended outputs;
c) reporting on the performance of the quality management system and on opportunities for improvement (see 10.1), in particular to top management;
d) ensuring the promotion of customer focus throughout the organization;
e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented."



 
   
 
 
5.3 Organizational roles, responsibilities and authorities - practical implementation in R-Tech/EU-VRi
 
  
   
 
 
7.1.1 Support: Resources General:
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5752
Last Update by: Katarzyna Tetlak, 24/Oct/17

as from the standard:

"7 Support
7.1 Resources
7.1.1 General

The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system.

The organization shall consider:
a) the capabilities of, and constraints on, existing internal resources;
b) what needs to be obtained from external providers."


 
   
 
 
7.1.1 Support: Resources General - practical implementation in R-Tech/EU-VRi
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5753
Last Update by: Katarzyna Tetlak, 24/Oct/17

R-Tech/EU-VRi determines and provides the resources needed:

a)    to implement and maintain the management system and continually improve its effectiveness
b)     to enhance customer satisfaction by meeting customer requirements

Resource allocation is done with consideration of the capability and constraints on existing internal resources, as well as needs related to supplier expectations.

Resources and resource allocation are assessed during management reviews.

The relevant entries can be found under the following links:

https://www.risk-technologies.com/home.aspx?lan=230&pag=194#bl4294

 
   
 
 
7.1.2 Support: Resources People:
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5754
Last Update by: Amrita Choudhary, 24/Oct/17

as from the standard:

7.0 Support
7.1 Resources
7.1.2. People

The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.

 
   
 
 
7.1.2 Support: Resources People - practical implementation in R-Tech/EU-VRi:
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5755
Last Update by: Amrita Choudhary, 24/Oct/17

R-Tech/EU-VRi senior management ensures that it provides sufficient staffing for the effective operation of the management system, as well its identified processes.

The relevant entries can be found under the following links:

https://www.risk-technologies.com/home.aspx?lan=230&pag=194#bl4294

PROC-HRM: Personel Data
PROC-HRM: New Employees
Training Plan
Personel Responsibility per Project
ISO 9001:2008 § 6.2 Human resources

 
   
 
 
6.1 Planning: Actions to address risks and opportunities
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5756
Last Update by: Anabela Reis, 25/Oct/17

as from the standard:

"6. Planning
6.1 Actions to address risks and opportunities

6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:
a) give assurance that the quality management system can achieve its intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement.
6.1.2 The organization shall plan:
a) actions to address these risks and opportunities;
b) how to:
            1) integrate and implement the actions into its quality management system processes (see 4.4);
            2) evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.
NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.
NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new customers, building partnerships, using new technology and other desirable and viable possibilities to address the organization's or its customers' needs."

 
   
 
 
6.2 Planning: Quality objectives and planning to achieve them
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5757
Last Update by: Anabela Reis, 25/Oct/17

as from the standard:

"6.2 Quality objectives and planning to achieve them

6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system.
The quality objectives shall:
a) be consistent with the quality policy;
b) be measurable;
c) take into account applicable requirements;
d) be relevant to conformity of products and services and to enhancement of customer satisfaction;
e) be monitored;
f) be communicated;
g) be updated as appropriate.
The organization shall maintain documented information on the quality objectives.

6.2.2 When planning how to achieve its quality objectives, the organization shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated."


 
   
 
 
6.3 Planning: Planning of changes
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5758
Last Update by: Anabela Reis, 25/Oct/17

as from the standard:

"6.3 Planning of changes

When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner (see 4.4).
The organization shall consider:
a) the purpose of the changes and their potential consequences;
b) the integrity of the quality management system;
c) the availability of resources;
d) the allocation or reallocation of responsibilities and authorities."

 
   
 
 
6.1 Planning: Actions to address risks and opportunities - practical implementation in R-Tech/EU-VRi
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5762
Last Update by: Anabela Reis, 25/Oct/17

Note: R-Tech/EU-VRi deviates slightly from the approach towards risk and opportunity presented in ISO 9001. Instead, R-Tech/EU-VRi views “uncertainty” as neutral, but defines “risk” as a negative effect of uncertainty, and “opportunity” as a positive effect of uncertainty. R-Tech/EU-VRi has elected to manage risks and opportunities separately, except where they may overlap. Formal threat management may not be utilized in all instances; instead, the level of risk assessment, analysis, treatment and record keeping will be performed to the level deemed appropriate for each circumstance or application.

R-Tech/EU-VRi considers risks and opportunities when taking actions within the management system, as well as when implementing or improving the management system; likewise, these are considered relative to products and services. Risks and opportunities are identified as part of the SWOT analysis for EU-VRi/R-Tech, as well as throughout all other activities of the QMS.

Risks and opportunities are managed in accordance with the Corrective and Preventive Measures, which defines how risks are managed in order to minimize their likelihood and impact, and how opportunities are managed to improve their likelihood and benefit.

The relevant entries can be found in the links bellow:
https://www.risk-technologies.com/home.aspx?lan=230&pag=696#bl2580
https://www.risk-technologies.com/home.aspx?lan=230&pag=548#bl954

 
   
 
 
6.2 Planning: Quality objectives and planning to achieve them - practical implementation in R-Tech/EU-VRi
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5763
Last Update by: Anabela Reis, 25/Oct/17

As part of the adoption of the process approach, R-Tech/EU-VRi utilizes its process objectives, as discussed in 4.4 above, as the main quality objectives for the QMS. These include overall product-related quality objectives; additional product-related quality objectives may be defined in work instructions or customer requirements.

The process objectives have been developed in consideration that they:

a)    be consistent with the quality policy;

b)    be measurable;

c)    take into account applicable requirements;

d)    be relevant to conformity of products and services and to enhancement of customer satisfaction;

e)    be monitored;

f)     be communicated;

g)    be updated as appropriate.

Process quality objectives are defined in the minutes of management review per section 9.3 below.

The planning of process quality objectives is defined in section 4.4. above.

 
   
 
 
6.3 Planning: Planning of changes - practical implementation in R-Tech/EU-VRi
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5764
Last Update by: Anabela Reis, 25/Oct/17

Changes to the quality management system and its processes are carried out in a planned manner according to the Quality management system planning.

The relevant entry can be found in the link bellow:
https://www.risk-technologies.com/home.aspx?lan=230&pag=194#bl1055

 
   
 
 
8.1 Operational Planning and control
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5765
Last Update by: Vanessa Pfau, 26/Oct/17

as from the standard:

 8 Operation

8.1 Operational planning and control

The organization shall plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6, by:

a) determining the requirements for the products and services;

b) establishing criteria for:

1) the processes;

2) the acceptance of products and services;

c) determining the resources needed to achieve conformity to the product and service requirements;

d) implementing control of the processes in accordance with the criteria;

e) determining, maintaining and retaining documented information to the extent necessary:

1) to have confidence that the processes have been carried out as planned;

2) to demonstrate the conformity of products and services to their requirements.

The output of this planning shall be suitable for the organization's operations.

The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.

The organization shall ensure that outsourced processes are controlled (see 8.4).

 
   
 
8.1 Operational planning and control - practical implementation in R-Tech/EU-VRi
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5766
Last Update by: Snežana Jovanovic, 26/Oct/17

 

R-Tech/EU-VRi establishes and implements documented plans and procedures that describe the processes and the controls required for the provision of services in awareness to the objectives, the potential for planned or unintended change, and the risks and opportunities.

The relevant entries can be found under the following links:

II.9.7 MANL: Product Realization and Quality Function Description: https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2563&pag=194&nr=9#bl999

II.9.8 MANL: Project Realization: https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2563&pag=194&nr=9#bl1147

III.11 Instructions and Procedures: Finance:

 

 

 

 

 

 
8.2.1 Customer communication
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5767
Last Update by: Vanessa Pfau, 26/Oct/17

As from the standard:

8.2 Requirements for products and services

8.2.1 Customer communication

Communication with customers shall include:

a) providing information relating to products and services;

b) handling enquiries, contracts or orders, including changes;

c) obtaining customer feedback relating to products and services, including customer complaints;

d) handling or controlling customer property;

e) establishing specific requirements for contingency actions, when relevant.

 
8.2.1 Customer communication - practical implementation in R-Tech/EU-VRi
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5768
Last Update by: Snežana Jovanovic, 26/Oct/17

In accordance with our commitment to exceed our customer’s expectations, R-Tech/EU-VRi highlights effective customer communication as an essential element of delivering customer satisfaction. Appropriate handling of customer communication helps to reduce customer dissatisfaction and in many cases turn a dissatisfying scenario into a satisfying experience. Customer communication occurs through the following formats, events and processes:

1.Leaflets,  brochures, specifications or technical data sheets relating to our projects, products and services

2. Enquiries, quotations and order forms, invoices and credit notes

3. Confirmation of authorised orders and amended orders

4. E-mails, letters and general correspondence

5. Customer feedback and complaints management process

The revelant entries can be found under the following links:

 

Hier die links

 
8.2.2 Determining the requirements for products and services
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5769
Last Update by: Snežana Jovanovic, 26/Oct/17

As from the standard:

When determining the requirements for the products and services to be offered to customers, the organization shall ensure that:

a) the requirements for the products and services are defined, including:

1) any applicable statutory and regulatory requirements;

2) those considered necessary by the organization;

b) the organization can meet the claims for the products and services it offers.

 
8.2.2 Determining the requirements for products and services - practical implementation in R-Tech/EU-VRi
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5770
Last Update by: Snežana Jovanovic, 26/Oct/17

 

R-Tech/EU-VRi develops appropriate requirements to ensure that we satisfy the needs and expectations of our customers or relevant interested parties. R-Tech/EU-VRi ensures that customer requirements are clearly articulated and that their requirements are captured and understood before the acceptance of an order.

Customer requirements include the following:

1. Previous customer requirements

2. Statutory and regulatory requirements related to the product

3. Other non-customer specified performance requirements

4. Any additional requirements determined by R-Tech/EU-VRi

 

The relevant entries can be found under the following links:

II.9.7 MANL: Product Realization and Quality Function Description: https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2563&pag=194&nr=9#bl999

 
8.2.3 Review of the requirements for products and services
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5771
Last Update by: Snežana Jovanovic, 26/Oct/17

As from the standard:

8.2.3.1 The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to customers. The organization shall conduct a review before committing to supply products and services to a customer, to include:

a) requirements specified by the customer, including the requirements for delivery and post-delivery activities;

b) requirements not stated by the customer, but necessary for the specified or intended use, when known;

c) requirements specified by the organization;

d) statutory and regulatory requirements applicable to the products and services;

e) contract or order requirements differing from those previously expressed.

 

The organization shall ensure that contract or order requirements differing from those previously defined are resolved.

The customer's requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements

 

8.2.3.2 The organization shall retain documented information, as applicable:

a) on the results of the review;

b) on any new requirements for the products and services.

 
 
7.1.3 Support: Resources Infrastructure:
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5772
Last Update by: Amrita Choudhary, 26/Oct/17

as from the standard:

7.0 Support
7.1 Resources
7.1.3. Infrastructure

The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.

NOTE Infrastructure can include:

a) buildings and associated utilities; 
b) equipment, including hardware and software;
c) transportation resources;
d) information and communication technology.

 
   
 
 
7.1.3 Support: Resources Infrastructure- practical implementation in R-Tech/EU-VRi:
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5773
Last Update by: Amrita Choudhary, 26/Oct/17

R-Tech/EU-VRi management is responsible for ensuring that buildings, workspaces, associated utilities, process equipment (both hardware and software), and supporting services (such as transport or communication) are sufficient to support product conformity. 
The main infrastructure is the IT one which is key for all activities of R-Tech/EU-VRi. The full list of project web sites is available as well as the list of software packages being used in projects.

Related link:

 INSTR-WM: Web Site(s) structure

 
   
 
 
7.1.4 Support: Resources Environment for the operation of processes:
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5774
Last Update by: Amrita Choudhary, 26/Oct/17

as from the standard:

7.0 Support
7.1 Resources
7.1.4. Environment for the operation of processes

The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.

NOTE - A suitable environment can be a combination of human and physical factors, such as:

a) social (e.g. non-discriminatory, calm, non-confrontational);
b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective); 
c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).

These factors can differ substantially depending on the products and services provided.

 

 
   
 
 
7.1.4 Support: Resources Infrastructure- practical implementation in R-Tech/EU-VRi:
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5775
Last Update by: Amrita Choudhary, 26/Oct/17

R-Tech/EU-VRi management determines and manages the work environment to ensure product conformity. Areas used for administration, operations, development and storage of products/documents shall be clean, safe and organized.

The relevant entry can be found in the link below:
 
GEN: Office Related Information 

 
   
 
 
7.1.5 Support: Resources Monitoring and measuring resources General:
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5776
Last Update by: Amrita Choudhary, 26/Oct/17

as from the standard:

7.0 Support
7.1 Resources
7.1.5 Monitoring and measuring resources
7.1.5.1 General

The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. 
The organization shall ensure that the resources provided:

a) are suitable for the specific type of monitoring and measurement activities being undertaken;
b) are maintained to ensure their continuing fitness for their purpose.

The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.

 

 
   
 
 
7.1.5.1 Support: Resources Monitoring and measuring resources General - practical implementation in R-Tech/EU-VRi:
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5777
Last Update by: Amrita Choudhary, 26/Oct/17

R-Tech/EU-VRi determines which devices will be subject to calibration based on its processes, products and services, or in order to comply with specifications or requirements. These decisions are also based on the importance of a measurement, and considerations of risk.

The relevant entries can be found under the following links:

Career Development Dialog (CDD)

 
   
 
 
7.1.5.2 Support: Resources Monitoring and measuring resources Measurement traceability:
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5778
Last Update by: Amrita Choudhary, 26/Oct/17

as from the standard:

7.0 Support
7.1 Resources
7.1.5 Monitoring and measuring resources
7.1.5.2 Measurement traceability

When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:
a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information;
b) identified in order to determine their status;
c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.

The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.

 

 
   
 
 
7.1.5.2 Support: Resources Monitoring and measuring resources Measurement traceability:- practical implementation in R-Tech/EU-VRi:
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5779
Last Update by: Amrita Choudhary, 26/Oct/17

R-Tech/EU-VRi management determines and manages the work environment to ensure product conformity. Areas used for administration, operations, development and storage of products/documents shall be clean, safe and organized.

The relevant entry can be found in the link below:
n.a

 

 
   
 
 
7.2 Competence
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5780
Last Update by: Amrita Choudhary, 26/Oct/17

as from the standard:

7.2 Competence 

The organization shall:
a) determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system;
b) ensure that these persons are competent on the basis of appropriate education, training, or experience;
c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;
d) retain appropriate documented information as evidence of competence.

NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the reassignment of currently employed persons; or the hiring or contracting of competent persons.

 
 
   
 
 
7.2 Competence- practical implementation in R-Tech/EU-VRi:
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5781
Last Update by: Amrita Choudhary, 26/Oct/17

Top management identifies emerging competency needs during management reviews. Emergent competency needs are converted into job descriptions for the type and number of positions that need to be filled through internal or external recruitment. Where required; competency training and monitoring is conducted in-house, although for more specialist skills, external courses are utilised. The effectiveness of training is evaluated and recorded. The company induction includes an introduction to our policies and objectives. Future competency training needs are identified as part of the Management Review process.

Staff members performing work affecting product quality are competent on the basis of appropriate education, training, skills and experience. The skill needs of the staff are identified and training plans are documented in detail. 

The relevant entries can be found under the following links:

Training Plan
Career Development Dialog (CDD)

 
   
 
 
7.3 Awareness
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5782
Last Update by: Amrita Choudhary, 26/Oct/17

As from the standard:

7.2 Awareness

Training and subsequent communication ensure that staff are aware of:

a)    the quality policy;
b)    relevant quality objectives;
c)    their contribution to the effectiveness of the management system, including the benefits of improved performance;
d)    the implications of not conforming with the management system requirements.

 
   
 
 
7.3 Awareness- practical implementation in R-Tech/EU-VRi:
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5783
Last Update by: Amrita Choudhary, 26/Oct/17

All employees are trained on the relevance and importance of their activities and how they contribute to the achievement of our policies and objectives. The company operates a formal system to ensure that all employees within the Organisation are adequately trained to enable them to perform their assigned duties. Where required; awareness training and monitoring is conducted in-house, although for more specialist skills, external courses are utilised. The effectiveness of awareness training is evaluated and recorded. The company induction includes an introduction to our Organisation’s policy statements and objectives. Welcome packages have been designed for newly inducted staff members and are provided to the incumbant on first day of work. Future training needs are identified as part of the management review process.

The relevant entries can be found under the following links:
Training Plan
Career Development Dialog (CDD)

 

 
   
 
 
7.4 Communication
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5784
Last Update by: Amrita Choudhary, 26/Oct/17

As from the standard:

7.4. Communication

The organization shall determine the internal and external communications relevant to the quality management system, including: 
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate;
e) who communicates

 

 
   
 
 
7.4 Communication - practical implementation in R-Tech/EU-VRi:
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5785
Last Update by: Amrita Choudhary, 26/Oct/17

Management Team of  R-Tech/EU-VRi ensures internal communication takes place regarding the effectiveness of the management system. Internal communication methods include:

a). Rules of good conduct
b). Respect the communication conventions
c). Customer communication

 

 
   
 
 
7.5 Documented information:
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5786
Last Update by: Amrita Choudhary, 26/Oct/17

As from the standard:

7.5. Documented information

The organization's quality management system shall include:

a) documented information required by this International Standard;
b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.

 
   
 
 
7.5 Documented information - practical implementation in R-Tech/EU-VRi:
 
 
https://www.risk-technologies.com/home.aspx?lan=230&pag=3025#bl5787
Last Update by: Amrita Choudhary, 26/Oct/17

At R-tech/EU-VRi, the management system documentation includes both documents and records

Note: the ISO 9001:2015 standard uses the term “documented information”; R-tech/ EU-VRi does not use this term, but instead relies on the terms “document” and “record” to avoid confusion. 

The Document Management provides clear procedures for managing the documents.

Documents required for the management system are controlled in accordance with procedure [How to name a file]. The purpose of document control is to ensure that staff have access to the latest, approved information, and to restrict the use of obsolete information. All documented procedures are established, documented, implemented and maintained.  

The relevant entries can be found under the following links:

 TEMPL-ALL: General Templates
CHK-ALL: Checklists
TEMPL-592: STZ 592 Templates
TEMPL-889: STZ 889 Templates
TEMPL-1091: STZ 1091 Templates
TEMPL-1167: STZ 1167 Templates
TEMPL-1190: STZ 1190 Templates
INSTR-DM: How to name a file
ISO 9001:2008 § 4.2.3 Control of Documents