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

Standard Requirements 

The new ISO 9001:2015 text for reference

 

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."

7.1.2. 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.

7.1.3. 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.

7.1.4. 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.

7.1.5 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.

7.1.5.2 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.

7.2 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.

7.3 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.

7.4. 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

7.5. 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.

 

 

 
   
 
 
7.1 Resources
 
 

General 

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:

GEN: Rules of good conduct

GEN: Office related information

INSTR-WM: Web Site(s) structure

 

People

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:

MANL: Resource Management 

PROC-HRM: Personnel Data

PROC-HRM: New Employees

Training Plan

Personnel Responsibility per Project

 

Infrastructure

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

 

Environment for the operation of processes

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 

 

Monitoring and measuring resources 

Outside of measuring personnel performance, calibration monitoring is not applicable for R-Tech/EU-VRi.

The relevant entries can be found under the following links:

Career Development Dialog (CDD)

 

 
   
 
 
7.2 Competence
 
 

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
 
 

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
 
 

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

Communication regarding the quality management system is done annually during the internal audit. Important information which requires immediate action will be conveyed in ad-hoc meetings as well as by email. 

In addition, internal communication methods include:

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

 

 
   
 
 
7.5 Documented information
 
 

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-1167: STZ 1167 Templates
TEMPL-1190: STZ 1190 Templates
INSTR-DM: How to name a file