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Standard Requirements 

The new ISO 9001:2015 text for reference

 

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 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 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 Actions to address risks and opportunities
 
 

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:
SWOT: https://www.risk-technologies.com/home.aspx?lan=230&tab=2950&itm=3008&pag=3068&nr=4#bl6171
Corrective/preventative actions: https://www.risk-technologies.com/home.aspx?lan=230&tab=2950&itm=3020&pag=3083&nr=17#bl5982

 
   
 
 
6.2 Quality objectives and planning to achieve them
 
 

As part of the adoption of the process approach, R-Tech/EU-VRi utilizes its process objectives, as discussed in article 4.4, 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 quality objectives and how they are to measured are presented in the quality policy .

 
   
 
 
6.3 Planning of changes
 
 

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&tab=2950&itm=2966&pag=194&nr=15#bl1055