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New UNI EN ISO 9001: 2015

sistemi di gestioneSince September 2015, the quality management systems are certified according to the new version of ISO 9001. The differences compared to the 2008 version are not few.

4. Context of the organization:

  • The organization must identify and analyze internal and external factors

relevant to its strategic objectives
that affect its ability to achieve the results expected by the management system for quality.

Define these factors is critical to think in a 'perspective of "Risk Based Approach" and organize accordingly the management system for quality.

5. Leadership:

  • Emphasis on the responsibilities of the management and its role in terms of support and motivation for human resources, implementation of the management system for quality.
  • The new law does not speak more than a Management Representative, but explicitly involves the top management
  • The involvement of the company management is critical to the successful implementation of a management system for quality and to improve its integration with the "" company system.

6. Planning

  • risk-based approach: fundamental to plan the management system for quality, and cuts across all the standards, it brings in new organizations responsibilities:

analyze risks and opportunities, classify them in relation to the seriousness of the consequences
plan actions to address the risks (elimination and / or mitigation of the same)
implement these actions
monitor its effectiveness
learn from experience, with a view to continuous improvement.

  • Organizations will need to determine the best way to assess risks and opportunities, in a manner commensurate with the complexity of the organization itself and its processes.

7. Support:

  • New point where they are conveyed support requirements, namely: resources, skills, knowledge, communication and documented information.
  • Awareness is higher requirement.
  • documented information:

It is the real novelty
It replaces the term "procedures" and "recordings"
It can be prepared and stored in the form that the organization considers most appropriate in accordance with their needs, risks and opportunities
It should not be interpreted as the disappearance of the obligation - from the organizations - to develop, maintain and record the requirements of the system.

8. Operational activities

  • The process approach is made more explicit.
  • Objective of the processes is to generate confidence in the organization's ability to

meet customer expectations
deliver products and services comply with the requirements of the standard.

  • The applicability of the "services" is made more explicit (in the previous edition it was all about "Product").
  • External provision (supplied from outside products and services):

replaces the term "procurement / outsourcing"
the emphasis is on its control: the organization must ensure that the procured externally and meets the requirements.

9. Performance evaluation:

  • The focus has shifted from the monitoring of the management system in the planning of the monitoring activities on the product and / or service.
  • The organization needs to identify what needs to be monitored, how and when the results of monitoring should be analyzed.
  • The monitoring, measurement and analysis are used to ensure:

the effectiveness of the management system for the quality
the continued fulfillment of the requirements and objectives that the organization has established.

10. Improvement:

  • Objective: To determine and select opportunities for improvement:

process
products and services
results expected by the management system.

  • Continuous activity: every time an opportunity for improvement is identified, the organization must determine how to implement it and what resources to use.

For more information, see the ACCREDIA site at the following link.
https://www.accredia.it/news_detail.jsp?ID_NEWS=1962&areaNews=&GTemplate=news.jsp

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New UNI EN ISO 14001: 2015

sistemi di gestioneWhat changes

4. Context of the organization:

  • The organization's context is set as a prerequisite for the definition of the scope of the environmental management system for planning, strengthening the orientation towards stakeholders.
  • The Organization, before identifying its scope and before schedule, must know the context in which it operates. The previous edition of the standard considered him already implicitly in the identification of environmental aspects and the overall planning.
  • To define the scope of application of the environmental management system (EMS), the organization must take into account internal and external factors which could affect the ability to achieve its environmental objectives. These factors are:

the context in which the organization operates
the needs and expectations of stakeholders.

5. Leadership:

  • Emphasis on the key role of top management: assigning specific roles and responsibilities, demonstrating its commitment to ensuring the effective implementation of the environmental management system.
  • The top management commitment must also be proactive to the protection of the environment, in all its aspects, including:

prevention of negative impacts
sustainable use of resources
mitigation and adaptation to climate change
protection of biodiversity and ecosystems.

  • The new law does not speak more than a Management Representative, but explicitly involves the top management
  • The objectives of the EMS are integrated with the organization's strategic planning.

6. Schedule:

  • In planning the environmental management system, the organization should consider the risks and opportunities in relation to:

to the significant environmental aspects
the legal requirements applicable
the requirements with respect to other internal and external factors

in order to weight them in a precise manner in the definition phase of the environmental objectives.

  • Explained the concept of risk, whose valuation should be based on three sources:

environmental aspects
legislative requirements
the context of the organization.

7. Support:

  • New point where they are conveyed support requirements, namely: resources, skills, knowledge, communication and documented information.
  • Awareness is higher requirement.
  • Documented information:

It is the real novelty
It replaces the term "procedures" and "recordings"
It can be prepared and stored in the form that the organization considers most appropriate in accordance with their needs, risks and opportunities
It should not be interpreted as the disappearance of the obligation - from the organizations - to develop, maintain and record the requirements of the system.

8. Operational activities:

  • Introduced the concept of Life Cycle Perspective, an approach that involves attention to environmental protection in all stages of production:

planning and development
identification of raw materials
Packaging and distribution
reuse and recycling
final disposal.

  • Life Cycle Perspective puts greater emphasis on environmental requirements in the procurement of goods and services and in the control of outsourced processes.
  • Life Cycle Perspective results from the norm in an explicit request for:

control the outsourced processes
determine the environmental requirements for the procurement
consider the environmental requirements of the development, delivery and treatment of end of life of products / services
consider the need to provide information on the potential environmental impacts during the delivery of products, services and treatment of end of life.

9. Performance evaluation:

  • Included more specific requirements relating to the assessment of environmental performance, including the need to establish criteria and indicators to analyze and evaluate its environmental performance.
  • Strengthened some elements related to the monitoring and reporting of performance.
  • It is required to determine more clearly the organization:

which aspects are to be monitored and measured, in relation to specific factors
the indicators by which the environmental performance will be measured
when the results of monitoring and measurements will be analyzed and evaluated.

10. Improvement:

  • Concept of "continuous improvement" also associated to environmental performance, in addition to the improvements in the management system.
  • It clearly explained the objective of the environmental management system, which is the improvement of the environmental performance of the organization. The new edition of the standard makes this goal more concrete and effective

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