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ISO 9001:2015 – Quality Management System

ISO 9001 is a standard that sets out the requirements for a quality management system. It helps businesses and organizations to be more efficient and improve customer satisfaction. A new version of the standard, ISO 9001:2015, has just been launched, replacing the previous version (ISO 9001:2008).

Key changes in the new standard:

  • Added the 10-clause structure and core text for all Management System Standards
  • More compatible with services and non-manufacturing users
  • Clearer understanding of the organization’s context is required “one size doesn’t fit all”.
  • Understanding the needs of the interested parties.
  • Process approach strengthened/more explicit
  • Concept of preventive action now addressed throughout the standard by risk identification and mitigation
  • The term documented information replaces the terms document and record
  • Control of externally provided products and services replaces purchasing/outsourcing
  • Increased emphasis on seeking opportunities for improvement
  • What are the benefits of ISO 9001:2015 standard?

    The new version of the standard brings the user a number of benefits. For example, ISO 9001:2015:

  • Puts greater emphasis on leadership engagement
  • Helps address organizational risks and opportunities in a structured manner
  • Uses simplified language and a common structure and terms, which are particularly helpful to organizations using multiple management systems, such as those for the environment, health & safety, or business continuity
  • Addresses supply chain management more effectively
  • Is more user-friendly
  • ISO 14001:2015 – Environmental Management System

    ISO 14001 is a standard that sets out the requirements for an environmental management system. It helps businesses and organizations to be more efficient in meeting their environmental goals.

    Key changes in the new standard

    The key changes in ISO 14001:2015 can be summarized as below -

    1. Understanding the Organization and its context. This element requires the organization to identify its context by determining the following, as relevant to the EMS:

  • External circumstances – political, regulatory, international, national, etc.
  • Internal characteristics – i.e., strategic direction, culture, capabilities
  • Environmental conditions that could affect the organization – climate, natural resource availability, etc.
  • 2. Understanding the Needs of Interested Parties. This requires the organization to determine:

  • Interested parties. Who are they?
  • What are their needs and expectations?
  • Interested parties would include regulatory agencies, and their needs and expectations would be the legal requirements, or referred to as “compliance obligations,” in the new standard.

    3. Leadership and Commitment. The new standard emphasizes leadership, and wants top management to demonstrate its commitment to the EMS. While no documentation is required, auditors will be looking for evidence to show conformance to these requirements.

    4. Actions to address Risks and Opportunities. This element requires the determination of risks and opportunities surrounding “context” and interested parties as per Items 1 and 2, above. Warning: This will take some thought.

    5. Environmental Aspects of Products – When identifying environmental aspects, the new standard will ask the organization to identify aspects associated with products from a life cycle perspective, and include the life cycle stages that it controls or has influence over. This element may necessitate environmental controls associated with design, use, end of life and disposal.

    Operational Controls. There is a healthy list of operational controls an organization must implement, including several new ideas:

  • Controls for the design and development of product life cycle stages
  • Consideration of potential significant impacts on product delivery, use, end of life and disposal
  • Environmental requirements for purchasing
  • What are the benefits of ISO 14001:2015 standard?

    The new version of the standard brings the user a number of benefits. For example, ISO 14001:2015:

  • Puts greater emphasis on leadership engagement
  • Helps address organizational risks and opportunities in a structured manner
  • Uses simplified language and a common structure and terms, which are particularly helpful to organizations using multiple management systems, such as those for the environment, health & safety, or business continuity
  • Effectively meet the environmental goals
  • Is more user-friendly