Risk Based Thinking, Transition to ISO9001:2015

iso-9001-2015

How Technologic Systems is preparing for the transition to ISO 9001:2015

ISO 9001 was designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service. ISO 9001 deals with the fundamentals of Quality Management Systems, including the eight management principles upon which the family of standards is based. However, with the advent of ISO 9001:2015 upon us, it is clear that the paradigm regarding quality is changing as words and phrases like “Risk-Based Thinking”, “Leadership”, and “Evidence-based Decision Making” make their way into the forefront of Strategic Business Planning.

The new ISO 9001:2015 standard moves the subject of Management Systems into the boardroom. While this will be a cultural change, it is also a great opportunity for the enterprise leaders to improve their business overall.

Transition is an opportunity — What do you need to do?

  1. Take a completely fresh look at the QMS
    1. Map out where we are today, where we need to be.
  2. Attend a one–day transition course to understand the differences.
    1. Technologic Systems has already successfully completed transition and Process Based Internal Auditor training.
  3. Highlight the key changes as opportunity for improvements
    1. This provides the opportunity to take a fresh look at your organization from an enterprise level and improve our business as a whole. This will be done at the next company Management Review meeting in Q4 2016.
  4. Make changes to our documentation to reflect the new structure (as required)
    1. By using the process approach, major changes may not be necessary.
  5. Implement new requirements on leadership, risk and context of organization
    1. Technologic Systems will be taking a deep look at Risk Based thinking methodologies and applying them to everyday business.
    2. Top management will show how we ensure the management system achieves its intended outcome(s) and how we direct and support persons to contribute to the effectiveness of the management system and promote continual improvement.
    3. Top Management will understand all the inputs and outputs i.e.; the context in which it operates and address the internal and external aspects that make up that context.
    4. Top Management understands risks and opportunities are the main elements of uncertainty, which can affect the business overall for better or for worse. The basic premise of risk based thinking is to reduce, control and eliminate occurrence upstream.
  6. Review effectiveness of current control set
    1. Top Management understands that performance evaluation (persons, product and suppliers) is a more critical part of the process and also where ROI is measured. Policies and procedures for monitoring with the proper metrics, measuring, analyzing and evaluating the management system are addressed. Decisions should be data driven.
  7. Assume every control may have changed
  8. Carry out an impact assessment and plan accordingly with a good detailed project plan and assign owners for accountability.

Author: John Marshall

Director of Quality/EH&S/Compliance for Technologic Systems

  • Paul S Attrell

    Sound advice John