ISO Quality Systems

Based on the draft version of ISO 9001:2015, the new revision to ISO 9001, will contain many major changes. The new standard will be much less prescriptive and references several Lean management principles and tools creating a need to "Integrate" Lean-ISO by merging Lean practices into the QMS/ISO Procedures. Lean-ISO is creating a competitive edge through improved customer satisfaction!

Lean-ISO assures an organization becomes efficient and effective by managing its way of doing things through systemizing its process. Following a Lean-ISO process ensures that nothing important is left out and that everyone is clear about who is responsible for doing what, when, how, why and where.

Leanovations provides support, from our team of experts, a focus on Lean-ISO implementation and certification guidance and leadership support in developing a Quality Management Systems (QMS). Over a million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today.

Providing expertise in both Lean-ISO Guidance/Quality Leadership perfectly aligns with Leanovations philosophy, where Leanovations stands for Lean + Innovations together. Implementing a successful Lean-ISO integration means an organization becomes efficient and effective by managing its way of doing things through a systemized process. In Lean establishing standard work, where we can predict the outcome in time and quality is a great foundation that supports the systemized ISO process. The Leanovations team has expertise in…

ISO9001 – A Quality Management System standard based on a number of quality management principles including a strong customer focus, the process approach, and continual improvement. Using ISO 9001:2008 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.

ISO13485 – A Quality Management System standard for the medical device industry where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

AS9100 – A Quality Management System standard for the aerospace industry. The standard incorporates all of ISO9001 and includes specific requirements relating to aviation, space and defense, as well as land- and sea-based systems for defense applications.

ISO14971 – A standard that specifies the requirements for the application of risk management to medical devices and applies to all stages of the life-cycle of a medical device.

ISO17025 – A standard that specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.

ISO/TS 16949 – A standard used in conjunction with ISO 9001:2008, which defines the quality management system requirements for the design and development, production, and installation and service of automotive-related products.

ISO14001 – An Environmental System Standard that specifies requirements for an environmental management system to enable an organization to develop and implement a policy and objectives which take into account legal requirements and other requirements to which the organization subscribes, and information about significant environmental aspects.

Leanovations approach to Lean-ISO integration is to implement a "Quality Management" leadership culture that meets the customer's quality requirements and applicable regulatory requirements, while aiming to enhance customer satisfaction, and pursue continual improvement of its performance in pursuit of these objectives. The International Organization for Standardization (ISO 9001-2008) introduced a revised Quality Management standard based on an emphasis on measuring customer satisfaction along with a compatibility with ISO 14001 - Environmental Management Systems. Leanovations has been teaching, coaching and guiding companies through our “Lean to Green (L2G) Process” helping companies with implementing business sustainability that has a positive impact on 3-P's; the People, Planet and Profits.