The Nine Main Changes to the New ISO 9001:2015 Quality Management System QMS Standard.

ISO 9001:2015 is the new business improvement tool that helps drive continual improvement and deliver results in your organization. It helps your business stand out, gain a competitive edge, and grow.

It’s more than a quality management system, it’s a complete operational tool designed to improve performance. It uses a process approach to ensure customer satisfaction and places quality right at the heart of your organization, complementing business strategy and helping enhance performance over time.

Some of the core concepts of ISO 9001:2015 are:

Concept                                                                                                                                                 Comment

Context of the organization Consider the combination of internal and external factors and conditions that can have an effect on an organization’s approach to its products, services, investments and interested parties.
Issues Issues can be internal or external, positive or negative and include conditions that either affect or are affected by the organization.
Interested parties A person or organization that can affect, be affected by or perceive themselves to be affected by a decision or activity. Examples include suppliers, customers or competitors. You may refer to them as stakeholders.
Leadership Requirements are specific to top management who is defined as a person or group of people who directs and controls an organization at the highest level.
The risk associated with threats and opportunities Refined planning process replaces preventive action and is defined as the ‘effect of uncertainty on an expected result’.
Communication The standard contains explicit and detailed requirements for both internal and external communications.
Documented information The meaningful data or information you control or maintain to support your QMS.
Performance evaluation The measurement of quality performance and the effectiveness of the QMS, covering the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results.
Nonconformity and corrective action Evaluation of nonconformities and correct actions.
Management review Will need to be carried out, with requirements relating to inputs and outputs of the review.

The changes to the New ISO 9001:2015 QMS standard implementation in your organization will require training to processes staff etc, if you need the full detail requirements of the New ISO 9001:2015 QMS standard, Gap analysis, Auditing process, Transitional process from Old to New ISO 9001:2015 implementation in your organization at an affordable cost, please contact us / call our mobile number and/or send us an email.

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