ISO 9001: 2015

ISO 9001

The ISO 9001 International Standard for Quality Management Systems defines the fundamental requirements for a properly developed, documented, implemented, and maintained Quality Management System. The heavily modified requirements of the new standard govern regulatory compliance of Quality Management Systems for the next decade. The adage “failure to plan is planning to fail” perfectly fits any organization’s response to compliance with the modified requirements of new ISO 9001: 2015, which need to be addressed by September 2018.

The revised edition of ISO 9001 introduces numerous changes, leading quality management towards more active involvement in company business, becoming an organizational asset. The changes introduced by ISO 9001:2015 should be seen as an opportunity to improve those areas that have not performed well in the past.

The ISO 9001 remain relevant to organizations of all sizes and types, within any sector increasingly focused on effective and efficient processes able to deliver business-driven outcomes.

We will review the new and modified requirements of ISO 9001:2015, such as: “documented information”, “risk-based approach”, “high-level structure”, “context of the organization”, “integration with business practices”, “knowledge management”, “applicability of requirements”, and more.

We will also discuss the interpretation of these changes, define a critical path for the transition process, and help you design and navigate the introduction of necessary changes in a cost effective manner, while simultaneously maintaining compliance with the regulatory requirements

CONSULTING For over 25 years Quexx International Ltd. has been involved in the design and implementation of Quality Management Systems (QMS) compliant with ISO 9001 Requirements. We have assisted over 30 companies in achieving and maintaining their ISO 9001 registration in a cost-effective manner.

Quexx services may include:
– Analysis of your contractual and regulatory needs and expectations
– Gap analysis – the assessment of your present Quality Control/Quality Assurance Practices
– Preparation of Quality Assurance Manual, including procedures, instructions, and forms
– Development of specifications, procedures and Inspection and Test Plans
– Assistance in implementation and integration of QMS with your business practices
– External and Internal Audits
– Preparation of the QMS for the assessment by the client or Registrar
– Assistance during QMS assessment – Ongoing support to the ongoing maintenance of implemented QMS

BENEFITS: Quexx International Ltd. consultants have extensive experience and expertise and are dedicated to providing you with services of exceptional quality. We realize that your trust in our competency and your investment in our consulting services should, whenever possible, result in doing more with less, running your business smarter not harder.

The benefits of Quexx services include:
– A simple, effective and practical QMS, tailored to suit your specific business needs
– No hassles (and extra costs) associated with external training
– An unrestricted bidding position for contracts which require ISO 9001 compliance
– Cost-efficient compliance with ISO 9001 and other regulatory requirements
– Trained and motivated personnel – Controlled documentation, repetitive processes, and improved performance
– A sound foundation for continuous improvement

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