ISO 9001:2015 Quality Management System

ISO 9001 is the internationally recognised standard for the quality management in organisations of any size and any industry. The standard it specifies the requirements for a Quality Management System (QMS) where an organisation needs to demonstrate its ability to provide products or services that fulfil customer and applicable regulatory requirements and aims to enhance customer satisfaction. ISO 9001 is designed and intended to apply to any product or service, made by any process anywhere in the world.

It is based on the plan-do-check-act methodology, which helps organizations establish, implement, monitor and measure their processes to deliver results that align with the organization’s requirements and continually improve performance by taking appropriate action.

The ISO 9001 standard is focused on eight principles of quality management which are listed below:

Customer focus

Organizations depend on their customers and for this reason they should strive to understand their current and future needs, meet these requirements and strive to exceed their expectations.

Leadership

Leaders establish the purpose and direction of an organization and they should create and maintain the internal environment in which people is encouraged to become fully involved in achieving the organization’s objectives.

Involvement of people

Organizations are as good as its people, nothing more nothing less. For this reason the full involvement of the staff is required at all levels. People’s full involvement guarantees that individuals’ abilities are fully used to benefit the organisation.

Process approach

The process approach decrees that desired results are achieved more efficiently when activities and resources are managed as process.

System approach to management;

Identifying, understanding and managing interrelated process as a system contributes to the organization’s effectiveness & efficiency in achieving objectives.

Continual improvement

An evaluation of your current capabilities against the standard.

Factual approach to decision making

Effective decisions are based on the analysis of clear and correct data and information.

Mutually beneficial supplier relationships

The organization and its suppliers depend upon each other and a mutually beneficial relationship creates value for both parties.

The organization and its suppliers depend upon each other and a mutually beneficial relationship creates value for both parties.
An organization and its suppliers are interdependent but at the same time both of them are depended on the end user. Having a mutually beneficial relationship enhances the ability of both to create value on their product and services.
VISION ISO provides low-cost on-site consultancy for developing a tailor-made Quality Management System (QMS) with the ultimate aim of helping your company improve and increase its competitiveness and achieve certification from an accredited certifying body.
We will help you understand and apply the quality management system requirements while ensuring that your program proceeds smoothly, from executive commitment to ongoing process management. A QMS based on the ISO 9001:2015 standard is recognized worldwide as an excellent tool for improving performance, increasing customer satisfaction and maintaining regulatory compliance.
We have a time proven four-phase System Implementation Procedure which has guided a large number of companies through the implementation and development of Quality Management Systems, as follows:

Phase 1: Gap Analysis

We identify the gap between the standard’s requirements and the current condition of the organization. This is achieved by collecting information about the current practices used within the existing management system and by comparing them with the requirements of the standard to see whether they are satisfied or not..

The consultant and the client draw up the framework for the design and development of the system. To be more specific in this phase the middle and top management team are educated on the requirements of the standard. Then with the guidance of our consultants the management defines the scope of the management system, the organization’s policy, the objectives/goals and the structure. Once this is clear the consultants proceed with the development of the updated Management System.

Phase 2: Design and Development

Phase 3: Implement and Improve

We run the Management System, monitor it, measure it and review it with the intention to collect information to confirm that it runs smoothly. Also in this phase all the activities and their updates are presented to the employees and they are trained so as to conform with the updated system. Any required changes are carried out in order to ensure smooth operations.

A management review and internal audit are held, followed by an external audit. To be more specific in phase 4, we work alongside top and middle management and we are focused on the effectiveness and the efficiency of the management system. This is achieved through the internal audit and the management review where we review and address the processes and the organization performance (this includes any resistance to the system and/or embedding desired culture and behaviour changes). Also we identify further opportunities to improve the effectiveness and efficiency of the management system. Once these actions are completed we proceed with the external audit the third party certification.

Phase 4: Assessment and Review