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Get your iSO 9001 2015 Certification with Canjain. Our experts will help you in obtaining iSO 9001 2015 Certificate without any hassle.
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ISO 9001 2015 is an international standard for maintaining, creating and implementing a Quality Management System (QMS). ISO 9001 2015 was first introduced in September 2015 and is already the most widely adopted standard in the history of standards. It outlines a framework for improving quality & a vocabulary of understanding for any company or organisation looking to provide goods & services that steadily meet the customers expectations & requirements and other pertinent interested parties in the most effective manner. The Quality Management System is the collective of all the resources, cultural values, processes & assets that support the goal of customer satisfaction & organizational efficiency.
ISO 9001 2015 doesn’t order what a company or an organisation’s objectives should be or how to achieve them. In simple terms, it doesn’t tell any company or organisation how to run its business. This standard defines the controlling principles that can be used to create efficiencies by streamlining & aligning processes throughout the organisation, meet regulatory requirements and help organisations to expand into new markets where clients demand ISO Certification.
This certification provides your customers reassurance that you have set up a QMS based on the 7 management principles of ISO 9001. In fact, ISO 9001 is such a vital and significant standard that it is used as the foundation when industry groups desire to create their own industry standards; this includes ISO 13485 for the medical devices industry, and AS 9100 for the Aerospace Industry and so on.
A survey of this certification in 2017 tells that in spite of the global recession, the number of companies or entities that have implemented the ISO 9001 QMS still remains stable globally. ISO 9001 Certification for individuals is not a requirement of the standard, but this certification is the best method to get knowledge and competence regarding this standard.
QMS or Quality Management System is defined as a set of interrelated or interacting elements to create policies, objectives & processes to achieve those objectives regarding quality. Quality Management System is part of the overall management system based on a business risk approach to operate, monitor, establish, review, implement, maintain & improve quality.
ISO 9001 2015 specifies requirements to implement, monitor, maintain, establish, plan, operate and continually improve a Documented management system used to manage quality. The requirements under ISO 9001 2015 are flexible, standard, and useful to all types of organisations. Hence, this standard aligned & united with other Management Systems such as Business Continuity Management, Energy Management and other management systems due to their identical structure.
The standardisation of Quality Management evolves with ISO 9001 2015 by adding:
Following are some important clauses of ISO 9001 2015:
The clause defines the scope of the ISO 9001 2015 standard and the scope of this standard comprises specifying requirements for a Quality Management System of any organisation.
The supporting standard referenced in this standard is indispensable for its application is ISO 9001:2015, which covers fundamentals & terminology.
Terminology used throughout this standard comes directly from ISO 9000:2015, QMS – Vocabulary & Fundamentals.
When you are implementing a Quality Manual System, the 1st step is to align your business objectives & intent with the QMS. Know the external & internal issues, needs & expectations of interested parties, QMS scope & its processes.
This clause covers leadership responsibility. Top management must demonstrate leadership & commitment, establish & communicate a quality policy and ensure responsibilities & authorities are communicated, assigned & understood.
This clause covers organisational OMS planning to address organisational risks, changes, opportunities & quality objectives.
This clause of ISO 9001 2105 covers the resources required for the Quality Management System, such as ensuring employees are capable & aware, providing resources, and including Documented details to support your QMS.
This clause covers the control & plan processes required to meet the requirements for goods & services (such as production & service provision, design & development, the release of goods & services, external providers, etc,).
The ISO 9001 requires your organisation’s Quality Management System to measure, analyse, monitor, and evaluate your QMS.
This clause of ISO 9001 2105 covers continual improvement. Select opportunities for improvement, take action against non-conformities, implement corrective actions as necessary & continually improve your quality management system.
Following are some vital Documents you need to produce if you want to be compliant with ISO 9001 2005:
Following are some Mandatory Records:
Following are other records that are only mandatory when the relevant clause is not excluded:
There are many non-mandatory Documents that can be used for the implementation of ISO 9001. However, the following are some non-mandatory Documents to be most commonly used:
For the company QMS to be certified, you need to finish the implementation first. After finishing all your paper works & implementing your processes, your company also needs to perform the following steps to ensure a successful certification:
This is in place for you to check your QMS processes. The goal is to confirm that records are in place to confirm compliance with the processes & to find problems and weaknesses that would otherwise stay hidden.
A review by your management to evaluate the facts regarding the management system processes in order to make appropriate decisions & assign resources.
After the internal audit & management review, you need to correct the root cause of any identified problems & Document how they were resolved.
The company certification process is further diving into 2 different stages:
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