ISO 9001 Certification is also called as Quality Management System certification. It is defined as the interrelated or interacting elements of organization which is used to formulate the policies and objectives of quality in order to achieve the requirements of Customer satisfaction and improved quality. ISO standards are based upon the Principles that would be discussed under the ISO requirements. The ISO 9001 clauses are also given below which will brief our readers about the skeleton of the system and key areas that would help us understand the ISO 9001 Requirements.

ISO 9001 Requirements?

ISO has defined the system clearly when it has published the standards, every standard would have a family that would include the guidelines, requirements, certifiable standard, etc. in order to understand the requirements of the ISO 9001 Certification we need to understand the basic elements in the standard. There are two major elements that would be helpful for our readers to understand the system – Quality Principles and ISO 9001 Clauses.

ISO 9001 Principles or quality management principles?

The principles would help us to stay on track while the implementation of ISO 9001 Standards, we need to understand the definition or the ISO 9001 meaning in order to start with the implementation in any organization. These principles are embedded in the standard in the form of sub-clauses that are intended to follow and achieve these principles.

Quality management principles are 7 in number and the same has been mentioned below:

  1. QMP 1 – Customer Focus
  2. QMP 2 – Leadership
  3. QMP 3 – Engagement of People
  4. QMP 4 – Process approach
  5. QMP 5 – Improvement
  6. QMP 6 – Evidence based decision making
  7. QMP 7 – Relationship Management 

We now shall understand each principle and what they mean.

Principle 1 – Customer Focus

Customer is considered as the interested parties in this standard and the analysis of the risks for the same has to be made. Customer needs and requirements have to be understood and achieved using the quality management system.

Principle 2 – Leadership

Leaders are the forerunner in this Management system wherein they create a conducive environment to implement the standards and provide guidance to the other employees whose engagement is essential.

Principle 3 – Engagement of people

The management system demands the involvement of people at all levels of the workforce and the system must be implemented such that all contribute towards it.

Principle 4 – Process Approach

A defined process that would have eliminated the maximum risks would benefit the organization to provide consistent product or services to clients.

Principle 5 – Improvement

Renewing its objectives would help the organization to grow and also address new operational risks that would arise in due course of activity.

Principle 6 – Evidence-based decision making

Any organization needs to evidence the incident and the actions taken in order to effective face the action that needs to be resolved, this also implies that we need to evidence the actions performed in the process in order to analyze the improvement points and other elements that would benefit the organization.

Principle 7 – Relationship Management

An organization must consider its other external interested parties that contribute towards business and grow together hence relationship management is very crucial.

As we now know about the principles, we would request you to kindly reach out to the industries experts CertPro to acknowledge you more on the different approaches we can take towards achieving the demands of the standard. ISO services are provided by CertPro with professional touch and training are provided on all the principles in our Standard knowledge transfer section during the implementation cycle.

ISO 9001 Standard

ISO 9001 Clauses?

As we already know about the two major elements of ISO 9001 certification, lets now educate ourselves with the ISO 9001 Clauses that are the skeleton of the standard. The ISO 9001 Clauses are framed using the Annex SL (now called as Annex L) risk-based thinking approach which has 10 main clauses that would provide the basic framework for various of ISO Standards. Annex SL has these clauses in which 7 clauses are very important and needs to be implemented in any organization. 

Clause 1 – Scope

Clause 2 – Normative references

Clause 3 – Terms and definitions

Clause 4 – Context of the organization

Clause 5 – Leadership

Clause 6 – Planning

Clause 7 – Support

Clause 8 – Operation

Clause 9 – Performance Evaluation

Clause 10 – Improvement

 

Now we shall understand the demands of the clauses that are important during any implementation, The first three clauses are not important to be implemented but rather helpful to understand the whole standards, experts go through rigorous training on the same and then qualify as the lead auditors to perform auditing at an organization. The actual implementation starts from Clause 4 and we have tried to explain the interlinking between the principles and clauses.

Clause 4 – Context of the organization

In this clause, the organization has to understand the interested parties and principles 4 & 2 are involved and this would be a crucial stage to decide upon the number of processes and the leaders heading the implementation cycle.

Clause 5 – Leadership

The clause speaks clearly of the leadership that is required and also has involvement of the customer focus in the Annex L. principles 1, 2 & 3 are involved in this clause.

Clause 6 – Planning

The clause is very crucial and it involves not only the principles but also the Deming cycle or PDCA cycle (https://en.wikipedia.org/wiki/PDCA). This clause speaks of the principles 2, 3, 4 and it is crucial in any organization to implement this.

Clause 7 – Support

The clause is the backbone of the activities that need to be performed by each of the employees who need to contribute towards the implementation of the system. Principles 3, 7 are very much involved in this clause

Clause 8 – Operations

The Do and Check are part of the clause and the principles 1, 5 & 7 are involved. The ISO requirements are majorly captured here, the generation of most of the evidence is witnessed here.

Clause 9 – Performance Evaluation

The parameters that are based on the evidence obtain monitoring and measuring activity here and the efficiency of the system is gauged in this clause, principles 6 plays an important role to set the objectives and verification methods to evaluate.

Clause 10 – Improvement

With the name we can guess the principle involved, it is principle 6 which would play the most crucial role wherein the PDCA cycle involves Act in this clause and scope for improvement is decided here.

ISO 9001 Standard

What did we learn?

We have now understood that the ISO has a defined structure and the clauses and principles are explained here. CertPro itself has a systematic approach towards assisting the clients and the ISO services also include ISO training which would boost the confidence amongst the employees contributing towards the implementation. CertPro specializes in the ISO Trainings and ISO Certifications all over the globe. We have Lead Auditors who perform implementation at the customer premises with a vision about various other standards that can be integrated at later stages using Integrated management system. ISO 9001 standards easy to be achieved with assistance from CertPro who are experts in the ISO Certification Consultant sector.

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