ISO 9001 is defined as Quality Management system which helps organizations to demonstrate the quality perseverance consistently and provides a basic framework for other standards that can be integrated with the Quality Management system. It is technically called as ISO 9001:2015 – Quality Management System.
It was reviewed recently in 2015 where in the version of the latest ISO certifications is 2015 which is based on Annex SL with defines the ISO 9001 clauses that shall be learnt further in our blog. ISO 9001 meaning can be derived as the Certification that helps organizations to channelize their management system and demonstrate the ability to provide consistent products and services to their customers which meet the regulatory and Statuary requirements. ISO 9001 Services help the organization to initiate risk-based thinking approach and provide quality requirements of customer with effective utilization of leadership within the organization. ISO 9001 Standards help to involve the Employees who are recognized under the leadership clause to implement the standard in the organization. It has various clauses that needs to be implemented in order to achieve the maximum effectiveness of the standard in the organization.
ISO 9001 Meaning
A Quality Management System is a set of an interrelated or interacting elements that an organization uses to formulate its Quality policies and Quality Objectives and to establish benefiting processes that are needed to ensure the following of these policies and achieving the objectives.
ISO 9001 means to provide a framework that would enable the organization to understand the customers requirements in respect to quality, this enriches the organizational knowledge amongst the employees contributing to the business and enables them to provide maximum benefit in provision of a consistent output.
ISO 9001:2015 is the most common and the basic standard that is applicable to all the organizations irrespective of their size, location & Nature of business as it based on the platform of Quality Management principles and Annex SL which is presumed to be the skeleton of all management systems according to ISO.
What is ISO 9001 Certification?
The ISO 9001 Certification as we already know is called as Quality Management System, we now shall try to understand the history and elements of ISO 9001 Certifications. ISO Certifications on Quality Management system began in 1987 with the first standard being published by the ISO Organization. ISO 9001 has changed since then 5 times and versions are given below.
ISO 9001 Standards
ISO 9001 Standards is a simple but effective management tool to enhance the business opportunities of any organization. It is from the ISO 9000 Family of Quality Management systems where in ISO 9001 Certification is certifiable to organizations, it deals with the requirements that an organization needs to fulfill to be complaint of ISO 9001 certification. ISO 9001 Services have a brief history starting from 1987.
ISO 9001 Certification
ISO 27001 Certification
ISO 20000 Certification
ISO 22301 Certification
ISO 21001 Certification
ISO 41001 Certification
ISO 50001 Certification
ISO 29001 Certification
ISO 14001 Certification
ISO 45001 Certification
ISO 22000 Certification
FSSC 22000 Certification
ISO 17025 Certification
ISO 13485 Certification
CE Mark Certification
- ISO 9001:1987 which was based on BS 5750 series of standards from BSI that was presented to ISO in 1979.
- ISO 9001:1994 which was having a new addition of preventive actions with a lot of emphasis on the documented evidences which turned out to be a disadvantage for the version.
- ISO 9001:2000 which saw the need for approvals before finalization, records and control of records as documented evidence.
- ISO 9001:2008 which witnessed the addition of two other standards to the ISO 9000 family. It was in continuation of ISO 9001:2000 version with minimal changes.
- ISO 9001:2015 is the current version and is based on QMS Principles and has a risk based thinking approach with preventive actions being a thing of past and risk calculation taking over.
Now that we know the history of the standard, we need to now understand the elements of the standard. The Quality management systems is based upon the principles that govern the standard and is also based on the risk based thinking that is designed to identify the risks and opportunities in the organization and consider the importance of the interested parties which are an integral part of the management system.
ISO 9001 Certification – What are its elements?
ISO 9001 standards follow the principles of the quality management system that targets upon achieving a standard procedure of enhancing the organization in these various sectors of any organization. ISO 9001 series of Quality management system principles includes 7 major principles as listed below.
Quality managemnst principles (QMP) are:
- QMP 1 – Customer focus
- QMP 2 – Leadership
- QMP 3 – Engagement of People
- QMP 4 – Process Approach
- QMP 5 – Improvement
- QMP 6 – Evidence based decision making
- QMP 7 – Relationship Management
We have tried to give a brief about the principles and ISO 9001 clauses in the ISO 9001 standards where in you can find more information on the Standards and clauses. We would advice you to kindly go through the same to understand the ISO 9001 certification and the simplicity of achieving one. ISO 9001 Requirements are also captured in the same in detail.
ISO 9001 Clauses
ISO 9001 clauses are 10 and are based on Annex SL and provides the PDCA cycle or called as Deming cycle. The clauses are also based on the Quality management System Principles that are part of the ISO 9000 family. ISO 9001 Clauses are:
- Normative references
- Terms and definitions
- Context of the organization
- Performance evaluation
- Continual Improvement
These clauses has to be implemented in the organization and audited by lead auditor in order to achieve the ISO certification, ISO 9001 Certification layout is similar to the previous versions and also follows the Plan-Do-Check-Act as per the requirements of ISO 9001.
ISO 9001 Requirements
The ISO 9001 requirements are the fulfillment of the clauses of the standard and it would be very essential to understand the documents requirements, these clauses have the basic mandatory documents that would evidence the following of the standard in the organization. The documents can be self- made, or any ISO expert could assist you with this. CertPro has expertise in customizing the basic mandatory documents and guide the employees to complete them with professional approach and training. CertPro also offers the basic kit which would have the mandatory documents list and the policies and procedures that needs to be implemented. CertPro assist the organizations to achieve the ISO Certification with all the evidences being generated and implemented with guidance for maintenance and monitoring of the implementation.
Do we understand ISO 9001 Certification?
With this write up we understand what is ISO 9001 with a brief overview about its history and the background, we have also understood about the elements which are a part of ISO 9001 certification we have understood that it has 7 principles to be followed with 10 clauses which are the requirements of the standard. ISO 9000 Family is also briefed in the above blog, we would suggest all our readers to get complete information on the same by talking to the subject matter experts in CertPro who could provide complete ISO services to any organizations globally.