ISO 9001 is defined as a Quality Management System which helps organizations to demonstrate the quality of 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.
The meaning of ISO 9001 can be deduced as the Certification that helps organizations to channelize their management system and demonstrate the ability to provide consistent products and services to their customers while meeting the regulatory and statuary requirements. ISO 9001 Services help the organization to initiate a risk-based thinking approach and provide quality requirements of customer with an effective utilization of leadership within the organization. ISO 9001 Standards helps to involve the employees who are recognized under the leadership clause to implement the standard in the organization. It has various clauses that need 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 interrelated or interacting elements that an organization uses to formulate its Quality policies and Quality Objectives and to ensure that the stipulated policies are being followed to achieve those objectives. ISO 9001 means to provide a framework that would enable the organization to understand customer requirements with respect to quality. This increases an organizational awareness amongst the employees contributing to the business and enables them to increase their output and productivity.
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. It is based on the platform of Quality Management principles and Annex SL, which is presumed to be the skeleton of all management systems according to the ISO.
What is ISO 9001 Certification?
ISO 9001 Certification as we already know is called as Quality Management System. We shall now 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 5 times since then and the 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. It deals with all the requirements that an organization needs to fulfill to be ISO 9001 compliant. ISO 9001 Services has a brief history starting from 1987.
ISO 9001 Certification
ISO 27001 Certification
ISO 20000 Certification
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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 was based on the BS 5750 series of standards
- ISO 9001:1994 had a new addition of preventive actions with a lot of emphasis on the documented evidences which eventually turned out to be a disadvantage for the version.
- ISO 9001:2000 which saw the need for approvals before finalization and records and control of records acted as documented evidence.
- ISO 9001:2008 witnessed the addition of two other standards to the ISO 9000 family. It was a continuation of the ISO 9001:2000 version but with minimal changes.
- ISO 9001:2015 is the current version and is based on QMS Principles. It has a risk based thinking approach where preventive actions were kept at the back end and risk calculation took over as the front-runner (or paramount importance).
- Now that we know the history of the standard, we need to 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.
ISO 9001 Certification – What are its elements?
ISO 9001 standards follow the principles of the quality management system that targets the achieving of a standard procedure of enhancing the organization in various sectors of any organization. ISO 9001 series of Quality management system principles includes 7 major principles as listed below.
Quality management principles (QMP) are given below:
- 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. We highly recommend you to kindly go through the same to understand the ISO 9001 certification.
ISO 9001 Clauses
There are 10 ISO 9001 clauses and they are based on Annex SL that provides the PDCA cycle or the 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 given below:
- Normative references
- Terms and definitions
- Context of the organization
- Performance evaluation
- Continual Improvement
These clauses have to be implemented in the organization and audited by a 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 act as evidence towards following the standards in the organization. The documents can be self- made or any ISO expert could assist you with the same. CertPro has ample expertise in customizing the basic mandatory documents and in guiding the employees to complete them with a professional approach. CertPro also offers the basic ISO kit which would have the mandatory documents list and the policies and procedures that needs to be implemented. CertPro assists organizations to achieve the ISO Certification with all the evidences that are required. We also provide professional guidance on maintenance and towards monitoring the implementation of the same.
Do we understand ISO 9001 Certification?
By now, you will be aware of the ISO 9001 concept along with a brief overview about its history and the background. You are also aware about the elements that are part of an ISO 9001 certification. The certification has 7 principles to be followed along with 10 clauses which are the requirements of the standard. ISO 9000 family is also briefed in this blog. We would suggest all our readers to get complete information on the same by contacting our subject matter experts at CertPro who can provide you with more details on ISO services.