Advancement and benefits associated with ISO 9000 series
Yogita Chowdhary, Babita Kumar
Sanskar College of Pharmacy Education and Research, U.P.
*Corresponding Author E-mail: Yogitachowdhary85@gmail.com
ABSTRACT:
ISO 9000 is a set of internationally recognized standards for quality assurance and management. Published by the International Organization for Standardization, it aims to encourage the production of goods and services that meet a globally-acceptable level of quality. ISO 9000 is a quality management standard that presents guidelines intended to increase business efficiency and customer satisfaction. The goal of ISO 9000 is to embed a quality management system within an organization, increasing productivity, reducing unnecessary costs, and ensuring quality of processes and products.ISO 9000 was first published in 1987 by the International Organization for Standardization (ISO). It was based on the BS 5750 series of standards from BSI that were proposed to ISO in 1979.. ISO 9000 is defined as a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements needed to maintain an efficient quality system. They are not specific to any one industry and can be applied to organizations of any size. They are issued by certification/registration bodies (also called Registrars or CB's), which are independent of ISO. CB's need to be accredited by an IAF member to be internationally recognized. ISO 9001 supports you to increase the control of your business processes. The more you control your business, the more your consistency rises. Increased consistency means your customers are getting the same good service or same good products every time they are making business with you. ISO 9000 aims to improve quality and facilitate business objectives.
INTRODUCTION:
International Organization for Standardization (ISO) is an international standard of QMS This written international standard is implemented by ISO. It is an independent organization with more than 150 national standard bodies1. To serve the satisfaction to the customers, an organization needs standards through QMS and ISO. The needs of standard are for the following points: For customer satisfaction and safety, which depend on output of the organization For maintaining the quality system that is auditable and verifiable with continuous mode2.
To establish an effective QMS through ISO 9000 series the following points are necessary.
1. Responsibility of the Management of the Organization:
The policy to maintain the quality should be ensured by the management of the organization. The quality policy should be implemented and maintained in all the spheres of the organization3.
2. Quality System and Design Control:
The supplier of raw materials should maintain the quality and documents regarding specifications of the materials. The products should meet predetermined quality and standards.
3. Documentation regarding Stakeholder's Contract and Purchasing:
The well documented contract review with different suppliers should be maintained by the management. The capability of the contractor should be defined and documented. The details of purchasing and all data should be in documentation and maintained for the record to attain the desired quality management in the organization.
4. Process Control:
The design of work flow should be decided, planned, defined and implemented. The responsibilities should be defined to the personnel for the equipment, process and the change if any in the protocols that should be well documented, reviewed and proposed for the prior approval from the higher and concerned authorities. The production plan, installation and service should be finalized by keeping in mind that the variations in reaction condition shall alter the quality of the finished products. The inspection of validation of equipment, calibration process and efficiency are the important concerns.
5. Final Inspection and Testing of Finished Goods: The inspection and analysis for the finished products should be well documented and, test procedure and result should be reviewed and maintained for the record. The product that does not meet certain specifications should be prevented for the further process and installation.
6. Actions taken to Overcome the Errors:
The possible causes for the errors should be identified and eliminated. The non-conformities of the products can affect the quality parameters and to maintain the quality management, the preventive actions should be taken, reported and documented. The implementations of the corrective measures should be confirmed.
7. Internal Audits:
The effectiveness of the organization and system is determined by the quality internal audits. The audit report will assure the functioning of the system is adequate or not to maintain the desired quality of the products. The audit report shall be maintained and the corrective steps should be taken by the responsible individual in their respective areas if any deficiencies found. The audit in regular intervals assures the quality of the process in the organization.
8. Training and Providing Education/Awareness regarding the Standards:
The personnel involved in the system shall be provided training, proper education
Table No 1: Advancement of ISO 9000
|
ISO 9000 series |
Function |
|
ISO 9000 |
Quality assurance and quality management concepts, guidelines for selection and use. |
|
ISO 9001 |
Concepts for QA in design, production and development with service and installation. |
|
ISO 9002 |
Concepts for QA in production, service and installation. |
|
ISO 9003 |
Model for QA in final inspection and finished good testing. |
|
ISO 9004 |
Guidelines for quality assurance and quality management implementation, efficiency and improvement. |
Fig No 1: Stating the model of ISO 9000 series.
BENEFITS OF ISO:
· Responsibility of the Management of the Organization4
· Quality System and Design Control
· Documentation regarding Stakeholder's Contract and Purchasing
· Process Control
· Final Inspection and Testing of Finished Goods5,6
· Actions taken to Overcome the Errors
· Internal Audits
· Training and Providing Education/Awareness regarding the Standards
ADVANTAGES OF ISO7,8
· Increment in marketability
· International recognitions
· Reliability in the market
· Capability of providing quality products to satisfy the customer
· Improvement in relationship with customers and stakeholders
CONCLUSION:
ISO 9000 can help a company satisfy its customers, meet regulatory requirements and achieve continual improvement. It is base level of quality system. It aims to enhance customer satisfaction through the effective application of system including process for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirement.
REFRENCE:
1. Ashok A. Hajare, 2021, Niral Prakashan, A Textbook of Industrial Pharmacy .
2. K.P Sampath Kumar, Debjit Bhowmik, Rishabh Bhanot, Shambaditya, 2021, Nirali Prakashan A Textbook of Industral Pharmacy..
3. Poksinska, Bozena; Dahlgaard, Jens Jörn; Antoni, Marc (2002). "The state of ISO 9000 certification: A study of Swedish organizations". The TQM Magazine. 14 (5): 297.
4. Tsim, Y.C.; Yeung, V.W.S.; Leung, Edgar T.C. (2002). "An adaptation to ISO 9001:2000 for certified organizations". Managerial Auditing Journal. 17 (5): 245.
5. Beattie, Ken R. (1999). "Implementing ISO 9000: A study of its benefits among Australian organizations". Total Quality Management. 10: 95–106.
6. Stamatis, D H (8 August 1995). Understanding ISO 9000 and Implementing the Basics to Quality. CRC Press.
7. Sharma, Divesh S. (2005). "The association between ISO 9000 certification and financial performance". The International Journal of Accounting. 40 (2): 151–172.
8. Buttle, Francis (1997). "ISO 9000: Marketing motivations and benefits". International Journal of Quality & Reliability Management. 14 (9): 936–47.
Received on 11.03.2022 Modified on 23.08.2022
Accepted on 12.11.2022 ©Asian Pharma Press All Right Reserved
Asian J. Pharm. Res. 2023; 13(1):45-46.
DOI: 10.52711/2231-5691.2023.00008