1,2Department of Pharmaceutics, Government college of pharmacy, Karad,
3,4Vasantidevi Patil Institute of pharmacy Kodoli,
5Anandi pharmacy collage Kalambe tarf Kale.
The article talks about the qualitative advantages of employing ISO 9000 and certifications, as well as the possible synergistic benefits that may be obtained from a unified quality environment system. The International Standards Organization is known as ISO. International standards are created and published by ISO, an independent body. In this paper presents some of the most important studies of ISO 9000 certifications means advantages of ISO disadvantages of ISO also all principles and elements of ISO 9000 all series of ISO 9000 included in this paper. in this paper presents customer care or safety of customer. Quality product to give customer and give guarantee that goods and services are high quality, safe. The ISO 9000 certification processes have demonstrated proven net benefits that were detailed in this review paper. To support the advantages of both standalone certificates and the combination of the two certifications, further quantitative research with longer time periods is thus required. While ISO 9000 has several benefits, it also has certain drawbacks.
The International Standards Organization is known as ISO. International standards are created and published by ISO, an independent body. The Greek term "ISOs," which meaning "equal," is whence ISO gets its name. It serves as certification or evidence that a business is upholding all requirements for the effectiveness, safety, and quality of the goods and services it offers to clients. Representatives from several national standards organizations make up ISO, an international standard-setting body. Producing goods or offering services that satisfy client demands, industry standards, and/or organizational technical specifications is what quality is all about. The term "quality" has hundreds of meanings, this being one of them. But quality is always the most important thing that all society, organizations, and people are searching for and trying to achieve. According to the ISO International Standard, a business must strategically decide to implement a quality management system. Numerous factors, including goals, the goods offered, the procedures used, and the organization's size and structure, affect how a quality management system is designed and implemented. The International Standards do not intend to suggest that documentation or the structure of quality management systems should be uniform. The ISO is non- governmental organization. The head quarter is located at Geneva Switzerland and it is considered as world largest organization. It helps to facilitate global trade by creating common standards across the country. which involves with developing international standards. Over the years since it began functioning ISO has set more than 20000 standards in different areas from manufacturing and agricultural to the food safety health care. A global union of national standard bodies is known as the International Organization for Standardization, or ISO. By establishing similar standards across countries, it facilitates global trade and is the leading creator of voluntary international standards worldwide. More than 20,000 standards have been established, ranging from technology and manufactured items to food safety, agriculture, and healthcare. The largest standards organization in the world, ISO is a non-governmental organization that serves as a link between the public and commercial sectors.
•Many of its member organizations are required by their governments or are a part of their national governmental structures.
•Some members were established by national alliances of industrial groups, giving them a distinctive foundation in the private sector.
•As a result, ISO makes it possible to agree on solutions that satisfy corporate goals as well as societal demands.
Figure no.1: ISO covers industries
ISO is represented in each nation via a network of national standards organizations. In order to handle standards development, ISO now has 777 technical committees (TC) and subcommittees, with members from 162 countries. There is only one member per nation, and ISO members are the leading standards organization in their respective nations. In their respective nations, each member represents ISO. Companies or individuals cannot join ISO. [1]
Objectives
Advantages Of Iso Certification
•Increase in Customer Satisfaction:
When your company is effectively accredited to ISO standards, quality becomes consistent and business processes become more defined. You will put more of an emphasis on meeting the needs of your clients with your goods and services. Customer satisfaction will rise as a result, and you will become more competitive in the market.
•International Acknowledgement and Recognition:
An international organization renowned for upholding quality standards is ISO. If you register under ISO certification, businesses all around the world will recognize and value the certification.
•Happier Staff:
You will gain a thorough grasp of the standards and how to effectively meet them. Your employees will understand how they contribute to meeting the company's overall goals and achievements.
•More customers:
More clients will be drawn to you once you establish yourself in the cutthroat industry due to the high standards of quality you uphold when providing them with goods and services.
•Consistent Quality and Efficiency:
You will understand exactly what is expected of you and what criteria you must adhere to in order to finish business procedures. Processes that are consistent aid in preventing duplication, recognizing issues that arise throughout work, and finding quick, practical solutions.
•Reduced Costs:
Redundancy, needless overlaps, and the source of scrap will be found by examining the quality and safety requirements. Over time, this might help you cut down on or get rid of the scrap.
•More Business Opportunities:
Both customer satisfaction and product prices will increase. By obtaining ISO certification, you will be able to increase quality, take advantage of opportunities, and expand your management business across existing and new markets around the nation.
•Proper management Visibility: Being ISO certified has several advantages, one of which is that employees are educated to manufacture goods and services using objective facts rather than conjecture.
•Less Disruptions:
Any issue that disrupts business operations may be quickly identified and resolved at the source to ensure it doesn't recur. This aids in lessening organizational interruptions.
•External Audit Benefits:
Because they bring in a third party to examine the company processes and have firsthand experience with similar issues, external audits are advantageous to the corporation. Their expertise will provide you a superb opportunity to see what's happening within the operations of your company. (Expert bells) [2]
Disadvantages Of ISO
•The process of being certified might be challenging.
•It takes time to become qualified.
•Getting certified requires work.
•The amount of bureaucracy involved is substantial.
•Increased Accountability Is Needed for Certification
•Smaller businesses may find ISO 9001 certification to be too expensive.
•It Is Not Adequate for Service Sectors
Management occasionally fails to follow ISO Standards because they do not comprehend their complexity. Many companies do not take advantage of the advantages that come with ISO certification. The reason is because they frequently steer clear of implementing ISO standards. [2]
Scope Of ISO
•Whoever wishes to comprehend the language used in management of quality (e.g. customers, suppliers, etc.) Consultant and instructors who provide guidance.
•Businesses looking to achieve long-term success by putting in place a quality management system;
•consumers looking for assurance that a company will regularly deliver goods and services that meet their needs;
•businesses looking to have assurance in their supply chain that requirements for goods and services will be fulfilled
•Groups and interested parties looking to enhance communication by sharing a common terminology related to quality management.
•Providers of quality management instruction, evaluation, or guidance;
•Creators of relevant standards.
ISO 9000
Defination:
An efficient quality assurance system for manufacturing and service businesses is defined, established, and maintained by the ISO 9000 family of standards.
Introduction:
The criteria of the ISO International Standard are outlined in detail in eight clauses. The ISO 9000 Quality Management System is founded on eight principles, which are like the foundation of a structure. Any effective ISO 9000 QMS must adhere to these eight principles, which are:
Emphasis on the Customer
2) Guidance,
3) Participation of Individuals,
4) The Process Method,
5) System-Based Management,
6) Continuous Enhancement,
7) Using Facts to Make Decisions, and
8) Supplier Relationships That Benefit Both Parties [3]
Research, designing, constructing, shipping, installing, and service are all included in the ISO 9001 paradigm. The manufacture, installation, and maintenance processes are guaranteed by the ISO 9002 model. The ISO 9003 model is only applicable to testing and inspection. The ISO 9004 or 9004-2 model addresses customer interaction activities and service quality enhancement. It is very difficult to alter impressions that have been repeatedly validated by consultants, other companies, and regular audits by certifying authorities during the past 20 years. ISO 9000 is what it is, whether that perception is correct or not, whether it is a set of documents or a badge on the wall. It is obvious that we must take action if this was not the intention of ISO 9000. However, why should these attitudes be altered? Can 340,000 organizations have made a mistake, after all? While some organizations did make good use of ISO 9000, they are probably in the minority. Additionally, several companies decided not to pursue ISO 9000 certification and TQM-focused efforts, but they also produced unsatisfactory outcomes. It may be helpful to examine these views as an introduction to this ISO 9000:2000 guide. Specifically, examine how we have come to think of ISO 9000, quality, quality systems, certification, and inspection. Understanding these impressions should help us approach the new norm differently, or at the very least, give us something to think about. [4] When you want to create a quality management system that gives you assurance that your company can produce goods that meet the demands and expectations of your customers, you employ ISO 9001. It is the ISO 9000 family standard that an outside organization may certify your quality management system against. The standard acknowledges that services, processed materials, hardware, and software meant for your client are all considered "products."
Numerous firms saw the value of quality management and thought that ISO 9000 would be an excellent starting point for their quality improvement approach. According to Kanji (1998), one of the key features of the ISO 9000 series is its structure, which provides a uniform set of elements, processes, and standards that are applicable everywhere. It also offers a foundation for creating, assessing, putting into practice, defining, and approving a quality assurance system. Additionally, it establishes standards of excellence for the corporate community and a common language for international trade. [5]
The ISO 9000 series of standards was created to offer recommendations to help businesses set up and run a Quality Management System (QMS). ISO 9000 is now the most popular and sought-after quality management system, with hundreds of thousands of certified businesses worldwide. The success of the ISO 9000 series has been measured by market penetration. It's difficult to understand why the standards are so widely used. The research community rarely questions directly why the management standards have been successful, despite the fact that there is a lot of publishing activity in the field, mostly focused on the standards' application and advantages. People's engagement in ISO 9000 implementation depends on their motivation and the implementation approach they choose. [6] Staff members are interviewed as part of an evaluation to make sure they comprehend the operation of compliance. After reviewing the organization's documentation for compliance, the assessor writes a thorough report outlining any areas of the standard in which the company does not comply. After that, the organization commits to fixing issues within a given time frame. The organization can obtain certification if all issues have been resolved. All of the prerequisites for developing and sustaining a quality management system in accordance with ISO 9000 are outlined in the ISO 9001 standard. Some people are unaware of this little distinction between ISO 9001 and ISO 9000. To be clear, the distinction between ISO 9000 and 9001 may be summed up as follows: ISO 9000 defines a quality management system, whereas ISO 9001 specifies the criteria to achieve that definition. ISO 9001, which outlines the standards for a quality management system, is the only standard in the family that may be certified to, however it is not required. It may be used by any organization, regardless of size or sector. More than a million companies and organizations in more than 170 countries really hold ISO 9001 certification. The standard is identified by the number that follows ISO. One of the most well-known ISO standards, ISO 9001 establishes requirements for general quality management systems. The larger ISO 9000 family includes ISO 9001. Every ISO 9000 standard makes reference to quality management. In essence, the goal of this standard is to assist businesses in becoming more effective and effectively satisfying the demands of their clients. [7]
Purpose Of ISO:
•To satisfy clients that want ISO 9000
•to market in the European Union
•to finish in the home market
•To enhance the system of quality
•To reduce recurring audits by both similar and distinct clients
•to enhance the performance of subcontractors.
Principles Of ISO 9000
1.Customers focus:
Customer happiness is essential to your company's success. As a result, you must comprehend the needs of your customers both now and in the future, satisfy their demands, and work to go above and beyond. Controlling client satisfaction is essential.
2.Leadership:
The senior executives in your company are the leaders. They provide the organization's goal and direction cohesion. They should create and maintain the internal environment that enables people to actively contribute to achieving the company's objectives. Building trust, empowering staff, recognizing their accomplishments and hard work, and setting tough goals to keep them motivated are all important components of creating a successful workplace.
3.Engagement Of People:
People at all levels make up an organization, and when they are all actively participating, their abilities may be used to the benefit of the business. To guarantee that workers have the resources they need to do their jobs and contribute to the success of your company, ISO 9001 mandates training.
4.Process Approach:
A process is a set of steps that use resources (people, equipment, etc.) to transform inputs into outputs. All organizations are composed of a number of interconnected processes.
5.Improvement:
One of the organization's long-term goals should be to continuously enhance its overall performance. Employees should be encouraged to improve by upper management, who should also track the consistency of such changes.
6.Relationship Management:
The company must find and choose vendors (as well as other interested parties) who can control expenses, maximize resources, and provide value. You should work together while building connections to make sure that you are both focused on ongoing development.
There is no one right approach to implement the aforementioned ideas since your business is unique. However, implementing ISO 9001 might help build a solid basis for improved quality and customer satisfaction.
7.Mutually Beneficial Supplier Relationships:
A mutually beneficial connection between an organization and its suppliers increases both parties' capacity to generate value. Important advantages include:
8.System Approach to Management:
The ability to recognize, understand, and manage interrelated activities as a system affects how effectively and efficiently the business achieves its objectives. Important advantages include:
9.Evidence Based Decision Marketing:
Evidence-based decision making, or EBDM, is the deliberate and purposeful use of empirical data and research-supported principles to choices made at the case, agency, and system levels of the legal system. [8]
ISO 9000 Series
1.ISO 9000: Foundations and Terminology for Quality Management and Quality Assurance Standards
2.ISO9001: Requirements for the quality management system (proof of suppliers' capacity to create and produce the product)
3.ISO9002: purpose of external quality assurance
4.ISO9003: Model of a quality system for ensuring quality in final testing and inspection12
5.ISO9004: Rules for enhancing performance.
6.ISO9000:2015 – All of these ISO 9000 standards employ this particular terminology and set of fundamentals.
7.ISO 9001 : 2015 - This requirements standard aims to:
oGive guidance on how to meet important legislative requirements;
oProvide guidance on how to meet quality standards; and
oIncrease stakeholder satisfaction (customers, shareholders, etc.).
oHave a plan in place for determining and putting the improvements into practice.
i.ISO 9004:2009 – This offers recommendations for sustaining the effectiveness of quality management systems via assessment and enhancement of performance.
ii.ISO19011:2011 – For any auditing management system, this lays forth guidelines.[8]
Benefits Of Iso 9000
Benefits Of Iso 9001 Certification For Your Organization:
1.Enhanced efficiency: Put in place policies and procedures that prioritize quality.
2.New income- acquire new contracts and bids while optimizing your workflow and looking for ways to save costs.
3.Higher staff morale: You may lower mistakes and boost productivity by making sure that everyone is working toward the same goal.
4.International recognition: ISO 9001 might assist you access international trade because it is recognized in over 188 countries.
5.Use a fact-based approach when making judgments to make sure your business choices will benefit your company in the long run.
6.Improved supplier relationships: Your company's legitimacy stems from ISO 9001, which gives suppliers more faith in your work.
7.Better record keeping: ISO 9001, like any management system, makes sure you record your procedures from beginning to end. assisting you in managing client complaints and increasing the effectiveness of your processes.
8.Increased customer satisfaction: Make sure you have a feedback system in place that will enable you to comprehend the wants of your clients, pinpoint areas in need of development, and cut down on resource waste.
9.Continuous improvement: You may identify opportunities for improvement and maintain an advantage over your competitors by employing trend analysis and non-conformity reporting.
10.Increase marketability– ISO certification increases the organization marketability.
11.This ISO 9001 certification process help to find out deficiency of organization and hence help to make it better.
12.This ISO certification is helpful to improve quality of product and process.
13.ISO certification offers better or higher customers justification
14.ISO 9001 certification helps to improve management control.
15.It helps to improve communication and interaction with different department.
16.A decrease in mistakes, complaints from consumers, and non-compliant goods, services, and expenses, as well as a rise in customer retention.
17.A better working environment.
18.Finding documents and other garbage that are ineffective.
19.A decrease in the quantity and duration of customer audits and assessments, which will save the resources required for these kinds of operations.
20.Support for trade liberalization via standard terminology and regulations. [12]
Benefits Of ISO 9001 For Customer
1.Better service quality- which also has the advantage of more on-time delivery
2.Fewer returns are necessary since issues are identified and resolved faster, often without the client's knowledge.
3.Assurance of service: A company's certification is proof that it provides reliable, consistent, and suitable solutions.
4.Better experience: Enhancing the rapport between stakeholders and customers will improve the customer experience as well as raise the likelihood that the consumer will come back in the future. [10]
Steps In ISO 9000 Registration Process
1.Identification of key drives
2.Obtaining the standard
3.Defining strategy
4.Planning and availability of resources of developing the quality management system
5.Understanding process
6.Determining training needs
7.Developing management system documentation
8.Implementing quality management system
9.Pre- assessment audit
10.Certification [11]
Elements Of ISO 9000
1)Quality system (quality manual and supporting procedure)
2)Better management (policy implementation)
3)Design and process control
4)Documentation and data control
5)Control on customer satisfaction
6)Product identification
7)Inspection and testing
8)Corrective and preventive action
9)Control of quality record ( for internal and external audits )
10)Internal quality audits (self assessment)
11)Training
12)Accountability of Management
13)The Quality System.
14Entering an order.
15)Control of Design.
16)Data and Document Control.
17)Buying.
18)Management of Products Provided by Customers.
19)Product Tracability and Identification.[12]
Certification
Additionally, the only 9000 family standard that is accredited to is ISO 9001. Organizations can still use ISO 9001 principles informally without obtaining certification, as it is not a prerequisite.
In theory, only companies are able to "get certified." To conduct audits on businesses, however, people can become Registrars or Certified Lead Auditors.
With an emphasis on certain facilities or departments designed to enhance performance in that area, certification will often encompass the whole business.
Here is a brief summary of the key details about the ISO 9001 standard:
• A global standard for a quality management system (QMS) is ISO 9001.
• The wider ISO 9000 family includes ISO 9001.
• The only standard to which certification is possible is ISO 9001. "ISO Certification" and "ISO 9000 Certification" are nonexistent; only "ISO 9001 certification" exists.
• Organizations or businesses must obtain ISO 9001 certification; individuals cannot.
• On the other hand, people can get qualified to audit other businesses as ISO 9001 qualified Lead Auditors.
• The organization's size is irrelevant. One person or 100,000 might be involved.
• ISO 9001 is a universal standard for quality control that applies to all industries.
Unlike other standards that are product-focused, ISO 9001 is process-focused. Although your product should be good if your process is good, it is not intended to determine product quality. [13]
Importance of certification audits. Almost little research has examined certification audits as a crucial need for attaining ISO 9001:2000 benefits. This study demonstrated that certification audits might be a useful instrument for improving the QMS's efficacy and ongoing development. The third-party evaluation procedure was typically thought of as a standard step in the ISO 9001-3 certification process. A lot of organizations are still unaware of the potential for change that external audits may provide. Some quality managers voiced fears that they "will now have the police longer" in their company after the Swedish accrediting authority introduced rules for the "man-days" utilized for audits. This viewpoint makes sense if audits are simply seen as a need to be fulfilled in order to earn the certification, rather than as a chance to get outside counsel, suggestions, and assistance. However, longer audits can only be beneficial because they allow more time to examine the issues of the audited organization, which could result in higher quality. This article was accepted for publication in the International Journal of Productivity and Quality Management, which will appear in Issue 2, Volume 5, 2010. [14]
Limitations Of the ISO 9000 Series of Standards
1)Cost:
Becoming an ISO 9000 certified business is not inexpensive. The type of business, its size, and other variables that vary for each type of organization all have a significant impact on the certification process's cost.
2)ISO Certification Process
The full execution of the initial certification does not mark the end of the ISO 9000 certification process. It needs to be upheld for the duration of the business, or at the very least, the duration of the business's ISO 9000 certification. Consequently, it may result in costs.
3)Employee buy-in
The certification process will swiftly collapse and lose its purpose if the staff members lack the motivation or ability to comprehend and carry out the rules and procedures necessary to preserve the ISO 9000 status.
4)Competitive disadvantages
Individuals who are unaware of what ISO9000 is might not be impressed by the ISO9000 certification and instead decide to work with less costly rivals who are not ISO 9000 certified and can thus operate at a lower cost. [9]
Deferences Between Standards and Requrements
Standards are specified levels of quality criteria that are necessary in order to accomplish other goals. According to ISO, standards comprise specifications, rules, and requirements that show the path to high-quality production. There are several standards in the ISO9000 series; we call these standards a family of standards. [9]
CONCLUSION
Programs for the International Organization For Standardization's 9000 certification have demonstrated proven net benefits, which were detailed in this assessment. Their integration can yield further advantages. Nevertheless, the majority of recent research is restricted to qualitative results and a brief time period. To support the advantages of both standalone certificates and the combination of the two certifications, further quantitative research with longer time periods is thus required. To ascertain if the improvements in financial performance metrics are due only to ISO certifications or to additional political and economic reasons, ISO-certified and noncertified businesses must be compared. While ISO 9000 has several benefits, it also has certain drawbacks.
REFERENCES
Madhushri Mane*, Rajlaxmi Patil, Amruta Nikam, Pritee Mudagal, Nita Sid, International Organization for Standardizations 9000, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 2, 136-145. https://doi.org/10.5281/zenodo.14793380
10.5281/zenodo.14793380
