ISO 9000

Make your business ISO 9000 compliant. Get a stamp of unmatched quality in all your business operations. Be an epitome of trust, safety & efficiency in the market with ISO 9000 certification.

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Overview

ISO 9000 was first published in 1987 by ISO (International Organisation for Standardization). It was initially based out of the BSI’s BS 5750 series of standards but later it was proposed to ISO in 1979. ISO 9000 is nothing but a set of standards where it helps the customers and stakeholders meet their provisions related to the product or service. Moreover, the ISO 9000 ensures that the requirements are within the statutory and regulatory borders. With that in a note, the ISO 9000 family comprises several QMS (Quality Management Systems) standards. The standards cover the guidelines, tools, and direction for the companies and organizations. This, however, helps to ensure that the company’s or the particular organization’s products or services consistently meet their customer’s necessities and also to improve the quality consistently. ISO 9000 deals with the essentials of Quality Management Systems, which apparently includes the seven quality management principles that carry the family of standards.

Over one million organisations worldwide are independently certified, making ISO 9001 as one of the most popularly used management tools in the world recently.

In order to increase efficiency and productivity, organizations can follow these standards. By complying with these provisions allocated by the government, the firm can gain access to new and more diverse markets in any chosen field. Companies or organizations that are ISO certified are more engaging to vendors and consumers as it ensures that their products and services are reliable and competent. and that there is an approved standard in place for their processes.

The organization which delivers approved standards is made up of members from 160+ countries. Officially, it started its operations and plans in 1946. Since that point, ISO has published more than 19,500 International Standards for a variety of industries which includes technology, manufacturing, health, electronics, and environmental sectors. Since the ISO has published well-established and prominent standards for the industries in the world, the ISO 9000 family is one of the most well-known and widely implemented systems in the world. The ISO 9000 series focuses on Quality Management and has experienced many improvements and updates over the years.

What is an ISO?

ISO means International Organization for Standardisation. ISO is an independent organisation that provides standards in terms of quality, safety, and efficiency of products and services provided by businesses. With the increasing competition among the business, it is important to deliver high-quality goods & services in order to sustain in the market. ISO certification helps to improve your business credibility as well as the overall efficiency of the business.

First of all, you need to choose the type of ISO certification required for your business. There are various types of ISO certification available such as:

  • ISO 9000:2005 - Quality Management System
  • ISO 9001:2008 – Quality Management
  • ISO 14001 – Environmental Management
  • ISO 27001 – Information security Management
  • ISO 22008 – Food Safety Management and so on.

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History - Roots Of ISO 9000:

Long back, while in World War II, the Ministry of Defense in Britain determined to implement a set of standards to reduce slips and blunders, thus resulting in avoiding troubles and tragedy while manufacturing war weapons and equipment. The MoD bought this to ensure the efficiency of the products which were their life-savers. Apparently, the MoD would first inspect the procedures used during the manufacturing of the products rather than inspecting the product first. Secondly, the MoD would examine the manufactured product to ensure consistency in quality. This is being continued even today. However, this is how the certification body should audit the company or organization to ensure the excellence and sustainability of the product or service provided. The introduction of the MoD standards has brought in the need for a system to take place in a rightful way so that the industries would grow up making the nation proud. Not only the defence needs the quality of products used, but also other industries like agriculture, health, technology, etc fields are also in need of it. The quality assurance helped the public to obtain trust and guarantee towards their vendors or product manufacturing companies. Now that it has become a trend and an important aspect in the market to procure the ISO certification.

In the United Kingdom (UK), almost till the 1970s, the vendor used to ensure the quality and consistency of the credentials of their suppliers. It was the vendor’s responsibility to inspect and make sure that the products are working fine with better quality. Simultaneously, the British Assessment Bureau, which was a well-known and trusted certification board, was not liking this method and exclaimed to be a waste of time and money. A Government committee, in 1969, suggested and urged to follow the same procedure everywhere. The government said that “suppliers’ methods should be assessed against a generic standard of quality assurance.” In 1979, acknowledgement to that, the British Standards Institution announced the world’s first management systems quality standard, the BS 5750. Then the new standard which was declared came up with common contractual documentation, confirming that the overall industrial production has to be controlled. The BS 5750 replaced individual industry standards and assured quality and consistency to all users or consumers across all industries in the UK. Then evolved the ISO 9000:1987 which was internationally equivalent to BS 5750.

ISO 9000 Certification:

More than researching on the ISO 9000 certification, it is better if the research takes place on the ISO 9001 certification. Since an organization cannot become ISO 9000 certified. Firstly, it was issued in 1987 and lastly updated in 2015, ISO 9001 sets out a standard for the quality management system criteria. ISO 9001 standard is the only standard within ISO 9000, that can be given the certification. Therefore, it is incorrect to say that an organization is ISO 9000 compliant. However, a business can be ISO 9001 certified or compliant. An ISO 9001 certification is not a regulatory but a prestigious claim. ISO states that more than one million companies and organizations across 170 countries have been certified to ISO 9001.

Benefits

There are various benefits when you apply for the ISO 9000 quality systems. It helps the suppliers in marketing the products in a far more better and secure way. Also, they can easily achieve customer satisfaction in a cost-effective model. Let us have a look at the benefits of owning an ISO 9000 certificate.


  • If you have received the ISO 9000 certification at the earliest for the first time, there would be no waste of time, costs would be minimized and profit will be maximized.
  • It acts as a permit and allows you to plan tasks. This helps them to perform well resulting in yielding reasonable results.
  • It provides the means for identifying and settling down problems in prior.
  • It helps in preventing their recurrence.
  • It helps to create quality awareness and job satisfaction among employees.
  • By documenting the company’s experiences, the company can save it for staff training purposes to improve their performances.
  • It provides data that can be used to determine the administration and production level of operating processes and merchandises.
  • It generates objective evidence to build confidence among customers.
  • Quality systems. By combining high quality with low cost, this can give the company a tremendous competitive advantage.
  • ISO 9000 would greatly help in the improvement of their image, credibility, and acceptability in international businesses for grabbing the market in a shorter duration.
  • Increased involvement of management in business and enhanced employee empowerment.
  • Potential acceptance into a global supply chain.
  • Increased marketability and production.
  • ISO 9000 provides evidence that a company or organization is capable of providing quality products and production.
  • Results in enhanced sale and customer retention.
  • Reduced operational expenditures.
  • The ISO 9000 registration reveals the gaps and flaws in which the final product quality can be improved.
  • Improved internal communication.
  • The ISO 9000 certification process focuses more on self-analysis and operations management.
  • Acts as an attractive asset to the investors

Elements of ISO 9000 Quality Management Systems

The standards of ISO 9000 possesses some elements for an organization's quality management system in the following areas:


  • Management Responsibility
  • Quality System
  • Order Entry
  • Design Control
  • Document and Data Control
  • Purchasing
  • Control of Customer Supplied Products
  • Product Identification and Tractability
  • Process Control
  • Inspection and Testing Control of Inspection, Measuring, and Test Equipment
  • Inspection and Test Status
  • Control of Nonconforming Products
  • Corrective and Preventive Action
  • Handling, Storage, Packaging, and Delivery
  • Control of Quality Records
  • Internal Quality Audits
  • Training
  • Servicing
  • Statistical Techniques

ISO 9000 - Principles Of Quality Management

The ISO 9000:2015 and ISO 9001:2015 standards are based on seven quality management principles to promote organizational improvement.

The seven quality management principles are

  • Customer focus
  • Leadership
  • Engagement of people
  • Process approach
  • Improvement
  • Evidence-based decision making
  • Relationship management
  • Supplier relationship

Let us see the key points one by one to know more about each quality management principle.

Customer focus

Customer focus is the firstmost major principle of ISO 9000:2015 quality management. It helps to understand the needs of existing customers and future customers. This principle aligns organizational objectives with customer needs and expectations, thus resulting in better prospects. Customer focus meets customer requirements along with customer satisfaction. It manages customer relationships which aim to exceed customer expectations as well. Moreover, you will have a better scope to learn more about the customer experience and comfort of each customer.

Leadership

Secondly, leadership is the next principle of ISO 9000 quality management. Leadership establishes a vision and direction for the organization to lead further. Leadership helps you to set challenging goals, equips, and empowers employees to work smart and sensible. Evidently, it established trust and connection towards the people around them. Leadership prepares you for following organizational values. A leader recognizes employee contributions and supports their efforts.

Engagement of people

This significant principle of ISO 9000 quality management is the engagement of people wherein it ensures that people’s abilities are accepted, used and valued. Although it makes people accountable, it makes sure to enable people to participate in the continual improvement of work. Engagement of people includes the evaluation of individual performance, facilitates the learning and knowledge sharing modes amongst peers. Leaders can enable an open discussion of problems and detentions.

Process approach

The principle, process approach manages activities as processes and measures the capability of activities produced. It also helps to identify linkages between activities, prioritize advancement in availing opportunities and deploy resources effectively. There are process analysis tools that you can use to get better results.

Improvement

The principle of improvement helps in improving organizational performances and capabilities. Also, it aligns developmental and promotional activities. Every quality management will empower people to make improvements and create awareness of the current trends. It would be better if an improvement consistency is maintained and analysis takes place. For every record achieved, there should be a celebration for the improvements that have been implemented.

Evidence-based decision making

Evidence-based decision making ensures the accessibility of accurate and reliable data used in each report. It is to be noted that you should use appropriate methods to analyze data and review it with credible sources. Possibly, make decisions based on analysis and examination of anything. One of the best notes is that balance data analysis with practical experience can be made possible. There are many tools for decision making. Use those tools for better evidence-based decision-making principles.

Relationship management

Relationship management helps mainly in benefitting the principles of ISO 9000. Out of all the principles, relationship management benefits the most by identifying and selecting suppliers to manage costs, optimize resources, and create values. Perhaps, it helps to establish relationships considering both the short term and long term. The relationship management principle serves to share expertise, resources, information, and plans with partners. Indeed, the collaboration on improvement and development activities keeps the systems going. It recognizes supplier successes and resources related to managing the supply chain.

ISO 9000 Series:

ISO 9000 family or ISO 9000 series relates to the group of quality management standards that comes under the standardized process. The following are the family or series of ISO 9000 quality management.

  • ISO 9000 Quality management systems – Fundamentals and Vocabulary, referenced in all ISO 9000 Standards.
  • ISO 9001 Quality management systems – Requirements, contains the requirements an organization must comply with to become ISO 9001 certified.
  • ISO 9002 – Guidelines for the application of ISO 9001:2015
  • ISO 9004 – Managing for the sustained success of an organization, provides guidelines for sustaining QMS success through evaluation and performance improvement.

ISO 9001:2015 is the current version of the ISO 9001 standard. Likewise, ISO 9000:2015 is the recent version of the ISO 9000 standard of the quality management system. ISO 9001 measures the requirements, while the other standards in the 9000 families i.e. ISO 9001, ISO 9002 and so on provide guidelines and information. People often say “ISO 9000 certified“, but what they mean is they have met the demands of the ISO 9001 standard. If you want to get ISO 9000 certification, you should go through the process of getting ISO 9001 certification. Because that is the legal and available document to be procured in the quality management system. The ISO 9000 Series of Quality Standards is not industry-specific and is suitable for any manufacturing, distribution or service-based organization. It is managed by Technical Committee (TC) 176, comprised of international members from many industries and backgrounds.

ISO 9000 Auditing

Formally, if you or your organization wishes to certify with ISO 9000, then the audits will occur after you have executed your refined processes. There are three types of audit that help you to define the process stages in simple ways.


  • First Party Audit:

    The first party audit is also known as the internal audit. The first-party audit checks that the newly minted process runs according to new procedures. Auditors will finally provide feedback so that you have an opportunity to correct any gaps.

  • Second Party Audit:

    A second-party audit is usually a customer audit to ensure that the operations and procedures run according to the customer requirements. These audits can also occur for organizations that are not certified and are not undergoing certification.

  • Third-Party Audit:

    A third-party audit is also called an external audit. A representative of a registered company manages the third party audit. Successful completion of the audit leads to ISO 9000 or other standard certification respectively.

When your documentation, including the quality manual and procedures, are sent for the desk audit, the audit begins then. The registrar performs the audit. The auditors then carry out a site visit of at least two days follows, where they spot the suspicious and markable areas and ask questions to determine if the organization is ISO compliant and to measure the employee knowledge of procedures taken forward.

Cost Involved

The cost of ISO registration varies with the following aspects:

  • Manpower of your company
  • Product/Service you offered
  • Process complexity
  • Certification body
  • Accreditation body
  • Number of locations or branches of your firm

Maybe sometimes, some organizations can hesitate to get the ISO 9000 certification because of its cost. But there are many factors that benefit the organization through the ISO certification. As mentioned above, the cost will vary according to the registrar fee, internal resource cost and lots more, but you should take a deep analysis of the benefits that you will get through this. Take this opportunity to invest in something which profits you more. It becomes an investment in the growth of the company. The size and complexity of your organization will greatly influence the cost of implementation. There is one way that can help to control the size of the organization is to limit the scope. While this can take place to benefit the business’s intended outcomes, companies may be attentive that the scope directly impacts the cost of the ISO 9000 certification. For instance, additional branches and locations require additional audit days, so the benefits of including branch offices should be carefully considered.

Despite the fact that the size and complexity of the organization greatly impact the cost of certification, you have the choice of how you will implement ISO 9001 and this part has the greatest influence on the cost. However, to reduce the cost, you can create your own template and have your own consultant for the documentation works. This might overall reduce your investment in the registration of ISO certification. You should notably hire a registrar to register for your ISO certification. The registrar involved in registering ISO 9000 is responsible for the registration audit. The cost for the registrar is separate where it will depend upon the size and strength of the organization. Also, the charges depend on how much time they spend auditing and how much days they spend on auditing the organization. Additionally, if the registrar is not local, then you will have to take care of the travel costs, accommodation, and there are administrative and accreditation fees as well.

Difference Between ISO 9000 and ISO 9001

Though ISO 9001 comes under the family of ISO 9000 quality management, there are differences between the two. ISO 9000 basically is a collection of vocabulary and definitions for the entire quality management system series. Whereas to obtain the ISO 9001 certification, gap analysis and internal audits process are required. It is very important to know that ISO 9000 is standard which owns the entire quality management family which understands all of the other specific standards, while ISO 9001 is where you implement instead of actions. Both the ISO 9000 and 9001 standards are based on a number of quality management principles including a strong customer focus, motivation, and quality management implementation, continual improvement and approached the process. This is the major difference between ISO 9000 and ISO 9001. And we shall talk about the similarities between the two. Both the ISO 9000 and ISO 9001 fall under the quality management category and are recognized by the same terminology. Both the standards require review and maintenance in order to deliver the quality of work.

Conclusion:

Hence, we hope you must have known everything about ISO 9000. In short, it is a principle-based international standard that describes a Quality Management System that organizations can use to be more efficient and improve customer satisfaction. Here, you have covered what ISO 9000 is, its history, ISO 9000 advantages, ISO certification, elements of ISO 9000 Quality Management system, principles of ISO 9000, ISO 9000 series, cost and time involved, what is ISO, ISO auditing and lots more. Thereby, by registering for an ISO 9000, you can gain more privileges, customer retention, and reliability in the market.

Frequently Asked Questions

Yes, ISO 9000 is necessary for even the smallest companies. Any company can be benefitted from an ISO 9001 Quality Management System
Easily transfer your company’s ISO Certification or another management system to quality systems registrars through a simple process.
  • What are the company’s internal and external success factors?
  • What are the stakeholder’s requirements?
  • How has the company resolved identified risks and improved opportunities?

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