ISO 9001- An enabler for real Quality Transformation

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ISO 9001- An enabler for real Quality Transformation

“Most people spend more time and energy going around problems than in trying to solve them” by Henry Ford.

ISO presents the International Organization for Standardization. ISO helps organizations to improve the quality of their products & services and constantly meet their consumers’ expectations. ISO 9000 group presents many features of quality management and comprising specific ISO’s renowned standards.

The ISO 9000 standards are made by an International consensus of countries to generate global standards of service & product quality. These standards structure a Quality Management System (QMS) and are utilized by any organization despite product, organizational size, service, or whether it’s a public or private company. ISO covers all technical fields & is not restricted to any particular discipline.

You can certify your business against any of these quality systems: ISO 9001, ISO 9002, ISO 9003.

  • ISO 9001 defines the quality system requirements for an organization whose business processes vary from design and development to production, installation, and service. It applies to manufacturing & service businesses engaged in all these activities.
  • ISO 9002 is the subgroup of 9001. It is a suitable standard for organizations that don’t design & develop products, since it does not include the design control requirements of ISO 9001 standard. It applies only to production & installation activities.
  • ISO 9003 is the suitable standard for an organization whose business processes don’t include design & process control, purchasing, or servicing. It applies to final inspection & testing to ensure that final products and services meet specified requirements.

If applied wisely, ISO 9000 is a qualifier for international markets or particular domestic customers. Certification, as it may be a profitable marketing tool. The standards are a sound design for a quality system. ISO 9000 structure can enhance a company’s cost structure by 5%-20%.

Who Should Use ISO?

Any organization whose consumers make their buying decisions on quality issues should consider using these standards. Organizations whose customers need conformance & certification as a qualifier will require a conformance certificate from an approved Assessor.

  • An organization that recognizes quality as a marketing tool may get certification as part of its marketing strategy in quality transformation.
  • In markets where quality is not a dominant issue, organizations may use the standards as a guide, but not attempt certification.
  • The organization may use the standards for their suppliers requiring certification as a condition of doing business. 

Depending on the business transformation processes, an organization can select any quality system. None is considered more essential than another; it’s important to determine the suitable standard before pursuing certification.


Also See- What is Lean in Office and its Importance?

ISO 9001

ISO 9001 was launched in 1987 by International Organization for Standardization. It has ISO version 2008 and ISO version 2015, and it is the International Standard that defines the basis for Quality Management System (QMS). This standard helps organizations to increase the consistency of quality products & services, improve customer satisfaction and decrease risks. It’s the most famous standard in the ISO 9000 standard series & the only standard in the series to which organizations can certify.

ISO 9001 version 2015 is an internationally recognized set of requirements for developing the rules, policies, processes, and procedures to provide products and services that meet consumer needs and enhance customer satisfaction. It can be used by any organization, large or small, despite its field of activity. Using this helps to ensure that customers get consistent, good quality products & services, which results in many business benefits.

Genuinely, there are over one million companies & organizations in over 170 countries certified to ISO 9001. These standard depends on Quality Management Principles comprising a strong customer focus, the motivation & implication of top management, the process approach, and continual improvement.

ISO 9001 is based on the PDCA (Plan, Do Check, Act) approach and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to attain efficient quality management in an organization. Specific sections of the standard include information on many topics, such as:

  • Management of resources, including human resources & an organization’s work environment.
  • Requirements for a QMS, comprising documented information, planning & identifying process interactions.
  • Responsibilities of management.
  • Product realization, comprising different steps from design to delivery.

Benefits of ISO 9001

When properly implemented & maintained, a good quality management system brings many benefits to organizations of all sizes. Organizations that attain ISO 9001 certification experience several benefits, including:

  1. Improves customer satisfaction.
  1. Improves operations & decrease waste.
  1. Attract new business opportunities.
  1. Meet customers’ requirements for ISO 9001:2015.
  1. Enhance company reputation.
  1. Determine & eliminate organizational risks.
  1. Save Cost.

ISO 9001:2015

In September 2015, ISO 9001:2015 officially replaced ISO 9001:2008. This updated revision comprises many of the processes from the previous revision of the standard, with a higher focus on risk-based thinking and understanding the context of the organization. It is the present revision of the standard.

The revision helped the ISO 9001 standard be more applicable to organizations in different industries, beyond the manufacturing sector. Modifications initiated in the ISO 9001: 2015 are intentional to make sure that ISO 9001 carries on with adapting to the changing environments in which organizations work.

Few updates in ISO 9001:2015 are:

  • A significance on risk-based thinking to improve the application of the process approach.
  • The introduction of new terminology.
  • Restructuring some of the information.
  • Improved applicability for services.
  • Increased leadership requirements.

How to be an ISO 9001 Certified Company?

To start your ISO 9001 journey in lean transformation, the primary step is to buy a copy of ISO 9001:2015.

The following are 7 steps organizations can take to begin the journey towards it’s certification:

  1. Learn more about the requirements ISO 9001:2015 standard by reading the standard.
  1. Make sure enough resources are in place to implement ISO 9001, including time & team members. Engage leadership in implementing this standard management system.
  1. Perform an analysis of your organization’s operations and determine gaps to ISO 9001:2015 requirements.
  1. Design & develop needed ISO 9001:2015 management system documentation, comprising a quality policy, quality objectives & procedures.
  1. Ensure the requirements of the ISO 9001 QMS.
  1. Perform an ISO 9001:2015 internal audit. This may need employees undergoing additional ISO 9001 internal auditor training.
  1. Go through a certification body audit.

How much it costs to get ISO 9001 certification?

ISO 9001 certification costs will vary from company to company. Every company is distinct; for instance, few include the design & development process, and few don’t, and the amount of effort required to implement the essential processes to meet the requirements (and the costs associated with this) will vary. Similarly, the cost of having the certification auditors come in will be different depending on the complexity of your processes and the number of employees engaged. 

Different categories of cost include certification costs, learning about ISO 9001 standards, external help, cost of employee time, and finally, the costs to maintain your QMS.

Check out the Video-


Seven Quality Management Principles

The ISO 9001 Quality Management System is based on 7 principles, each one an evaluative focus for a system QMS. These 7 principles are:

  1. Customer Focus

The main focus of quality management is to meet customer requirements & to strive to exceed customer expectations. If you are trying to provide products & services that meet customer requirements, you first need to be focused on what those needs are. For the QMS to succeed, top management needs to provide resources and enough ongoing review of the system.

  1. Leadership

Leaders generate conditions so that people get engaged in attaining the organization’s quality objectives. Leadership develops alignment. Alignment in strategies, company policies, vision & direction, processes, allocation of resources, etc. Standard within leadership is created to attain and succeed in company goals during business transformation.

  1. Engagement of People

The people who work at your organization are the essential asset, and their knowledge and experience need to be understood in the QMS. Simply put, organizations with engaged & empowered employees thrive.  Organizations need to lead and delegate by trusting their employees with the task ahead. Give recognition, empower your people, and foster positivity to survive in VUCA.

  1. Process Approach

A process is any activity that takes inputs and creates outputs; these inputs & outputs need not be simply physical; some are information or energy. By understanding how a process attains results, an organization can optimize its systems & improve performance while undergoing through lean transformation. One main benefit to this is achieving “consistent and predictable outcomes through a system of assigned processes. A company will only survive if it gets better over time, so the QMS needs to focus on finding ways to do things better.

  1. Improvement

The only constant thing is “Change”. For organizations to remain competitive and current, constant improvement is required. Reacting to changes internally & externally; be it shift in leadership, consumer habits, or economic shifts; can create new and positive opportunities.

  1. Evidence-based Decision Making

Proper management can’t be done if you don’t know how a process is truly working, especially during transformation. Make sure you are using sound & precise measurements when you are making decisions. Facts, evidence & data analysis lead to higher objectivity and confidence in decision making. If your decisions are based on facts, you can better manage and improve the QMS.

  1. Relationship Management

Suppliers and interested parties have an impact on your business and its success, whether you admit it or not. Sometimes the only way to improve the products and services is to have the suppliers improve their products and services. To make this work, you need to maintain a relationship with the suppliers.

Final Word

ISO 9001:2015 is a quality management system standard that can be used by any organization of any size, in any industry, to become more effective, improve operations & amplify their profitability. By implementing an ISO 9001 QMS, organizations can focus on continuous improvement and enhance customer satisfaction.

Frequently Asked Questions-

  1. What does ISO 9001 mean?

     ISO 9001 is a set of principles that assists organizations to ensure that they can fulfill customer and other stakeholder demands within statutory and regulatory provisions that are associated with a product or service. ISO 9001 standards deals with the fundamentals of QMS, comprising of the seven quality management principles that underlie the house of standards. ISO 9001 deals with the requirements that organizations that want to fulfill the standard must.

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