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iso9001:2015

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What is Quality in ISO 9001?

The Concept of Quality in ISO 9001

Quality can be defined as “fitness for use,” “customer satisfaction,” “doing things right the first time,” or “zero defects.” Webster’s dictionary defines quality as “a degree of excellence” and “superiority in kind”.

Within an organization, quality is controlled and measured using a quality system – a mechanism that coordinates and maintains the activities of the organization needed to ensure that the characteristics of products, processes or services are within certain bounds. A proper quality system considers all interested parties – everyone directly or indirectly affected by these activities and is typically documented in a quality manual. The quality manual dictates the associated processes and documents that specify procedures and standards to achieve and maintain quality of goods, services and outputs of the company.

Basic Elements in a Quality System

There are three basic elements in a quality system: Quality Management, Quality Control, and Quality Assurance.

  • Quality Management being the means of implementing and carrying out the quality policy.
  • Quality Control being all the techniques and activities of an organization that continuously monitor and improve the conformance of products, processes or services to specifications.
  • Quality Assurance being all the planned and systematic actions necessary to assure that a product or service will satisfy the specified requirements.

As stated in an ANSI/ASQ standard: “Quality control has to do with making quality what it should be, and quality assurance has to do with making sure quality is what it should be.”

Quality Audits

How can an organization determine if their Quality System is effective? This is done through a quality audit – an independent assessment comparing the various management and quality activities to a specific standard.

An independent assessment implies that the person performing the audit is not associated with the activity being audited. In the past, the specific standard to which a quality system was compared was up to the business owners themselves. Be it customer satisfaction, internal approval or whatever was deemed acceptable to leave the factory. It wasn’t until 1987 that an ISO technical committee developed and published the ISO 9000 family of standards – quality standards that set the benchmark for the minimum requirements for an adequate quality system. – Source

What are Quality Standards?

Quality Standards can be defined as “documents that provide requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and services are fit for their purpose”. – Source

Using standards, an organization can effectively share their goals, processes, procedures, and vocabulary needed to meet the expectations of their stakeholders. Standards provide organizations with an effective road map for the understanding, procedures, and vocabulary needed to meet the expectations of their stakeholders. Because standards provide descriptions and terminology, they allow for ease in international communication and help increase trust between international consumers, suppliers and trade.

One specific standard that is most well known and attributed to Quality is ISO 9001.

ISO 9001 is the internationally recognized QMS standard that was designed as a business improvement tool to help organizations of any size continually improve and streamline operations, reduce operating costs, satisfy more customers and win more business. 


Read more from ISO Update:


ISO 9001 helps organizations from the ground up, working to standardize their processes effectively to work towards the end goal of providing exceptional outputs to their customers. Your whole system should work in a way that it constantly measures and checks that you are working in such a way as to produce the highest quality output. This is not simply in measuring the weight or using the right material, but this also encompasses your hiring process, your training methods, and your day to day activities. ISO 9001 sets up the framework for how you can properly measure, monitor and improve your processes in such a way that sets you up for success in the short and long term. ISO 9001 is an internationally recognized and trusted standard, often required to do business internationally.


Want to learn more about ISO 9001? Are you considering certification? Ask an expert:

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The concept of risk has always been implicit in ISO 9001; this new revision only makes it more explicit and builds it into the whole management system.

In ISO 9001:2015, risk management is being added with focus on risk-based thinking.  Here a systematic approach to risk is established by considering and including it throughout the standard.



In the Introduction the concept of risk-based thinking is explained. Risk is defined as the effect of uncertainty on an expected result, where:

  1. An effect is a deviation from the expected – positive or negative.
  2. Risk is about what could happen and what the effect of this happening might be.
  3. Risk also considers how likely it is to take place.

The main goal of this quality management system is for an organization to achieve conformity and customer satisfaction. In ISO 9001:2015 a risk-based thinking is used to achieve this goal.

  • In Clause 4 (Context) the organization is required to determine the risks which may affect its ability to meet the system’s objectives. The new ISO 9001 recognizes that the consequences of risk are not the same for all organizations, and this is why every organization will need to consider risk quantitatively as well as qualitatively, depending on their context.
  • In Clause 5 (Leadership) top management is required to demonstrate leadership and commit to ensuring that risks and opportunities that can affect the conformity of a product or service are determined and addressed.
  • In Clause 6 (Planning) the organization is required to take action to identify risks and opportunities, and plan how to address each of them.
  • Clause 8 (Operation) establishes that the organization is required to plan, implement and control its processes to address its risks and opportunities.
  • In Clause 9 (Performance evaluation) the organization is required to monitor, measure, analyze and evaluate the risks and opportunities.
  • In Clause 10 (Improvement) the organization is required to improve by responding to changes in risk.

These requirements are considered to cover the concept of preventive action (which has been replaced) and takes a wider view that looks at risks and opportunities. By understanding those risks and exploring ways in which the risks can be mitigated, the organization will also have an opportunity to drive change and improvement.

In order to effectively meet the quality management system’s goal, ISO 9001:2015 will require organizations to consider their risks as part of their management’s plan, which will call for an improved commitment and more involvement of top management.