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quality management system

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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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When Quality Fails - ISO Update

Standards function to provide the end-user with quality products and services, but they also protect the vitality and reputation of a business. Your system should be built in such a way that it is constantly putting measures and checkpoints in place that does not allow product to leave your hands until it is safe, and up to yours and your customers’ standards. So, how does a product of subpar quality leave your plant? Who is responsible? How did your management system allow this failure to happen? When your product fails, or worse, you must issue a recall and you want to assign blame. Who is to blame? Why did your system fail you?

Case Study – Toyota Unintended Acceleration Recall, 2009

If an auto manufacturer finds flaws in their cars and lists a product recall, the public’s perception of this company will suffer. No greater example of this exists than the 2009 recall of Toyota sedans.

Toyota issued a recall of 8.5 million of their sedans in 2009 due to unintended acceleration caused by floor mat issues, brake problems and “sticky” gas pedals. The recall was issued in response to accidental deaths and provides an example of the grave consequences that may arise from poor execution of a QMS. In this case study, findings suggest that Toyota ignored quality warnings when failures began to happen. This is not a problem that is exclusive to Toyota, but rather an industry, and worldwide, problem. Read the full case study here.

InfoTrend dives into the deteriorated public opinion of Toyota immediately following the recall from the period of 2009-2011 in the United States. They deeply investigated the effects the media had on the public’s opinion, and how the recall shaped their opinion of the brand, being pro-, con- or neutral about the brand.

In 2014, Simply Communicate discussed the strategy Toyota took to rebuild their company image, and their internal culture and morale after the damage took its toll on the company. The shift in the culture at Toyota was substantial, losing talent, working hard to keep talent, and striving to keep employees, even if it meant shifting their jobs, all without losing more profits.

The NHTSA has a handy recall check for those in North America to verify their VIN number against any product recall it may be involved in.

It’s not easy to bounce back from catastrophic product failure, and that is especially true for organizations without multi-millions of profits and bail-out opportunities. It is the goal of a properly implemented ISO 9001 QMS to prevent these failures from happening in the first place. How did my system allow this failure to happen?

How does Failure Occur, and who is to Blame for a Product Failure?

If, or when, a product failure occurs, your organization shouldn’t point fingers. The first question you need to ask is “how did my quality management system allow this failure to occur?”. A simple investigation tactic you may want to implement is “Root-Cause Analysis – 5 Whys”. This method prompts you to ask yourself and your organization “why” until you have a root-cause (this could take fewer or more than 5 “why’s”). The basic framework allows you to develop pathways for why a failure happened in the first place, and where you can identify areas for improvement.

Read more about the 5-Why’s Method and Root-Cause Analysis from ISixSigma

Failures should not be a cause for removal of your certification or attempted to be hidden from your auditor. Failures, especially those caught by your system, should be celebrated. Consider them an indication that your system is working if the problem is caught, and an area for improvement is identified. Feedback is essential for growth, and even negative feedback should be viewed in a positive light and mentality.

Why is Quality Important for My Business?

The aim of any business is to maintain quality to an acceptable standard and failure to do so can result in any number of serious consequences. Quality control is important to guarantee customer satisfaction and more importantly retention. Customers are only likely to be retained and return for another experience if previous services have lived up to their expectations of a certain quality. More importantly, quality also has an effect on company reputation which is paramount to attracting new customers and profits.

Perhaps to customers, the quality of goods or services is the most important aspect of your company, this role proves to be vitally important for the survival and growth of an organization. Maintaining consistent quality without incurring massive costs should then be a primary goal for any organization.

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Documented Information for ISO 9001:2015

As we move into the final months for transitioning to ISO 9001:2015, many companies are still asking themselves what documentation is required. Back with the 2008 release, most companies were comfortable with the six mandatory procedures that were expected of them as well as the need for a quality policy and manual. The update to 2015 has however removed the requirement for a quality manual and blurred the distinction between procedures and records.



With the new release, both documents and records are termed “documented information” and must be controlled and maintained. This is what will form the evidence required to show that you are conforming to the requirements of your quality management system.

Clause 4.4 of ISO 9001 requires your organization to maintain the documented information that is required to support the operation of your processes and to retain that information to be able to have confidence that those processes are being completed as planned.

So what is required by the standard?

The following is a clause-by-clause breakdown of what is required by the standard. However, some of these clauses can be excluded if the company does not perform the relevant processes:

Mandatory records:

  • 7.1.5.1 – Monitoring and measuring equipment calibration records
  • 7.2 – Records of training, skills, experience and qualifications
  • 8.2.3.2 – Product/service requirements review records
  • 8.3.2 – Record about design and development outputs review
  • 8.3.3 – Records about design and development inputs
  • 8.3.4 – Records of design and development controls
  • 8.3.5 – Records of design and development outputs
  • 8.3.6 – Design and development changes records
  • 8.5.1 – Characteristics of product to be produced and service to be provided
  • 8.5.3 – Records about customer property
  • 8.5.6 – Production/service provision change control records
  • 8.6 – Record of conformity of product/service with acceptance criteria
  • 8.7.2 – Record of nonconforming outputs
  • 9.1.1 – Monitoring and measurement results
  • 9.2 – Internal audit program
  • 9.2 – Results of internal audits
  • 9.3 – Results of the management review
  • 10.1 – Results of corrective actions

Other Mandatory Documents:

  • 4.3 – Scope of the QMS
  • 5.2 – Quality policy
  • 6.2 – Quality objectives
  • 8.4.1 – Criteria for evaluation and selection of suppliers

So what does this mean?

You should still tailor your quality management system to meet the requirements of your own business and all of the interested stakeholders. This can be done in any way that your organization sees fit; although a quality manual is still one of the easiest methods. As long as these processes and associated records can be shown to meet the requirements of ISO 9001:2015 effectively then that is fine. If not then the relevant action should be taken to ensure that all of the required clauses are covered.



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Lean System

Introduction to the Lean System

As with anything in life, you will get out as much from your ISO 9001 management system as you put into it. If you treat it as a documentation requirement and burden on your business just to get certification then you are unlikely to see any real benefits; in fact, you may even stifle your own growth.

The aim of any ISO 9001 QMS is to enhance your businesses product or service quality by standardizing and continually improving all of your business processes. This in turn will help you to increase productivity and drive out waste of all forms within your business.

Why Use Lean System with ISO 9001?

ISO 9001 outlines what is required for a certifiable QMS. However if you read ISO 9004 you will see that it suggests a huge amount more than 9001 requires as a minimum. Merely aiming for what the standard requires so that you achieve certification is not going to help you actually improve your business in a way that is going to help you grow it.

A QMS should always consider the customer first, not the standard. It should also be put in place to continually improve the business and its output. Something that is also provided through implementing a Lean system.

Lean Manufacturing has grown out of what is known as the Toyota Production System (TPS), and is why Toyota managed to dominate the world automotive market in such a short space of time. Lean is in its simplest form just another QMS; when you implement Lean you put in place the controls and systems to provide the customer exactly what they want, where they want it, when they want it, in the right quantity, without any waste or delays.

Lean provides you with a host of tools such as 5S, which helps you to set up a highly visual, organized and efficient working space, through to continuous improvement techniques such as Kaizen. Lean fits perfectly within any ISO 9001 QMS and can only help you to further improve and grow your business using proven tools and techniques.

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