Hutton & Associates

Quality Assurance/Quality Improvement Specialists

The term ISO 9000 is probably familiar to you, whether you work for an organization which has been certified or for one which is still attempting to obtain a certification.  Thousands of companies have already undergone ISO 9000 certification and many more are applying for one.  So what exactly is ISO 9000 and what can it offer your organization?

Understanding ISO 9000

ISO is short for 'isos', a Greek word that means equal.  It is a term meant to encompass everything that what we now know as the ISO quality management system stands for.  The term ISO is now used in order to create a single, unifying term that will remain the same regardless of the country or region where it is being practiced.

Plan – establish objectives and make plans (analyze your organization's situation, establish your overall objectives and set your interim targets, and develop plans to achieve them).
Do – implement your plans (do what you planned to).
Check – measure your results (measure/monitor how far your actual achievements meet your planned objectives).
Act – correct and improve your plans and how you put them into practice (correct and learn from your mistakes to improve your plans in order to achieve better results next time). 

What is Certification?

In the context of ISO 9001:2015 “certification” refers to the issuing of written assurance (the certificate) by an independent external body that it has audited a management system and verified that it conforms to the requirements specified in the standard. 

What to expect during ISO certification

An organization's ISO certification relies on its performance as assessed during auditing.  Auditing is done two ways:  one is by internal auditors (members or employees of the organization who have been especially trained to perform the job) and the other is by an independent accreditation body.
During the auditing, the organization applying for ISO certification provides samples of its procedures, processes, products, services and other documents that show proof of the company's functions and related activities.  If there are problems or non-compliance, these are detailed in a list, which are then presented to the management.  Related corrective measures are then implemented.
Correcting these problems is critical because if an organization fails to do so or at least to show proof that it does not really require a request for action, then they may not be issued an ISO certification.
Should there be multiple business sites, such as those located at different geographical areas, an ISO certification will have to be applied for and issued independently for each.

What is the goal of ISO 9000?

The ISO 9000 series is designed to be used as a standard on which organizations can improve trade by creating, refining and improving their key business processes.  

How does ISO 9000 work?

One thing to remember about ISO 9000 is that it is, at its core, a quality management system.  It provides guidelines and a set of standards for organizations to follow and comply with.
To obtain a certification in ISO 9000, an organization must first decide on developing its own quality management system (QMS) based on the ISO 9000 requirements.  The standard itself will help regulate the processes involved not just in the creation of the QMS but also in its implementation.
To ensure that the ISO 9000 standards are indeed being followed, monitoring is performed regularly through internal and in some cases, external auditing.

What types of industries can benefit from ISO 9000?

The ISO 9000 standard is applicable for most business processes and organizations.  It covers a wide range of industries, such as manufacturing, servicing, processing, electronics, printing, banking, finance and accounting, telecommunications, fabrication, transportation, sanitation, product design, construction, instrumentation, engineering, insurance, agriculture, food processing, entertainment, forestry, electronics and consulting.

What are the requirements of a QMS?

a set number of standards that are used for important business processes

  • record keeping

  • detection of defects or review of problems in products and services

  • continual improvement

What is a Management system? 

Management system refers to what the organization does to manage its processes, or activities, so that its products or services meet the objectives it has set itself, such as:
satisfying the customer's quality requirements, 
complying with regulations, or 
meeting environmental objectives. 

Plan – Do – Check – Act

The Plan – Do – Check – Act (PDCA) cycle is the operating principle of ISO's management system standards.