A Quality Management System Based on ISO 9001

What is ISO 9001?

ISO 9001 is an international standard which specifies the requirements for establishing, implementing, maintaining, and continually improving a quality management system (QMS) in any organization, regardless of the type, size, or products and services it offers. 

While ISO 9001 is very concise and simply provides the requirements for a QMS, there are other standards which complement and are related to it. For example, ISO 9000 provides the fundamental concepts and principles of quality management and explains the terms and definitions related to QMS and ISO 9001. Other related standards can assist organizations when implementing a QMS based on ISO 9001; however, they only provide guidelines and not requirements, and organizations cannot be certified against them.

Recently, ISO reported that over one million organizations are certified against ISO 9001, making it the most successful standard developed by ISO. Even though ISO 9001 is a renowned standard that has been around for many years, there are still many misconceptions around it. 

One of the main misconceptions regarding ISO 9001 is that it requires a lot of paperwork. However, ISO 9001 does not necessarily require the documentation of all processes. In addition, the standard’s flexibility allows organizations to choose a documentation approach that fits them best, without requiring excessive paperwork. 

Who can implement a QMS based on ISO 9001?

Organizations that seek to meet the needs and requirements of their customers or other interested parties, regardless of their size, type, or the industry in which they perform, can implement and benefit from a QMS based on ISO 9001.

The main principle of ISO 9001 is customer focus. The standard addresses customer focus (clause 5.1.2) and customer satisfaction (clause 9.1.2) throughout the document in order to make sure that organizations are aware of the importance of meeting customer requirements. 

By fulfilling the requirements of the clauses mentioned above, organizations maintain their existing customers and attract new ones, which means that organizations will benefit financially too. 

Furthermore, ISO 9001 requires organizations to address risks and opportunities (clause 6.1) and continually improve their QMS. The standard also encourages organizations to engage and include the personnel during the implementation of the QMS so they too can contribute to improve the quality in the organization.

Having a certified QMS based on ISO 9001 will enable organizations to earn the trust of customers, enter new markets, and improve their business.

In order to be effective and reach its objectives, organizations must integrate the QMS in everyday processes in order to. 

ISO 9001 is designed to enable organizations to use the process approach combined with the plan, do, check, act (PDCA) cycle. This allows organizations to integrate their QMS with other management system standards developed by ISO. In addition, the PDCA cycle enables organizations to continually improve their QMS and it prevents mistakes from reoccurring.

What does ISO 9001 require regarding documentation?

In a way, earlier versions of the standard paved the way to the misconception that ISO 9001 requires a lot of documentation. They were based on the motto “Write what you do, then do what you write.” For example, the 1987 and 1994 version required 20 documents only for procedures, while the 2000 and 2008 version required 6. 

ISO 9001:2015 requires organizations to document the quality policy and objectives or any changes that may occur in the QMS. Nevertheless, this version allows organizations to decide on the extent of documented information that they want to retain or maintain. The reasons for retaining documented information include:

• Proving conformity to the standard
• Communicating information in the organization 
• Maintaining organizational knowledge
• Tracing back changes or measurement used
• Keeping reference for improvement

PECB uploaded a webinar on how to implement ISO 9001:2015 using a minimal documents approach that you could watch by clicking on this link: https://www.youtube.com/watch?v=PnCjPlGGb68.

ISO 9001 is not intended for an identical QMS in all organizations and does not enforce organizations to implement the QMS in a specific way. While ISO/TS 9002 and ISO 9004 offer guidelines on implementation, organizations are not obliged to follow them. ISO 9001 only sets the requirements that organizations need to meet, but does not state how organizations should meet those requirements.

ISO 9001 allows the flexibility in many areas. For example, organizations do not necessarily need to implement the QMS across all their departments. Instead, they can include only the departments that they see as necessary to be included in the QMS. In addition, ISO 9001 has requirements that might not be applicable to some organizations. In such cases, organizations are not obliged to comply with such requirements, as long as they the non-applicability of the requirement. 

How can PECB help?

Wherever you may live, as long as you have an internet connection, you can enroll in a PECB training and get certified. PECB is a certification body accredited by IAS, UKAS, and is a member of many other organizations such as IAAR, IPC, EBIOS, etc.  PECB offers five different courses for ISO 9001. ISO 9001 Introduction, ISO 9001 Foundation, ISO 9001 Lead Implementer, ISO 9001 Lead Auditor and ISO 9001:2015 Transition. For more information and to check out which course is more suitable for you, please follow the link: https://pecb.com/en/education-and-certification-for-individuals/iso-9001.