ISO 9001: Quality Management Systems

ISO 9001 is an international standard for a quality management system (QMS). There are several different documents in the ISO 9000 family of standards, but ISO 9001 is the most popular and the only standard in the series that requires certification. 

By definition, a Quality Management System or QMS is a collection of policies, processes, documented procedures and records which outlines the set of rules that determines how an organisation creates and delivers its products or service to the customers. It must be tailored to the specific needs of the company as well as the products or services provided. ISO 9001 provides guidelines to ensure that any important elements that a QMS needs to be successful are not overlooked. 

The first version of the standard, ISO 9001, was published in 1987 by the International Organization for Standardization (ISO). This was replaced by ISO 9001:2008 in 2008 and now, the latest edition (ISO 9001:2015) was published in 2015 following more than three years of revision work by experts from nearly all 95 participating and observing countries. 

ISO 9001:2015 

ISO 9001:2015 is the internationally recognised standard that outlines the requirements for the creation, implementation and maintenance of a Quality Management System. The main goal of this standard is to improve the overall experience and satisfaction of customers. Additionally, it also aims to improve the internal systems of the organisation, allowing it to produce quality products and services while promoting consistent on-going growth and trust in the company.

It’s worthy to note that ISO 9001:2015 is not a standard aimed at defining product quality but rather a process-based standard used to monitor and control product processes to meet the required results.

Who can become certified? 

Any organisation, regardless of its size or industry, is eligible to become certified to the ISO 9001:2015 standard. The ISO 9001 structure is split into ten sections. The first three are introductory, with the last seven outlining the requirements for the Quality Management System. These are: 

• Section 4: Context of the organisation – The organisation must evaluate its context and align its objectives with the QMS. Determine the internal issues and external issues, the needs and expectations of interested parties, quality management system scope and its processes that can impact the planning of the QMS.
• Section 5: Leadership – These requirements emphasise the need for top management to contribute to the implementation of the QMS. Those in managerial positions must demonstrate commitment to the QMS by ensuring customer focus, defining and communicating the quality policy to others and assigning roles and responsibilities to employees throughout the organization.
• Section 6: Planning – Managerial staff must also plan for the on-going function and improvement of the QMS. Both the risks and opportunities within the organisation must be assessed and quality goals must be set. Furthermore, plans must be made to ensure that these objectives are successfully met.
• Section 7: Support –This section deals with the management of the Quality Management System’s resources. It emphasises the importance of controlling resources such as human resources, infrastructure and the work environment.
• Section 8: Operation – This section deals with the aspects of the planning and creation of the product or service. It includes requirements for the planning, product requirements review, design, creation and release of the product or service.
• Section 9: Performance evaluation – This section is concerned with the requirements needed to ensure that you can adequately monitor the QMS to ensure it is functioning correctly. It includes monitoring and measuring your processes, assessing customer satisfaction, internal audits, and ongoing review of the QMS.
• Section 10: Improvement –This last section includes the requirements to improve the organisation’s QMS over time. This includes the need to review process nonconformity and taking corrective actions for processes.

Overall, for an organisation to become certified, it must submit several documents that report its internal processes, procedures and standards. These documents demonstrate the company’s ability to provide consistent quality products and services. After certification, the organisation must be re-certified every three years in order to maintain their ISO 9001 certification status. 

How ISO 9001: 2015 can benefit an organisation 

As mentioned, any organisation can make use of a Quality Management System knowing that it will greatly benefit their future operations. Here are just a few of these benefits:

• A boost in company image and credibility
• An increase in customer satisfaction
• Fully integrated business processes
• Evidence-based decision making
• Ongoing improvement of business processes
• Better communication amongst employees

How WWISE can help 

WWISE helps in setting up the quality management system and integrating it with existing management systems for compliance with relevant ISO standards. We also provide training, GAP analysis audits, internal and external audit services, and assist with the certification process. Thereafter, we offer a compliance maintenance programme.

For further guidance on the right ISO Standard for your business contact WWISE on 08610 99473 or visit www.wwise.co.za.