The purpose of ISO 9001 is outlined in Clause 1 of the standard, a key section that warrants close attention as it defines its fundamental concepts and is often overlooked.
Requirements for a Quality Management System
ISO 9001 is not, in itself, a quality management system (QMS); rather, it sets out the requirements for designing, implementing, and maintaining an effective quality system over time. These requirements were established by industry representatives and national standards bodies to mitigate factors that could negatively impact product and service quality if not properly addressed.
A quality management system is that part of an organization’s management framework dedicated to acquiring and retaining customers by understanding their needs and delivering products and services that meet those expectations.
The Need to Demonstrate Capability in ISO 9001:2015
The standard explicitly states that it is intended for organizations that need to demonstrate their ability to meet customer requirements. Buyers may select suppliers based on:
- Performance, reputation, or recommendations (often used for generic services, low-cost, or non-critical products).
- Independent evaluation of a supplier’s capability (typically for customized products or services where quality can be directly assessed by the buyer).
- Third-party assessment of a supplier’s capability (preferred for complex or critical products and services where quality cannot be easily verified through direct inspection).
Most buyers rely on the first two options, but in cases where these are not viable—due to uncertainty, lack of resources, or impracticality—third-party certification provides a more reliable and cost-effective assurance of quality.
The ISO 9001 Certification is designed for use in the second and third scenarios, enabling buyers to establish common requirements for their suppliers and conduct evaluations, either internally or through third-party audits, to ensure compliance.
The Certification Process
Organizations seeking to do business with clients and demonstrate compliance with quality requirements undergo a third-party audit. This can be conducted either by the client or an independent, accredited certification body such as Acsq.
The audit is performed against ISO 9001 requirements, and if no major non-conformities are identified, the organization is awarded a certificate. This certification serves as evidence of the organization’s ability to meet the standard’s requirements, enhancing its credibility with customers.
With an ISO 9001 certification, customers can place trust in a supplier’s ability to deliver the required products and services consistently.
Compliance with ISO 9001 is not legally mandatory; however, it may become a contractual or regulatory requirement in certain industries. For example, obtaining certification might be essential for:
- Participating in tenders and procurement processes.
- Registering in supplier lists for specific clients.
- Meeting industry-specific compliance obligations.
While adopting the standard is a strategic decision, in many industries, it becomes indispensable for market access. In such cases, top management typically drives the certification process to align with industry expectations.
Meeting Customer Requirements
A common misconception is that customer requirements in ISO 9001 refer only to explicit verbal or written requests. However, ISO 9000:2015 defines a requirement as a stated, implicit, or obligatory need or expectation.
This includes:
- Contractual and specified requirements.
- Regulatory and legal obligations, such as safety, reliability, and performance continuity.
Similarly, the definition of a customer in ISO 9000:2015 extends beyond direct purchasers to include consumers, end-users, retailers, beneficiaries, and any entity that utilizes the organization's products or services.
Compliance with Legal and Regulatory Requirements
ISO 9001 does not mandate adherence to all legal and regulatory requirements, but only those applicable to the products or services provided. These vary by industry, market, and region.
For example, while labor laws may apply to an organization’s internal operations, they are not considered relevant to ISO 9001 unless they impact product or service compliance.
Delivering Consistent Quality and Enhancing Customer Satisfaction
Organizations must demonstrate their ability to continuously provide products and services that meet customer expectations and regulatory requirements.
The concept of consistent delivery was introduced in the 2000 version of ISO 9001 and has been reinforced in subsequent editions. The 2015 revision explicitly emphasizes this in Clauses 8.2.2 and 8.2.3, which address the determination and review of customer requirements.
Beyond meeting current needs, organizations are encouraged to anticipate future customer expectations and enhance their products and services accordingly.
This forward-thinking approach ensures long-term customer satisfaction and strengthens the organization's competitive edge in the market.