Choosing the right quality framework

In today’s business landscape, quality management is non-negotiable. However, the challenge many organisations face is choosing the right quality framework that aligns with their industry, size and operational needs.

While ISO 9001 is the most widely adopted standard, industries such as oil and gas, aviation, healthcare and manufacturing often require sector-specific frameworks, such as API Q1/Q2, AS9100, IATF 16949 or ISO 13485.

This raises two important questions:

• Who decides which quality framework fits which business?
• Why do some industries require specialised frameworks while others rely on ISO 9001?

Let’s break it down.

Understanding the scope of quality frameworks

General versus industry-specific standards

Quality management systems (QMSs) can be broadly categorised into:

General standards: These apply to all industries and provide a flexible structure for managing quality. The most recognised example is ISO 9001, the global benchmark for quality, focusing on process efficiency, risk management and customer satisfaction.

Industry-specific standards: These frameworks build on ISO 9001 principles, but add sector-specific requirements to ensure compliance with regulatory and safety-critical aspects. Some key examples include:

• API Q1/Q2 – oil and gas sector (American Petroleum Institute standards for suppliers and service providers);
• IATF 16949 – automotive industry (focus on defect prevention and supply chain quality);
• AS9100 – aerospace industry (risk-based thinking, safety and reliability);
• ISO 13485 – medical devices (stringent regulatory and product-safety requirements);
• ISO 22000 – food safety management.

Each industry has unique challenges, risks and regulatory requirements that general frameworks such as ISO 9001 may not address fully. This is why specialised standards exist.

"Choosing the right quality framework is not just about compliance, it is about business strategy."

Anar Malikov CQP FCQI, Director at TCS, Azerbaijan

Who decides which quality framework to follow?

The decision on which quality framework to implement is influenced by several factors, including industry regulations and legal requirements.

Some industries are highly regulated, requiring specific frameworks by law. For example, if you manufacture medical devices, ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes is mandatory for regulatory approval.

On the other hand, businesses may adopt a quality standard because clients demand it as a prerequisite for contracts. An example of this is seen in the oil and gas sector; major operators require suppliers to be API Q1/Q2 certified.

Small companies may not need complex frameworks and can start with ISO 9001, expanding to industry-specific standards as they grow. For instance, a startup engineering firm may initially certify to ISO 9001, but later transition to AS9100 if it then moves into the aerospace supply chain.

Some organisations adopt stricter quality frameworks voluntarily, to differentiate themselves and build trust with stakeholders. For example, an automotive parts manufacturer may choose to adopt IATF 16949 to show best practice and to stand out in a competitive market.

Why is ISO 9001 the default choice?

Many businesses start with ISO 9001 because it is:

• globally recognised and accepted across industries as the foundation of quality;
• flexible, allowing businesses of any size or type to tailor their QMS;
• a stepping stone that serves as a base for more advanced, industry-specific certifications.

ISO 9001 is not always enough, however. It focuses on general process quality, but does not cover product-specific risks, safety or regulatory requirements that industries such as oil and gas, healthcare and aerospace demand. This is why companies in high-risk sectors move beyond ISO 9001 and adopt specialised standards.

Choose the right framework

When selecting a quality framework, key points to consider can include:

• the industry you are in – if you operate in a highly regulated sector, an industry-specific framework is a must;
• your customer requirements – check if your clients mandate a specific standard for doing business;
• your company’s long-term strategy – if you plan to expand into new industries, consider a scalable approach, starting with ISO 9001;
• the risks involved – high-risk industries (eg, oil and gas, medical devices) require stricter quality controls beyond ISO 9001.

Example selection paths

Scenario 1: Small manufacturing company

• Starts with ISO 9001 → expands into IATF 16949 (if automotive) or AS9100 (if aerospace).

Scenario 2: Medical device startup

• Starts directly with ISO 13485, as it is mandatory for regulatory approval.

Scenario 3: Oilfield equipment supplier

• Chooses API Q1/Q2 as it is required by oil and gas customers.

Summary

Choosing the right quality framework is not just about compliance, it is about business strategy. Whether starting with ISO 9001 or adopting an industry-specific standard, the goal is to build a robust, scalable quality system that enhances performance, reduces risks and ensures customer trust.

Instead of blindly following a one-size-fits-all approach, businesses must align their quality management system with their industry needs, regulatory environment and growth objectives.

At the end of the day, quality should serve the business – not the other way around.