Another point of contention with ISO 9001 critics is the misconception that in the service sector, quality management systems must also address technical aspects, not just procedural ones.
For example, in the medical field, the quality management system is used (correctly) solely for patient management, not for medical treatment. In legal practices, quality is focused on administrative aspects, not legal issues. If it is not understood that the quality management system addresses only non-technical issues, leaving the technical aspects to sector professionals, one risks losing sight of the true purpose of the standard.
It is obvious that a patient who receives incorrect medical advice will remain dissatisfied, even if their paperwork is in order as per certification requirements. However, the principle underpinning all literature on quality is that, to achieve customer satisfaction, both the product and service must be considered. A defective product delivered on time, within budget, and with a smile is still a defective product!
Although the new version of ISO 9001 allows organizations to determine the scope of their QMS and, in theory, separates it from more technical work, the requirements clearly mandate that organizations ensure the compliance of their products and services and improve customer satisfaction. Additionally, they must ensure that individuals whose work impacts the performance and effectiveness of the quality system are competent, which can continue to fuel significant misunderstandings.
The final misunderstanding we want to address relates to the idea of "Documenting what is done and doing what is documented." This approach has for years been seen as the essence of quality, even endorsed by audits that asked:
- What do you do?
- Which procedure is it documented in?
- Can you provide evidence of compliance with this procedure?
The approach to quality, therefore, seemed simple:
- Say what you do (i.e., establish appropriate controls and quality management systems)
- Do what you say (i.e., ensure that everyone involved follows the established processes)
- Show what you have done (e.g., demonstrate compliance with the quality system)
In fact, it might seem that this was the principle of ISO 9001 before the 2000 version, but even then, it wasn't what the standard required. The standard explained that an organization should establish, document, and maintain a quality system as a means to ensure that the product or service met specified requirements. What wasn't understood then (and what is sometimes still not understood today) is that much more than a series of documented procedures is needed to ensure that a product or service meets the specified requirements.
In subsequent versions of the standard, the requirement evolved to require the organization to establish, document, implement, and maintain a quality management system to ensure that customer requirements were determined and met the goal of increasing customer satisfaction. Therefore, if, after documenting what is being done and doing what was documented, and demonstrating this to the auditor, the quality management system fails to:
- Ensure that products and services meet specified requirements;
- Ensure that customer requirements are determined;
- Ensure compliance with customer requirements;
- Improve customer satisfaction;
the quality management system must be considered ineffective. Documenting what is being done while ignoring the possibility that what is being done may not align with requirements opens the door to customer complaints. This approach, however, tended to focus solely on tangible activities, neglecting how people think, the informal networks that make things happen, and the values that shape behavior and lead to action, presenting an imperfect picture of how an organization is managed.
If products are tested before shipping, documented as being tested, and then demonstrated to auditors as being tested, what has been done is documented, and what is documented has been done, ensuring that the products are compliant and customer satisfaction is met. However, if the people performing these tests are not focused on the customer, they might skip some tests to go home earlier. If all that's available is a simple record stating that all tests were performed, the company could be in trouble.
To ensure that what needed to be done was actually done, trust in people is necessary, and this requires a different approach, which could be why ISO 9001:2015 places more emphasis on humans to:
- Address risks to prevent or reduce adverse effects;
- Manage social and psychological factors of the process environment;
- Ensure that people are aware of the implications of non-compliance with quality;
- Take action to prevent human error.
The suggestions and requirements for working well are all there in the standard, it's just a matter of being willing to embrace them.