Management systems should not be just documents

In the end, ISO 9001 just requires having documents, right?

"In the end, ISO 9001 just requires having documents," means "ISO 9001 is a QMS model that emphasizes documentation."

Therefore, to obtain ISO 9001 certification, without documents, nothing can start. Even if the documents are considered a wasteful pile, regardless of the actual business execution status, as long as there are documents, everything can be discussed." We will reflect on this misunderstanding.

At the beginning of introducing ISO 9001, the hardest part was "documentation." Many companies spent most of their efforts on documentation and document management when implementing ISO 9001. This leads to the impression that ISO 9001 = document (management), resulting in the misunderstanding that "in the end, ISO 9001 just requires having documents."

As a result, people think that as long as document management is carried out, ISO 9001 certification can be obtained, and even believe that the company's quality assurance system is established. It can be imagined that in the end, they complain that ISO 9001 is useless.

The background of this misunderstanding, I believe, is the failure to understand the essence of documents, the purpose of documentation, and what kind of documents are good documents.

So, what documents should be prepared and to what extent? The 2015 version of ISO 9001 has the following requirements.

1) Documented information required by this standard;

2) Documented information determined by the organization as necessary to ensure the effectiveness of the quality management system;

3) The standard requirements are already very clear. How to interpret b)? Because there is no clear judgment standard, people think "then collect everything" or "collect as much as possible." In other words, it gives the impression that "everything must be collected, and very difficult work must be done." The criterion for deciding whether to prepare documents is to look at "the capability of the person performing the task." If it is only necessary to convey "please perform XX task" to a person capable of accurately performing the task, then procedural documents are not needed, or only the most basic instructions are sufficient.

On the other hand, if the capability is insufficient and good business output cannot be achieved without documents, new documents need to be created or existing documents need to be revised in more detail.

In short, the level of detail in business standards depends on the capability of the business practitioners. This requires considering what level of practitioners are needed, confirming whether they meet the actual business requirements, and providing education and training to improve their capabilities as needed.

The second criterion for deciding whether to prepare documents is to look at "the importance and impact of the business in company operations." When the quality of business output greatly affects the quality of products and services provided to customers, or when the business is an important source of competitive advantage in the overall business, the documents for this business need to be prepared and expressed in more detail than other businesses.

In reality, before introducing ISO 9001, it is impossible for an organization to have no documents at all; there will be documents in some form. For these existing documents, if the business matches the recorded content and they can be used, they should be judged according to the above standards and directly used as the company's standard documents. If the recorded content deviates from the actual business situation and the documents cannot be flexibly used, but are still adopted as company standards, it will cause confusion in actual business and should be discarded.

If there are no existing documents, many necessary new documents may need to be created. ISO 9001 does not specifically require completing 100 or 1000 documents to obtain certification. After fully considering the resources spent and implementation sequence, the company can prepare documents in phases according to its own plan. For example, if originally 100 new documents were to be written, but only 50 were completed during the ISO 9001 audit, there will generally be no major problem. On the contrary, it is more important to recognize what new documents (the remaining 50) must be written next and to have a realistic writing plan.

Therefore, obtaining ISO 9001 certification is not the ultimate goal; it should be understood as just the beginning of improving the organizational system to provide products and services that meet customer needs. After obtaining ISO 9001 certification, the remaining 50 documents should be completed according to the planned schedule.