In a standard operating procedure (SOP), companies define their processes, for example how they develop medical devices or provide services.
Standards such as ISO 9001 and ISO 13485 require standard operating procedures. Companies can define these specifications in their quality management manual directly or in independent documents.
ISO 9000 defines a procedure as follows:
“Specified way to carry out an activity or a process”
Source: ISO 9000:2015 3.4.5
Based on the above definition, a standard operating procedure is the superset of a process description. In practice, however, the two terms are often not precisely differentiated.
A process instruction includes the description of the entire process, e.g., software development process. It defines phases, roles and activities. For example, it requires a software system test at the end of development. How, i.e., using which methods, these tests are carried out (e.g., with equivalence classes) can be part of a referenced work instruction or standard operating procedure.
If the process instruction describes all procedures, the process instruction and standard operating procedure are the same.
The standard operating procedure should describe:
If the description of the activity and method is more comprehensive, we recommend moving this to a work instruction.
In contrast to a work instruction, a standard operating procedure generally describes a required sequence of activities that are often performed by several people.
Johner Institute advisers and auditors generally use the following chapter structure
Use flow charts. They give you a quick overview.
Fig. 1: Example of Flowchart in a SOP
Tables are an alternative way of showing the information. These are only suitable for sequential processes.
Specification of the software requirements
Software requirements specification.
User interface designer
Table 1: Example of section of a tabular standard operating procedure
The requirements that establish that manufacturers have to define and follow standard operating procedures can be found in these regulations, among others:
Standards, such as ISO 13485, requires companies to [have] procedures, such as document control, design and development planning, procurement and corrective actions.
Fig. 2: Standard operating procedures required by ISO 13485. Our free starter kit contains this mind map as an enlargeable PDF.
ISO 13485:2016 revised the list of standard operating procedures required. The mind map above shows these standard operating procedures in detail. A more general list of the procedures required in given in English below:
The free starter kit includes the above mind map and an infographic that tells you the standard operating procedures that you have to complete or revise to fulfill the requirements of ISO 13485:2016.
Strictly speaking, these standards (e.g., ISO 13485) require that the manufacturers
all the above procedures.
Note that ISO 13485 requires many other activities, but they do not necessarily have to be described by a standard operating procedure.
MDR requires fewer standard operating procedures than ISO 13485. At least, explicitly. On the other hand, there are procedures that manufacturers must define according to the MDR, which ISO 13485 does not mention as explicitly, for example, risk management.
It should be noted that ISO 13485 does require risk management as an activity.
Conclusion: If you act in accordance with the current edition of ISO 13485, you essentially fulfill the quality management requirements established in the MDR, e.g., in Article 10 and Annex IX.
There are arguments in favor of integrating these standard operating procedures directly into the QM system or QM manual, and there are arguments against it. Arguments against the integration of standard operating procedures into the quality management manual are:
But separating the QM manual and SOPs is not always the best solution. Small companies with only one or only a few products are sometimes better served by an integrated document set.
Are you unsure which option is better for you? Please feel free to contact us. We're happy to help.