It is not a law, not a regulation, it is an international standard for quality management systems. ISO 13485 is specific to the medical device industry, but can be used by any company in the industry. This includes industrial design firms, translation services, contract manufacturers, contract sterilizers, contract research organizations and companies that provide services such as installation, repair or user training. Even a consultancy firm such as Medical Device Academy can use ISO 13485 to ensure the quality of our consultancy services.

The purpose of setting up a quality system is to provide a set of rules for your company to follow to ensure everyone knows what to do and how to do it, and if something goes wrong you have the documentation available to find out why. An ISO 13485 quality system also ensures that you meet the legal requirements for medical devices in each country where you sell a device.

If your company implements a quality system that complies with ISO 13485, you must prepare the following documentation:
A quality policy
Quality objectives
A quality manual
Procedures
Detailed work instructions
Recordings

Most medical device manufacturers will request a copy of your ISO 13485 certificate as a method of qualifying new suppliers. Therefore, you may want to get ISO 13485 certification for marketing purposes so that your business can increase sales. However, as a contract manufacturer, it is not a legal requirement to be ISO 13485 certified.

The standard does not tell you exactly what your procedures should say. No templates are provided in the standard. In fact, you won't even find examples in the standard. Therefore, no matter what anyone tells you, there are multiple ways to meet the requirements of ISO 13485. Unfortunately, that also means that there are many bad practices that you shouldn't copy because they don't meet the requirements.

If you would like to purchase a copy of ISO 13485:2016, we recommend the following source as the cheapest we know of:
https://www.evs.ee/en/evs-en-iso-13485-2016-a11-2021

ISO 13485 is divided into numbers. Clauses starting with clause 0, the introduction, and ending with clause 8, measurement, analysis and improvement. Unlike ISO 9001, ISO 13485 distinguishes between clauses that are not applicable and clauses that are excluded. In ISO 13485 you can only exclude design, that is article 7.3. In case of non-applicability you can only claim clauses or sub-clauses within clauses 6, 7 and 8 as not applicable. The reason for the inapplicability must be justified because it does not apply to your device or the activities you perform. For example, if your company makes devices that do not need to be sterile, then sub-clause 7.5.5 (special requirements for sterile medical devices) does not apply.

As mentioned in article 0.3, ISO 13485 is based on the process approach to quality management. This means that for your business to function effectively, you need to identify and manage a number of linked processes. Each process can be defined by seven elements:
1. Description of the process
2. Process inputs – registrations and raw materials
3. Process outputs – records and completed devices
4. Equipment and working environment
5. Human Resources
6. Procedures and forms
7. Process statistics

Here is an overview of the remaining clauses in the ISO 13485 standard:
1. Scope
2. Normative references
3. Definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement

If your company wants to establish an ISO 13485 quality system, you can purchase procedures, write procedures, or a combination of both. However, setting up the quality system is just the beginning. It requires a lot of documentation (paper or electronic) and you have to continuously monitor the processes and make corrections or improvements to maintain the quality system. Therefore, you must maintain metrics for each process, conduct at least one full internal quality system audit each year, and conduct at least one management review each year. Whenever a change is made to a process, you must review and approve the changes in writing. You may have to retrain people on the new process, and the changes never stop. Therefore, it is important that there is management support for the quality system and that people have the mindset that the quality system requires year-round dedication to maintain the effectiveness of the quality system.

If you need help implementing your ISO 13485 quality system, watch our step-by-step video on how to obtain ISO 13485 certification:
https://youtu.be/NC-UnMYb1FU

To schedule a call with Rob Packard, use his calendar link:
https://calendly.com/13485cert/30min

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