Understanding the ISO 13485 Standard for Medical System Suppliers

If you polled a group of people and asked them to define the word “quality,” you would probably get mixed responses. Most people have a good idea of what quality means to them, but it is not as easy to define quality in terms that would include everyone’s interpretation of its meaning. For some words, especially those that deal with abstract concepts, a bit of ambiguity is fine. However, when an assessment or judgment of the quality of a tangible item or activity is necessary, more explicitness is required.

Medical devices are probably the most critical electronic systems developed as they are used to preserve or enhance lives. This level of responsibility mandates that these systems adhere to well-defined regulations and standards to ensure they are able to perform their intended functions with no injury to patients. One of the most important of these standards is ISO 13485, which defines how to manage the quality of medical devices throughout their life-cycle. This includes explicit quality management system (QMS) requirements for organizations involved in providing systems and services to the medical device industry. As adherence to the ISO 13485 standard is mandatory, a good understanding of its intent and content overview is necessary. With this information, specific provisions that impact the PCB design and development process can be further explored.

ISO 13485 Overview

ISO 13485 is an international standard intended to reassure organizations purchasing and utilizing medical devices that the developers and suppliers of these devices have instituted and implemented a QMS that meets certain minimum requirements. Suppliers and developers demonstrate their compliance and commitment to this level of medical device quality by becoming ISO 13485 certified. If a company or entity participates in or provides design and development, production, storage, distribution, installation, servicing or other technical support, their related operations most likely fall under the QMS standard. The major requirements are listed below.

ISO 13485 Requirements Overview

Section 4: General Requirements

4.1. Establishing your QMS

4.2. Documenting your QMS

Section 5: Management Requirements

5.1. Management support

5.2. Customer emphasis

5.3. Quality policy establishment

5.4. QMS planning

5.5. Internal roles, responsibilities and communication protocol

5.6. Management oversight procedures

Section 6: Resource Requirements

6.1. Resource allocation

6.2. Personnel allocation

6.3. Infrastructure allocation

6.4. Work environment control

Section 7: Product Realization Requirements

7.1. Product realization planning

7.2. Customer requirement assurance

7.3. Design and development requirements

7.4. Purchasing process requirements

7.5. Production and servicing requirements

7.6. Monitoring and measurement control

Section 8: Remedial Requirements

8.1. General remedial requirements

8.2. Monitoring and measurement requirements

8.3. Noncorming products control

8.4. Data analysis

8.5. QMS improvements

Obviously, ISO 13485 is quite detailed and provides a clear roadmap to be in compliance and obtain certification.

PCB Manufacturing for ISO 13485 Compliance

Sections 4, 5 and 6 of the ISO 13485 standard deal particularly with how to establish a QMS within your organization and the resource requirements for its operation and management. Section 7, which is probably the most detailed area of the standard, describes the requirements for the design and development process. Successfully complying with the requirements of this section is your responsibility; however, it greatly depends on the level of quality control of your contract manufacturer (CM). Specifically, your CM can support your adherence to ISO 13485 requirements by doing the following:

PCB DEVELOPMENT SUPPORT OF ISO 13485 REQUIREMENTS
ISO 13485 Section 7 Requirement	PCB Development Stage(s)	CM Support
7.1 and 7.2	Design	You should establish an open, transparent white box relationship with your CM from day one. Communicate openly with your CM and promote the free flow of data and information, especially customer requirement changes.
7.3	Board fabrication, component procurement and PCB assembly	Get access to DFM guidelines tailored to CM equipment capabilities.
7.4	Component procurement	In conjunction with your CM, institute methods to avoid counterfeit components and component shortages.
7.6	Board fabrication, component procurement and PCB assembly	Enlist your CM’s support in tracking materials and components, performing or aiding in testing requirements and collection of pertinent data.

Your ability to fully comply with the spirit, as well as the regulations, of the ISO 13485 standard is best supported by the optimization of your board fabrication, component selection and PCB assembly (PCBA), which requires selecting the best CM.