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Do Medical Device Companies Need ISO Certification?

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Do Medical Device Companies Need ISO Certification?

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There is undoubtedly no shortage of rules that directly affect the medical companies in today’s regulatory environment, particularly given that pharmaceutical goods are supplied abroad. Pharmaceuticals, for instance, must adhere to 21 CFR Part 211 in order to be supplied in the United States. The United States Food and Drug Administration (USFDA) has the authority to enforce compliance with the Code of Federal Regulations, which has significant consequences if disregarded.

ISO certification

Considering ISO 9001:2015 certifications makes sense for pharmaceutical managers given the requirement for compliance, quality, and safety. Pharmaceutical businesses work hard to ensure client satisfaction by offering dependable, high-quality products and services.

By creating standards that can be adopted into any company, regardless of size, complexity of supplied products/services, or other factors, the International Standards Organization (ISO) as a whole seeks to ensure that goods and services are both trustworthy and safe. A quality management system has been designed, maintained, and supported by top management, as evidenced by certification to ISO 9001:2015.

Strong pharmaceutical quality systems already incorporate a number of ISO 9001:2015 components, such as rules (both domestic and international), regulatory guidelines, best practices, and industry expectations.

As a result, the emphasis of this article will be on supplier quality, where ISO 9001:2015 plays a significant role in establishing a quality system standard for suppliers, rather than how to implement ISO 9001:2015 into a pharmaceutical organization’s quality system.

Certification Updates

Updating to ISO 9001:2015 will be beneficial because this standard is widely accepted and many vendors of excipients and packaging components already have the ISO 9001 certification.

Numerous advantages come with the new iteration of ISO 9001:2015, including increased leadership engagement in the management system, risk-based thinking, streamlined terminology, an uniform structure, and the alignment of QMS policy and objectives with organizational strategy.

However, the top five (5) areas of attention for pharmaceutical sector suppliers who are certified to — or at the absolute least, claim compliance to — (when obtaining certification) and while evaluating their suppliers should be as follows, not necessarily in order of importance:

  1. Risk-based thinking, first
  2. Quality Management Systems
  3. Change
  4. Process Approach
  5. Leadership

To get the greatest results possible in every aspect of company, risk-based thinking is essential. Although this idea has always been part of ISO 9001, ISO 9001:2015 makes it more clear by placing greater attention on possible areas that might directly affect the operation and overall effectiveness of the QMS.

Additionally, the whole management system applies the process approach and incorporates risk-based thinking. The standard includes requirements for determining the QMS process, identifying and addressing risks and opportunities, defining top management’s responsibilities for raising awareness of this concept, and, most importantly, identifying and addressing risks and opportunities that may affect product/service conformity.

Companies and ISO certifications

A company may gain several advantages from risk-based thinking, including better governance and a proactive culture of compliance and progress.

It would be the job of the package provider to identify the risk associated with a single source for a vital material needed for manufacturing and to develop a strategy to reduce it, such as by vetting multiple sources of the material.

Wouldn’t you want to make sure that analysis is done to guarantee that there is a constant, compliant supply of the components your business needs to service the market as a client who relies on the packaging supplier?

Although the standard does not call for a formal risk management program, it nevertheless makes sense to investigate the procedures suppliers have in place and decide whether your business will find them acceptable when conducting supplier evaluations.

When looking for a defined risk management program, ISO 31000 Risk management – Principles and guidelines may be a resource (not necessary for ISO 9001:2015 certification).

The need for a medical device QMS has always been present. Is there anything that is important enough to say more about? A strategic vision for a quality management system must be present, as well as strong senior leadership backing.

“Top management should exhibit leadership and commitment with respect to the quality management system…,” states Section 5.1.1 of ISO 9001:2015. In order to make sure that the emphasis is on support, management, continuous improvement, resourcing, communication, and successfully integrating the requirements of the QMS into the organization’s business operations, there are five (5) and ten (10) direct commitments.


From the standpoint of the customer, top leaders—not only those who are quality-focused—should be held responsible for the QMS and its results. It is crucial to look at the unbiased data that shows senior management commitment and attention to the QMS when you are evaluating your suppliers.

There are new requirements for modification in ISO 9001:2015. There are 4 in total: 6.3 Changes planning, 8.1 Changes operational planning and control, 8.3.6 Changes in design and development, and 8.5.6 Changes control.


An organization’s QMS and processes may need to be changed after they are put in place in order to implement continuous improvement and reduce risk. The process for evaluating and implementing change must be “carried out in a planned and methodical manner”6 and take into account a number of factors, such as the motivation for the change and potential results, potential effects on the QMS, and how the change will be suitably resourced.

These requirements—as well as a number of others—are already included in the quality systems used by the pharmaceutical sector, but for some organizations, this may be a novel method of operation. The possibility for “unintended consequences” that follow the implementation of the change is an intriguing issue in many change control procedures.


The Organize-Do-Check-Act (PDCA) cycle and risk-based thinking are combined in the process approach to help a company plan its processes and how they interact. In a nutshell, the PDCA cycle, as per the standard, enables an organization to guarantee that its processes have enough (controlled) resources and that opportunities for improvement are found and addressed5.

Many firms across all sectors place a strong emphasis on organized, documented procedures and rigorous adherence to the necessary standards, yet occasionally, a very important component is specified but not implemented completely. Unfortunately, that is leadership rather than management per se.


As was already said, senior management is assigned a certain set of duties for the QMS. There needs to be proof of their obligations. The organization will determine how that is documented or objectively proven, but there must be proof that this has been done. In addition to top management, enhanced leadership duties also include quality management.

Although we are always surrounded by laws that control the production and distribution of pharmaceutical goods, attention should be paid to ISO 9001:2015, with a focus on certification status as well as how your suppliers show compliance.


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