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Control Quality with ISO 9001 in Life Sciences & Regulated Industries

Life sciences and other businesses in regulated industries demand a robust quality system. 

Your patients and customers trust that your products continually meet their requirements and specifications. It is a sacred trust that has life and death implications. While GxP requirements define specifics for life science vectors, ISO 9001 standards help draw in a broader community of regulated businesses with like-minded quality and process improvement goals.

What is ISO 9001?

Your Quality Management System (QMS) is your company’s set of rules defined by processes and procedures to ensure you deliver customer satisfaction with your products and services. ISO 9001 for your QMS will provide a common-sense approach to the implementation and management of these company rules.

ISO 9001:2015 is the current standard for how to administer your quality management system. It is the globally recognized standard for quality management systems and has been implemented by over one million companies worldwide. 

Complying with ISO 9001 standards is important because it provides a framework for delivering a safe and effective product to customers again and again. ISO certification is validation for potential consumers that your company has dedicated time, effort, and resources into a dedicated process of quality to ensure your product (or service) is dependable and can be relied on repeatedly.

What requirements does ISO 9001 create?

The ISO 9001 standard encompasses ten clauses to adhere to for your quality management system. However only clauses 4-10 are considered actionable and auditable. Those mandatory clauses are:

Clause 4: Context of the Organization

This clause scopes the requirements for your overall quality management system to ensure they align with business objectives

Clause 5: Leadership

Provides requirements for management’s responsibility in implementing a quality management system successfully

Clause 6: Planning

Covers plans to address risk management and planning to achieve your quality objectives

Clause 7: Support

Details the needs of your QMS to ensure your team has access to documented information and support

Clause 8: Operation

Covers planning and process requirements to deliver products

Clause 9: Performance Evaluation

How to monitor, measure and analyze your QMS

Clause 10: Improvement

Details how to ensure continuous improvement through nonconformities and corrective actions
These requirements are designed to be implemented into a process cycle to Plan-Do-Check-Act. When followed in sequence, they provide a loop to continually monitor the effectiveness of your quality system.

Are the ISO 9000 standards the only standards to consider?

ISO 9001 is a set of standards published by the International Organization for Standardization or ISO. The ISO 9001 standard is capable of applying to companies in any industry. However, the ISO has published over 20,000 different standards for technology and manufacturing industries (see ISO's most popular standards), and some of them are of particular importance to medical companies.

Medical and life science companies may also want to be aware of three other ISO standards:  ISO 13485:2016 Medical devices — Quality management systems,  ISO 14971:2019 Medical devices — Application of risk management to medical devices ISO 31000. Let’s take a quick look at these standards.

ISO 13485:2016 - Quality Management Systems for Medical Devices

The ISO 13485:2016 standard is the most important standard for medical device companies to be aware of compared to ISO 9001. This standard is often considered the first step in meeting EU regulations for medical devices. If you make or distribute medical devices, you will be best suited to implement ISO 13485.

While ISO 9001 and ISO 13485 have similarities, it is important to know that there are also significant differences. The latest release of ISO 13485:2016 was released to support an earlier structure of ISO 9001 before it was updated to ISO 9001:2015. Because ISO 13485 was written specifically for medical device manufacturers (while ISO 9001 is reported to be more generally applied), it has additional requirements to be aware of.

The ISO 9001 Academy from Advisera has a detailed explanation of the differences between ISO 13485:2016 and ISO 9001:2015.

ISO 14971 - Risk Management for Medical Devices

ISO 14971 has been widely adopted by the medical device industry and is often a compliance requirement for products with international offerings. According to ISO, this standard “specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.”

ISO 31000 - Risk Management

Risk management is important for all life science companies. ISO 31000 was developed to set standards within your risk management process for internal auditing and external auditing. ISO 31000 cannot be used for certification, however.

What is the business impact of implementing ISO 9001?

As discussed earlier, a major benefit of adopting and ISO standard is to ensure that your company consistently delivers a trustworthy experience to your customers. This is of paramount importance for biotech and life science companies.

Studies have also shown that a commitment to quality has reputational advantages that can drive sales and increase revenue. In 2012, for instance, the International Organization for Standardization (ISO) performed a meta-analysis of published studies to determine whether companies who were certified to ISO 9001 saw any measurable impact on their financial performance.

The analysis found that implementation of the ISO 9001 standards delivered internal benefits to lower costs, such as increasing product control, efficiency, and productivity. Additionally, a successful implementation drove external benefits as well, including increased sales and access to new markets.

Some of these benefits, the ISO reported, were a direct result of the quality initiatives undertaken by these companies to become certified. Better process controls, productivity targets, and improved product quality all helped to increase customer satisfaction and drive sales.

There were also benefits that the ISO attributed to the way certification “signaled quality” to potential customers and partners. According to signaling theory, which was first articulated in the 1970s, there is an information gap, where customers don’t understand the ins and outs of a product or the processes that go into manufacturing it. Customers in these situations look for “signals” of quality, such as certification to a quality standard or management system standards that showcase a commitment to quality.

The ISO determined that ISO 9001 certification led to increased sales, which they believe could be due to signaling theory. Both implementing this international standard and becoming ISO 9001 certified were shown to increase financial performance.

Is ISO 9001 certification beneficial for life science companies?

Industries with many regulatory requirements, like life sciences and biosciences companies, have experienced significant changes in the regulatory environment in the past decade. The standards in the current version ISO 9001:2015 haven’t really changed very much. What has changed over the past 10 years is that the businesses responsible for implementing and maintaining a quality management standard are increasingly aware that not everyone can apply the same priority to all of the controls.

Each organization must decide and justify the systems and standards that they are implementing based on the value (or potential value) to the business. As noted, ISO 9000 standards are able to be used by any industry. But as life science and bioscience companies exist with additional regulatory requirements, and impact the lives of customers more than many other industries, the ISO 9000 standards can be very impactful.

The implementation of a quality management system that is certified against the ISO 9001 standard has been shown to directly impact revenue. But adopting the process approach of ISO 9001 also nets benefits that are especially important for life science companies.

ZenQMS believes that adopting a company culture of quality creates multiple stakeholders throughout a company. When bringing medical products to your market, focusing solely on regulatory compliance does not translate to a quality product that delivers your customer needs.

A process approach to quality throughout different teams becomes possible with an ISO 9001 certified quality management system. The ability to quickly identify areas for improvement, while clearly demonstrating connected quality control across your organization will assist in delivering the internal benefits of ISO 9001 implementation.

Getting started with ISO 9001 Quality Management

ISO doesn’t provide certification or conformity assessment. The process of certification against ISO standards is carried out by external certification bodies. In other words, an organization that pursues certification must understand and implement the standards first, and engage with such a third party after implementation, for an extensive audit and cascade of audits thereafter that, if implemented properly, will result in a certification of conformity with the implemented specific ISO standard.

For a successful outcome, the project of implementing ISO standards, should, like any other quality-related project, be endorsed by top management and be a top priority for an organization. As such, quality leaders should request resources to support the efforts of implementing and maintaining conformance.

For example, the implementation of an eQMS can elevate the ability of the organization to manage documents and records, assign and track training. and. staff competence, manage non-conformities, assign Corrective and Preventive Actions (CAPAs) and assess their effectiveness, support the internal audit program, manage changes related to products and manage externally provided products or services. If you look at ISO 9001:2015 standard alone, those listed components are key requirements of the standard. 

How to get ISO 9001 Certification

Successful ISO 9001 certification depends on the proper implementation of the standard within your quality management system. 

Organizations of any size are able to achieve ISO 9001 certification for their quality management system.

ISO 9001 Certification is a serious undertaking for any organization that seeks it, but there are tremendous business advantages that we will discuss. The amount of time and resources it takes to implement an ISO 9001 Certified Quality Management System will vary from company to company. Small companies may be able to implement in fewer than six months, while larger enterprise companies may find the process taking up to two years. 

Because of this, some companies will choose to use outside consultants to help implement these standards. Other companies may choose to use an in-house team to implement. Both choices offer their own advantages and disadvantages in terms of cost, timing, and internal ownership of the process. 

9001Simplified has a detailed walkthrough of the steps to ISO 9001 Certification which include: 

  1. Preparation
  2. Documentation
  3. Implementation
  4. Internal Audit
  5. Certification

Maintaining your ISO 9001 System

If your company accomplishes ISO 9001 Certification, it will be certified for a three year period. However, you should expect to have your quality management system audited frequently --both internally (at a minimum annually) as part of the mandatory internal audit requirement and externally (at a minimum annually) by the Certification Body for surveillance to ensure you are continually adhering to the ISO 9001 standards and your QMS. 

While there are many reasons your quality management system could fail, we believe most could be avoided with company leadership adopting an approach of Intelligent Quality. Intelligent quality is achieved by businesses that are living the letter and spirit of their quality systems in the most efficient way possible. And for these businesses, quality becomes the basis for their reputation and serves as a competitive advantage in the marketplace.

It is important that your entire company is able to adopt the quality mindset to ensure your efforts are continually meeting customer's safety and expectations.

Additionally, your QMS must be able to evolve as your process becomes refined and your business continues to grow. Establishing a quality management system and living the spirit of the ISO 9001 standards will only be successful if they continue to follow the Plan, Do, Check, and Act model discussed earlier.

"The idea that we can get an ISO certification and just stick it over there with those people that are responsible for that work, you'll find will not actually get you where you want to be."

Ryan Coleman
Dayspring Technology

Additionally, your QMS must be able to evolve as your process becomes refined and your business continues to grow. Establishing a quality management system and living the spirit of the ISO 9001 standards will only be successful if they continue to follow the Plan, Do, Check and Act model discussed earlier. 

Quality Management Software for ISO 9001

ISO 9001 does not require the use of a quality management system software (or an eQMS). Using a quality management system software (or eQMS) can make the process of ISO 9001 certification and continual improvement easier and seamless.

Maintaining the integrity of your QMS is tremendously important and is best implemented throughout a company when the processes are not manual and cumbersome. An eQMS will enable you to keep documented information in a unified system, helping the organization achieve traceability between processes and records, and visibility to staff members including top management .

ZenQMS is designed with the ISO 9001 standard in mind. We use our platform to manage our own internal quality system, and our quality management system is ISO 9001:2015 certified

Below are a couple of ways you can satisfy ISO clauses by utilizing the built-in features of  ZenQMS rather than trying to invent the wheel.

ISO 9001 7.2 | Competency

Automate constant competency

Keep your team's training up-to-date and documented by connecting your document control and training management. For example, when an SOP is upversioned, ZenQMS will prompt the team members assigned to it so that constant competency is always maintained. 


ISO 9001 7.5 | Documented Information

Instantly create traceability

Link records across your quality activities so that during operations or audits the traceability of inputs and outputs are clear. With ZenQMS, a CAPA that requires a change in a procedure can be linked to an actual version update of an SOP which provides evidence of corrective/ preventive action.