Case Study – ISO 14001 & OHSAS 18001 Certification – Hologic

“We understand all of our systems better because we did this. This process broadened our scope of understanding the entire business.”

Jeffrey Joaquim Senior Manager, Corporate EHS

“Although it appeared that ISO 14001 and OHSAS 18001 were going to burden the factory with some unnecessary tasks; during the training and after the certification we realized added value and cost savings.”

Greg Safarik, Vice President, Breast Health Manufacturing Operations

Using Pinnacle Enterprise Group’s Lean EHS®, Hologic achieves a combined ISO 14001 and OHSAS 18001 certification in 7 months.

Medical Device Manufacturing, Diagnostics




  • Reduced product standard cost & operational overhead.
  • Reduced Accident Incident Rate.
  • Energy conservation in the areas of power, air, and waste.
  • Total company awareness and involvement in environmental, health and safety.
  • Reduction of the company’s overall environmental footprint.
  • Reduction of the overall environmental footprint of suppliers.
  • ISO 14001 and OHSAS 18001 certification with zero non-conformances in less than 7 months.

The Industry Leader

Hologic is a manufacturer and supplier of diagnostic medical imaging systems and surgical products focused on women’s health. The company is the leader in mammography, breast biopsy, and other technologies related to detection and treatment of cancer and other women’s disease.

Hologic’s Breast Imaging Solutions manufacturing site in Danbury, CT is not a stranger to management systems. In the medical device industry, quality and advanced management methods are a must to ensure operational excellence on a highly competitive landscape. The company enjoys long-term success by continually adhering to Lean Manufacturing principles and maintaining a mature and robust ISO 13485 Quality Management System (QMS).

Early Concerns

Hologic’s long-term use of and familiarity with their QMS is a primary reason that, when ISO 14001 and OSHAS 18001 certification discussions began, there were well-founded assumptions regarding the implementation process. Among these assumptions were concerns that concurrently implementing an environmental management system and an occupational health and safety management system could be a long-term project lasting two years or more. The management team saw a need to prepare the operation to absorb the efforts and activities required to bring the organization through the process without being overburdened.

Especially interesting to Hologic’s management team was the search they began to identify external experts to assist in the ISO 14001 and OHSAS 18001 implementation process. Many were willing to take on the project, but it seemed difficult to locate a consultant with a methodology and an acceptable level of familiarity with concurrently facilitating both ISO 14001 and OHSAS 18001 implementation.

During the screening and interviews of candidates, Pinnacle Enterprise Group founder Kirill Liberman was given the opportunity to present an approach for the project that no other consulting organization offered – implementation of both standards at the same time and the development of a single integrated Environmental, Health and Safety Management System (EHS). Not only did Kirill Liberman suggest simultaneous implementation could be accomplished smoothly, but he demonstrated tools and a methodology specifically designed to guide the process – Pinnacle’s Lean EHS®.

With Pinnacle Enterprise Group on board, Hologic decided on attempting the combined ISO 14001 and OHSAS 18001 certification. They discovered not only that Pinnacle’s Lean EHS® implementation approach worked, but it also turned many of their previous concerns into non-issues, while creating immediate low-hanging fruit to benefit the operation.

A Vision Beyond ISO 14001 and OHSAS 18001 Certification

The Lean EHS® is a visual process-based methodology that applies Lean Management concepts – such as visual management, flow, and just-in-time – to the design of an ISO based management system infrastructure. Traditional non-value-added volumes of text procedures are replaced with process maps that provide both a view of each process and demonstrate its relationship to other processes of the business. The traditional documentation bureaucracy is replaced by a user-friendly visual interface that supports training, process analysis, and organic continual improvement.

This is exactly what Hologic discovered as they began to implement the Lean EHS®. There were really three factors that made the project successful.

First, by using the Lean EHS® developed by Pinnacle, Hologic easily reduced the amount of documentation created. Instead of large amounts of verbiage for personnel to grasp; the process maps at once become the ISO 14001 and OHSAS 18001 documentation and the EHS training tool. The visual aspects of the Lean EHS® simplified training and became more readily used by everyone because it helps them visually understand why and how each process is integral to the business.

“Training all employees is key to a successful launch of any initiative,” stated Greg Safarik, Vice President, Breast Health Manufacturing Operations. “The format used, offered simplicity with all the desired and required elements for certification.” he added.

Second, in order to complete both implementations together in less than 7 months, Pinnacle worked with Hologic to take advantage of all the requirements of each standard which are similar, identical, or related to each other. Therefore, ISO14001 and OHSAS 18001 were not viewed as two unique sets of requirements, but complimentary systems which add value to the business. Common processes reduced both documents and bureaucracy. This enabled Hologic to fit a two system implementation, which everyone thought would take as many years, into an efficient 7-month program.

Greg Safarik adds, “Senior management was convinced that we should get certified for ISO 14001 and [then] OHSAS 18001 the following year. After all the procedures were written and we [observed] the commonality between the two, we decided to get certified for both at the same time. Using guidelines of the Lean EHS® and integrating the two, we successfully received certification for both.”

Finally, Hologic saw the Lean EHS® could be used to enhance the business and to create immediate improvements by rapidly implementing best practices. The Lean EHS® created an environment of total company awareness and involvement in environmental health and safety. Instead of a project team and some key stakeholders attempting to push the project throughout the company, the entire organization became connected with implementing the program.

“People understand all of our systems better because we did this,” stated Jeffrey Joaquim Senior Manager, Corporate EHS, who lead Hologic’s implementation team. This process broadened their entire scope of knowing the business.

The results of the combined implementation and the entire program were significant focused business improvements. While the initial concern was burdening the operation with unnecessary tasks, the project leadership admits that both during implementation and after the certification they realized added value and cost savings.

Some of the lowest hanging fruit in operational savings came from energy conservation. Hologic reduced power consumption almost immediately. The cost to air condition the facility was also driven down. The company saw immediately measurable decreases in the amounts of waste being discharged by the plant.

Integral cost reductions went deeper than simply labor and materials enabling Hologic to reduce overhead using the knowledge and information learned through the combined systems. For example, the Lean EHS® helped Hologic drive down packaging costs through changes in packaging materials. Among the tangible results were a lower standard product cost, opportunity for increased margin, and competitive advantage.

In addition to the bottom line benefits, Hologic realized a decrease in its environmental footprint during the implementation. Today, the facility is proud of its zero contribution to landfill. Furthermore, the lessons learned created a trickle-down effect which resulted in reductions for the environmental footprint of suppliers. Hologic actually initiated requirements of their suppliers designed to facilitate best practices with Hologic. These practices ultimately contributed to business improvements for suppliers.

Even the auditors remarked positively not only concerning a successful audit with zero non-conformances, but they were able to clearly identify a number of positives the company had achieved. All parties are confident that the Lean EHS® will continue to gather momentum as it matures.

6 Responses to “Case Study – ISO 14001 & OHSAS 18001 Certification – Hologic”

  1. Chris Carson says:

    I think the benefits section is one of the best articulated rationale for EHS implementation. Many “case studies” provide a general overview rather than specifics, which I really like.

    It’s also great that the approach was to integrate as your business management system should encompass all areas and not be segmented into disciplines. Having seen Pinnacle’s Lean EHS it shouldn’t even be a question as to why it should be done, but it’s still concerning that a lot of practicioners wouldn’t even consider whether it could.

  2. Kirill says:

    Thanks for the feedback, Chris. I think it is valuable for the readers of this blog.

    Hologic did a great job and had progressive leadership that supported the project. These factors are often overlooked or underappreciated. Perhaps I should write an article about the importance of leadership and support to the success and value of an ISO 14001 & OHSAS 18001 based EHS.

    I hope you see more of your comments soon.

    Kirill Liberman

  3. Janice R. says:

    Thank you for providing a summary of financial impacts of management system integration. It is very difficult to sell an initiative such as this without a promise of cost savings. I plan to share your article with key personnel in my organization, as we’re considering developing an integrated management system.

  4. Kirill says:

    Welcome to the Blog, Janice.

    I am glad you found this case study helpful.

    Quantifying the ROI of an integrated ISO 9001, ISO 14001, and OHSAS 18001 management system has been difficult for most of my career. The problem is that most companies don’t know the cost of having poor and un-integrated management systems. Most organizations just accept their current sate as the norm and never measure or quantify the cost of maintaining multiple systems separately. I suspect this will change as Pinnacle helps more clients convert and integrate their traditional ISO 9001, ISO 14001, and OHSAS 18001 management systems to a Lean BOS.

    Kirill Liberman

  5. Quality Junky says:

    Hey Kirill,

    Another good one. Do you have any customers that have done ISO 9001, ISO 14001, and OHSAS 18001 at once? It would be great to get some info and lessons learned from a company that did all three as one integrated management system. This is a topic that keeps getting kicked around with my colleagues and some industry groups I’m in. It seems that there may be some difficulties or road blocks that people are running into. Any info you can post here would be very helful.


    Quality Junky

  6. Kirill says:

    Hi Quality Junky,

    Good to hear from you again.

    I recently helped Acciona Energy NA achieve ISO 9001, ISO 14001, and OHSAS 18001 certification. Please forgive my shameless bragging, but we set a record in the process. We implemented all three standards as part of one integrated QMS, EMS, and OHS management system (called Lean BOS), in less than 6 month, and with zero non-conformances. I am bound by a confidentiality agreement, but I can share that there are some key lessons from this experience that should be shared. I will approach Acciona again to see if they would like to be the subject of a case study. In the meantime, feel free to contact me with any specific challenges you and your colleagues may be facing. I will be glad to share any insight and provide guidance.

    Kirill Liberman

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