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The ISO 9000 Journey

Medical Device & Diagnostic Industry
| MDDI Article Index

Originally published March 1996


Stephen L. Thoreson

In early 1995, Becton Dickinson Vascular Access (BDVA) and Becton Dickinson Div. (BDD), Sandy, UT, achieved registration to the ISO 9000 series of standards compiled by the International Organization for Standardization (ISO). This article provides a travelogue of that journey and some common sense advice, based on experience, for others that go down this path.

BDVA manufactures intravascular catheters for both central and peripheral applications. BDD manufactures surgical scrub brushes and sponges and bottled antimicrobial solutions and gels. The two business units share a manufacturing facility and operate using a shared quality system. From management and accounting standpoints, however, the business units operate independently.


Management decided to pursue ISO 9000 quality system registration for two reasons: it appeared that it was becoming a de facto standard for conducting business worldwide, and it satisfied a quality system prerequisite for complying with European Union CE marking requirements. Although ISO 9000 certification is not a requirement for CE marking, its worldwide recognition makes it a viable option. The company considered both issues significant for continued success. BDVA and BDD chose ISO 9001 as their desired certification target, because both business units were involved in design, manufacture, and distribution of products.

This challenging registration process was further complicated by organizational and operating structure issues. In addition to the BDD manufacturing plant, BDVA is organized into four focused plants, one of which is a border operation with sites in Arizona and Mexico. Each plant has a separate management structure and maintains its own good manufacturing practices (GMP) quality system. BDVA's division management is located in Sandy, and BDD's Sandy division management is located in New Jersey.


The company's existing quality system was based on the GMPs. What I, as the leader, knew about ISO 9000 quality systems and the certification process was limited, and so self-education was a first item of business. The standard was studied in depth. ISO 9000 videotapes were viewed repeatedly. The education process included professional training and industry networking.

Because the ISO registration would
affect many individuals across broad organizational and geographic spans, developing cross-organizational teams was the approach that could most thoroughly address everyone's needs and get the job done most effectively. Every team had a minimum of six members and included at least one representative from BDD­Sandy, one from each of the four BDVA manufacturing plants, and one from division. Teams were allowed to add additional members as they deemed necessary. Each member was selected from the organizational discipline most closely aligned with the team's assignment. Members' personal knowledge in the area and ability to contribute were also part of the selection process.

The number of teams required was another question. The answer was not readily forthcoming, but it was believed, in general, that too few teams would reduce employee involvement and buy-in, whereas too many could create a management nightmare. Finding a balance was important. By organizing the ISO 9001 clauses into groupings of like or related requirements, the need for 13 teams was identified. Table I (see below) indicates the way the clauses were grouped. The core team consisted of the 13 team leaders, 5 plant coordinators, and 1 program director; the extended project team (all participants) ultimately numbered about 130.

Before selecting team members, the company provided an overview of the ISO 9000 program to all employees. The company's quality assurance staff conducted this training, which provided employees with the program's goals and objectives. It also enabled management to make educated selections of team members and provided selected team members with an understanding of the task at hand. Following this training program, senior managers made team member selections. For each team one member was given the additional responsibility to act as team leader.

Each team addressed the ISO 9001 clause or clauses as assigned from Table I. This included studying and understanding the requirements, developing and documenting systems that would address those requirements, and effectively implementing the systems developed.

Team members ensured that the views
and needs of their respective areas were accurately represented. Team members jointly developed and implemented the ISO-compliant systems and procedures. Team leaders were also required to call and facilitate team meetings and to track and report their teams' progress to the core team.

Since each team focused on addressing specific elements of the quality system (a horizontal structure), they sometimes lacked the broader view. This led to implementing one final managerial function. The quality assurance managers from each plant were named plant coordinators. These coordinators represented the broader view and ensured that the individual quality systems were compatible and worked together within their functional area (vertical integration). They also ensured that manufacturing documentation for their area was accurate and up to date.


It was the company's goal to develop a quality system that would comply not only with the requirements of ISO 9001, but would continue to meet GMPs and also adhere to EN 46001.1 To ensure that the teams were aware of the combined requirements, an ISO/GMP/EN comparison document was prepared and provided to each team. This document also included the ISO 9004 guidance2.

Each team inventoried the existing GMP quality system to determine what elements were already in place that satisfied the combined requirements and to identify gaps, including systems that would require revision to meet the requirements and any systems that would require ground-up development. This information was used to develop a master project plan that documented what needed to be done, by whom, and when. Progress was tracked against this master plan.

Using the experience of already-registered firms as a guideline, the company determined that 18 months was a reasonable time frame in which to complete the program. Working backward from the target date, time lines were assigned for the completion of interim milestones, which were set for each level of documentation and based on the findings of the earlier gap analysis.

The teams worked according to the master plan. Each team leader submitted a monthly report to document progress. The core team met once a month to exchange information. One monthly update meeting, held early in the program, was conducted with the core team in Mexico to acquaint the team leaders with that operation and participants. The program manager reported to a steering committee composed of top-level managers. The reports consisted of key milestones and any issues that could not be resolved by the project team. The entire process, from formation of teams to ISO
registration, took 21 months, during which approximately 12,000 hours of employee time were logged to the effort.


The placement of information was the focus of many discussions. Also, achieving and maintaining consistency in all documents--considering the many different groups involved--was a tremendous challenge. The teams undertook some quality-system benchmarking, but examples were sparse at that time. After much struggle, the company implemented a documentation
hierarchy involving four document levels.

Level 1: The Quality Manual. The primary purpose of the quality manual is to identify the subsystems, provide the rationale for their development and implementation, and define the scope of each subsystems (i.e., what procedures make up the whole of that subsystem). The quality manual is a quick reference for determining the components of the quality system. It also provides a complete quality-system document hierarchy and directs the reader to
related Level 2 documents.

Level 2: Policy and Procedure. These documents describe the "what" of the business; they are a quick reference to the workings of the quality system. Each quality-
system element has at least one Level 2 document associated with it. Level 2 documents provide an overview of the scope and interrelationship of various procedures within each subsystem. These documents can also help outsiders, such as third-party auditors, understand the system. Each Level 2 document points to related Level 3 documents.

Level 3: Task Instruction. These documents provide step-by-step instructions for carrying out specific tasks and are directed at the person performing the task. They reference related Level 4 documents.

Level 4: Forms. These are records of the results of work performed and provide objective evidence that the quality system is functioning effectively.


Registrar selection was a challenge because the world is full--and getting more so--of registrars. Therefore, the company employed a methodical selection process to identify key traits of the ideal registrar. These traits included:

* EU-based with a high likelihood of becoming a notified body under the European Medical Device Directive.

* English speaking.

* Well known and respected.

* Recognized worldwide.

* Capable of providing timely service.

* Experienced in the medical device industry.

* Competitively priced.

The program manager and plant coordinators evaluated various available registrars to determine which best met the selection criteria and ultimately selected the British Standards Institution (BSI). The program manager was the primary contact for all communications and contracts.


Early on the core team felt that the system subelements were so deeply intertwined that the only workable strategy for implementing the quality system would be through a comprehensive training activity and same-day implementation. For the most part, the schedule proceeded on this basis. A few teams completed their work early and were eager to implement and debug their systems. They were given approval to do so provided that they ensured that any incompatibilities with other subsystems would not create a noncompliant situation, and that they take responsibility for related organizational training and the rollout.

As the individual rollouts took place, it became apparent that the subsystems were not as intertwined as feared. On the contrary, they proved to be, in great part, independent. Because of this, management directed teams to publish and implement procedures as available, thereby avoiding last-minute documentation and implementation pile ups.

After all the systems were in place, the core team provided a series of functionally tailored training sessions. These sessions
involved every employee, including members of the field sales force. The training included an overview of all elements of the quality system. Each employee received a copy of the training materials and an internally developed ISO training booklet. From that point forward all managers were responsible for ensuring compliance in their areas.


Employee motivation proved to be a problem. With many competing organizational demands and limited available time, ISO preparation did not always take priority. To maintain organizational interest throughout the course of the program, wall displays containing team pictures and explanations of their assignments were posted. The program objectives and quality policy were also displayed. Program time lines and progress charts were exhibited. A quality system newsletter was published periodically to report progress updates, and additional periodic communications were also used during the program. Following the preassessment, an ISO team luncheon was held to celebrate progress to date and, after the program concluded, another luncheon was held to recognize participants and distribute mementos.


The internal quality audits system was among the first to be implemented. Qualified individuals, as defined by the audit procedure, formed audit teams. This enabled the company to carry out internal audits as the ISO program progressed. These audits provided a mechanism for identifying problem areas, documenting those deficiencies, and assigning them to appropriate teams.

Becton Dickinson corporate auditors conducted a quality system preassessment when the program was about two-thirds complete. BSI conducted a second preassessment about three-quarters of the way through. These preassessments provided invaluable outside perspective on system adequacy and effectiveness and identified remaining major deficiencies.


The initial assessment was postponed three months beyond the original target date primarily to allow for further debugging and to generate necessary objective evidence that the total quality system was functioning effectively. At the time of the initial assessment, most systems had been operating from three to six months.

There was much apprehension at the time of the initial assessment. Despite hard work and preparation and the experience of two preassessments, the first experience with the real thing was intimidating. Nonetheless, when the assessment was concluded, only a small number of minor nonconformances and observations were noted, and no major deficiencies were cited. The assessors recommended the two business units for registration pending receipt and acceptance of a corrective action plan that would address the audit findings.

This case study represents the way in which ISO 9000 registration was achieved by these two business units. Although it is only one way to accomplish this task, it proved to be a successful approach.


1. Quality System--Medical Devices--Particular Requirements for the Application of EN 29001, EN 46001, Brussels, Belgium, European Committee for Standardization, 1993.

2. Quality Management and Quality System Elements--Guidelines, ISO 9004-1, Geneva, Switzerland, International Organization for Standardization, 1994.

Stephen L. Thoresen is director, quality management systems, for Becton Dickinson Vascular Access. He served as program leader for the company's ISO 9000 effort.


Before undertaking an ISO 9000 program, clearly identify the reasons for pursuing registration; know what benefits the company expects to derive from the effort. Those expectations and benefits should be articulated to the organization by top management and management should maintain ongoing visible support to the program throughout its duration.

Don't be overly optimistic about the reception the initiation of an ISO 9000 program will receive. Employees will likely see it as a necessary evil, outside the realm of normal business operations and heaped onto an already full plate. Communicate the vision and sell the benefits.

Choose an organized and persistent leader with quality system experience. Allow this person adequate time and resources to progress effectively. This person should be commissioned by, and responsible and connected to, top management.

Early on, consider using an experienced ISO consultant or benchmark progress against registered companies. This should provide a picture of what the final quality system might look like and insight into some different ways of achieving this.

Involve a sizable but manageable cross section of the company in the effort, thereby expanding quality system knowledge and expertise within the organization. Select capable and committed program participants.

Recognize that this project will require a significant amount of work and expense. Avoid adding to existing heavy workloads. Relieve program participants of other duties to enable them to participate effectively. Make ISO success a part of their annual goals and performance appraisal.

Organize teams with cross-functional representation. Within reason, allow the team leaders to select their team members. Teams should consist of employees who have knowledge and expertise in the specific area under consideration.

Clearly define the responsibility and accountability for each team. It is equally important to make sure that team members understand their responsibility within the team. Select leaders with proven management ability. If possible, provide team training, including consensus management, and provide each team with ISO 9000 training.

Promote communication and coordination among the various contributing groups. Make sure someone oversees the big picture (most logically the program manager).

Once organized, conduct an internal audit to determine what is completed and what still needs to be accomplished (gap analysis). Use existing systems and procedures whenever possible; develop new procedures only when absolutely necessary.

Develop a detailed master plan with aggressive, but achievable, time lines. Track progress against the plan. Ensure that work
progresses at a steady pace to avoid work pile ups around critical deadlines.

Communicate the goals and progress of the program to the organization. Recognize and reward program participants.

Identify a documentation hierarchy before writing the first document. Determine how many document levels will be required and identify the purpose of each level. Minimize levels of documentation as much as possible.

Develop documentation from the bottom up (e.g., develop task instructions and recordkeeping that satisfy the requirements of the standard). Create higher-level road-map documents, such as a quality manual (Level 1), after establishing a functioning system.

Develop flowcharts of the processes before writing procedures and keep the procedures simple. Do not combine different procedures into a single document. Employ skilled technical writers to develop documents or mandate a standard document style. Have the procedures reviewed and approved by the people who use them.

Take a methodical approach to registrar selection. Identify key qualifications.

Develop, document, approve, and implement procedures and systems and train staff as quickly as possible to maximize debug and run time. Avoid a mass rollout. Keep an eye out for troublesome system interactions created by piecemeal implementation. Adjust the system to accommodate such situations later.

Conduct early internal auditing using trained auditors. Identify deficiencies and take corrective action. Enlist the help of third-party auditors, through preassessments, to identify shortcomings in the system, recognizing that preassessments will not pinpoint every shortcoming.

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