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Originally published January 1996
Commentary
Getting through ISO 9000 Certification
Robert E. James
Compliance with an ISO 9000 standard is rapidly becoming a basic requirement for doing business all over the world. Participating in an ISO 9000 certification program is a win-win activity for a manufacturer. It demonstrates to customers one's commitment to a proper quality management system. It provides a method for increasing efficiencies and reducing costs. All these benefits help ensure that the company's product is of consistent quality and meets customer expectations.
From an internal perspective, there are many benefits to ISO 9000 standard compliance. Such programs enable a manufacturer to institute, monitor, and improve quality assurance systems and help reduce operating costs. They also encourage nonmanufacturing groups to get more involved in quality matters, including quality improvement programs. Most importantly, I have seen that ISO standard compliance programs motivate employees, both individually and as members of a team.
Achieving compliance with and certification to an ISO standard depends on a number of steps.
Initially, a representative of the manufacturer should investigate the benefits, basic cost, and process of achieving ISO 9000 certification. Information is available from many books, journals, and trade and professional associations. It is essential that top management understand the overall program and be totally committed to its completion.
An ISO 9000 steering committee with a defined and documented role should then be formed. I recommend that it have a representative from each functional department at the location involved.
Each committee member should be thoroughly familiar with the ISO 9000 standards. Information is available through associations such as the American National Standards Institute and the American Society for Quality Control. Other information, including data on successes and failures in the ISO 9000 process, also facilitates decision-making.
The committee should determine the ISO 9000 standard with which the company plans to comply. For a site where products are developed and modified a company would normally pick ISO 9001, which includes design control requirements. ISO 9002 (no design controls) is normally used at production-only locations.
The committee should then determine what certification group will be used, making sure that the one selected is itself properly accredited to conduct assessments and certify under ISO 9000 standards. I recommend that the committee invite representatives of potential certification groups to make on-site presentations. It must investigate the history, check out the references, and of course determine the cost of the potential certification group. Manufacturers seeking to certify more than one location may be able to negotiate savings.
The next major task is to determine the manufacturing location's current level of compliance. My rule of thumb is that a facility in a good state of compliance with good manufacturing practices (GMPs) is at least 80% in compliance with ISO 9001/9002.
The committee must review existing policies and procedures against ISO 9000 standards requirements, identify deficiencies, determine the necessary corrective actions, and set a schedule for their implementation. The review includes scrutiny of the location's quality manual to be sure that it addresses all components of the chosen ISO 9000 standard. Periodic internal assessments are necessary to ensure that compliance targets are being reached.
ISO 9000 lead assessor training for at least one person per location is helpful. Trained assessors help to keep the program on the right path.
Once the committee feels comfortable that programs are in place and progress is being made toward complete compliance with the chosen ISO 9000 standard, it makes a formal application to the certification group. The group then opens a client file for the company and requests a copy of the quality manual for review.
The committee supplies the manual, into which it has already incorporated all the ISO 9000 standard components. The certification group provides an outside critique. The committee makes any necessary amendments to the manual before proceeding further.
An optional step that I encourage is an on-site preassessment. This event is a "friendly" audit, so termed because its course is controlled by the manufacturer. Such a preassessment allows for a candid dialogue regarding what is available and what is expected and any discrepancies between the two. It provides an opportunity for the manufacturing group to work with the certification group personnel, easing the way for future assessments.
Considering the results of the preassessment and the time that will be required for any corrective actions, the committee and the certification group set a certification date. The date should be far enough in the future to allow documentation and implementation of all policies and procedures. By the date of the certification, the manufacturer should have sufficient documented experience that the systems are working properly.
On the certification date the assessment for certification takes place. Usually two or more certification group assessors perform this audit, which covers all ISO 9000 standard components. There is usually a review of findings each day. The manufacturer passes muster if the assessors find no major deficiencies, such as a missing quality system. If they do find a major deficiency, the manufacturer must take corrective actions and schedule another assessment.
The assessors may recommend certification in spite of minor deficiencies by accepting the manufacturer's corrections of them. Once they recommend it, the group formally provides the ISO 9001 or 9002 certification.
Maintenance of a manufacturer's certification includes periodic reassessments by the certification group. These reassessments usually occur once or twice a year.
The ISO 9000 certification process can take months or years, depending on a manufacturer's original state of compliance and the commitment of the people involved. Keys to success include keeping everyone informed of progress made and having as many people as possible involved in this team activity. Everyone from the line operator to the CEO should have a stake in such an important program.
Once certification is achieved, celebrate! Recognition of everyone's contribution to such a success not only is appropriate but also strengthens commitment of personnel to maintenance of the certification.
My dream is that FDA will eventually exempt from GMP inspections manufacturers that are either ISO 9001 or ISO 9002 certified. The rationale for this is simple. The GMP requirements and ISO 9000 requirements are becoming harmonized. Also, the ISO 9000 certification process is continuous, with at least annual reassessments by an independent outside certification group.
Such a policy would free FDA staff for other pressing tasks. Is it possible? Of course! Will it be achieved? Only time will tell. Perhaps the legislative process could assist in making my dream come true.
Robert E. James is director, regulatory affairs and quality systems, Becton Dickinson Microbiology Systems (Cockeysville, MD). He is a member of IVD Technology's Editorial Advisory Board.
