Four members of the BCCM have recently achieved ISO 9001:2000 certification. The formal planning for this certification started in April 2004 and the initial certification audit took place in June 2005. Apparently, this implementation time is short, which was possible only because of the ground work that had been carried out over the preceding years.
This article presents the reasons why the BCCM decided to evolve from internal quality control of the biological material to an internationally recognised quality-management system and the steps taken in that evolution.

The reasons

At the beginning of this project, the BCCM had to define its goal and answer the following questions: “How can a quality-management system (QMS) add value to culture collections working in a consortium?” and “Why does the BCCM need a QMS and for what purpose?”
Each BCCM member felt the need to improve its internal operations, formalise its know-how, and empower its employees. Implementing a QMS at the consortium level was also intended to group the BCCM around one common target and consequently to move the consortium further towards a coherent, albeit decentralised entity.
More generally, it is vital for culture collections to meet the expectations of their customers and stakeholders. Thus, culture collections need to integrate the current socio-economic logic and to combine high-level research and scientific services with sound management. This is also the philosophy behind the OECD concept of Biological Resources Centres (BRCs) for the OECD wants the traditional culture collections to evolve towards infrastructures that will support the future of the life science and biotechnology.

For all these reasons, the BCCM/LMG, BCCM/LMBP, and BCCM/MUCL collections and the coordination team started the implementation of a QMS that complies with the ISO 9001:2000 standard. In order to increase the chances of success of this project, the BCCM consortium applied the methods of project management on a stringent schedule.
The BCCM/IHEM collection had already been accredited according to the ISO 17025 :1999 standard. Therefore, this collection did not elect to go the ISO 9001 :2000 route but decided to extend its QMS to meet the requirements of the ISO Guide 34.

Step 1: the choice of a consultant

First, the BCCM consortium decided to hire a consultant in order to facilitate the process. But the business of a culture collection is an unusual activity in the world of quality management, so it was not possible to find a consultant who had the required knowledge and relevant experience of our sector. Consequently, the BCCM consortium focused on candidates who had considerable experience in implementing quality-management systems in microbiological laboratories in the pharmaceutical sector or in the food industry. It was also important to find one who could understand the working of the BCCM consortium and who would be at ease with all the BCCM staff levels.
The consultant chosen was given a mentoring role. He had to limit the paperwork to what was absolutely necessary, reduce the bureaucracy, and give advice and guidance where appropriate so that the ISO 9001:2000 requirements could be complied with.
The preparation of the documents and the implementation itself were done by BCCM staff. This allowed the BCCM consortium to integrate and retain the consultant’s knowledge and skills.

Step 2: the choice of multi-site certification for better consortium coherence

A multi-site organization is: “an organization having an identified central function at which certain activities are planned, controlled or managed and a network of local offices or branches (sites) at which such activities are fully or partially carried out” (IAF GD 2:2003 Guide 62 Issue 3 annex 3). Since the BCCM is a network of four culture collections coordinated by the coordination team of the Belgian Science Policy, it largely complied with this definition.
However, in order to meet the eligibility criteria for multi-site certification more fully, the BCCM QMS had to be centrally administrated. Therefore, the BCCM quality management system is built around a single strategic plan with objectives that are shared by all the BCCM members. This QMS is subject to central management review and monitored in function of common Key Performance Indicators (KPIs). The documentation of the QMS is harmonised and the planning of the internal audits is centrally managed. The treatment of complaints, non-conformities, corrections, corrective and preventive actions is also harmonised as far as possible and centrally monitored.
This multi-site QMS allows the BCCM to have one single certificate – the group certificate- with the scope, the name and the address of the BCCM consortium. The group certificate also contains a list of all the BCCM members to which the certification is issued. The BCCM members covered by this group certificate share a common responsibility for this recognition. In addition to the group certificate, the BCCM members covered by the certification have specific sub-certificates that specify their scope in more detail and include a clear reference to the group-certificate.
With so many critical features of the management system harmonised and monitored at consortium level, it goes without saying that this multi-site certification has enhanced the corporate identity and coherence of the BCCM.

Step 3: the selection of the certification body

Although the initial certification audit happens at the very end of the implementation process, the selection of the certification body occured early in the course of this project.
The BCCM consortium contacted several certification bodies listed in the Belac (Belgian Accreditation Structure) directory of ISO 9001:2000 certification bodies. This directory lists certification bodies that have been officially approved by Belac as competent for certification in specified business sectors. For the BCCM, this was the first independent confirmation of the competence of a certification body in performing high-standard third-party auditing.
Hence, since the ISO 9001:2000 certification is focused on customer satisfaction, it was critical for the BCCM consortium to work with an international certification body well known by its customers and stakeholders worldwide.
There were also stringent selection criteria for the assessor. Indeed, it was clear from the beginning that it would not be possible to find an assessor with detailed knowledge of the working of culture collections. The BCCM thus chose to focus on an auditor who combined a good knowledge of the ISO 9001:2000 standard with much experience in quality-management systems in microbiological laboratories.
After the evaluation of the submission files and interviews with the candidate assessors, the BCCM chose to work with SGS S&SC as its certification body. The certification audit was performed by a team of two assessors: one lead auditor who was acquainted to the assessment of quality management systems and one expert auditor who had detailed knowledge of the operation of a microbiological laboratory.

Step 4: the development and implementation of the QMS

The development, implementation and improvement of the QMS itself followed the “process approach” as promoted by the ISO 9001:2000 standard.
First, the BCCM senior management demonstrated its involvement in this project by answering to questions like: “What does the BCCM want to be within five years?” “Who are the BCCM customers and stakeholders?” “What do these people expect from BCCM?” “What level of service will BCCM offer?”
Answering these questions led to a clear statement of the mission of the BCCM and a strategic plan defining the goals of the consortium.

Interviews of staff of the BCCM collections and of the coordination team developed an understanding of how work happens in the consortium and identified the sequences of all the processes needed to run the activities of the consortium. Thanks to similarities in the processes in the different BCCM collections (Accession, Control, Preservation, Storage, Distribution), the BCCM consortium prepared a general process map that fits its members.

In addition to the documents required by the ISO 9001:2000 standard, the critical processes were documented at the appropriate level of detail. Since the BCCM QMS is multi-site, a defined level of harmonisation of the documents was necessary. All the BCCM members use the same documentation structure, and all the documents have the same header lay out. There is one unique quality manual, which is managed by the coordination team. The procedures and forms were harmonised as far as possible with account being taken of the situation of the four BCCM members in different host institutions and thus the need for some autonomy and flexibility.

For each process, an owner was defined, that is, an individual with the responsibility and necessary authority for the management of a process and its interactions. Each process then needed to be planned. This meant ensuring that an appropriate description of the activities within the process was prepared, which included definition of the people, the responsibilities, and the equipment needed to run the process.
To comply with the monitoring and measurement requirements of the ISO 9001:2000 standard, the BCCM held a brainstorming session and defined the controls and the performance indicators (KPIs and PIs) that were needed to measure the effectiveness and the efficiency of a process.

Throughout the entire ISO 9001:2000 project, the involvement of all the BCCM employees was critical. This was only possible by working with quality managers in the different collections who had the task of the communicating of, the training for, and the implementation of the QMS at each site. This allowed documents to be prepared that reflected what was actually happening. It also enhanced the wider acceptance and greater consortium-wide ownership of the QMS.

Step 5: The monitoring and the measurement of the QMS

In order to determine how well the newly implemented QMS was working, the BCCM conducted internal audits within the collections and the coordination team. For that purpose, the consultant trained a pool of BCCM staff in the skills necessary to become competent internal auditors.

The functioning of the BCCM QMS was also assessed during the management reviews. These meetings took place locally at each BCCM member’s premises. The results of these local management reviews fed the BCCM general management review. Here, the BCCM senior management looked overall at external information from the customers as well as at internal BCCM information (results of internal audits, corrective and preventive actions, measurement of KPIs and PIs). All this information was reviewed against the BCCM strategic plan and objectives in order to confirm or modify the long term orientation of the BCCM.

Next step: Towards a worldwide multi-site QMS for BRCs?

During this project, the motivation of all the partners enabled the BCCM to overcome many obstacles. In the future, the challenge will be to maintain the QMS and to ensure that it continues to deliver improvement. Hence, for the BCCM, this is not the end but the beginning of the story. The BCCM will certainly go further than the present scope and standard for its QMS. The reflection is in progress. Meanwhile, now that the ISO 9001:2000 certification cycle has been completed, the BCCM will be able to evaluate the improvements achieved based on tangible evidences.

This project also provided valuable experience for international initiatives related to the coordination of the ex-situ conservation and the sustainable exploitation of biological material. With this, the OECD goal of establishing a global network of BRCs (GBRCN) comes immediately to mind. Obviously, for a BRC to participate in such a network, it must comply with the OECD “Guidance for the operation of Biological Resource Centres”. This document presents common operating rules for BRCs with a two level approach: the general requirements applicable to all BRCs and the domain criteria specific to the type of material concerned. The OECD wants this GBRCN to be an international body managed by a central administration. Here also, the basic elements for an embryo of multi-site QMS are present: a central office, a network of local sites and common operating rules. Will this embryo evolve towards a mature worldwide multi-site QMS for BRCs ? The question deserves wise consideration.