ISO 9001 Certification Obtained in Four Months
By Tim Jones
Aquafine Corporation achieved ISO 9001 certification in fewer than four months. In that time it assembled a completely formatted policy manual, procedures, and work instructions. It did so despite being unable to scavenge materials from a previously unsuccessful certification attempt.
The International Organization for Standardization instituted the design and manufacturing standards as part of the ISO 9000 documentation system for improving business processes. As part of its efforts to increase production efficiencies and manufacturing quality, Aquafine began the ISO 9001 certification process in 1995.
ISO 9001-certified companies must design and implement a well-documented quality-management system that provides all employees with the tools to do their jobs, make the right decisions, and improve efficiency and customer satisfaction. The conformance to ISO 9000 requirements is generally verified by a third-party audit by an approved registrar*.
To get the certification process going, Aquafine hired a consultant to prepare a draft copy of the quality manual and general procedures. The consultant spent several months researching and documenting the company's assembly and manufacturing processes. He relied on paper-and-pencil note taking, a word-processing program and manual routing of documents for approvals.
ISO auditors found the consultant's documentation to be complete. However, they deemed the manual and procedures out of format and unacceptable as finally submitted for certification. The auditors found that the company did not adequately control documents and data that relate to the requirements of the standard or assemble the documents in a compliant format.
Aquafine next searched for an approach to bring the documents into compliance with a minimum of expense and effort. Specifically, the company wanted a software package that would assist in formatting documents for ISO certification. At the same time, it would automate document control, approval, and auditing procedures.
The company examined several software packages before discovering a document-management program** that automates the process of formatting ISO 9000 documents. This feature allows users to focus on entering content.
Management chose the program for its pre-formatted and pre-structured document architecture, which contrasted with the approach used by the outside consultant. Each task along the way--from generating the high-level policy manual to the detailed instructions--would be consistently enforced in document structure and format.
Aquafine's first step was to rebuild the policy manual and procedures using the previous material as a starting point. Straightforward templates and wizards that guide users through the standards allowed the staff to acclimate to running on the system after a one-day training session.
Previously, the document had been created on a word-processor and had been formatted manually. The second time around, Aquafine provided information in response to the prompts of the Policy Writer 9000 Wizard. The software generated a document in the proper format including customized introductory sections, quality system-element responsibilities, a glossary of terms, and a bibliography. The tool enabled the company to deliver a first draft of the manual in less than one day.
Aquafine then worked through the entire wizard-style interview interface while creating the procedures. By automating the procedures' format and structure, the company could concentrate on the content--increasing procedural productivity and reducing the time to compliance.
The software also let Aquafine build and save custom document templates for reuse, ensuring consistency across procedures--even with multiple authors.
The company automated document and data control tasks. If a user missed an element, it was simple to add the missing materials, tools, gauging, or safety instructions, and expedite approval of the revised procedure.
The next step was to document the work instructions. To do this, Aquafine interviewed workers and department managers about current production, assembly, and manufacturing techniques. Formatting them to standard went quickly once the techniques were assembled. (The entire process took about three weeks, with the production manager creating 30 instructions in that time.)
Again, the company relied on a series of easy wizards to guide users in building compliant instructions based on the standards. Once the instructions were properly formatted, they were presented to the employees that actually do the job to ensure that they represented what was actually being done.
In addition to its increasing the speed of creating documents, Aquafine benefited from the system's comprehensive document control features. Once the user registers a document, the system maintains a complete document history, including details about who authored and approved the document, when it was released, privileges of the users, notes, comments, and version history. Previous document versions are automatically removed from circulation. This made the company confident that all documents were current and reflected the most recent changes -a confidence missing during its first attempt at certification.
The registrar found the documents to be complete, formatted, and in compliance with the standards. In fact, the auditors-being so impressed-- made a point to inquire about the system used to prepare the documents.
Certification was granted in February 1998 based on the formatted materials and complete record of document control.
Achieving ISO certification has made a big difference to Aquafine.
Workers now have the documentation to manufacture consistently high-quality products using standard work instructions for each particular task.
The company has reduced defects and wasted materials since implementing the more efficient practices.
ISO certification also has meant that customers can be sure of high-quality production practices. In fact, many clients no longer perform their own audit during contract negotiations since granting of ISO certification.
The compliant software was key to helping the company obtain ISO certification. The staff moved quickly, generating the manual in a few hours; the procedures in about a month; and the work instruction in three weeks. It took just four months from the time the system was purchased to receipt of certification.
*Registrars are independent companies accredited by a national accreditation body.
About the Author: Tim Jones is director of Quality and Business Development, Aquafine Corporation, Valencia, CA