While market surveillance is a well-known concept in a regulatory context, a similar approach has been shown to be effective when applied to the voluntary certification of quality management systems, according to a recent report by the United Nations Industrial Development Organization.
In a series of articles, The Auditor Online will share highlights from the “Good Practices: Experience in the Market Surveillance of ISO 9001 Quality Management Systems” report, which presents the case for accreditation bodies or stakeholders completing market surveillance visits to certified organizations to ensure the quality of their products or services.
According to the report, user feedback on the performance of ISO 9001-certified suppliers and the accredited certification process reveals ongoing debate around the effectiveness and credibility of accredited certification.
The debate centers on whether organizations are deriving tangible benefits through ISO 9001 certification, if the certification process is being performed effectively, and whether ISO 9001-certified suppliers can be relied upon to provide “consistent, conforming products and services” to customers.
Systematic feedback was gathered between 2009 and 2015 from purchases regarding their perceptions of ISO 9001-certified suppliers, and from ISO 9001-certified organizations about the implementation and certification process. Feedback was gathered through a survey and a market surveillance activity which involved one-day visits to certified organizations. These visits aimed to determine confidence levels related to various aspects of the organization’s quality management system and the overall level of confidence in the certification process.
To reflect their confidence level in organizations being examined, assessors assigned the following grades:
- Grade One: “Little or no confidence.” Little or no evidence to support the implementation of this topic.
- Grade Two: “Some evidence presented, but not at all convincing.” Some evidence was presented, but in the professional judgement of the assessor, there would probably be evidence to support a nonconformity if a detailed audit trail were to be followed in a full system audit.
- Grade Three: “OK—No reason to doubt that this is being addressed correctly.” The “default” grade, where there is no evidence to suggest reasons for concern, based on the assessor’s experience and professional judgement.
- Grade Four: “Clear evidence that this is being done, and meets the intent of the relevant standard.” Sufficient objective evidence provided a high degree of confidence that the organization meets requirements.
- Grade Five: “We can be proud to use this organization as a benchmark for this topic.” To be reserved for truly excellent performance.
A key finding was that there were notable differences in the performance and level of confidence in organizations certified by different certification bodies and under accreditation from different accreditation bodies. Other findings included:
- More than 95 percent of certified organizations surveyed considered the effective implementation and accredited certification of quality management systems to have been a “good” or “very good” investment.
- Overall perception of the ISO 9001 standard and accredited certification was good, although the role of accreditation wasn’t well understood by purchases or certified organizations.
- The purchasers surveyed were mainly satisfied with the performance of their ISO 9001-certified suppliers. In general, ISO 9001-certified suppliers performed “better” or “much better” than non-certified suppliers. However, poor responsiveness of certified organizations to customer complaints was one area of concern.
Overall, the performance of the certified organizations that were visited was good, which demonstrates the effectiveness of the accredited certification process. However, between six and eight percent of organizations returned unsatisfactory results, and one percent raised serious doubts about the validity of their certification—which calls into question the effectiveness of the certification process.
According to the report, market surveillance activities can be used in place of traditional accreditation methodologies such as office assessments and witnessed audits to investigate complaints or concerns.
Market surveillance can also uncover trends, strengths, and weaknesses in the implementation of quality management systems in particular regions or sectors—all of which is useful information for certification bodies to focus their attention on during surveillance and renewal audits.
To give the data context, the report describes independent third-party certification as a common method sought by organizations to demonstrate that they have met all the requirements of ISO 9001. The certification consists of a certificate of conformity and ongoing surveillance to ensure that the system is maintained in accordance with the standard.
To demonstrate competence to administer management system certification, a certification body may become accredited by an accreditation body. This accreditation is based on the requirements defined in ISO/IEC 17021-1 and is supplemented by other discipline-specific or sector-specific requirements in some cases.
Continue to read The Auditor Online in the coming weeks for more findings from the “Good Practices: Experience in the Market Surveillance of ISO 9001 Quality Management Systems” report.