Top 10 Pitfalls of Earning Certification
The process of earning all requisite compliance certifications is costly and time-consuming. On the other hand, the benefits of achieving compliance far outweigh these two primary obstacles to gaining certification. To lower the cost of achieving compliance, manufacturers must be aware of the unforeseen pains of satisfying certification audits: below are the top 10 pitfalls to negotiate.
Inadequate documentation remains one of the top reasons manufacturers do not pass regulatory audits after the first inspection. Along those lines, documentation is one of the most emphasized components of standards such as ISO 9001 and AS 9100. Deploying an integrated document control software module is one way to overcome this challenge.
Understanding the Role of ISO
One of the most common misconceptions is that ISO issues certifications. In fact, the role of ISO is to develop and publish industry standards. ISO itself does not certify a manufacturer as compliant; rather, certification bodies certify a manufacturer as compliant to ISO, not by ISO.
Publicizing ISO Certification
Another error manufacturers make is improperly publicizing ISO certification. To avoid infringing on ISO copyrights, companies should never use ISO’s seal or refer to the business as “ISO certified”, since ISO itself does not certify manufacturers. ISO also recommends that manufacturers refrain from displaying ISO certification marks on products.
Manufacturers must realize that enforcement mechanisms vary among quality management standards. The consequences of nonconformance to government-mandated regulations are well known in the manufacturing industry. However, some industry-specific standards, such as ISO 14000, have less-than-clear enforcement mechanisms for noncompliance.
Along the lines of enforcing government and industry-specific standards, manufacturers must understand that no central repository of certification records exists. For example, the compliance history of suppliers may solely reside within a private third-party firm’s records, or records may lie only within the supplier’s own internal systems. Independently verifying certification histories is difficult.
Understanding the Role of Certification Bodies
Further complicating the issue at hand, certifications earned in one country may or may not equate to certification in another. Since the inception of ISO, this aspect of compliance certification has attracted much criticism. For instance, the U.S. does not maintain a standardized federal database of AS 9100, TS 16949 and FDA GXP certification records. However, some nations have created official government certification bodies.
Certification of Multiple Sites
Certifying multiple sites requires that manufacturers coordinate several separate audits. When organizing such audits, manufacturers should perform initial audits of support processes first. Organizing audits in this order allows registrars to judge the quality of operations among different manufacturing sites. If companies do not begin audits with support processes, the cost of compliance can rise dramatically.
Several standards, such as ISO 9001, explicitly state the requirement to manage employee competency. Manufacturers must not overlook the fact that registrars will conduct employee interviews to gauge the effectiveness of a company’s training program. Companies should breed an awareness of quality management to prevent this oversight.
The qualifications of auditors vary from one certification body to another. As such, the quality of the inspection itself depends upon the expertise of the individuals performing the audit. Simply stated, some countries do not regulate the qualifications of registrars. This can mean that an auditor’s qualifications in one country are inadequate in another country which raises the cost of compliance.
Understanding the Role of the Auditor
Quality management standards adhere to a process-centric philosophy, so auditors should ideally stay within these bounds. The whole purpose of achieving certification is to add value to a company’s quality management programs. Certification bodies that do not provide such value may do more harm than good by advising manufacturers to make changes that do not add real value. Each of these pitfalls can raise the cost of compliance. To mitigate these challenges, manufacturers must remain steadfast, maximizing quality management systems by leveraging IT resources to the fullest extent possible.
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