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How ISO 9001 Perpetuates Flawed Concepts
While ISO 9001:1994 (the 2nd release of the standard) wasn't perfect, it was clear, and concise consisting of only 9 pages. It held potential. However, rather than improving this standard, ISO took it in the opposite direction. ISO 9001:2015 is 29 pages filled with ambiguous/vague and subjective requirements.
Perpetuating of "flawed" Concepts
When ISO 9001 was first released, in 1987, it was based on many military standards and the philosophical approach of many so-called “Quality Gurus” of that time. Unfortunately, rather than evolve through embracing more modern concepts (e.g., Lean, Six Sigma, Lean Six Sigma), ISO 9001 has remained “stuck” in the past. The worst aspect of ISO 9001:2015 is that it perpetuates many of the flawed concepts that were promoted by Philip Crosby's motivational management approach calling for “Zero Defects”… ignoring the proven concepts promoted by Walter Shewhart & W. Edwards Deming.
Consequently, to the educated Quality Professional, ISO 9001 is a living philosophical battleground. In some cases (particularly with AS 9100) the standard even contains contradictory requirements. While ISO 9001 (and all of the QMS standards using it as a base) promotes the concept of continuous improvement, it also mandates the institutionalization of flawed concepts that perpetuate the status quo. Worse, QMS certification to these standards promotes mediocrity and further hinders improvement.
AS9100 Contradictory Requirements
C, 2. ensuring that when sampling is used as a means of product acceptance, the sampling plan is justified on the basis of recognized statistical principles and appropriate for use (i.e., matching the sampling plan to the criticality of the product and to the process capability).
When using ANY sampling plan, an AQL (or equivalent) must first be determined. The AQL (defined in ISO 2859-1:1999) represents the maximum percentage of defective units, beyond which a batch is rejected. For example, an “AQL of 1.5%” means “The company is willing to ACCEPT that there will be no more than 1.5% defective items in the entire order quantity, on average over several production runs”. Companies usually establish different AQLs for critical, major, and minor defects.
Now, the contradiction is contained in AS9100 is sec. 8.7.1:
”The organization’s nonconformity control process shall be maintained as documented information including the provisions for:
− defining corrective actions for nonconforming products and services detected after delivery, as appropriate to their impacts (see 10.2).“
Obviously, if the company must define “corrective actions for nonconforming products and services detected after delivery”, then it makes no sense to allow the establishment of ANY sampling plan (including c=0 plans) BECAUSE that sampling plan allows for an ACCEPTABLE number of defects to be shipped!
Even more interesting, AS9101F, sec. 3.3 defines a “Major Nonconformity as:
• any nonconformity that can result in the probable delivery of nonconforming product or service;
Consequently, using a sampling plan (compliant with AS9100, 8.5.1C,2) can result in a Major Nonconformity!!!
Conclusion
There are a multitude of problems with ISO-based standards AND the 3rd Party Certification industry. In order for ISO-based standards to continue to be relevant, they must be modernized with a focus on adding value (from the perspective of users). Once the various standards are revised, then the 3rd Party Certification industry must undergo some significant changes to greatly increase the value (as determined by the customers of the certified companies) that certifications are intended to provide.
As the number of companies requiring their suppliers to be ISO 9001 registered drops, the number of certifications issued will decline. This will eventually lead to the death of the 3rd Party Certification industry… unless it pressures ISO to make course corrections soon.
With the release of ISO 9001:2015, Gafta determined it to be inadequate and stopped recognizing ISO 9001 as equivalent to their certification.
