Table of Contents

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.

Perpetuatuation 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.

Quality Policy

A perfect example of a non-value added requirement intended to support the “Zero Defects” motivational management approach is contained in ISO 9001 & AS91xx is sec. 5.2:

Quality Policy

5.2 Policy
5.2.1 Establishing the Quality Policy
Top management shall establish, implement, and maintain a quality policy that:
a. is appropriate to the purpose and context of the organization and supports its strategic direction;
b. provides a framework for setting quality objectives;
c. includes a commitment to satisfy applicable requirements;
d. includes a commitment to continual improvement of the quality management system.

5.2.2 Communicating the Quality Policy
The quality policy shall:
a. be available and maintained as documented information;
b. be communicated, understood, and applied within the organization;
c. be available to relevant interested parties, as appropriate.

The above is contrary to No. 10 of Deming’s 14 Points for Management…

Eliminate slogans, exhortations, and targets for the workforce asking for zero defects and new levels of productivity. Such exhortations only create adversarial relationships, as the bulk of the causes of low quality and low productivity belong to the system and thus lie beyond the power of the workforce.

I've never seen a single instance of a “Quality Policy”, or lack thereof, have any impact on the QMS at all.

Quality Objectives

Another example of a non-value added requirement intended to support the “Zero Defects” motivational management approach is contained in ISO 9001 & AS91xx is sec. 6.2:

6.2 Quality Objectives and Planning to Achieve Them

6.2.1 The organization shall establish quality objectives at relevant functions, levels, and processes needed for the quality management system.
The quality objectives shall:
a. be consistent with the quality policy;
b. be measurable;
c. take into account applicable requirements;
d. be relevant to conformity of products and services and to enhancement of customer satisfaction;
e. be monitored;
f. be communicated;
g. be updated, as appropriate.

The organization shall maintain documented information on the quality objectives.

The above is contrary to No. 11b of Deming’s 14 Points for Management…

11b. Eliminate management by objective. Eliminate management by numbers, numerical goals. Substitute leadership.

The primary reasons that Deming opposed “management by objective” are:

  1. The “objectives” are typically driven by emotion rather than data, are often outside of the process's capability… and are therefore unachievable. This results in the workers being blamed rather than management focusing on improving the processes.
  2. When an “objective” is achieved, management celebrates success (e.g., the pizza party), losing sight of the true goal… which is continual improvement.

My experiences in performing ISO 9001 & AS91xx audits over the past 25 years support Deming's concerns.

AS9100 Contradictory Requirements

The AS 9100 standard contains at least one contradictory requirement.

AS9100 Contradictory Requirements

An example of a contradictory requirement contained in AS9100 is sec. 8.5.1:
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.

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 if we adopt a more lax interpretation of the above requirement, 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 being issued by the Certification Body!!!

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.