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ISO 9001 Drastically Revised

Are you wondering what’s new in the latest version of ISO 9001?

The simple answer is, “Just about everything.” The rumor is that the technical committee added a clause about risk-based quality management systems. The truth is that the revised standard has 11 major clauses instead of 9, and clauses 4-10 have been retitled, reorganized and rewritten. The technical committee essentially blew up the standard, and they had a little trouble putting it back together. Anyone that has an existing ISO 9001 quality system certificate will have a major task in front of them to revise and update their quality system documentation to address these changes. This article summarizes the major changes and provides some tools and suggestions for strategy to help you make the transition.

Exhibit 1 provides a comparison of the titles for the major clauses in the current and revised versions of ISO 9001. The clauses of the revised standard highlighted in green have been revised, but the organization and titles have been maintained. Clauses highlighted in yellow have not only been retitled, but the content from the current version of ISO 9001 was reorganized and rewritten.

Exhibit 1: Comparison Table of Major Clauses

Packard Chart_1

Examples of Changes Made
I had some trouble finding the clause for internal auditing. In the current version, management review is clause 8.2.2, while in the revised standard internal auditing was shifted to clause 9.2. You might expect control of conforming product to be shifted from clause 8.3 to 9.3, but control of nonconforming product is not even in clause 9. Clause 8.3 was combined with clause 8.5.2, corrective action, and the resulting clause is “Nonconformity and corrective action” found in the revised standard under clause 10.2. These changes might seem strange, but preventive action (the current Clause 8.5.3) was completely eliminated. There’s a note in clause 0.5 explaining the elimination of the preventive action clause and the introduction of risk-based thinking instead. Even the clause for management review was reorganized. Instead of placing management review under the clauses for “Leadership” (Clause 5), management review is found in clause 9.3 of the revised standard.

After being totally confused by the revisions made to ISO 9001, I struggled for a while to identify a logical strategy for updating an existing quality system to comply with these changes. One approach is to focus on the procedural requirements instead of the organization of the revised standard. Exhibit 2 compares the requirements for documented information of ISO 9001:2008 with the revised draft. In ISO 9001:2008, Note 1 in subclause 4.2.1 states, “Where the term ‘documented procedure’ appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.” This statement was revised in ISO 9001:2015 and now is referred to as “documented information” in Annex A.6. Unfortunately, there are 53 references to “documented information” throughout ISO 9001:2015, but Exhibit 2 attempts to reconcile these differences. The six requirements for a “documented procedure” in ISO 9001:2008 are highlighted in blue.

Exhibit 2: Comparison of Documented Information Requirements

Packard Chart_2