September, 2013 Newsletter Articles

ISO 9001:2015 Documented Information

Sep 1, 2013 in Newsletter | Comments Off on ISO 9001:2015 Documented Information

In ISO 9001:2008, clause 4.2.1 identifies the required documents for a quality management system as the quality policy, quality objectives, quality manual, and the procedures required by the standard. The required documented procedures are identified in later clauses as 4.2.3 (Control of Documents), 4.2.4 (Control of Records, 8.2.2 (internal Audit), 8.3 (Control of Nonconforming Product), 8.5.2 (Corrective Action), and 8.5.3 (Preventive Action). The Committee Draft of ISO 9001:2015 makes use of the term “documented information” to...

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ISO 9001:2015 Preventive Action

Sep 1, 2013 in Newsletter | Comments Off on ISO 9001:2015 Preventive Action

Clause 8.5.3 of ISO 9001:2008 is titled “Preventive Action” and requires organizations to determine the action to eliminate the causes of potential nonconformities in order to prevent their occurrence. This requirement, along with the need for a documented preventive action procedure, is missing from the Committee Draft of ISO 9001:2015. In ISO 9001:2015, clause 0.3.d, a significant change in the new standard is explained under Risk and Preventive Action. It notes that the Annex SL structure and text for all management system...

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ISO 9001:2015 Corrective Action

Sep 1, 2013 in Newsletter | Comments Off on ISO 9001:2015 Corrective Action

Clause 8.5.2 of ISO 9001:2008 is titled “Corrective Action” and requires organizations to eliminate the causes of nonconformities in order to prevent recurrence. This requirement has been moved to clause 10.1 in the Committee Draft of ISO 9001:2015 and renamed “Nonconformity and Corrective Action”. Clause 10.1 begins with a new requirement to react to nonconformities, and as applicable, take action to control and correct them, as well as, deal with their consequences. The requirements focused on corrective action remain...

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ISO 9001:2015 Internal Audit

Sep 1, 2013 in Newsletter | Comments Off on ISO 9001:2015 Internal Audit

The Committee Draft of ISO 9001:2015 has moved Internal Audit requirements from clause 8.2.2 in ISO 9001:2008 to a new clause 9.2. Internal audits must still be conducted at planned intervals to see if the quality management system conforms to the organization’s own requirements and those of the ISO 9001 standard. However, clause 9.2 has dropped determining conformity with “planned arrangements”. It was never really needed in ISO 9001:2008, since planned arrangements are organizational requirements. Clause 9.2 of ISO...

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