AS9100D:2016 – Key Changes

[튜터 유문종]

Key Changes

• Product Safety added in carefully selected areas.

• Human Factors added as a consideration in Nonconformity / Corrective Action

• Risk merged current 9100 requirements with the new ISO requirements and emphasis on Risks in Operations • Preventive Action current clause requirements absorbed into Risk & Opportunities and Nonconformance & corrective action clauses, 9100 additions reinforce prevention

• Counterfeit Products enhanced in carefully select areas and limited new requirements

• Configuration Management clarified and improved considerably to address stakeholder needs

• Product Realization & Planning clarified and enhanced planning throughout the standard

• Post Delivery Support merged current 9100 requirements with the new ISO requirements

• Project Management & Work Transfer combined with Operation Planning clause to address user interpretation issues

• Design Development and Supplier Management gap analysis -ISO text has been added back in a few places to meet the IAQG needs

• Quality Manual note added pointing to the requirements that make up a Quality Manual or the equivalent • Management Representative requirement added back in for QMS oversight

AS9101E Key Changes

• Specific call out of ISO/IEC17021 requirements by clause number e.g.

• 4.2.2.4 Audit Conduct - “The requirements of ISO17021 clauses 9.1.9.3 thru 9.1.9.5 apply. In addition, the audit shall be conducted …….....”

• Incorporation of AS9104/1 requirements including the new certification structures (single site, multiple site, several sites, campus, and complex)

• Defined audit approaches • General improvements to Audit Reports

• Updated the methods for recording of objective evidence:

- Objective Evidence Report (OER) no longer required

- Objective Evidence is recorded on PEAR reports for QMS processes that are directly related with Product Realization

- Objective Evidence is recorded on QMS Matrix for QMS processes audited that are not directly related with Product Realization

- Completed audit forms will be posted on OASIS

– can be implemented by all organizations (not just a third party audit process)

Now structured into (4) Sections

• Section 1 - Process Details: Inputs, Activities, Outputs and Interactions

• Section 2 – Process Results includes the identification of performance measures and KPIs.

• Section 3 - Process Realization summarizes audit trails and sources of evidence (formerly recorded on the OER).

• Section 4 – Process Effectiveness includes an eval‎uation matrix (to be used after a process has been assessed).

#Effectiveness?

Extent to which planned activities are realized and planned results achieved

Planned Activities?

- The means, methods and internal requirements by which an organization intends to achieve planned results of a given process to meet customer requirements Planned activities include conformity to process requirements and procedures.

• Planned Results?

- The intended performance of a process, as defined and measured by the organization Planned results include product conformity (Quality) and On-time delivery (OTD) to meet customer requirements, and may include other elements as defined by the organization.