Changes to AS9101 and AS9104-1 Will Increase AS9100 Certification Prework
Changes to AS9101, Requirements for Conducting Audits of Aviation, Space, and Defense Quality Management Systems and to AS9104-1, Requirements for the Certification of Aviation, Space and Defense Quality Management System Certification Programs are introducing two new processes to the certification cycle for AS9100, Quality Systems – Aerospace – Model for Quality Assurance in Design, Development, Production, Installation and Servicing: the Organization Certification Analysis Process (OCAP) and the Performance Based Surveillance/Recertification Process (PBS/RP). The AS9104 series of standards describe the nature and governance of the Industry Controlled Other Party (ICOP) scheme used to execute and manage accreditation of certification bodies (i.e., registrars), auditors, training programs and certification of organizations to AS9100.
The new OCAP process introduces a requirement for the Certified Organization (CO) — the entity being certified — to submit data to the Certifying Body (CB) — their hired, accredited AS9100 registrar — 90 days prior to the start of the audit. This data describes the CO’s organizational context, the scope of certification they are seeking, and the risks within the design and execution of the CO’s Quality Management System (QMS). The new AS9104-1 describes how the submitted OCAP report is analyzed by the CB for audit planning purposes and for determining an overall risk rating (High, Medium, Low) for the CO. This risk rating is used to provide reductions in certification and surveillance audit durations. Baseline audit durations are found in a table in AS9104-1 based on the number of CO employees. The rules for duration reductions and increases from the baseline are also defined.
Information in the OCAP reporting includes
- Single site or multiple sites with a central management function (the type of site categories is changed from five to the two named here)
- The size of the company
- Additional AS91xx standard(s) within scope
- If ISO 9001 will be included
- Exclusions of particular requirement clauses (i.e., not applicable)
- The complexity, uniqueness and maturity of the production or service processes
- Design responsibility
- The rigor of the internal audit program
- Nonconformance escapes/rates
- Customer satisfaction
- On-time delivery
- Process effectiveness determined from the prior AS9100 audit (i.e., PEAR report)
The OCAP is to be updated and resubmitted prior to each subsequent audit, surveillance or recertification. Updates would be necessary when significant changes to the aforementioned have occurred including when the CO is seeking a reduced or expanded scope.
The PBS/RP is used to further streamline audits. The baseline requirement expects 50% of the QMS elements are audited in the yearly surveillance follow-up audits that occur both one year and two years after the certification or recertification audit. The PBS/RP uses criteria to allow a CO to reduce that 50% to 33%, as long as 100% of the QMS elements are audited within 48 months. Audit duration reductions are also provided to COs that qualify to use the PBS/RP. COs will apply to the CB to use PBS/RP. The criteria are the following:
- Yearly review to confirm approval criteria is still met
- OCAP risk: Low or Medium for all sites and central function
- Self-audits cover all QMS elements yearly
- Self-audit process responds dynamically to results
- Auditors complete the “Lead Auditor” course per AS9104-3, Requirements for Aviation, Space and Defense Auditor Training, Development, Competence and Authentication
- CO has and applies an ethics policy
- No CB or customer-issued major QMS nonconformance in the prior 12 months for internal auditing, management review or Corrective Action processes
- No suspension of the CO’s AS9100 certification in the prior six years
- Meeting customer satisfaction metrics
Integration of these new rules will follow a phased approach. Accreditation Bodies (ABs) — entities that award accreditations to CBs — and CBs must transition to the new rules for CB accreditations within 12 months following publication of the updated standards. CBs and COs must transition to the new certification rules and processes in 18 months following publication.
Aligning and harmonizing AS9101; AS9104-1; AS9102-2, Requirements for the Oversight of Aviation, Space and Defense Quality Management System Certification Programs; and AS9104-3 with ISO/IEC 17011, Conformity assessment – Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies (and related ISO/IEC 17xxx standards) was also an objective for the updates to AS9101 and the AS9104 series. Given that the ICOP scheme is an internationally adopted scheme, final review and approval to publish the new versions of these standards is predicated on approval by each of the three Aerospace Quality Groups (i.e., Americas, Asia Pacific, European). These reviews are currently in process. The Americas Aerospace Quality Group is expected to provide roll-out information at that time.