ISO 13485:2016 - Medical Device Quality Management Systems The difference between ISO 14644-3:2005 and ISO 14644:2019ĭifference between Approval and Registration - ISO 13485:2016 It is estimated that less than 30% of the currently certified companies would be affected by the proposed phase-out of reciprocal certification. Current reciprocal recertifications will be phased out as certifications expire thus requiring AAR M-1003 recertification via the process detailed in Chapter 3. Only the AAR M-1003 application described in Chapter 1, section 1.6 of the standard would be valid. This would mean that, upon the effective date of the revised AAR M-1003 standard, no new reciprocity applications for certification would be entertained. Due to the fundamental program differences noted above, frequent instances of noncompliance, misunderstandings (e.g., ISO is management focused & AAR M-1003 is product quality focused), and evidence of the M-1003 program objectives not being fully realized, the Quality Assurance Committee (QAC) has recommended elimination of reciprocity as an option to achieving AAR M-1003 certification. Finally, other major industries (automotive manufacturing & aerospace) do not have ISO reciprocal agreements. Currently, AAR assigns the accredited auditors for each M-1003 audit while under the ISO reciprocal arrangement the company chooses its ISO registrar and the ISO registrar then assigns the facility auditor. ISO includes a customer feedback requirement however it is more oriented toward customer satisfaction than a continuous quality improvement process. The mandatory non-conformance reporting process has been strengthened, a process which ISO does not include. Recent changes to AAR Specification M-1003 include the addition of technical checklists for critical commodity groups, an emphasis on inspection and test plans and process control. And this, you could say, is 'straight from the horses mouth':Ĭurrently, AAR Specification M-1003 allows for certification to alternative standards such as ISO-9000 through the reciprocity process per Chapter 1, section 1.7. Here is a little info that might help to explain some of the major differences between ISO and M-1003.

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