Document ID: chunk:federal_register_of_legislation:F2019L00426:schedule:1
Version: federal_register_of_legislation:F2019L00426
Segment Type: schedule
Provision Reference: sch 1
Character Range: 4693–6460

Schedule 1—Conformity assessment standards
Note: See section 5.

Conformity assessment standards for quality management systems
  Column 1                                                        Column 2                                                                                                                                      Column 3
  Item                                                            Standard                                                                                                                                    Conformity assessment procedures
  1                                                             ISO 13485:2016 Medical devicesQuality management systemsRequirements for regulatory purposes                                                the conformity assessment procedures set out in clause 1.4 of Part 1 of Schedule 3 to the Regulations
  2                                                             ISO 13485:2016 Medical devicesQuality management systemsRequirements for regulatory purposes, other than clause 7.3 Design and Development  the conformity assessment procedures set out in clause 4.4 of Part 4 of Schedule 3 to the Regulations
  3                                                             ISO 13485:2016 Medical devicesQuality management systemsRequirements for regulatory purposes, other than:                                   the conformity assessment procedures set out in clause 5.4 of Part 5 of Schedule 3 to the Regulations
                                                                   (a) clause 7.3 Design and Development; and
                                                                   (b) clause 7.5.6 Validation of processes for production and services provision