Medicines and Related Substances Act, 1965
R 385
Occupational Health and Safety Act, 1993 (Act No. 85 of 1993)Guidance NotesPressure Equipment Regulations, 2009Regulation 12 - Risk Based Inspection |
| (1) | The user may, as an alternative to the in-service inspection and testing interval requirements referred to in regulations 11(1)(d), implement a risk-based inspection management system in accordance with the relevant health and safety standard incorporated into these Regulations under section 44 of the Act. |
| (2) | A risk-based inspection process and implementation shall be verified by a certification body accredited by the accreditation authority in terms of ISO 17021 specifically for risk-based inspections and approved by the chief inspector. |
Notes:
| (a) | ISO 17021 applies to certification bodies and ISO 17020 applies to inspection bodies. The functions required for Risk Base Inspection process and implementation requires the use of ISO 17021 and not ISO 17020 since criteria are different. |
| (b) | The new inspection interval for Cat 1 and higher shall also be approved by an approved inspection authority as in PER 11(1)(d) and frequencies in excess of 9 years can be approved provided it meets the RBI management system criteria. |
| (c) | Users who wish to implement a risk-based inspection management system need to apply to the DoL prior to implementation of such a system. Such application shall include proof that the user has applied to a Certification Body for accreditation. |
| (d) | The following documentation shall be prepared as a minimum by the user for the application to implement RBI to the DoL: |
| (i) | File of the RBI management programme |
| (ii) | The (Chief) RBI specialist and his/her qualifications |
| (iii) | List of all your RBI Team personnel and list of their competencies and qualifications |
| (iv) | Health and Safety standards to be used |
| (v) | Certification Body involved |
| (vi) | AIA Manufacturing involved in the approval as stated in PER Note (b) |
| (vii) | Letter of Recommendation from the AIA Manufacturing to implement RBI |
| (viii) | Target date of certification of RBI management system |
| (e) | The scope of application of the RBI quality system is determined by the user on an individual equipment basis. |
| (f) | The requirement of a typical quality management system shall at least comply to the elements as defined in Annexure SL of ISO Directive Part 1. |
