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ISO9001:2015 - 8.3 - Design & Development of Products and Services

CONFIRM procedure(s)/standard(s) have been read and the requirements understood by auditor prior to the audit

  • IMS-QMS-LL-DM-001 [Design]

  • Explain why the procedure has not been read for this audit?

  • IMS-QMS-LL-DM-002 [Pressure Equipment Directive]

  • Explain why the procedure has not been read for this audit?

  • ISO 9001 Section 8.3 - Design and development of products and services

  • Explain why the procedure has not been read for this audit?

VERIFY procedure compliance of the IMS procedures with requirements within ISO 9001 / PE(S)R / PED

  • Do the procedures sufficiently detail the controls to be applied to in-house generated design documentation? Including revision control, document numbering, document checking and approval.

  • Do the procedures sufficiently detail the controls to be applied to externally provided design documentation (sub-contractor or client provided designs)?

  • Are design and development inputs suitably considered, including any statutory and regulatory/jurisdictional requirements and customer specified requirements?

  • Is documented information necessary to demonstrate that design and development requirements have been met adequately specified?

  • Do the procedures sufficiently identify the planning requirements for design and development activities?

  • Are the responsibilities and authorities involved in the design and development process clearly defined?

  • Is customer review and acceptance of design documentation sufficiently defined and controlled?

  • Do the procedures sufficiently describe an appropriate system for the needs of the business?

  • Do the procedures effectively detail the identification of PE(S)R / PED categorization and documented evidence for ESR compliance?

  • Do the procedures correctly specify the requirements for the PE(S)R / PED technical file?

Operational Compliance Check

CHECK the correct PE(S)R/PED classification chart was selected

  • 5 random completed projects

CHECK an applicable and appropriate Conformity Assessment Module was selected based on the determined classification

  • 5 random completed projects

CHECK purchase orders raised on Approved/Notified Bodies detail the correctly selected Conformity Assessment Module

  • 5 random completed projects

CHECK hydrostatic test pressure requirements of PE(S)R/PED have been accounted for as well as design code requirements

  • 5 random completed projects

CHECK Declaration of Conformity certificates are signed by appropriate employees only

  • 5 random completed projects

  • CHECK contents of PE(S)R/PED technical file are present and available (Verify against 5 random completed projects)
  • Approved Manufacturing Drawing. Verify in-house checking/approval was performed and client approval was obtained prior to manufacture.

  • Design Calculations

  • UK/EU Declaration of Conformity. Ensure compliance with PE(S)R / PED for content of document as a minimum.

  • Hazard Analysis and Risk Assessment

  • ESR Checklist

  • Particular Material Appraisals (PMA) for non-harmonised materials, or reference to appropriate documents, as applicable. Ensure correct third party approval of PMAs for Cat III and IV equipment

  • Installation and Operation Manual (IOM)

  • Inspection & Test Plan (ITP)

  • Welding Procedures (WPS) and procedure qualifications (PQR), or reference to appropriate documents. Ensure correct third part approval for Cat II, III and IV equipment.

  • Welder performance qualification records (WPQ). Ensure correct third party approval for Cat II, III and IV equipment.

  • Non-destructive testing reports and operator qualifications, as applicable. Ensure correct third party approval of operator qualifications for Cat III and IV equipment

  • Material List and Material certificates. Ensure correct certificate type (EN 10204 3.1 for pressure retaining materials) and compliance with ESR 4.3 (PED only). Ensure traceability to weld consumable certificates.

  • Hydrostatic test certificate

  • Certificate of Manufacture and PD 5500 Form X (where applicable)

  • Calibration certificates for pressure test gauges

  • Photocopy/scan/photograph of final nameplate. Ensure correct use of UKCA/CE mark with appropriate AB/NoBo numbers (as applicable). Where equipment was "SEP" ensure no UKCA or CE mark was provided.

  • Dimensional Inspection Report / Final inspection report/release

  • Approved Body (UKCA)/Notified Body (CE) appropriate documentation (design appraisals/type approvals, QA module certification (e.g. H), etc.)

CHECK technical files are appropriately stored and accessible for a minimum period of 10 years from the date of certification

  • 2 completed projects from 8 to 10 years ago

CHECK design and certification log are continually updated listing job numbers, confirmation of design approvals, PE(S)R/PED module applied and PE(S)R/PED certificate numbers

  • Review log for up to date information

CHECK drawing revision on shop-floor is the latest approved revision

  • 3 random current project in production in workshop

Employee Interview

    INTERVIEW design department employees to determine understanding and competence
  • Name, title and facility/location of interviewee

  • Ask design engineer where design inputs come from and how they are verified as current?

  • Ask design engineer how legal and legislative requirements are considered? Assess knowledge and understanding of PE(S)R/PED applicability and application

  • Ask design engineer how PE(S)R/PED hazard classification and module selection is performed (Note, Langfields' "preferred" modules are given in Section 4 of IMS-QMS-LL-DM-002)

  • Ask design engineer how design documents (drawings and calculations) are revision controlled

  • Ask design engineer how the internal review/approval process is performed

Ask design engineer what requirements there are for SEP equipment. Note if any of the following are mentioned

  • No UKCA/CE marking permitted

  • No Declaration of Conformity is required

  • ESRs are not applicable

  • Identification of manufacturer (i.e. nameplate) is required

  • IOM is required

  • Ask design engineer if they know who can endorse Declaration of Conformity certificates and what the responsibilities of the signatory are by making the declaration. Does the interviewee understand the consequences of signing the document and consequences of false declaration?

  • Auditee Signature

Final Sign off

Final acceptance

  • Auditor signature

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