Certification Scope

General

The Scope of Certification documented in the FSM-Certificate determines the Company Specific Safety Lifecycle Phases, which are applied by the audited company, who also determines the phase responsibility of the audited company.

The wording "Scope of Certification" as part of the FSM-Certificate is a fixed term and should always be used in a coherent form in all technical documentations and other publications.

In general the objects of the certification procedure are defined in the standards IEC61508 and IEC61511 relating to the Management of Functional Safety, the Documentation, the Functional Safety Assessment as well as the Company Specific Safety Lifecycle Phases. Other safety standards can be considered upon request.

The Company Specific Safety Lifecycle Phases relate to the Safety Lifecycles Phases which are specified in IEC 61508 -Overall Safety Lifecycle, -E/E/PES Safety Lifecycle and -Software Safety Lifecycle as well as specified in the IEC 61511 -SIS Safety Lifecycle.

The “Scope of Certification” also refers to different parties responsible for different phases and its roles and activities within a safety lifecycle, e.g. SIS Integrators, Manufacturers, Engineering Procurement Centers as well as End Users / Operators.

As part of the audit process organizational and informational exchange / supply related to other respective Safety Lifecycle Phases between the Certified Company and its customer is considered.

Further “Services” offered by the Certified Company may not be included in the company specific “Scope of Certification”.

The Scope of Certification only refers to the listed company locations and their involved departments, which comply with the organizational FSM requirements for the listed Scope of Certification.

Please refer to the individual certificates for further detailed description of phase responsibilities, roles, competences and services of the audited companies.

Currently the following different scopes of certifications are applied to the Functional Safety Management. The applications of further scopes are under consideration.

Further definitions of the “Certification Scopes” can be presented and discussed upon request.


System Realization

IEC 61508 – E/E/PES safety related System Realization

In general this scope of certification relates to manufacturers, who are responsible for the development of safety related E/E/PE Systems.

The applied Company Specific Safety Lifecycle Phases are:


Applied Safety Lifecycle Full phase responsibility for Scope of Certification
E/E/PE safety related systems Phase 10 E/E/PE safety related System Realisation
Including phase responsibility for:
E/E/PES system safety lifecycle Phases 10.1 to 10.6 E/E/PE safety related Hardware Development
Software safety lifecycle Phases 10.1 to 10.6
E/E/PE safety related Software Development

Following typically applied company specific safety lifecycle phases respectively relate to the informational exchange / supply related to other respective Safety Lifecycle Phases between the certififed company and its customer:

Adjoining safety lifecycle phases Phase Specific role
E/E/PE system safety requirement specification Phase 9 Information exchange
Overall operation and maintenance planning Phase 6 Provide application information
Overall safety validation planning Phase 7
Provide application information
Overall installation and commissioning planning Phase 8 Provide application information
Overall operation, maintenance and repair Phase 14 Provide application information
Overall modification and retrofit Phase 15 Service / Feedback

HW-SW Development

IEC 61508 – E/E/PES safety related Hardware Development or E/E/PES safety related Software Development

This certification scope relates typically to subcontracted service providers of manufacturers, who are responsible for the development of safety related (E/E/PE) Hardware (see E/E/PES System Safety Lifecycle) or safety related Software (see Software Safety Lifecycle ) as part of a Phase 10 safety related E/E/PE development.

The applied Company Specific 61508 Safety Lifecycle Phases are, either / or:

Applied Safety Lifecycle Full Phase responsibility for Scope of Certification
E/E/PES System Safety Lifecycle Phases 10.1 to 10.6 E/E/PE safety related Hardware Development
with relationship to the Software Safety Lifecycle
Software Safety Lifecycle Phases 10.1 to 10.6
E/E/PE safety related Software Development
with relationship to the E/E/PES System Safety Lifecycle

Following intersection phases respectively relate to the support provided by the audited company to its clients without overall responsibility for different processes:

Adjoining safety lifecycle phases Phase Specific role
E/E/PE system safety requirement specification Phase 9 Information exchange
Overall operation and maintenance planning Phase 6 Provide application information
Overall safety validation planning Phase 7
Provide application information
Overall installation and commissioning planning Phase 8 Provide application information
Overall operation, maintenance and repair
Phase 14
Provide application information
Overall modification and retrofit Phase 15 Service / Feedback

SIS Integration

IEC61511 (IEC61508) – SIS Integration

This Scope of Certification relates generally to System Integrators in the meaning of a Service Providers for Operators or End Users, who are responsible for an application specific engineering of Safety Loops, including SIS (Safety Instrumented Systems) and, if applicable, sensors and actuators.

IEC 61511 is the applicable standard for this audit related to the process industry defined within the scope of the standard. However, where appropriate and/or where there is a lack of guidance within the scope of IEC 61511, applicable clauses of the standard IEC 61508 were used for SIS integration.

Working procedures relevant to IEC 61508 Part 2 and Part 3 [1], Phase 10, are not fully applicable since the audited company does not develop safety relevant hardware and (FVL) software. However, it assembles pre-selected qualified hardware as well as applies pre-defined, qualified or certified function blocks that are limited to application programming (FPL, LVL) only.

The applied Company SpecificSafety Lifecycle Phases are:

Applied Safety Lifecycle Full Phase responsibility for Scope of Certification
IEC61511: Design and Engineering of SIS Phase 4 SIS Integrator

Following typically applied intersection phases respectively relate to the support provided by the audited company to its clients without overall responsibility for different processes:

Adjoining safety lifecycle phases Phase Specific role
Safety requirements specification for the SIS Phase 3 Service; Information Exchange
Installation, commissioning and validation (SAT) Phase 5
Service; Feedback; Provide application information
Operation and maintenance Phase 6 Service; Feedback; Provide application information
Modification Phase 7
Service; Feedback; Provide application information