BYHON is a certification body that provides control and conformity certification of products according to the international standard IEC 61508: 2010 Parts 1-7 for Functional Safety.Discover
Why is Product Certification important?
With the increased development of international trade and following the increased demands to establish whether a product conforms with standards, it is becoming more and more important to prove such conformity. A certification will help companies to reach new customers and therefore open new markets. In terms of Functional Safety, a certification allows a company to demonstrate that a product complies with international safety and quality standards.
Functional Safety Product Certification
Functional Safety (FS) refers to the part of the overall safety that depends on the correct functioning of equipment involved in automation systems which is conceived to implement safety instrumented functions.
Functional Safety is of key importance in order to minimize the potential risk of accidents, harmful direct and indirect threats for people and the environment.
In order to assess the Functional Safety achieved by the product under analysis, BYHON certification roadmap is based on a Functional Safety Assessment (FSA) against the relevant clauses of IEC 61508 standards. Being the framework for all industry sector standards, IEC 61508 is applicable to all safety-related systems regardless of the application as well as to manufacturers and providers belonging to a broad number of industrial fields. As Functional Safety is increasingly becoming a priority due to the improvement of automation and devices’ capability, product certification in accordance with IEC 61508 standards is gaining importance all over the world.
As a certification body, BYHON provides expertise and safety engineering knowledge to assess the compliance with all applicable phases of IEC 61508 standards.
Our Certification Process
BYHON certification roadmap is based on a Functional Safety Assessment (FSA) process consisting in the evaluation of the adequacy of the Functional Safety achieved by the equipment being analyzed in respect to the relevant clauses of IEC 61508 standards.
This assessment process is carried out by means of the product design review and audit of client’s documentation, workflow and processes relevant for functional safety. Our certification process is developed according to the flowchart shown to the right.
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The above flowchart is based on the following workflow criteria:
The tasks flow is top-down. All steps are shown in a timeline way (what is above comes first);
Tasks shown in parallel branches can be developed independently and simultaneously since the implementation of each phase is not strictly related to the others;
Documents listed on the left or right of each phase (in white) represent the input of a phase.
Surveys carried out at client’s premises (shown in blue in the chart):
Detailed HW/SW Design Analysis & Review
Auditors review all product designs against functional safety requirements together with manufacturer designers. This survey can last several days depending on product complexity.
Functional Safety Management System (FSMS) Development Review
It aims at verifying the presence and applicability of a management system for the fulfilment of functional safety requirements
Quality Constraint Audit
Aims at verifying the implementation of the quality requirements required by IEC 61508 in the manufacturer QMS.
It will be issued upon positive testing of the equipment at client’s premises, according to the dedicated testing procedure, and a successful completion of all previous steps.
Documents issued by BYHON throughout the workflow (shown in orange in the chart).
GAP Analysis report
HW/SW Systematic Capability Assessment
Functional Safety Assessment Report
FS Label with ID Code
The assessment process consists in the evaluation of the adequacy of the following:
- The functional safety achieved by the equipment under analysis, within its particular environment, in respect to the relevant clauses of IEC 61508 standards and;
- The compliance to the relevant clauses of the standards achieved in the case of elements/subsystems.
The certification process described below is the general approach that BYHON follows for all equipment types. Depending on product complexity the tasks of the certification process can be arranged and scheduled differently.
The first task of the Functional Safety Assessment (FSA) consists in a detailed hardware/software design review carried out at client’s premises. It is based on all relevant documentation related to product design, safety requirements allocation and specification as well as the Safety Manual of the item. Any gaps in terms of design, documentation or processes are notified and documented by BYHON along with recommendations for their resolution. Once all gaps are fixed, the BYHON Assessor finalizes the product Failure Modes Effects and Diagnostics Analysis (FMEDA), a systematic analysis of product reliability and diagnostic capability by means of failure rates quantification and distribution based on the failure modes effects on the expected safety function.
Furthermore, the overall FSA includes software validation according to IEC 61508-3 and the assessment of other relevant requirements, such as systematic safety integrity (product robustness against systematic failures), common cause failures avoidance and diagnostic coverage constraints.
The implementation of the client’s Functional Safety Management System (FSMS) is also audited by BYHON through the evaluation of the relevant documentation, such as the organizational policy and strategy for achieving functional safety, the Functional Safety Management and Plan providing the sequence and scheduling of all safety lifecycle activities and their respective owners, as well as the relevant functional safety audits documentation.
The Quality Constraints Audit, an integral part of the Functional Safety Assessment, focuses on all relevant quality documents and procedures as well as manufacturing and testing documentation relevant for the effective organizational management of functional safety.
Functional safety validation tests and product validation tests
Prior to finalizing the FSA, BYHON oversees the functional safety validation tests performed at client’s premises aimed at proving that the product meets the safety specifications. Upon successful completion of product validation tests, BYHON issues the SIL Certificate accompanied by the FSA report and the Functional Safety label with the unique identification code of the product to easily recognize SIL compliant items.