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Engaging designers, manufacturers, suppliers, and integrators to provide an impartial and independent evaluation of equipment to ensure it meets the requirements of CE and / or UKCA legislation for safe and compliant market access under self-declaration.
The following areas are reviewed as a minimum:
· Technical File
· Essential Health & Safety Requirements
· Application of technical standards
· Risk assessment
· Instruction manual
· Method of internal quality control to ensure compliance of the manufactured equipment
· Test procedures
· On-site inspection & witness testing
The scope may be widened dependent on the nature of the equipment based on legislative and technical standard guidance.
A detailed Improvement Action Plan is produced and maintained throughout the process, outlining any non-conformities identified and tracking rectification actions.
An executive summary is provided to supplement the Technical File.
If a more formal statement of conformity, a Certificate of Conformity can be provided to support client self-declaration.
A UKAS accredited service for designers, manufacturers, and suppliers to provide an impartial and independent evaluation of equipment to ensure it meets the requirements UKCA (and CE for Northern Ireland) legislation for safe and compliant market access with Bureau Veritas as the notified body.
The process is much the same as 3rd Party Conformity Verification , with a few additional requirements to related to The Supply of Machinery (Safety) Regulations 2008, Schedule 2, Part 9.
On successfully achieving type approval, a formal Type Approval certificate is issued by Bureau Veritas under Schedule of Accreditation 5914.
Bureau Veritas will store a copy of the Technical File for 10 years after the last unit is manufactured.
Aimed at end-users and integrators (or anyone buying equipment with an expectation of legislative compliance), conformity validation offers an impartial and independent “sanity check” of the supplier provided documentation coupled with an on-site inspection (where necessary) to provide an expert opinion as to whether the supplier Declaration of Conformity / Incorporation stands up to scrutiny, giving the client confidence in their acceptance and use of the equipment.
This service is built on the inability to access detailed technical information, such as that within the Technical File, due to there being no requirement to provide it and it often being held behind strict confidentiality.
Where possible, and if requested by the client, Bureau Veritas will attempt to engage the supplier under NDA to access further detail. It’s noted this is a best effort attempt and engagement cannot be guaranteed.
A report is provided outlining any findings with the option capture and review any rectification actions carried out.
Gain access to a team with a combined 75 years of experience in the design, safety, and conformity of machinery, automation, and robotics that can provide input and guidance as an external partner on a project or for ad-hoc support to suit the needs of the business, regardless of the client’s current technical knowledge and compliance capabilities.
The service provides expert advice and guidance across all aspects of machine safety, from the overall lifecycle phases down to specific Safe Systems of Work, supplementing existing knowledge and processes to identify and fill potential gaps, or operating as an in-house resource, typically covering:
· Preparing for 3rd Party Validation or Type Approval
· Detailed advice and guidance relating to CE & UKCA legislation
· Interpretation and application of technical standards (BS, EN, ISO / IEC, etc.)
· ISO 12100 risk assessment
· Evaluation against technical standards & EHSRs
· Developing and compiling Technical Files
· Supporting process development and implementation
· Safe Systems of Work
· Training and competency reviews
· Providing training on safety and conformity
· Witness testing
Functional safety is a key field within machine safety and conformity, impacting everything from simple emergency stops to complex presence detection and monitoring systems that actively hold equipment in a safe state should a person become at risk of harm.
Ensuring your functional safety management is sufficient, driving safety systems that are correctly specified, implemented, and managed to achieve the necessary level of resilience and integrity is critical when relying on such measures to mitigate the risk of harm.
In addition, developing and implementing functional safety measures and management systems can be challenging due to the strict process and competency requirements that form the backbone of the discipline, which are often overlooked or simply not present within an organisation.
Working with those implementing functional safety to provide guidance through the process and requirements, or to act as an independent reviewer, Bureau Veritas can provide expert support to those working to achieve compliance in accordance with ISO 13849, IEC 62061, and the IEC 61508 family of standards.
Working with companies to develop new, or enhance existing, internal processes to enable high-integrity paths to CE and / or UKCA self-declaration or preparation for Type Approval applying extensive in-house knowledge of conformity and quality management across a variety of sectors and disciplines.
PUWER places legal obligations in relation to the safety of equipment used at work. It is necessary to meet the requirements, but there is no official method for demonstrating compliance.
PUWER assessments fill this gap by providing a structured and methodological approach applied and documented by highly competent persons with decades of experience in machine safety and the regulations.
A typical assessment will cover Regulations 4-24 (applicable to all equipment), with a team member performing a site visit, reviewing each piece of equipment, capturing images (where allowed), and writing up a report outlining any non-conformities or areas of improvement identified.
The client may then close-out the issues internally, or if requested a follow-up visit / review can be performed to enable closing out of the report formally.
Where additional coverage is required for special equipment such as mobile equipment and power presses (Regulations 25 - 35), this can be provided as an additional module.
Companies often perform in-house PUWER compliance activities, but the quality and effectiveness of the measures can sometimes be questionable, leaving the business and their accountable personnel exposed to potentially significant risk (fines and prison).
An impartial and independent audit by the team can help prove sufficiency and identify weaknesses of the in-house processes, allowing corrective actions to be completed and risk to be further mitigated.
Where a PUWER assessment or client identifies the need for regular inspections in accordance with PUWER Regulation 6 (where significant hazards may occur following incorrect installation, incorrect re-installation, a significant event, or when subject to any conditions that may result in deterioration), it is necessary to have a competent person produce a plan covering:
· What needs to be inspected
· How often it needs to be inspected (i.e. weekly, monthly, annually)
· How it is to be inspected (i.e. visually, functional test)
· What does a pass or fail look like
The extensive experience of the team allows inspection plans to be produced efficiently in accordance with the regulation and can also provide a framework for the recording and monitoring of inspection activities.
PUWER Introduction
A half day course targeted at non-technical personnel who need a general awareness of PUWER (typically those with accountability) but aren’t the responsible party for carrying out the assessments / inspections. The course aims to provide broad coverage of what PUWER is, where it applies, how it applies, and what the consequences of non-compliance can mean for the businesses (fines) and individuals (fines and imprisonment).
PUWER
A two-day course for technical personnel who need a detailed understanding of PUWER Regulations 4-24.
The course comprises a mix of classroom learning and practical application, with candidates engaging in live evaluation and discussion of equipment based at their premises.
PUWER (Additional Regulations 25-35)
Where additional specialist knowledge is required for mobile equipment and power presses (Regulations 25 - 35), this can be provided as an additional module.
PUWER Regulation 6
A half day course targeted at technical and non-technical personnel covering PUWER Regulation 6 statutory inspections outlining what an inspection is, what triggers the need for an inspection, who can plan an inspection, who can carry-out an inspection, and how it must be recorded.
All participants in training courses receive a certificate of attendance following completion.
Machine Safety Awareness
An additional half day module is available for technical personnel providing an awareness of basic machine safety concepts and application.
This course does not establish competency. The goal is to introduce machine safety to personnel, recognising limits of knowledge and capability, and to start the journey of becoming competent.
CE and UKCA Marking
A one-day course outlining the processes of CE and UKCA marking (focussing in UKCA and calling out differences throughout), covering the core concepts to be applied to ensure equipment entering the market are safe and compliant.
Robotic Safety Awareness
A half day course aimed at both technical and non-technical personnel, with a particular target of Health & Safety practitioners, who need an awareness of robotic safety as companies increasingly expand the use of robot arms and similar automated systems without fully understanding the inherent risks and misconceptions.
ISO 10218-1 Robot Design
A one-day course providing a detailed run through of ISO 10218-1 for designers of robots ranging from industrial to collaborative, building knowledge on the technical requirements and hazards to be addressed, and helping embed the core principles to drive compliant design throughout the equipment lifecycle with products delivered that are suitable for their intended market.
ISO 10218-2 Robot Cell Integration
A one-day course providing a detailed run through of ISO 10218-2 for robot cell integrators, outlining the various aspects of integration to be considered and the hazards that can be encountered, along with the responsibilities of conformity for each party involved in an integrated system.
All participants in training courses receive a certificate of attendance following completion.