Suppliers (External Providers)

Supplier Compliance and Ethics Guide

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We strive to develop strong business relationships with suppliers that can provide a wide range of goods and services at the best possible value to our company. We select only those responsive suppliers who provide high-quality, timely, lowest-cost and value-added goods and services. For critical commodities, we ensure the provision of these requirements by establishing long-term relationships with select suppliers. Our Supplier Compliance and Ethics Guide explains our suppliers’ role in supporting our Quality Policy & Objectives, Safety Requirements, and Code of Conduct/standards we follow in our business relationships.

ALL WORK AND CONDITIONS MUST COMPLY WITH ALL STATUTORY AND LEGISLATIVE REGULATIONS AT ALL TIMES.

Our Quality Policy and ISO Certifications can be viewed anytime at http://www.hegelelogistic.com/company/profile/certifications/

We seek to:

  • Ensure that the level of quality meets our internal and external requirements
  • Ensure that all persons working with or for us do so injury-free
  • Maintain compliance with government regulations
  • Improve response time to all internal and external customers
  • Assist internal and external customers in accomplishing their goals
  • Judiciously manage the spending of company funds for goods and services
  • Work with suppliers that can offer innovative ideas to help us increase the value of our operation

Supplier Performance Expectations

We have established performance expectations and measures to maximize our strategic, long-term supplier relationships. These standards also allow us to gather the data we need to routinely assess suppliers and make process improvements. Once included in our field of suppliers, your continuing share of future business will depend on your ongoing commitment to offer products and services that meet these goals. These performance expectations include, but are not limited to:

  • Quality — Maintains standards consistently
  • Delivery — Conforms to schedules and deadline
  • Sales — Representatives are knowledgeable about their field, commodities and company
  • Cost of Ownership — Competitive prices are offered over the life of the asset or engagement
  • Technical — Demonstrates ability to keep abreast of technological advances and incorporate them into products and services
  • Responsiveness — Demonstrates commitment to supporting our company’s changing needs

Quality Standards

We are obligated to follow many regulations and standards, e.g., FDA and ISO, relating to quality. As a supplier performing work for us, we must ensure you are aware of the relevant topics to follow and/or pass on to any subcontractors.

Recordkeeping

Our contracts with customers may include enforcement of federal or local regulations we are required to follow – these rules in order to meet these contract needs may be passed on to our suppliers. Mainly, we require adherence to good documentation practices (GDP) regarding all records that would be exchanged in the course of doing business. We require our suppliers to maintain and properly safeguard records in accordance with GDP for compliance with both ISO (9001 & 13485), FDA (21 CFR 820), and similar contractual requirements.

Records are a special type of document. Records are typically completed forms, checklists, or other evidence that demonstrate that requirements have been met and the effective operation of the quality system. Records are to remain legible. Records are to be controlled according to a written procedure which shall include the controls needed for the identification, storage, protection and disposal. Records are to be retained as required by applicable regulation or, if there is no applicable regulation, for a minimum of 2 years after purchase order date. A copy of a record is to be made available within 2 business days of request.

Where electronic systems are used for the control of documents, the system must be validated to ensure that only approved documents are made available at the point-of-use, write protection is provided, and approval forgery is prevented. Where records are stored electronically, the system shall have appropriate controls to ensure that only true copies of records are stored and controls in place to preclude unauthorized changes and loss.

ISO Standards

We do not mandate that all Suppliers be certified to an ISO standard. However, if an ISO certification does exist the Supplier shall meet the standard’s requirements as stipulated in the scope of certification. If a Supplier does not have a certified QMS system then we require that our Suppliers establish and maintain a quality system, i.e., “checks and balances” that is appropriate for the specific product being manufactured or the service performed that ensures the product or services provided by the Supplier meets our requirements as stated on Purchase Orders.

Quotes and Purchase Orders

The Supplier is required to ensure that it has received and understands all requirements from us, stated or implied. The Supplier is responsible for addressing any incomplete, ambiguous, or conflicting requirements received prior to commencing performance. The product shall follow the agreed quality (e.g. description, specifications, data sheets, drawings, product samples). Unless otherwise agreed, such a description and product samples do not rank as guaranteed product features. In each case, the Supplier shall check without delay whether a description provided by us is in any way obviously incorrect, unclear, incomplete, or not in compliance with the product. If the Supplier realizes that this is the case, it shall forthwith give notice in writing.

Deviations

The Supplier shall receive written authorization from us prior to making any changes to any purchase order requirement, including any of the requirements herein. Failure to comply with this could have a serious impact resulting in our end-user (customer) product, service, and/or medical device becoming adulterated within the meaning of Federal Regulations.

Customer Owned Property

The Supplier is responsible for identifying, controlling, maintaining, storing, and, where appropriate, calibrating Hegele/GMED owned property. The Supplier is required to timely notify us if any Hegele/GMED property is lost or damaged, or that its continued use could result in nonconforming product. This includes, but not limited to, meters, tools, fixtures, instruction manuals, installation aids, and software provided by to the Supplier to provide product to Hegele/GMED. The use of such property is limited to making/providing product for Customer and may not be used by the Supplier for any other purpose without written approval from an agent of Hegele/GMED.

Personnel Training and Competency

The Supplier is responsible for maintaining enough personnel (including subcontractors performing work/services on their behalf) with the necessary education, background, training, and experience to assure that the established quality system and process plan are correctly implemented. Personnel are to be competent and fully qualified to perform their assigned responsibilities according to an established training plan. Untrained, and unqualified personnel are only to perform work while under the supervision of qualified personnel, so they do not damage or otherwise cause harm to the product. The Supplier shall also ensure that its personnel receive up-to-date retraining, as appropriate, whenever processes, methods, technology or other changes reasonably suggest that retraining is necessary.

Records of all training must be maintained by the Supplier to document that personnel have been trained in accordance with the requirements of the established training plan and these records are to be made available within 2 business days of request.

Subtier Suppliers

The Supplier shall evaluate their own Suppliers to the extent necessary to ensure quality products are being provided. Approvals of subtier Suppliers are to be based on this evaluation. The Supplier shall establish and maintain an approved Supplier list. The Supplier is responsible for assessing the quality system and for the quality of product received from all third-party Suppliers it uses. If the Supplier receives production or test equipment, software, services, materials or other supplies from third parties for the manufacture or quality assurance of its products, the Supplier shall ensure that these are in compliance with its quality management system, whether it be by contract with these parties or through carrying out such tests itself as are necessary to assure compliance with its quality management system.

Corrective and Preventive Action

Basic requirements. The Suppliers shall establish procedures for implementing corrective and preventive action. The procedures shall include requirements for:

  • Mitigation Action – Action taken immediately to isolate and/or eliminate a detected nonconformance; immediate actions should be consistent with the identified issue; if no immediate action is required provide a rationale;
  • Risk Assessment / Effect on Product – Evaluate the issue for risk to product, process and/or business as applicable; evaluate the effect on product; if there’s no risk on product then provide a rationale;
  • Root Cause – Conducting a root cause analysis and clearly stating the root cause or causal factor(s) that underlie a product or process nonconformity. Methods may include analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems;
  • Corrective Action – Steps taken, i.e., a corrective action plan, for an existing nonconformity that has occurred in order to eliminate the cause of nonconformity and to prevent its recurrence; corrective actions address the root cause(s)/causal factors;
  • Effectiveness Verification Plan – Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished product;
  • Effectiveness Verification Results – Recording that the changes in methods and procedures, e.g., acceptance criteria, implemented did correct and prevent recurrence of the identified quality problems.

Occupational Health and Safety Standards

ALL APPLICABLE LOCAL AND/OR FEDERAL REGULATIONS MUST ALWAYS BE MET.

We require that our Suppliers have incorporated the following minimum standards, but do NOT require certification to ISO 45001:

  • OHS Policy: The Supplier shall have an OHS policy. The policy shall be appropriate to the nature and scale of the supplier’s OHS risks and shall include a commitment to prevention of injury and ill health and to continual improvement.
  • Risk Assessment: The Supplier shall identify and document its OHS risks and determine its relevant controls.
  • Management System: The Supplier shall consider OHS aspects in its management system.
  • Improvement Program: The Supplier shall have an OHS improvement program in place, including objectives and action plans.
  • Legislation: The Supplier shall comply with applicable OHS legislation and regulations.
  • In case of a conflict, the Local legislation and regulations shall always take priority.
  • Competence: The Supplier shall ensure that all employees are competent for their assigned tasks and have appropriate education, training and experience.
  • Reporting and Investigation: The Supplier shall have appropriate incident reporting and investigation procedures in place, including a process for corrective action.

Where applicable, our Suppliers must, as a minimum requirement, meet or exceed relevant regulations regarding, but not limited to:

  • General Duty;
  • Chemical handling;
  • Climbing and working at heights;
  • Construction and civil work management;
  • Crane and hoists;
  • Driver and vehicle safety;
  • Environmental and Occupational Noise;
  • Exposure to Radio Frequency Electromagnetic Fields;
  • Fire prevention and control;
  • Forklifts and other Powered Industrial Trucks (PITs);
  • Ladders & Scaffolding;
  • Lone working;
  • Manual Handling;
  • Personal Protective Equipment
  • Tools (Manual and Powered); and
  • Working with electricity.

The Supplier shall identify all relevant OSH regulations and standards that apply in advance of commencing the agreed scope of work. This includes all relevant maintenance and/or training records.

Industrial Equipment Competency and Permits

Applicable laws require that operators of certain types of tasks, plant and equipment must have a current certificate of competency or license, for example electricians, forklift and excavation equipment, cranes etc. Our rules are simple.

  • NO LICENCE OR CERTIFICATION = NO DRIVING/OPERATING EQUIPMENT AND/OR PERFORMING ELECTRICAL WORK.
  • Equipment owned by Hegele/GMED is not to be used without the expressed permission of your Company Representative.
  • No apprentices to be on-site without supervision of Qualified Trades person(s).
  • All licenses and certification records must be current and made available to within 2 business days of request.

Other Work Permits

The following work permit systems are in use on-site:

  • HOT WORK PERMIT: For flame cutting and welding, electric welding and cutting and grinding operations;
  • CONFINED SPACES PERMIT: controls access to confined spaces for all situations and reasons;
  • GENERAL WORK PERMIT: as needed on projects performed by suppliers.
  • WORK AT HEIGHT PERMIT: All contractors working above 2 meters, must complete a Hazard Identification and Risk Assessment and receive a Work at Heights Permit from Hegele/GMED prior to commencing work.

Machinery

  • No machinery or plant is to be shut down without the permission of the coordinator unless in case of emergency.
  • Lock Out and Tag Out procedures are to be followed where access is required to machinery, plant and energy sources for cleaning, maintenance, repair or installation projects and where removal of guarding is required.
  • Guarding is to be replaced upon completion ensuring that all interlocking and fittings are fully operational and safe.
  • Electrical Extension Cords and Power Tools must be in a safe condition and regularly inspected by an electrician. Approved inspection tags must be fitted on all leads and tools.
  • Residual Current Device must be used on all leads and power tools.
  • Inspection and maintenance records must be current and made available to within 2 business days of request.

General Safety and Security

At the end of each day’s work, the Supplier shall leave the job site in a tidy and safe condition such that no safety hazard is presented to employees and/or pedestrians. When the work has been completed to the satisfaction of the Company Representative the Supplier shall remove all tools, equipment and waste materials and leave the area in a clean and tidy condition. The removal of and appropriate Red/Hazard/Danger Tags shall be carried out by a Company Representative.

Equipment shall not be operated unless all guards are in place. Where it is necessary to remove any guards and operate a machine to carry out an adjustment, additional persons shall be posted in locations such that the operator can be warned.

All visitors must sign in and out of the site, as required, and posted smoking rules must be adhered to. This includes both traditional and electronic nicotine delivery devices.

We will not be responsible for the theft, loss or misplacement of the Supplier’s or the Supplier’s employee’s tools, materials or equipment.

Supplier’s employees moving through work areas shall keep to traffic aisles and shall restrict themselves to the areas with which they are concerned.

As required by the Company, all Supplier’s personnel engaged on the work shall wear and display, always when on site, badges issued for identification purposes. Such badges are to be returned at the conclusion of each workday.

Suppliers shall not discharge, or caused to be discharged, into the drains, or allow any spillage on sites to which they are working on behalf of Hegele/GMED, any liquids or solids for which the drains are not designated. We have the right to recover from the Supplier the cost of any fines or other penalties, which might be imposed because of illegal discharge into drains or work sites by the Supplier. Leakages of gasses or liquids, including oils and water, whether caused by the Supplier or not should be reported to the Company Representative.

All spills must be contained. All Hazardous Substances must be REMOVED FROM SITE EACH DAY upon completion of work unless special arrangements have been made.

Rigger Requirements for On-Site Deliveries

Please ensure this information is provided to the individuals and/or sub-contracts that will be assigned to our purchase order:

Medical Equipment Rigger

  • We define riggers as material handlers specialized in moving jobs that cannot be accomplished by ordinary means and use specialized material handling equipment expressly designed for moving objects weighing hundreds of thousands of pounds/kilograms in hospitals and other health care facilities as part of medical equipment installation projects.
  • Rigging team must work together as a cohesive unit, to avoid injures; damage to medical equipment; and damage to project sites.
  • Riggers must adhere to the direction of the Project Team Leader.

Physical Requirements

  • Must be able to stand and/or be on their feet 4-6 hours / day
  • Must be able to lift 50lbs as needed
  • Must be able to go up and down on ladder, steps, or other lifts as needed
  • Must be able to work in outdoor weather and/or unregulated temperatures for 4-6 hours / day

PPE Required (Bring to Site)

  • Safety Shoes (steel or composite toe) must be worn always.
  • Hard Hat, Safety Vest, Gloves, Safety Glasses – these items must be worn where risk warrants them necessary (e.g., active construction sites) and/or by direction of the  Project Team Leader.

Incident Reporting

Prior to commencing work, your purchase order contact or a Hegele/GMED QEHS Representative will brief you on specific safety requirements or other items relevant to the job.

Accidents, injuries, near misses, and hazards should be promptly reported to your purchase order contact and to safety@hegelelogistic.com

Please take the time to properly report accidents, injuries and hazards as this will assist in accident prevention and hazard reduction programs.

Compliance Reporting

Contractors must do site specific inductions when carrying out work at our customers’ sites. Where required, all contractors must sign in at reception prior to starting work and sign out when leaving site.

If the contractor or one of their employees is found not complying with this guidebook and or applicable OSH regulations, up to written notification will be provided to the Supplier. Repeat offences and/or major offences may result in termination of the business relationship.

Supplier Code of Ethics

A. GOVERNING PRINCIPLES

1. Conflicts of Interest
Suppliers should conduct business in a professional, honest, ethical and transparent manner. Suppliers should not engage in any activity that gives rise to an actual or perceived conflict of interest.

(a) Entertainment, gifts and payments

Providing or receiving gifts of money, goods or services solely for personal use, personal discounts, loans, gifts of non-business related travel or accommodations, personal favors or any other benefit, which might influence or raise doubts as to the impartiality of the recipient and damage the reputation of Hegele/GMED for fair dealing are prohibited.

Certain business courtesies such as payment of a reasonable amount for a lunch or dinner in connection with a business meeting normally would not be a gift within the context of this policy. Advertising novelties would not be inappropriate to give or receive, provided the item is of insignificant value and is widely distributed to others under essentially the same business relationship with the donor.

(b) Arm’s length dealings

Suppliers may only enter negotiations with Hegele/GMED employees who are independent of and can be reasonably stated as being ‘at arm’s length’ to, the Supplier.

(c) Illegal payments

Offering or accepting bribes, kickbacks or improper payments of any kind is strictly prohibited, without exception, in all circumstances.

2. Confidentiality of Information

Suppliers are responsible for complying with their obligations to protect Confidential Information of Hegele/GMED or of any customer, supplier or business partner of Hegele/GMED and ensuring that such Information is only used for the purpose for which it was provided.

Each Supplier shall adhere to and comply with the non-disclosure agreement it enters with Hegele/GMED. In the absence of a non-disclosure agreement, each Supplier must treat all information of, or supplied by Hegele/GMED, its customers, other suppliers and/or other business partners which is confidential, proprietary and/or not otherwise publicly available as Confidential Information including trade secrets, know-how, designs, inventions, techniques, processes, prototypes, undisclosed patents pending, finances, personnel records, business plans and proposals, capacity and production information, marketing or sales forecasts and strategies, client and customer lists, pricing lists or strategies, construction plans, supplier data, business leads, and all information relating to Hegele/GMED’s customer projects.

3. Compliance with Laws, Rules and Regulations

Each Supplier shall comply with all laws and regulations that apply to it wherever it conducts business and shall not, at any time, take any action which it or its employees knows , or reasonably should know, may be in violation of any applicable law or regulation, including but not limited to the following:

Health and safety: Suppliers are required to follow safe work practices and comply with all applicable health and safety guidelines relating to their work, including governmental requirements, operations- and facility-specific safety requirements, and contractual requirements. Suppliers are fully responsible for the health, safety, and continuous training of their employees. Suppliers shall minimize risks and implement best practice preventive measures against accidents and occupational illness, including an occupational health and safety management system.

Environmental responsibility: Vendors are expected to conduct their business in an environmentally responsible manner and not to engage in any activity that violates environmental laws or regulations wherever they conduct business.

Employment practices: Suppliers must adhere to local employment laws, including those related to maximum hours of daily labor, rates of pay, minimum age, privacy and other fair working conditions. The use of child labor must be strictly prohibited. Suppliers must promote equal opportunities and the equal treatment of their employees, irrespective of skin color, race, nationality, social origin, any disability, sexual orientation, political or religious beliefs, sex or age.

B. REPORTING OF VIOLATIONS AND OTHER ILLEGAL OR UNETHICAL BEHAVIOUR
Any Supplier or Supplier’s employee who becomes aware of any illegal or unethical behavior and/or any violation of this Supplier Code of Ethics has a responsibility to report his or her knowledge promptly to Hegele/GMED, by writing to qms@hegelelogistic.com. Except as required by law, persons reporting concerns may request that they remain anonymous. Hegele/GMED makes every attempt to protect the confidentiality of information provided, unless maintaining confidentiality would create a significant health, safety or legal risk.