What is it?

Kratom is an herbal product that originates from Southeast Asian evergreen tree and is native to Thailand, Malaysia, Indonesia and Papua New Guinea.  Kratom is used as a sedative or a stimulant, with its primary psychoactive component, mitragynine.

The leaves are consumed in various ways:

• Chewing
• Drying and Smoking
• Putting into Capsules, Tablets or Extract
• Boiling into a tea and drinking it

Still banned by several US States, Kratom is used for medical and recreational purposes.  Kratom is sold on the internet and advertised as an herbal supplement.  DEA is evaluating Kratom for placement as a controlled substance.

Benefits

Kratom offers relief from various issues (pain, depression and anxiety) and is an aid for getting off of “stronger drugs”.

• Increase Energy
• Increase Stamina
• Limit Fatigue
• Muscle Pain Relief
• Diarrhea Relief
• Treatment for Opiate Addiction/Withdrawal
• Increase Alertness
• Bossed Physical Energy
• Lessen Anxiety and Stress
• Sharpen Focus
• Enhance Sexual Function

Side Effects

• Sedation
• Nausea
• Sweating
• Dry Mouth
• Increased Urination
• Loss of appetite
• Itching
• Constipation
• Dizziness
• Confusion

What is the Legal Status of Kratom?

The Drug Enforcement Agency is evaluating Kratom for placement as a controlled substance and in 2016, listed it as a Schedule I drug category.  Still banned by several US States, Kratom is used for medical and recreational purposes.  Kratom is sold on the internet and advertised as an herbal supplement. 

ISO/IEC 17025 – Quality Management Systems for Laboratories and ISO 15189 – Medical Laboratories Requirements for Quality and Competence

Testing Laboratories ensuring content and quality of Kratom products require accredited / proven capabilities to provide accurate service to the industry.

• Common testing for the alkaloids identified in Kratom include: Mitragynine and 7-hydroxymitragynine
• All of these test may not be necessary but can be done to get approval from the FDA
  • Identification of Botanical Compounds
  • Organoleptic Testing
  • Microbiology Testing
  • Chemical Analysis
  • Analysis of Physical Properties
• An ISO 15189:2012 certification has been seen as a critical initiative towards harmonizing global practices in medical laboratories towards a common measure of quality assurance and safety. The approach considers many perspectives, including the interpretation of test results, the method patient samples are actually collected as well as the time required for the tests to be carried out
• An ISO 17025:2017 Accreditation promotes development of an international reputable image for your organization through Quality Assurance and Management Systems.
• ISO 17025:2017 Promotes a strong degree of consistency in compliance to laboratory laws and legislation both from an international and national perspective.

Who Should Implement a Kratom Management System (MKS) for Certification?

• Any facility wanting to assure customers products are safely processed for the intended application and meet all regulatory requirements for content levels of ingredients.
• Any facility desiring a strong marketing tool to showcase their commitment to meeting consumer and regulatory requirements for Kratom products as defined by federal and individual state requirements.
• All businesses, operations, and organizations needing disciplines in place to ensure consistent production and testing levels to reduce the loss of viable products and maximize profit.

Process for Getting Kratom Management System (MKS) for Certification

• The process for getting certification to the Kratom Management System starts with preparation of a well-developed Quality Control & Testing Plan.
• Consultants proficiently qualified in developing a comprehensive, MKS to meet Federal and State Regulations.
• QSE assists in selection of the proper utilization of ISO 17025 testing and analysis methods and implementation of a Quality Control & Testing Plan required to ensure that the organization can provide product that consistently achieves test results for all requirements.
• An ISO 15189: 2012 certification promotes development of an international reputable image for your organization through Quality Assurance and Management Systems. 
• An ISO 15189: 2012 certification promotes development of an international reputable image for your organization through Quality Assurance and Management Systems.
• Ensure that buildings, facilities, air quality, and equipment are secure to provide safe cultivation production, and processing to meet State and Federal regulations.

• Management needs to ensure the facility is physically prepared to provide clean, cross-contamination free production.
• QSE consulting firm provides the techniques for implementation, and trains organization’s internal auditors to become competent to perform internal audits/tests of product and systems to meet the State and Federal requirements.
• Once prepared, select certification body.
  • Kratom cultivation & production facilities achieve GMP Certification.
  • Kratom Certification:
    • Multiple Certification Bodies are prepared and available to provide Kratom Certification
• Once the facility successfully passes the certification body compliance audit on requirements for a Kratom Management System, the certification body issues the compliance certificate to the organization

Kratom Management System (KMS) Consulting, Auditing and Training Services from QSE

• Quality Management Consultants can prepare your facilities for Kratom related certification through implementation of a simplified, thorough Kratom Management System.
• QSE can provide guidance for certification and in selection of the Testing Services that best fit your company needs and marketing strategy.
• QSE Consultants are experienced in assisting small, medium and large organizations in developing, training, implementing, and maintaining a compliant / documented / consistent Kratom Management System designed specifically to fit your organizational needs.
• Provision of internal audits to ensure product and system meets all requirements and employees prepared for certification and interfacing with auditor.
• QSE consultants will ensure that certification is successfully achieved upon initial audit by the certification body.
• QSE provides guidance in:
  • Implementation of Kratom applications for those providing only this type of product or those that produce multiple product lines requiring assurance that cross-contamination is controlled and risk contamination eliminated through identification of potential contamination points in processes and equipment.
  • Development of a rigorous Quality Control Plan that minimizes hazards and ultimately benefits both organization and consumer.
  • Implementation of testing at appropriate stages to prevent contamination.
  • Establishment of an employee training program that gives results.
    • Employee involvement to achieve successful implementation.
    • Education on control of cross-contamination, Good Manufacturing Practices (GMPs), and sanitation/cleaning.
    • Proper training in hazard assessment and application of testing for identified hazard.
    • Procedure for prevention of cross-contamination.
    • A robust system that trains and compels employees to understand and adhere to defined roles, responsibilities, procedures and controls.

Why is Consulting Required for a Kratom Management System (KMS)?

• A good consultant firm can provide detailed explanation on the intent and properly define and implement the system to meet requirements.
• A comprehensive Kratom Management System can create confidence in customers and provide answers to all questions from product/process certification auditors.
• An experienced Kratom consulting firm provides experience in the techniques for developing and implementing the KMS.
• Consulting firm such as QSE provides audit and testing services to help the facility verify the accuracy and adequacy of the system and provide accurate levels of Mitragynine and 7-hydroxymitragynine in product.

• Annual surveillance audits are conducted to ensure implementation effectiveness of the established KMS.
• Thoroughness of preparation and ease of Kratom certification achievement by utilizing all of QSE’s 10-Step Approach.

QSE Difference in Training, Auditing & Consulting Services

• Quality Systems Enhancement Inc. (QSE) is a Premier Consulting, Auditing and Training firm with over 27 Years’ experience and capability for implementation of any Kratom Management System, ISO Standard, Sector Specific Standard, AISC Standard and all Food Safety
• QSE provides On-Site and On-line Training for all Kratom Certifications to ensure Awareness of Requirements and Effective Implementation along with internal Product/System Auditing.
• QSE’s Consultants have helped over 800 facilities to earn multiple ISO, Food Safety, Kratom, and many other certifications.
• Over 98 % of QSE customers passed ISO certification audits with no nonconformity first time around. QSE has a 100 % success rate in obtaining certifications for its customers.
• Unlike our competitors, QSE provides a unique, comprehensive, evidence based, simplified documentation system comprehensively encompassing all requirements to achieve Compliance which is easy to implement and provides product and system compliance results to earn
• QSE Consultant’s Kratom Audits are an effective management tool to run any business processes to enhance Bottom-Line
• QSE designed templates are tried and tested for thorough coverage of all standard requirements, accuracy and correctness and provide objective evidence during internal audits and certification / compliance audits.
• QSE’s simplified System is evidence and result based, and is easy to implement, easy to use and easy to audit. If required the QSE System can be integrated with other ISO or Food Safety Management System Standards.
• QSE‘s evidence-based system with proven lists, forms and tables results in certification with minimum or no nonconformities.
• QSE utilizes competent Kratom Auditors to conduct product and supply chain material audits

President QSE, Baskar Kotte is an original and an active member of ISO/US TAG/TC 176, the Technical Committee that originally developed the ISO 9000 family of standards, ISO/US TAG/TC 207 which developed the ISO 14000 family of standards, ISO/US TAG/ TC 301 (TC 242) which developed ISO 50001 and  ISO 19011 the Guiding Standards for Auditing. Mr. Kotte also participated and provided input to the development of the current ISO, ISO 14001:2015, ISO 45001:2018 family of Standards and ISO 19011:2018 revised standards.

Benefits of Kratom Management System (KMS)

Additional benefits not listed for each component are as follows;

• Benefit through identification of hazard points and high-risk ingredients to manage the risk of cross contamination.
• Discipline implemented to identify High-Risk items / Area / Equipment and implementation of a Quality Control Plan to control the risk.
• Additional Requirements that vary based on State specific criteria.
• A KMS provides consistency and confidence in organizational ability to provide consistent Kratom related product.
• Benefits of quality / compliant final product for the organization and the consumer.
• Bottom Line Benefits to ensure satisfied customer and meeting needs of the organization.