API / ISO CONSULTING

The first step should include contacting an API consultant to identify

  • The cost of application fees for API – Product monogram license.
  • The cost associated with conducting required stage 1 and stage 2 audits for QMS certification and product monogram license. Need to have a proposal and project plan covering all the phases of the implementation, training, consulting and certification
  • Administrative fees, if any.
  • Other associated costs such as airfare, hotel, meals and car rental.
  • Frequency and recurring cost for QMS/ API surveillance audits.
  • The cost for Product monogram license renewal after 3 years.
  • In general at the time of submission of API application, at least four (4) months of records must be available to provide evidence of conformance and implementation of the QMS 9001:2015 or as per API Q1 and API products docs / manufacturing record.
  • Another important point is to determine if a product design package will be required. If your company manufactures product i.e. API 11D1 then design package will most likely be required also design docs is required for API 5CT. We will discuss these points during consulting with consultant.

The 2nd step to understand the application process

  • The second step should be to determine the availability of expertise within your company to develop and implement an API Q1/ QMS for certification as well as meet API-6A, API 7-1, API 11D1, API 14L, API 19G1, API 19G2 requirements for product monogram license.
  • Need to purchase all (Internal & External) the required API, ISO, ASTM original standard.
  • Again, select a consultant or a dedicated team who has prior manufacturing experience within this industry, processes and product line. It will be very much important to have the product knowledge to your team & to consultant.
  • Confirm that the results of the gap analysis will be done with documents as per current system and required API certification.
  • Once you send your approval, Consultant will assign a dedicated API MONOGRAM, team from your company who will act as a project manager that project team will work as per instruction from consultant till you receive API MONOGRAM certification. Need to identify and conduct gap analysis to current level of your organization and where you stand with respect to API MONOGRAM standard requirements.
  • Need to provide awareness training to various employees in your organization on API MONOGRAM standard, various clauses of API MONOGRAM standard, implementation requirement of API MONOGRAM standard and documentation with respect to API MONOGRAM.
  • Need to work with your team to framework and finalize documentation covering manual, Standard Operating Procedures, Formats, Templates, checklists, design package etc. with respect to API MONOGRAM standard.
  • Need to provide implementation assistance to your team for implementation of all the requirements for API MONOGRAM standard and as per documentation prepared.
  • Need to provide internal auditor training to your team on API MONOGRAM
  • Need to assist your team to carry out API MONOGRAM internal audit or if required, consultant can do internal audit on your behalf.
  • Need to carry out API MONOGRAM pre-assessment audit and assist you close the API MONOGRAM audit observations to ensure your organization is 100% ready for the audit.
  • Need to finalize on the API MONOGRAM certification body as per your preference and finalize the date from API MONOGRAM audit from the certification body.
  • Determine the availability of resources and top management’s commitment those resources to the project.
  • Finally your organization receives API MONOGRAM certificate.
  • If there would be any NC’s during API audit, then consultant will make the closure of all the NC’s within the given time from API for submission of reply.

After achieving the API certification, there are some of the benefits your company will have;

  • Worldwide recognition as you pertain to international standards (API 11D1 composite list with certification no.)
  • Minimize wasting resources and costs as work as per the instructed API standards and procedures given in the manual.
  • Helps in better business processes and enter into the international market through these certifications.
  • Increase marketing potential as one of the API certified product manufacturer.
  • Meet more clients and increase business revenue as most of the clients will come through the API certifications.

But to achieve the certifications, the following is key process has to be achieve to get a license i.e. American Petroleum Institute (API) certification for API Product certifications as;

  • Appoint competent manpower (competent points) as per selected products.
  • Application to American Petroleum Institute API for certification
  • Singing contract with American Petroleum Institute API for certification
  • Identification of Technical product specification standard applicable to the 11D1 under API certification
  • Implementing necessary actions including documentation for complying with requirement of applicable technical specifications applicable to 11D1 under consideration of API American petroleum institute certification
  • Complying with Quality system requirements as per API standard requirements
  • Doing internal audit of developed system to comply with API requirements
  • Pre-assessment audit by API audit through consultant.
  • API certification audit by API.