2 Industrial Road, Suite 203, Fairfield, NJ 07004
973-402-5889

NEW JERSEY BASED ISO CONSULTING FIRM PROVIDES ISO TRANSITION CONSULTING SERVICES

Communications contact:
Jim Kachidurian
jim@jjkconsulting.com

NEW JERSEY BASED ISO CONSULTING FIRM PROVIDES ISO TRANSITION CONSULTING SERVICES

ISO Auditing, ISO Training & ISO Consulting firm with 100% success rate for companies in New Jersey, NYC and the state of New York offers services to achieve compliance to ISO Transition 2018 deadline.

Fairfield, New Jersey: JJK Consulting, a well-established Consulting firm with focus on ISO Auditing, ISO Training and ISO Consulting on requirements of international ISO quality management standards e.g. ISO 9001:2015, ISO 14001:2015, AS9100D:2016, ISO 13485:2016, etc. is expanding to meet the needs of many local companies for transitioning to the new ISO standard requirements. The fact, that 40% of companies have not yet completed the transition to these new ISO standards regarding their often by customers required implemented quality management systems, can lead to loss of the precious ISO Certification on September 2018. This means that local companies who lose their ISO certificate, are in danger to lose also their best customers, as these certifications helps customers to evaluate their suppliers.

From our New Jersey based HQ, JJK Consulting comes in and helps these local companies with affordable on-sight expert consulting services with special “TRANSITION CONSULTING PROGRAMS” to become compliant in the time left before the September 2018 deadline.

Jim Kachidurian, the founder of JJK Consulting pointed out: ”The fact that the International Accreditation Forum (IAF), who oversees ISO Certification standards, has put another “difficulty” layer on the entire September 2018 deadline matter, which is that after March 15, 2018 all audits have to be conducted towards the new ISO standards, puts even more pressure on New jersey and New York based local companies and organizations, who needs to transition to the new standards. There are literally not enough local experts available who can assist local companies with these matters on affordable rates without heavy travel expenses involved. When our local based certified ISO Consultants come in, our clients can rest assure, that we help them through the entire process in time and cost-effective ways without expensive nationwide travel involved”.

What can a New Jersey, NYC or NY based client (small to large company or organization) expect from a local on-sight ISO Transition Gap Assessment, Training  or ISO Consulting provided by JJK Consulting?

  • The ISO transition gap assessment, ISO training and ISO consulting will be conducted on-sight by a certified local ISO consultant with decades of hands-on ISO imple
  • mentation experienceThe assessment considers every aspect to ensure a successful implementation; besides regulatory and process aspects, also risk and local safety aspects are assessedThe as
  • sessment report includes not only the identified strengths, weaknesses, and opportunities it also describes a recommended detailed implementation roadmap with activities, deliverables and responsibilities for cost and time 3rd party audit readiness without heavy travel cost involved.

Jim adds: “All our ISO Consultants live within a 50 miles NYC radius and are by themselves certified auditors to help our clients meet their ISO QMS transition goals for standard-based systems like quality (ISO 9001:2015), aerospace (AS9100D:2016), medical (ISO13485:2016 & FDA/QSR), cosmetics (ISO22716), environmental (ISO14001:2015), QMS/GMP and many other standards for many industries. This advantage eliminates the burden many companies have in regard to heavy travel cost involved with industry experts who are certified in ISO standards, but coming from out of state. We offer local companies three various stages of local ISO Consulting services: Assessment, Implementation and Coaching Inclusive Interim Audit Management. The Gap Assessment Analysis provides our clients with a clear picture of implementation timeline, costs and internal resource commitment on affordable rates.

The service offers also a free local consultation session in advance of the initial engagement within a 50 miles NYC radius. Companies really don’t need to risk their certificate anymore.

JJK CONSULTING offers local ISO expert services for the following standards:

ISO 9001 2015

With the transition deadline for the upgrade to ISO 9001 2015 coming up in September 2018, current local  ISO 9001 2008 certificate holders must seek out consulting assistance to ease the implementation process. Don’t risk your certificate!

Call today and let our local experts walk you through the process. We offer local on-sight Gap Analysis to include not only a detailed report of findings but a Roadmap with Milestones and Timelines. After the Gap Analysis, you will have a clear picture of implementation costs and internal resource commitment without heavy travel cost involved. We can take on as much or as little as is required.  We are offering a free local  consultation session within the 50 miles NYC radius in advance of the initial engagement.

Jim’s commitment: “Our team of local consultants has combined the experience of over 200 years in the regulatory and compliance field. Let our local experts prepare you for a painless audit that will not only yield a certificate but add real value and significant travel cost reduction advantage”.

AS9100D:2016

The AS9100D Quality Management System standard contains requirements for Aviation, Space and Defense Organizations and was released in September 2016. The standard, who was released by the IAQG (International Aerospace Quality Group) inherited all ISO 9001 v 2015 requirements and has added very specific aerospace requirements.

New “highlights of the standard are detailed requirements for the aeronautics, space and defense industry, including “Risk Based Thinking”, “Process Approach”, specific requirements for product safety , counterfeit parts management, external provider risk control, software program management, process validation inclusive clear requirements for regulatory adherence and customer requirements.

Auditable Clauses written up in typical classic Plan (P), Do (D), Check (C) and Act (A) ISO modality are:

4-Context of the organization (P)

5-Leadership (P, D, C, A)

6-Planning (P)

7-Support (D)

8-Operation (D)

9-Performance evaluation (C)

10-Improvement (A)

 

For a no-obligation proposal, please contact us.

 

Medical Device (ISO13485:2016)

Medical Device quality management certification requirements can be a bottleneck in getting new or improved products to market. Regulatory missteps in launching new medical devices can cost companies thousands or even millions of dollars in lost sales. Companies that can successfully navigate the regulation requirements for medical devices and launch a new standards-compliant product have a real market advantage. JJK Consultants are local experts in guiding clients through the complexities of medical device regulations. We do not take a quick fix approach. We do more than help clients obtain their desired certification. We are dedicated to our local community and our expert consulting team is committed to adding real value to each local based client’s bottom line. Our local consultants have guided countless companies to successful certification in the following standards and regulations.

FDA QSR

FDA 21 CFR Part 820 governs the methods organizations use to design, manufacture, package, label, store, install and serve all finished devices for human use. Under this regulation local manufacturers, specification developers, contract manufacturers, re-labelers and re-processors must develop a quality regulations system (QSR). This regulation does not define the specifics of the QSRs. It details the requirements covered entities must follow in establishing their QSRs.

FDA QSR Consulting Services

Our local consulting team has worked with global Fortune 500 companies and small start-up manufacturers.  We can assist clients in range of QSR services from helping clients establish design controls through conducting audits. We will scale our consulting efforts to match the needs of each client’s products and culture. Our local consulting services can include:

Design control procedures, implementation and audits
Design development plan
DMR (device master record)
Risk management program development, and analysis
Medical Device product design history file compliance
Biocompatibility and sterilization assessment
Medical device standards assessment
Process validation (IQ/OQ/PQ)
Change control
ISO 13485:2003 (CMDCAS) transition to ISO 13485:2016 (MDSAP)
UDI Compliance Service
CE Marking Service

For a no-obligation proposal, please contact us.

 

Cosmetics Certification (ISO 22716)

JJK Consulting Inc. can help your local company to tackle the Globalized GMP Challenges for Cosmetics and Cosmetic Ingredients. Our local team will guide you through the requirement for the domestic or international market. The global experience of our group of professionals will evaluate and customize your systems and processes to assure excellence in compliance and certification. Many of the QMS/GMP processes are critical to today’s Cosmetics industry standards. Our team has over 50 years of experience in cosmetics and can help local companies to achieve goals in certification and quality.

Pharmaceuticals Regulations (FDA)

Today, few industries face more regulations than pharmaceutical manufacturers. We work with companies that need to meet the top-quality standards for drug manufacturing, including cGMP, GLP, GCP and 21FR Part 11.

cGMP (FDA)

If you want to sell pharmaceuticals in the US, you must meet the US FDA’s requirements for Current Good Manufacturing Practice (cGMP). By adopting a cGMP, you can prove that you manufactured a specific batch of a regulated product to meet a pre-defined manufacturing standard. The FDA regularly conducts cGMP inspections of companies that manufacture, produce, store or label drugs sold in the US. The FDA will inspect facilities for a variety of reasons, including:

As a part of the agency’s normal routine inspection process

-In response to complaints
-To verify the truthfulness of a submission

Regardless of the reason for the FDA’s inspection, your entire team must be ready. If your staff does not understand and prepare for an FDA inspection, you risk a negative outcome, which can cost you. Our consultants will help you fully understand and get ready for your FDA inspection.

cGMP Services

To prepare your facility for a FDA cGMP Inspection, our consultants will

Review your Standard Operating Procedures (SOP)
Conduct an audit and provide a GAP analysis
Identify deficiencies and recommend corrective actions
Guide you in preparing your staff and site for inspection
Advise you on how to interact with the FDA inspector
And more

GLP

Good Laboratory Practice (GLP) is a quality system focused on the process and conditions companies use to plan, perform, monitor, record, archive and report non-clinical health and environmental safety studies. A company adapts a GLP to protect the integrity of its scientific data and to provide the FDA (or EPA) with a clear, auditable record of open-ended research studies.

GLP Services

With our GLP consulting services, our team can:

Inspect your subcontractors and vendors for GLP compliance
Analyze your data reports against GLP requirements
Inspect your facilities and relevant computer systems
Review your SOPs
Advise on how to remediate any GLP deficiencies in your systems or SOPs
Guide you through GLP certification
And more

GCP

Good Clinical Practices (GCP) is an international quality standard for designing, conducting, recording, and reporting trials, which involve human subjects.

GCP Services

Our consultants collaborate with clients to help them develop GCP-compliant processes. The JJK Consulting group is not a contract research organization (CRO). We only provide GCP consulting services. With our independence from the clinical trial process, we can objectively evaluate your clinical trials without triggering any potential conflict of interest.  Our objectivity means we will always have your best interests as our main interest.

With our GCP consulting services, our team can:

Tour your facilities
Review your standard SOPs
Evaluate your QMS
Appraise your compliance with your SOPs
Assess your vendors’ qualifications, management and certification programs
Review the qualifications and training of the CRO team members
And more

21 CFR Part 11

Title 21 CFR Part 11 refers to the section of the US FDA regulations related to electronic records and electronic signatures. If your organization uses a computer system to manage electronic records related to an FDA-regulated product or program, your system must comply with this regulation.  Our consulting team thoroughly understands these requirements.

21 CFR Part 11 Services

To ensure that your systems comply with 21 CFR Part 11, our consultants will:
Analyze the risks of your current electronic records systems
Review your SOPs
Asses your computer system against your SOPs and FDA’s compliance requirements
Identify non-compliant elements
Prepare a remediation plan
Assist your team in making changes
Provide ongoing support to assure your systems remain compliant

No matter if you are developing a new validation or qualification program, require immediate remediation to a compliance issue, or want to have your existing solutions audited, JJK will provide you with the services you need.

For a no-obligation quote, please contact us.

 

Food Safety

Major food manufacturers, distributors and food retailers are now sourcing suppliers from distant locations. To lessen the risk of a high-profile food safety incident, companies in the food industry are adapting Global Food Safety Initiative (GFSI) standards. GFSI recognizes a number of Food Safety Management Systems Certification programs, based on the Hazard Analysis Critical Control Point (HACCP) system, including:

Safety Quality Food (SQF)

Food Safety Systems Certification (FSSC) 22000 and ISO 2200

British Retail Consortium (BRC)

If you want to sell food products to major corporations, you must meet international food safety standards. Only suppliers obtaining third-party certification to a GFSI standard can give buyers objective proof of their food-product’s safety.

When your organization achieves certification to a GFSI-accepted standard, you will gain your potential customers’ trust. All large buyers in the food industry demand some type of certification. If you want to remain competitive in this industry, you must obtain and maintain certification.

Services

Our experienced team of food-standards consultants will prepare your company to meet the most recognized food safety and quality standards. Our team can help you through the entire process of implementing a food safety program to comply with relevant international standards. We work with companies just starting to develop a food safety system and established organizations needing compliance assistance.

Our consultants will:

Assist you determining the best audit scheme for you
Assess your current food safety process against your target scheme
Help you develop and implement a safety program meeting your target standard
Guide you through the certification process
Experience

Our food standards consultants have provided auditing and consulting services to the most prestigious companies in the world for decades including Nestle and Coca Cola. Our professionals have successfully guided clients through food-standards certification countless times. As a team, we know what to expect. With our experience, our clients get fully prepared and experience no surprises at audit time.

To receive a no obligation proposal on how we can help your company meet the international food safety standard, please contact us.

QMS/ GMP

QMS

A quality management system (QMS) covers a set of business processes focused on achieving quality policy and quality objectives to meet customer requirements.

GMP

Good manufacturing practice (GMP) is a system that ensures organizations produce and control products consistently aligned with quality standards. GMP is part of a QMS that covers the manufacturing and testing of pharmaceuticals, active pharmaceutical ingredients, diagnostics, foods, and medical devices. Regulators develop GMP requirements to minimize the risks involved in pharmaceutical production.

Although many countries develop country or region-specific pharmaceutical and medical device quality standards, GMP guidelines follow a few basic principles.

With a GMP, the entity must:

Clearly define and control its manufacturing process
Validate critical processes to ensure consistency and compliance with established specifications
Evaluate and validate any changes, which have an impact on quality
Write instructions and procedures in clear and unambiguous language
Train staff to perform operations in line with documented procedures
Keep manufacturing records and document and investigate deviations from the set standard
Keep records of distribution to enable tracing and history of a specific batch
Establish a system to enable any necessary product recalls for specific batch
QMS and GMP Services

Our team of local consultants can help you establish and maintain a standards-compliant GMP system. We can help you:

Design and implement a QMS appropriate for your organization and target markets
Prepare for regulatory submissions
Design and implement an effective validation system for processes and suppliers
Audit suppliers and/or vendors
Conduct a pre-certification audit for all processes
Establish the appropriate record keeping and tracking systems
And more

Regulators use Quality Management Systems and Good Manufacturing Practices as the foundation for their certification standards. JJK consulting has constructed a team of veterans across every industry and business sector. Our approach will demystify the process and lead to measurable, repeatable results that have bottom line impact.

To discover how we can help you improve your bottom line with a well-structured QMS system, please contact us.

Social Accountability

JJK Consulting employs some of the industry’s most experienced professionals having worked extensively with global companies like Chrysler, Nestle, Coca Cola, Estee Lauder and Walmart. They have worked across North America and most are multilingual. Social accountability and sustainability is a global movement and our team is at the forefront. Social responsibility is good for your most important resource, your people and ultimately good for business.

ISO Certification Preparedness

When you engage JJK Consulting, you gain a collaborative partner to guide you through the complex requirements of meeting industry standards for quality, safety or security. We work with your managers on-sight through three basic phases to prepare you as our client for 3rd party certification. You as local client can utilize our local experts for a single phase or for all three phases.

Phase 1: Assessment

We understand that your first concerns involve time and money. You want to know how long it will takes to get certification-ready and how much the preparation will cost. Since each situation is unique, the best first step is a comprehensive assessment. Our consultants will thoroughly review your current processes related your target certification standard.

After we complete the assessment, you will receive a detailed GAP analysis. Our GAP report pinpoints where your systems meet standards and where they fall short. As a result of this assessment, you have a road map of tasks, times and costs you need to invest to achieve certification.

ISO Certification Preparedness

Phase 2 Process Consulting

While the GAP analysis provides the working plan for meeting your target standard, the terms can seem alien to individuals unfamiliar with the standards industry. To help your staff understand and prepare for the certification process, we can work with you to familiarize your staff with the process.

Once your team is familiar with the certification roadmap, our consultants will work with you throughout the process. We will guide you in correcting any notable deficiencies. To help you reduce costs, we work carefully to utilize as many of your existing procedures as possible. Our consultants will serve as your implementation guide. We will help you implement and properly document your quality, safety or security system to comply fully with your target standard.

ISO Certification Preparedness

Phase 3: Audit & Certification

After your company implements the management system and fully documents your procedures, we can conduct a pre-assessment or internal audit. Our consultants have all audited for an accredited Certification Body. We understand what the Certification auditor or inspector wants to see.

After our team conducts an internal audit and helps you address any remaining deficiencies, your organization is fully prepared for its Certification Audit. If a local client needs ongoing support, our team can remain involved throughout the certification process. We are also committed to local clients for the long-haul. Local companies must nurture their quality management system to maintain the system’s effectiveness and to remain internationally competitive. We help clients with ongoing local consulting support services. With this ongoing support, local clients minimize their risk of triggering a costly re-audit.

To get a quote now call ph 973-402-5889.

About JJK Consulting: JJK Consulting is a New Jersey based professional ISO Consulting firm headquartered in Fairfield, New Jersey, providing local companies and organizations with or without a quality management system in place, a range of solutions to common ISO Certification/transition problems, assessing risks, costs and benefits of ISO Certifications and assisting clients sort out the best option for transitioning to the new ISO Standards while eliminating heavy travel expenses. The local available services includes on-sight ISO Transition Gap Assessment, ISO QMS Implementation and ISO Coaching Inclusive Interim Audit Management especially within the New Jersey/NYC/NY areas. Clients receive immediate actionable implementation strategies and achieve ISO Certification readiness within time and budget. The local available expert team of inhouse ISO Consultants has combined experience of over 200 years in the ISO, regulatory and compliance field, with many “zero findings” 3rd party audits conducted for local clients.

 

Contact: information:

JJK Consulting
350 Passaic Ave Suite 205 Fairfield, NJ 07004
Ph 973-402-5889
jim@jjkconsulting.com