Quality Management System (QMS): implementation, improvement and secure

Our team of former quality managers and engineers have walked in your shoes and can help your company to structure a robust quality management system. Whether you need support to develop and implement a brand new QMS or just a ad-hoc consultation to prepare, improve, secure and transitioning your current QMS you can count on us. We will support you for ISO family/IATF/API certification through all phases until achieving the ultimate goal.

 

ISO 9001:2015 Quality Management System

ISO 9001-2015 can be used for any type of company ranging from aerospace, service, software  to non profit organizations and provides the basis for other certifications such as IS0 14000, IATF 16949, AS9100, IRIS and API. Some decades ago the ISO standard helped companies to stand out against competitors and nowadays it is the basic foundation for any company to keep its competitiveness. Not mentioning some customers may only do business with certified ISO 9001 companies. 

We can help both small organizations design and implement a brand new quality management system (QMS) targeting its first ISO 9001:2015 certification, as well as helping well-established companies struggling with lack of resources and expertise to maintain their certification and also improve their system towards a higher level of excellence. Without taking unnecessary extra steps and shortcuts our approach is focused on essential activities to integrate the ISO 9001 requirements into the organization’s business processes and needs. 

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View the steps normally involved in certification and make use of our expertise to ensure full compliance.

• Initially we examine your key activities to understand the company core business and demands.

• Conduct gap assessment of your existing QMS to verify where your company is regarding the desired standard.

• Assess the level of compliance and effectiveness of your QMS and if it`s reflects the company processes. Then we develop a detailed road map

• Advise on compliance and efficiency improvements. We support the development/adjust of procedures needed   

• If necessary we provide tailored training related to ISO/API/IATF requirements to your staff to ensure full understanding and adherence to the company QMS.

• Conduct internal first-party audit and management review to prepare your organization for receiving third-party audit 

• We will write factual audit reports and assist your team regarding corrective actions

• Once corrective actions are implemented you are ready for receiving the third party audit. If necessary we offer support and guidance throughout your official audit process.

• Your company is submitted to the certifying body and upon confirmation awarded with desired certification.

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IATF 16949 

IATF 16949:2016 is the revised automotive quality management system standard developed by the International Automotive Task Force (IATF). The standard brings everything you need to know about achieving best practice when designing, developing, manufacturing, installing, or servicing automotive products and It is designed to be used in conjunction with ISO 9001:2015 containing supplemental requirements specific to the automotive industry rather than being a stand-alone QMS. The key benefits are related to​ a clear focus on continual improvement, emphasizing defect prevention and reduction of variation   and waste, time and cost savings, by avoiding multiple customer specific certification audits​, helps you to reduce production variations and improve your manufacturing efficiency which can positively impact your bottom line. Moreover, IATF 16949 helps create a common quality system approach to the entire supply chain facilitating access to the industry's best practices.

In addition to the eight quality management principles (customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, fact-based decision-making, mutually beneficial supplier relationships) our IATF 16949 consultants are engineers with automotive background and adopt a risk-based approach focusing on:  ​​​

• Ensure your company has a warranty process that addresses and integrates all applicable customer-specific requirements and warranty party analysis procedures. 

• Operational performance and customer feedback (customer scorecards/metrics)

• Enhanced product traceability requirements to support latest regulatory changes

• Integration of many common industry practices previously found in customer-specific requirements. 

• Requirements for both first and second-party auditors, including a documented process to verify internal auditor and trainer competency

• Clarification of sub-tier supplier management and development requirements

• Addition of a product safety section to ensure intended performance during the entire product life cycle without causing harm or damage

• Requirements to adopt a process to assess the risk of changes and take appropriate action

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API - Spec Q1/Q2

The American Petroleum Institute (API) establishes and maintain standards for the worldwide oil & gas industry. Certifying for API Spec Q1 & Q2 or Monogram specification qualifies an organization to work in Oil and Natural Gas industry with global recognition. API Spec Q1 is a quality management system standard for manufacturing organizations in the oil and gas industry while Spec Q2 is specific for service supply organizations.

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The API Spec Q1 meets all of the ISO 9001 requirements, plus additional elements deemed valuable by the oil and  gas industry. It is designed to promote reliability in the manufacturing sector of the oil and gas industry. Obtaining API Q1 certification helps organization to continually focus on risk management to minimize process variation and ensure a high product quality. 

 

The API Spec Q2 is designed to deliver the best in class service for clients in the oil & gas industry minimizing the likelihood of failure/error during a service execution and supply provision. The API Q2 major focus is to improve the quality of services by identifying and standardizing the customers expectations for the execution of upstream services like well construction, intervention, production, abandonment as well as other related services such as equipment maintenance and inspection activities.

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In addition to ensure the best in class service and higher product reliability for your clients, obtaining API Spec Q1/Q2 certification your organization also shows commitment toward quality improvement, greater operational efficiency, increased profitability, safety, compliance, customer satisfaction and retention. 

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The API Monogram is an API registered certification mark. Through the API Monogram Program, licensed manufacturers are given the authority to apply the mark to product that meets API Spec Q1 so that is easily identifiable and traceable in the field. Furthermore, is highly recognized across the world as the seal of approval for quality and reliable product performance. The rights and authorities to use the mark are facility and location specific and can only be applied to new products in conjunction with the facility’s license number and manufacturing date.

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You can count on Maxima Quality API consultancy approach 

Our team is formed by engineers with practical experience in oil & gas industry to help you obtain and maintain the API certification Q1/Q2. In addition to the traditional GAP analysis, process audit and quality management review:

• We focus on API specifics for dissecting the standard and translating the requirements into understandable terms.

• If you already count with ISO 9001 certification we can review the QMS in place to align your system with the main API requirements to avoid redundancy work.

• Verify the company scope including the justification for QMS exclusions if applicable.  

• We will conduct a detailed internal audit covering compliance of all the clauses of API Q1 & Monogram.

• We provide specific guidance about the API Monogram requirements such as the need to provide a validated design package if your products are listed under API advisory 6 and product details for each API Monogram license.

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ISO14001 Environmental Management System

The benefits for implementing ISO 14001 are beyond than just reducing environmental footprint. It improves your company reputation, provides a financial advantage through improved efficiencies and reduced environmental costs and creates a marketing advantage which improves demand for the company's services and products. 

Following a comprehensive review of your business, our consultants will identify areas of improvement and if required will design a brand new environmental management system (EMS). We will ensure your company:

• Decreases consumption of energy, storage of material costs, transport, emissions, discharges  and disposal costs.

• Communicates environmental knowledge throughout the organization. 

• Has a systematic approach to addressing environmental concerns.

• Reduces environmental impact and controls environmental risk.

• It commits to social responsibilities.

• Compliance with environmental laws & regulations.​​

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ISO 45000:2018 Occupational Health & Safety Management System

ISO 45001 standard specifies requirements for an occupational health and safety (OH&S) management system, with guidance for its use, to enable an organization to proactively improve its OH&S performance in preventing injury and ill-health. The benefits for adopting an effective OH&S program are not limited only to provide a safe working environment for employees and subcontractors but leads to effective risk management, reduced injuries and illnesses, compliance with legislative requirements, reduce workers compensation costs, improved corporate governance and operational efficiency. Not mentioning the large financial penalties applied for non-compliance under OH&S legislation including possible prison sentences. Organizations that are certified to OHSAS 18001 can migrate to ISO 45001 by March 2021 if they want to retain a recognized certification.

Our consultants can help you organization with:

• Migrate from OHSAS 18001 to ISO 45001.

• Establish an OHS policy aligned to the organization.

• Hazard identification, risk assessment and control of hazards/risks associated from the organizations products and services.

• Identify and comply with relevant legislative and regulatory requirements.

• Set OHS objectives and targets.

• Conduct health surveillance and workplace safety audit.

• Emergency Preparedness and Response.

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 Our ultimate goal is promote your organization as a safe and reputable company to deal with.

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ISO 13485 Quality Management for Medical Devices

Ranging from simple stethoscopes to complex devices like pacemakers with micro chip, medical devices are essential for safe and effective prevention, diagnosis, treatment and rehabilitation of illness and disease. The ISO 13485 standard is designed for organizations and its suppliers that are involved in one or more of the stages of the product life cycle, from design and development to production, installation, storage, servicing and sales of medical devices.  It also applies to suppliers of external parties that provide product such as raw materials or services. The primary objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. This regulatory framework specifies the need for the organization to identify and comply with regulatory requirements as defined by each country, industry or discipline. Regulatory requirements are often more specific than the prescripts of the ISO 13485 standard, particularly in the areas of complaint handling, labeling control, among others and must be included in the structure of the QMS to provide evidence of compliance. Our approach focus on specific aspects such as:

• The promotion and awareness of regulatory requirements as a management responsibility. Examples of market-specific regulatory requirements include 21 CFR 820, FDA and the Medical Devices Directive 93/42/EEC, required for doing business in the European Union.

• The importance of following good manufacturing practices "GMP" for production and testing.

• Controls in the work environment to ensure product safety.

• Focus on risk management activities and design control activities during product development.

• Specific requirements for inspection and traceability for implantable devices.

• Specific requirements for documentation and validation of processes for sterile medical devices.

• Specific requirements for verification of the effectiveness of corrective and preventive actions.

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ISO/IEC 27001 Information Security Management System

ISO/IEC 27001 is an international standard on how to manage information security. It details requirements for establishing, implementing, maintaining and continually improving an information security management system (ISMS)  to help organizations make the information assets they hold more secure. Our approach aim to deliver a conceptual framework, structures, processes, resources and information that defines the essential Information Security Management activities and responsibilities. We will ensure the company's top management has adequate controls in place to minimize residual business risk, ensuring that security continues to meet corporate, customer and legal requirements.​

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Project Quality Engineering / Project Coordination

Problems with product launch timing, quality, and cost issues are very common but not inevitable.  Our goal is to infuse quality from the first moment a product is defined and designed, and make it continues on throughout the development cycle. We can provide experienced professionals to “fill the gap” or undertake specialist roles in your projects. Our engineers have extensive experience managing large scale and complex projects working as a quality gate-keeper to ensure customer and business interests are protected at stage-gate reviews. Moreover they are able to interpret any demanding customer specifics requirements related to quality to create your product quality plan to fully comply with those requirements. 

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RFQ/RFP - Request for Quotation/ Proposal 

A vendor misinterpretation due poor specification or lack of information provided can ruin a product, project or service. Sometimes sourcing personal know exactly what they need however they do not have the skills and experience necessary to specify technical materials and products. You can let your procurement team focuses exclusively on the negotiation and cost aspects while we can help creating accurate RFQ/RFP for products and services following the main international standards.

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Formulation of Policies and Procedures

Policies and procedures streamline internal processes, ensure compliance with laws and regulations, and give guidance for decision-making. Moreover are a essential step towards ISO certification. However employees can’t follow procedures that don’t exist, contradict other policies, or fail to address a significant shift in technology or practice. Our experienced and qualified team has a flexible approach that will help you to produce a set of procedures tailored to your business objectives. In a short time we are able to map your main process inputs and outputs to deliver efficient and clear procedures and policies linking those to your company quality management system. 

 

Lean Manufacturing Implementation

At Maxima Quality we support you along the lean philosophy incorporation into your organization.  We offer a practical approach to the use of lean tools, structured to complement and improve quality management. Our approach of operational excellence is not limited only to the shop floor but also extend to supporting areas that add value. Our ultimate goal is to implement long lasting cultural changes in which progress is measured and linked to the organization business processes and KPI’s.

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1. Diagnostic study and gap analysis

To understand the organization and current practices, estimation of wastes, identification of potential improvement areas and projects is necessary to visualize quick win opportunities together with deliverables for each improvement projects.

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2. Training 

Train personnel on lean concepts, 5S, value stream mapping, line balancing, cell design, SMED, KANBAN, autonomous maintenance, SPC and mistake-proofing.

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3. Identification and implementation of improvements that are needed 

Selection of product family and defining projects with specified timeline and roadmap. Trained personnel are supported by site experts for handholding and implementation of the projects.

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4. Process standardization 

Demonstration of gains and its sustenance by providing validated work instructions, procedures and KPI.

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5. System monitoring and change management 

To ensure management is committed to lean deployment as a culture, leadership shall have special session about the importance of cultural change.

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WPS – Welding Procedure Specifications (plus PQR, WQT, WPQ)

Welding specifications are extremely important for establishing and controlling your process variables and skill levels to ensure a welded joint will achieve the mechanical properties specified. Our welding engineer is AWS certified and experienced to guide you for creating and implementing the welding documentation required.

 

Business Continuity Plan 

BCP is a management process that identifies potential threats to an organization and the impacts to business operations. It is important to maintain the ability of the organization to function continuously even during an incident or disaster. The benefits of a BCP are that the organization is able to proactively identify risks to its operation, and have in place a capability to mitigate and manage those risks applying an effective response to major disruptions. How that works? We will work together with your cross functional team to identify critical products and services that support the company objectives to create a business impact analysis (BIA). Based on the BIA, available resources and future business requirements will be documented and policies created. Personnel will be trained in carrying out the self-assessment and internal audit and in the end the BCP will be embedded in the culture of the organization through ongoing education and information program for existing and new staff. 

 

Creation of Quality Manual 

A Quality Manual is a top-level document that describes an organization’s Quality Management System (QMS). It is a very useful document that not only gives guidance and direction to an organization’s own personnel, but gives a potential customer, inspector or auditor an appreciation of an organization from the outside. A good Quality Manual covers "how" an organization intends to achieve the requirement of the standard that it is based on. If the creation of such an manual is done as a collaborative process it is an ideal opportunity to create a culture of quality and define exactly what that culture is.
While ISO 9001:2015 does not require a quality manual, our position would be to retain one, if for no other reason than to cross-reference procedures with the current version of the standard. The conformity matrix is a useful tool for doing this, and also to identify any gaps between what the organization has and what the new standard requires, it is simply a matrix whose rows are the clauses of the standard, and whose columns are the organization’s procedures and processes.

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PPAP Preparation – Production Part Approval Process

Our methodology of project management under APQP takes as the basis all the best practices of the automotive sector, and allows through several validations of project stages, the development of new products in order to achieve the objectives of quality, cost and term agreed with the client.

Our approach simplifies management and reporting, seeking the right and necessary, ensuring quality and identifying and managing project risks from design, production, verification, to launch. 

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Support for Annual Management Review 

A Management Review is a structured meeting that involves owners and/or top management of the business and takes place at regular intervals throughout the year but must occur at least annually. The objective of the management review is to ensure that your quality system implemented remains suitable, adequate and effective. 

 

Setting Business Dashboards and KPI`s 

Each business has KPIs relevant to their specific industry. Depending on the size of your business, the KPIs could involve the overall performance of the business or smaller tasks related to each department such as sales, marketing, finance, and customer service.

The key to setting KPIs is to identify desired outcomes for the business, and isolate means and ways employees can meaningfully help to achieve these outcomes. Whether it be increasing profit, reducing costs or acquiring a certain number of new customers, the KPIs must relate to specific business outcomes.

Using the SMART criteria is an effective way to assess the relevance of a KPI and save time on chasing less important objectives.

Each letter outlines certain criteria the KPI should meet:

• Specific: Is the objective specific enough?

• Measurable: Can the progress be easily measured?

• Attainable: How realistic is the goal?

• Relevant: Is the goal relevant to the needs of the business?

• Time-frame: How much time is needed to achieve the goal?