ISO 9001:2015 will replace ISO 9001:2008. The revised ISO 9001 was published on Wednesday 23rd September 2015.
ISO 9001:2015 identifies requirements for a quality management system where an organization requirements to demonstrate its ability to consistently offer product that meets customer and applicable statutory and regulatory requirements, and aims to increase customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to client and applicable statutory and regulatory necessities. All requirements of ISO 9001:2015 are generic and are intended to be applicable to all organizations, regardless of type, size and product providing.
“We have now gone a step further, and ISO 9001:2015 is even less prescriptive than its predecessor, focusing instead on performance. We have achieved this by combining the procedure approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization.
All ISO standards are reviewed every five years to confirm that they remain relevant to the market environment. ISO 9001:2015 is the final result of a multi-year procedure involving representatives from ISO member countries and stakeholders from around the world.
ISO 9001 2008 had five main sections (4 to 8) and ISO 9001 2015 now has seven (4 to 10). This is because the new edition uses the new Annex SL template. According to ISO, all future management system standards (MSSs) will use this new layout and share the same basic needs. As a result, all new MSSs will have the same basic look and feel.
Section 4.3 of ISO 9001 2015 says “The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system”. So once you’ve determined the scope of your QMS, ISO 9001 2015 says that every necessity must be applied within the boundaries defined by your statement of scope if it applies in your case.
ISO 14001:2015 was published 15 September 2015 and is the replacement for ISO 14001:2004. For organizations currently using ISO 14001:2004 there will be a three-year transition period to switch to ISO 14001:2015.
Understanding the organization and its context
This new concept relates to the factors and conditions affecting organizational operation e.g. regulation, governance and environmental conditions.
Environmental conditions are the elements of the environment which can be affected by the organization (air quality, water quality, land use, etc.), or those which can affect the organization (climate change, existing land contamination, etc.).
Understanding the needs and expectations of interested parties
Consideration should be given to who the interested parties might be and what their relevant interests might be, e.g. employees, neighbors, customers, shareholders, board members, competitors, regulators, etc.
The needs and expectations of interested parties can become compliance obligations.
Leadership and commitment
Top management of the organization are now required to demonstrate leadership and commitment to the EMS in a number of specified ways.
ISO 14001 2004 is an environmental management standard that defines the environmental policy of an organization. This standard supports organizations to protect the environment, check pollution, and progress their overall environmental performance. ISO 14001 is a useful tool for an organization to step up from just maintaining regulatory compliance to an organization with improved productivity and improved competitive benefit.
ISO 14001:2004 identifies environmental necessities that the organization identifies as those which it can control and influence. It does not itself state exact environmental performance criteria. ISO 14001 is flexible – it is as applicable to both the small business and the multinational organization.
ISO 45001 is an International Standard that identifies requirements for an occupational health and safety (OH&S) management system, with guidance for its use, to permit an organization to proactively develop its OH&S performance in preventing injury and ill-health. ISO 45001 is intended to be applicable to any organization regardless of its size, type and nature. ISO 45001 enables an organization, through its OH&S management system, to integrate other aspects of health and safety, such as worker wellness/wellbeing; however, it should be noted that an organization can be necessary by applicable legal requirements to also address such issues.
Who is 45001 appropriate for?
The standard is flexible and can be adapted to manage occupational health and safety and suits a wide range of organizations including:
- Small and medium-sized enterprises
- Public and not-for-profit organizations
- Non-government organizations (NGOs) and charities
- Large organizations and enterprises
Benefits of ISO 45001 Occupational Health and Safety Management
- Progresses compliance with current legislations
- Remove or minimize OH&S risks
- Transform operations from detection to prevention mode
- Decrease work-related injuries, ill -health and deaths
- Progress OH&S performance and efficiency
- Protect and progress brand reputation
The CE marking (an acronym for the French “Conformite Europeenne”) certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety. Manufacturers in the European Union (EU) and abroad must meet CE marking requirements where applicable in order to market their products in Europe. For a list of countries that require the CE marking, see: CE Marking Countries. A manufacturer who has gone through the conformity assessment process, may affix the CE marking to the product. With the CE marking, the product may be marketed throughout the EU. CE marking now provides product access to 32 countries with a population of nearly 500 million.
Unfortunately, there is no comprehensive list of the products that require a CE marking. Therefore, it is the manufacturer’s responsibility to determine if a product requires a CE marking. The “New Approach Directives” are documents that contain the legislation issued by the European Commission on the requirements that need to be met and procedures that must be followed in order for a particular product to be CE marked for sales in the EU.
In order to determine if your product needs a CE marking, you should look in each directive that you judge as related to your product. Our Guide to navigating the CE marking process is organized by directives: CE Marking Guide. Under each directive, we explain the route to CE marking certification step-by-step and in one place.
Some products require conformance to more than one directive. For example, the Safety of Machinery directive, the Electromagnetic Compatibility (EMC) directive, and the Low Voltage Equipment directive may all apply to one product.
Principles of the CE Marking
- Only the manufacturer or his authorised representative shall affix the CE marking.
- The CE marking shall be affixed only to products to which its affixing is provided for by specific Community harmonization legislation, and shall not be affixed to any other product.
- The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant Community harmonization legislation providing for its affixing.
- The affixing to a product of markings, signs or inscriptions which are likely to mislead third parties regarding the meaning or form of the CE marking shall be prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking is not thereby impaired.
- Member States shall ensure the correct implementation of the regime governing the CE marking and take appropriate action in the event of improper use of the marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use.
Benefits of CE Marking Certification
There are a significant number of advantages of CE marking for the manufacturer and for the consumer. In particular:
- CE marking provides manufacturers with market access to the whole European Economic Area, since countries within this area may not restrict the placing on the market of products bearing the CE marking.
- It guarantees that the product conforms to the regulations in the specific directive(s)
- It is a guarantee for the manufacturer that the product is safe for consumers
- It may significantly reduce damage claims and liability premiums.
ISO/IEC 20000-1:2011 is a service management system (SMS) standard. It identifies necessities for the service provider to plan, establish, implement, operate, monitor, review, maintain and progress an SMS. The necessities include the design, transition, delivery and development of services to fulfill agreed service necessities.
ISO/IEC 20000 is an international IT standard that permits companies to demonstrate brilliance and confirm best practice in IT management. The standard makes sure companies can achieve evidence-based benchmarks to constantly progress their delivery of IT services. ISO/IEC 20000 was released in 2005 based on the IT infrastructure library best practice framework, and updated in 2011.
According to ISO IEC 20000-1 2011, service suppliers must be capable to show that every necessity is being met if they wish to claim that they comply with this standard. No exclusions are permissible.
ISO/IEC 20000-1:2011 is process-based; certification recognizes organizations that can link business objectives with operating efficiency. Companies that achieve management system certification to ISO/IEC 20000-1:2011 have demonstrated efficient implementation of documents and records management, top management’s commitment to their clients, establishment of clear policy, good planning and implementation, good resource management, and capable procedure control, measurement, and analysis. constant development has been institutionalized.
Benefits of ISO/IEC 20000-1:2011
- Competitive benefit
- Gives a scalable standard which can be useful to any size IT operation
- Easy roadmap to IT Service Management achievement
- ISO/IEC 20000-1 certification gives objective evidence of compliance to ITIL best practices
- Certification drives constant service development
- For internal IT, ISO 20000-1:2011 certification enhances perceived value of IT services
- Third party endorsement of compliance to ITSM best practices.
- Performance developments like:
- Improved system availability
- Reduction of system outage
- Reduction of critical incidents
ISO 22000 describes the requirements for operating an effective food safety management system integrating the use of the Hazard Analysis and Critical Control Point (HACCP) techniques and defined prerequisites for the safe production of food.
The ISO 22000 model is a systematic approach to developing, planning, validating, establishing, implementing, monitoring, verifying and improving the food safety management system. Implementation is split down into several distinct stages including:
This section of the standard is designed to enable top management to establish and maintain commitment to the development and improvement of a food safety management system.
The need for measurable objectives is intended to support top management understanding how the food safety management system is performing and therefore what improvements and updating may be required to enable the ongoing production of safe food.
- Food Safety Policy: Establish a policy that is appropriate to the role of the organization in the food chain ensuring it conforms to both statutory and regulatory requirements and agreed food safety requirements of customers.
- Objectives: Establish measurable objectives relating to food safety in support of the food safety policy.
- System definition:
- Define the scope of the food safety management system in terms of products, activities and sites.
- Documented food safety management system.
- Development of internal and external communication on food safety issues with relevant interested parties.
- Development of a food safety management system that enables all food safety hazards to be identified and controlled.
- Establish procedures to manage potential emergency situations that can impact food safety.
- Responsibilities: Responsibilities and authorities defined and communicated. Appointment of a food safety team leader and establish a food safety team.
- Review the continued suitability, adequacy and effectiveness of the food safety management system at planned intervals and identify opportunities for improvement and updating of the system.
- Resources: Provide adequate resources for the development, maintenance, updating and improvement of the food safety system.
Planning and realization of safe products
- All relevant information needed to conduct the hazard analysis shall be collected, maintained, updated and documented.
- The food safety team shall conduct a hazard analysis to determine which hazards need to be controlled.
- A combination of control measures shall be put in place and managed through pre requisite programmes and/or by HACCP plans.
- Traceability systems will need to be implemented to enable the identification of product lots/batches back through to raw materials and delivery records in the event that recall or withdrawal is warranted.
- There shall be procedures in place to handle potentially unsafe products, withdrawals, disposal.
Benefits of ISO 22000 Certification
- Applies to all organizations in the global food supply chain.
- Internationally recognized standard
- Complies with the Codex HACCP principles.
- An auditable standard which provides a framework for third-party certification.
- The structure aligns with the management system clauses of ISO 9001:2008 and ISO 14001:2004.
- System approach, rather than product approach.
- Improved documentation.
- Systematic management of prerequisite programs.
- Increased due diligence.
- Dynamic communication on food safety issues with suppliers, customers, regulatory bodies and other interested parties.
RoHS, short for Restriction of Hazardous Substances, is specific to the European Union. The law revolves revolves the handling of hazardous materials, ranging from the manufacturing to the disposal of the material. While created inside of Europe for members of the European Union, other regions around the world have utilized and created offshoots of the RoHS. This includes nations throughout Asia (China, Japan and South Korea) and versions of it inside of North America as well. Manufacturers of hazardous material must become RoHS compliant in order to sell and distribute the product inside of the European Union, which is exactly why it is so vital for a company to obtain these credentials. The specific process set in place to assist these companies is rather straight forward though, so it should not prove difficult to follow through with the RoHS certification and RoHS compliance regulations.
In order to obtain the certification, it is necessary to seek out a third party company that provides test reports of the material, material declarations directly from the supplier and what is known as a Declarations of Conformity. It is all about testing the material, making sure its housing, manufacturing and distributing is aligned with the set forward regulations of RoHS,
When working with these third party organizations, they test the presence of different chemical compounds and components, including lead, mercury, cadmium, hexavalent chromium, polybrominated diphenyl ethers and polybrominated biphenyls.
Benefits of RoHS
- Increase of communication across the supply chain serves as a platform for the implementation of REACH and other initiatives.
- Tighter process control, overall reduced number of defects and increased production efficiency (contradicts information appearing elsewhere in the report)
- Increased skill levels in the global workforce due to retraining and the knowledge transfer to Asia and less developed countries (assumes that globalization is driven by RoHS). In addition, “Japanese people and knowledge are seeking inspiration in Europe and the US” (the condescension toward Japan is hard to understand given the statistics on innovation contained within the report).
- Less leaching in landfills because WEEE contains less hazardous material and increased incentives for recycling because lead-free solder contains silver and gold
- Pressure on other sectors (such as aerospace and IT industrial controls) and countries to move to cleaner processes and reduced use of hazardous materials (such as China RoHS and Korea RoHS)
- Competitive advantage for EU manufacturers in markets where RoHS legislation is pending or contemplated
The Capability Maturity Model Integration, or CMMI, is a procedure model that gives a clear definition of what an organization should do to promote behaviors that lead to enhanced performance. With five “Maturity Levels” or three “Capability Levels,” the CMMI defines the most essential elements that are necessary to build great products, or deliver great services, and wraps them all up in a comprehensive model.
CMMI standard for capability maturity model is a confirmed approach to performance management with decades of results showing it works. Organizations having CMMI certification have predictable cost, schedule, efficiency and excellence—business results that serves as discriminators among their competitors.
The CMMI certification is one of many purposes representing the company’s commitment to achieving high level of brilliance performance in the area of software development as well as project management. QRO Cert associated with many software companies internationally and helped them to implements system under well structured our CMMI certification company in their organization which resulted in easy CMMI certification.
Benefits of CMMI Certification
- Centralized QMS for implementation in projects to make sure uniformity in the documents which means less learning cycle for new resources, better management of project status and health
- Cost saving in terms of lesser attempt due to fewer defects and less rework
- Culture for maintaining Quality in projects begin in the mind of the junior programmers to the senior programmers and project managers
- This also results in enlarged Productivity
- Incorporation of Software Engineering Best Practices in the Organizations as explained in CMMI Model
- Enhanced Productivity
- Improved client Satisfaction
- On-Time Deliveries
- Reduces Costs
- Overall enlarged Return on Investment
Total Quality Management (TQM) is a comprehensive and structured approach to organizational management that seeks to improve the quality of products and services through ongoing refinements in response to continuous feedback. TQM requirements may be defined separately for a particular organization or may be in adherence to established standards, such as the International Organization for Standardization’s ISO 9000 series. TQM can be applied to any type of organization; it originated in the manufacturing sector and has since been adapted for use in almost every type of organization imaginable, including schools, highway maintenance, hotel management, and churches. As a current focus of e-business, TQM is based on quality management from the customer’s point of view.
TQM processes are divided into four sequential categories: plan, do, check, and act (the PDCA cycle). In the planning phase, people define the problem to be addressed, collect relevant data, and ascertain the problem’s root cause; in the doing phase, people develop and implement a solution, and decide upon a measurement to gauge its effectiveness; in the checking phase, people confirm the results through before-and-after data comparison; in the acting phase, people document their results, inform others about process changes, and make recommendations for the problem to be addressed in the next PDCA cycle.
The principles of quality management
- customer-focused organisation – organisations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations
- leadership – leaders establish unity of purpose, direction and the internal environment of the organisation. They create the environment in which people can become fully involved in achieving the organisation’s objectives
- involvement of people – people at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the organisation’s benefit
- process approach – a desired result is achieved more efficiently when related resources and activities are managed as a process
- system approach to management – identifying, understanding and managing a system of interrelated processes for a given objective contributes to the effectiveness and efficiency of the organisation
- continual improvement – continual improvement is a permanent objective of an organisation
- factual approach to decision making – effective decisions are based on the logical and intuitive analysis of data and information
- mutually beneficial supplier relationships – mutually beneficial relationships between the organisation and its suppliers enhance the ability of both organisations to create value
Six Sigma is a methodology used to improve business processes by utilizing statistical analysis rather than guesswork. This proven approach has been implemented within a myriad of industries to achieve hard and soft money savings, while increasing customer satisfaction. SixSigma.us is at the forefront of Six Sigma certification and consulting services. We assist organizations with all aspects of the implementation process from training Champions to certifying employees at various belt levels. We can help your company determine the right individuals for training and how to choose potential projects.
The Six Sigma methodology is defined by 5 DMAIC steps. DMAIC is the acronym for Define – Measure – Analyze – Improve – Control. In addition to the 5 DMAIC steps, there is also a step zero that occurs first. It is known as six sigma leadership.
Six Sigma quality-improvement methods focus on streamlining processes, reducing errors and improving product quality. The White Belt is offered to provide an overview of Lean and Six Sigma. With this Belt you will be able to begin your journey toward the professional competencies of the Yellow Belt, Green Belt, Black Belt, and Master Black Belt. After obtaining this first level belt, you can become a qualified team member of a Green Belt or Black Belt project.
White Belt Training is the first step to fully understand Lean and Six Sigma methodology and your role in it. If you are uncertain about the Six Sigma methods or if you want to get to know more about its impact, this course is perfect for you.
Six Sigma quality-improvement methods focus on streamlining processes, reducing errors and improving product quality.
The Yellow Belt Certifcation gives you a broad understading of Lean and Six Sigma quality-improvement methodologies. It helps you develop the capability to understand and use basic measuring tools to gather accurate data and share their expertise in the problem-solving process.
Yellow Belts are tasked with identifying, controlling, and monitoring potential profit loss areas and reporting this information to the Green Belts and Black Belts within the organization.
The Green Belt Certifcation gives you full understanding of Lean and Six sigma quality-improvement methodologies. This certification will immerse you in the vast improvement process culture, you will learn to improve daily processes using Len and Six Sigma tools. And, you will also learn to define improvement projects to satisfy the customer and reduce variation.
Green Belts are a key piece in Six Sigma projects. Their efficiently executed Lean and Six Sigma techniques can help boost a company’s financial condition. The skills and effective tool use will help individuals to learn and do more within their fiels of work.
The Black Belts are considered the primary problem solvers in a Lean and Six Simga process. They are devoted full time to conduct Six Sigma projects, DMAIC Projects. As a Six Sigma Black Belt, your mastery of Six Sigma techniques and strategies will help you lead top-quality projects and mentor Green Belts in your organization, where together you will identify and implement breakthrough improvements for enhanced bottom-line results.
Master Black Belt
Master Black Belt is the highest level of Six Sigma expertise. By the end of this level you will succeed in statistical analysis, strategic and policy planning, as well as implementation. As a Master Black Belt your responsibilities include deployment, training, coaching, mentoring, and providing technical support to Green Belts and Black Belts. Your goal as a master is to cultivate a greater appreciation and understanding of the statistical awareness required to be a Six Sigma leader.
At the beginning of each topic is a detailed review of the must knows from Black Belt level material. One result of building the Master Black Belt curriculum from the Black Belt material is to create a deeper understanding of the DMAIC roadmap. In addition, increasing the knowledge base of statistical methods will assist future Master Black Belts to become better leaders of four week Black Belt programs.
Halal, as per Quaran, means ‘permitted’ or ‘lawful’. Halal certification is necessary for food, cosmetics and other products which come in direct contact with food items. In many countries like: Middle east, Saudi Arabia, Iran etc. Halal certification is necessary to sell the food items. Halal is often used in reference to foods and drinks, i.e. foods that are allowable for Muslims to eat or drink under Islamic Sheridan (law). The criteria specify both what foods are allowable, and how the food must be ready. The foods addressed are mostly types of meat and animal tissue.
Muslims usually use two terms to describe every subject as Halal or Haraam. Halal is an Arabic word which means permitted, legal with respect to which no restriction exists, and the doing and consuming of which the Law-giver, Allah has permitted.
- To educate through continuous promotional tours around India & world with the objective of inspirational and encouraging Muslims to choose and use only Halal certified products.
- To position the halal market as an economically viable tool and induce product manufacturers to make sure that their products are halal certified.
- To facilitate the advertising and sourcing of halal certified products and services for direct manufacturers, buyers, agents, investors and business communities in India and around the world.
- To help global Halal agencies in their hard work to support product manufacturers to look for halal certification for their products and services.
The knowledge of removing waste in any procedures is a premium business skill. The workplace organization and incessant development system of 5S forms the foundation of all waste removal and operational brilliance practices and lean improvement activities.
5S Certification may be as informal as making your own award when your workplace first passes its internal 5S Audit, but it is an important component in having a complete and successful 5S environment.
The purpose of performing 5S Certification is to visibly demonstrate both development and compliance. This is especially important to make improvements in a large workplace with many employees.
Implementing 5S Equals Improved Safety
- Clutter is removed, revealing hidden electrical, chemical or mechanical hazards.
- Employees who have their eyes open for spotting ways to increase using 5S principles will be more conscious of their surroundings and potential safety hazards.
- Cleanliness confirms spills get cleaned up ASAP, eliminating the potential for slips and falls.
- Unsafe practices are eliminated through the standardization step of 5S
- Having needed tools, materials and supplies close to where they are required greatly reduces travel (movement) and as a result reduces the potential for injury.