Management System Certification

ISO 9001:2015 Quality Management System - New Standard New Approach

During the last decade, various elements affecting businesses and operation methodology of each business itself have been changed, radically. Geography, technology, Culture, Policies, Human Competency as well as Political Stability has started playing vital roles in each business, eventually affecting business results in terms of growth or downfall. In simple words, such factors are proving itself as 'Risks'.

ISO 9001 standard emphasizes on elimination of various risks from business and makes it sustainable in the long run. This standard is also called as a complete business standard that enhances overall profitability and strengthens organization - customer relationship. Implementation of management system w.r.t. ISO 9001 standard requirement makes every organization, small or big, a profit making centre permanently.

Businesses extracts benefit from best practices. ISO 9001 system focuses on making every process accountable and error free. Basic quality management is a result of good practices.

This international standard, ISO 9001, defines the areas common to all businesses that affect quality performance and the procedures that should be in place to ensure that customer requirements are fully met in a controlled and measured way.

ISO 13485:2016 - Quality Management System For Medical Devices - New Standard New Approach

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

All requirements of ISO 13485:2016 are specific to organizations providing medical devices, regardless of the type or size of the organization.

If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2016 reflect exclusion of design and development controls.

If any requirement(s) in Clause 7 of ISO 13485:2016 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.

The processes required by ISO 13485:2016, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization.

ISO 14001:2015 Environmental Management System - New Standard New Approach

ISO 14001 set of international standards brings a world-wide focus to the environment, encouraging a cleaner, safer, healthier world for all. This guideline encourages organizations to focus environmental efforts so that air, water and soil neither gets polluted cause of the organization's processes.

New ISO 14001 standard reduces conflicts between various groups working on environmental aspects throughout the world by providing them single interpretation of good environmental practice. Nowadays, in most of the regions of the world, it is becoming necessary to certify organization w.r.t. ISO 14001 environmental standard guidelines.

The standards apply to all types and sizes of organizations and are designed to adapt all sort of diverse geographical, cultural and social conditions. Organizations, similar in size and also engaged in similar activities, may implement different environmental management systems and monitor its performance in different way. Organization implementing this standard is bound to comply with applicable legislation, regulations and law of the land.

By complying with the requirements of this standard, organization enhances social bonding with the surrounding community.

ISO 15378:2017 Quality Management System for Primary Packaging Products for Medicinal Products

This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.

ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

ISO 45001:2018 Occupational Health and Safety Management System

ISO 45001:2018 is an occupational health and safety management system standard that promotes safe and healthy working environment for all people working within the organization at all levels. This management system enables an organization to prevent potential risk from happening in actual and improve performance of its processes.

ISO 45001:2018 helps the organization to define the occupational health and safety policies and objectives, including compliance to legal and other requirements. An organization implementing this standard shall focus to minimize risks, accidents and hazards, improve employee motivation and involvement. During implementation of this system, approach of top management has to be centralized in order to meet with current Occupational Health & Safety Management Standards as well as the law of the land. In many countries, OHSAS 18001 is becoming a mandatory requirement of Ministry Of Health And Industry.

Many national bodies like BSI, ANSI, JIS and others have developed standard based on these specifications or on their own.

ISO 10002:2004 Quality Management - Customer Satisfaction

ISO 10002:2004 gives guidance on the procedure for complaints handling related to products within an organization, including planning, design, operation, preservation and development. The complaint handling procedure described is appropriate for use as one of the procedures of an overall quality management system.

The handling of complaints through a procedure as described in ISO 10002 should improve client approval. Encouraging customer feedback (including complaints) should offer opportunities to maintain or develop client loyalty and approval, and progress domestic and international competitiveness.

ISO PAS 17712:2013 Freight Containers - Mechanical Seals Certification

ISO 17712:2013 establishes uniform processes for the classification, receipt, and withdrawal of mechanical freight container seals. It offers a single source of information on mechanical seals which are satisfactory for securing freight containers in global commerce.

What is new in ISO 17712:2013?
Proof of tampering remains an essential area in the new edition, but there is a significant change in approach. The new edition addresses tampering via third party procedure inspections as part of the manufacturer’s ISO 9001 quality operational processes.

ISO 17712 no longer needs third party laboratory testing against exact tamper related criteria. Instead, the necessity for tamper-related quality processes include internally-generated and -managed tests of tamper proof as part of a manufacturer’s documented quality program like ISO 9001.

A manufacturer may choose to conduct the tamper-evident testing in-house or employ a third party laboratory. In any case the testing would be against the manufacturer’s test protocol and specification. Since Clause 6 has neither tamper-evident test procedures nor a necessity for accredited testing, an outside lab cannot certify conformance with ISO 17712 Clause 6. A third party lab in such a condition basically provides a lab report to its client.

ISO 20000:2011 - IT Service Management System

ISO/IEC 20000 is the first worldwide standard specifically aimed at IT Service Management. It describes an integrated set of management processes for the effective delivery of services to the business and its customers.

ISO/IEC 20000 is aligned with and complementary to the process approach defined within ITIL from the Office of Government Commerce (OGC).

ISO/IEC 20000-1:2011 is the formal Specification and defines the requirements for an organization to deliver managed services of an acceptable quality for its customers. The scope includes:

• Requirements for a management system
• Planning and implementing service management
• Planning and implementing new or changed services
• Service delivery process
• Relationship processes
• Resolution processes
• Control processes and
• Release processes

ISO/IEC 20000-2:2011 is the Code of Practice and describes the best practices for Service Management processes within the scope of ISO/IEC 20000-1.

To ensure the quality, reliability and continuity of information technology services, an organization needs to implement methodologies and tools. Incorporating the principles of ISO 9001 and the major ITIL processes, ISO 20000-1 acts as a single framework for the delivery of an organisation’s Information Technology services.

ISO 22000:2018 - Food Safety Management System

ISO 22000:2018 Food Safety Management System specifies requirements for a food safety where an organization in the food manufacturing as well as supply chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption.

Food safety is a concern throughout the globe as human health issues can significantly impact on business and its growth in the real manner. ISO 22000:2018 specifies requirements to enable an organization

• To plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for the consumer,
• To demonstrate compliance with applicable statutory and regulatory food safety requirements,
• To evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction,
• To effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain,
• To ensure that the organization conforms to its stated food safety policy,
• To demonstrate such conformity to relevant interested parties, and
• To seek certification or registration of its food safety management system by an external organization, or make a self-assessment or self-declaration of conformity to ISO 22000:2018.

ISO 22716:2007 - Quality Management System for Cosmetic Producers

Europe, biggest market will require cosmetic products to be manufactured according to Good Manufacturing Practices (GMP). European Union’s new Regulation (EC) No 1223/2009 has decided 11 July 2013 as deadline for cosmetics producers to get their system certified as per ISO 22716 guidelines. Cosmetics manufacturers should prepare for this new requirement now in order to avoid any loss of market approval.

The entire focus of this international standard is to enhance quality of product and maintain very high quality hygiene. The requirements specified to demonstrate compliance with GMP are also in line with ISO 9001 Quality Management System that introduces a management systems approach to documenting and regulating the production, control, storage, and shipment of cosmetic products. The standard’s guidelines will provide interested organization practice suitable methods for controlling many factors that can affect product quality.

In order to spread thorough awareness among cosmetics manufacturers, Geotek Global is getting in touch with professionals in this industry, collecting and also updating necessary information with customers. Our team members are having in depth knowledge in the health and beauty segment, therefore we absolutely hold an edge while implementing GMP in manufacturing processes. In addition, Geotek Global has complete solution in terms of training and error free documentation tools.

*Pursuant to the regulations in effect, ISO 22716 certification constitutes a presumption of compliance, and does not replace inspections by the relevant authorities.

ISO 22301:2012 - Societal Security - Business Continuity Management Systems

This standard is addressed by leading business continuity specialists and gives the best framework for managing business stability in an organization. Requirements have been set out the principles, procedures and terminology of business continuity planning and protecting critical operations during times of crisis. It identifies the needs for establishing and implementing a stability management plan and acts as a reference point for all organizations, industries and sectors.

Standard covers the necessities for a robust business continuity management system, which will permit the company to minimize the risk associated with disruptions and to make sure control is maintained at all times. Disruptions to your business can result in revenue loss, data risk breakdowns and failure to deliver regular customer services as per service level agreements.

ISO 27001:2013 - Information Security Management System

ISO 27001 helps organizations to implement information security management systems (ISMS) to deal with increasingly competitive markets and the security requirements of customers, both implicit and explicit.

Certification to ISO 27001 adds value to the measures taken to protect the assets of your customers, as well as your own.

Certification of an organization w.r.t. ISO 27001 demonstrates its capacity to regularly identify the assets within its environment, define suitable protection measures and manage a coherent and effective information security system. Complemented by ISO 17799:2005 "Code of practice for information security management" and the July 2002 OECD guidelines, the ISO 27001 standard provides a framework for setting up, maintaining and improving a management system.

Built with the Approach Process and PDCA Model, it acts as a tool for all sectors and companies, subjected to strong competition and specific customer requirements.

ISO 28000:2007 - Specification for Security Management Systems for the Supply Chain

ISO 28000:2007 identifies the needs of a security management system, including those aspects dangerous to security assurance. Security management is linked to many other aspects of business management. Aspects include all activities controlled by organizations that impact on supply chain security. Other aspects should be considered where and when they have an impact on security management, including transporting these goods beside the supply chain.

For organizations working within, or relying on, the logistics industry, certification to the ISO 28000:2007 supply chain management standard offers a precise framework. It will minimize the risk of security incidents and therefore support offer problem-free 'just in time' delivery of goods and supplies.

The standard is appropriate for all sizes and types of organizations that are involved in the production of goods, manufacturing, services, storage or transportation at any stage of the products, enlargement or movement in the supply chain. It recognizes necessities for implementing and operating an SMS, including organization (security) structure, authorized personnel dependable for security management, assessing and maintaining competence of personnel and training for personnel responsible for security.

ISO 29990:2010 Learning Services for Non-Formal Education and Training

ISO 29990 is a quality management system standard for providers of education and training services. It provides a unified model for a quality and professional mode of operation, as well as an ordinary reference point for both LSPs and their clients for the conceptualization, development and delivery of the particular programme.

Learning Services Management Systems have been developed in reaction to the need for a generic model for professional practice and quality performance of learning service givers. The standard is essentially subdivided into two areas: learning services (for example, these services include designing, given that and monitoring of learning services) and management of the learning service supplier for example business planning, financial management, risk management as well as human resources management.

This Standard is the first Standard for learning providers that are applicable and applied on an international scale. The advantages for learning providers are transparency of their own services, global comparability and defined procedures for quality assurance.

ISO 50001:2011 - Energy Management System

Today 'Energy' is biggest resource for every industry and nation as well. Any industry, any nation that utilises 'Energy' in a right manner becomes successful in the long term. Effective energy management systems (EnMS) help interested organizations to establish processes to improve energy performance.

The new ISO 50001 Energy Management standard does not only focuses to improve energy performance, but also cut production or service costs, make operations easier and exceed customer expectations. In the long run 'Satisfied Customers' will make sure that you grow gradually.

By implementing ISO 50001 Energy Management System organization can reduce product costs, Greenhouse Gas (GHG) emissions and subsequent environmental impacts. ISO 50001 establishes an international framework for the supply, use and consumption of energy in industrial, commercial and institutional organizations.

In many countries, Energy & Resource Ministry is promoting this system in the industry and also providing support to interested organizations during implementation. Various national standard bodies have started adopting this standard as effective tool. ISO 50001 is need of today….. not tomorrow.

One of the noteworthy point is that there is no standard in existence named as ISO 50000. This is not a series like other ISO standards ISO 9000, 14000 and 27000. ISO 50001 is only one standard for energy management system certification. But ISO 50001 system can be developed, implemented and integrated with other ISO standards.

• Enable an organization to achieve continual improvement in its energy use and consumption or energy performance through a systematic approach
• Reduce emission of Green House Gases (GHG) and impact on the environment
• Protect interest of surrounding society, nation by complying with statutory & regulatory requirements
• Promote energy management best practices and reinforce good energy management behaviours
• Facilitates management to take decision on factual energy consumption data
• Promotes new technology to come in industry that reduced energy consumption

SA 8000:2014 - Social Accountability Standard

The most widely recognized global standard for managing human rights in the workplace is Social Accountability International's SA 8000:2001. It is the first auditable standard, suitable for organizations of all sizes anywhere in the world, and provides a framework for assuring all of your stakeholders that social accountability is 'Common Goal Of Management'.

Followings are key elements of the standard
Child Labor: No use or support of child labor; policies and written procedures for remediation of children found to be working in a situation; provide adequate financial and other support to enable such children to attend school; and employment of young workers conditional.

In many countries, Energy & Resource Ministry is promoting this system in the industry and also providing support to interested organizations during implementation. Various national standard bodies have started adopting this standard as effective tool. ISO 50001 is need of today….. not tomorrow.

Forced and Compulsory Labor: No use or support for forced or compulsory labor; no required 'deposits' - financial or otherwise; no withholding salary, benefits, property or documents to force personnel to continue working; personnel right to leave the premises after workday; personnel free to terminate their employment; and no use nor support for human trafficking.

Health and Safety: Provide a safe and healthy workplace; prevent potential occupational accidents; appoint senior manager to ensure OSH; instruction on OSH for all personnel; system to detect, avoid, respond to risks; record all accidents; provide personal protection equipment and medical attention in event of work-related injury; remove, reduce risks to new and expectant mothers; hygiene- toilet, potable water, sanitary food storage; decent dormitories- clean, safe, meet basic needs; and worker right to remove from imminent danger.

Freedom of Association and Right to Collective Bargaining: Respect the right to form and join trade unions and bargain collectively. All personnel are free to: organize trade unions of their choice; and bargain collectively with their employer. A company shall: respect right to organize unions & bargain collectively; not interfere in workers’ organizations or collective bargaining; inform personnel of these rights & freedom from retaliation; where law restricts rights, allow workers freely elect representatives; ensure no discrimination against personnel engaged in worker organizations; and ensure representatives access to workers at the workplace.

Discrimination: No discrimination based on race, national or social origin, caste, birth, religion, disability, gender, sexual orientation, union membership, political opinions and age. No discrimination in hiring, remuneration, access to training, promotion, termination, and retirement. No interference with exercise of personnel tenets or practices; prohibition of threatening, abusive, exploitative, coercive behavior at workplace or company facilities; no pregnancy or virginity tests under any circumstances.

Disciplinary Practices: Treat all personnel with dignity and respect; zero tolerance of corporal punishment, mental or physical abuse of personnel; no harsh or inhumane treatment.

Working Hours: Compliance with laws & industry standards; normal workweek, not including overtime, shall not exceed 48 hours; 1 day off following every 6 consecutive work days, with some exceptions; overtime is voluntary, not regular, not more than 12 hours per week; required overtime only if negotiated in the CBA.

Remuneration: Respect right of personnel to living wage; all workers paid at least legal minimum wage; wages sufficient to meet basic needs & provide discretionary income; deductions not for disciplinary purposes, with some exceptions; wages and benefits clearly communicated to workers; paid in convenient manner – cash or check form; overtime paid at premium rate; prohibited use of labor-only contracting, short-term contracts, false apprenticeship schemes to avoid legal obligations to personnel.

Management Systems: Facilities seeking to gain and maintain certification must go beyond simple compliance to integrate the standard into their management systems and practices.

Go-Green Certification

Go Green Certification helps every business and organization to understand & reduce environmental impact and improve sustainability. In Creative Management Consultants, we define key areas and specific guidelines in categories such as recycling, water conservation, energy conservation, waste reduction and "environmentally friendly" purchasing.

Going Green Is Saving Green

Many organizations presume that implementing system to save the environment and will add the cost in their operations without adding value to the services. Whereas this is not the fact. If 'Go Green' fundamentals are implemented in the right manner, the system itself will take care of the organization and reduce overall operation cost in the long run.

Save a drop of water today, collect ocean after year. Save a piece of paper today, see a dense forest after year. Benefits are dependent upon our point of view. Throughout the globe, many countries are trying to motivate manufacturing, service, education, retail, real estate, transport, aviation and rest all industries to start implementation of this framework with a common goal 'Going Green Is Saving Green' There is growing interest in a voluntary kind of environmental work that is still in its infancy stage in India, but luckily it is growing every day. The followings are key benefits.

• Lower operating cost and increase asset value
• Reduced waste sent to landfills
• Less energy and water consumption

This will surely deliver only one possible result .... 'A Better Tomorrow'.

It's hard to overlook, among the many striking advantages to Going Green, particularly how it takes less time to pay back upfront, the cost compared to non-green business and services.

Not only is there a long-term cost saving by going green, there are other benefits. Studies have illustrated employee productivity and increase academic performance increase when working on an infrastructure where the air inside cleaner and there's natural light. As a result, morale improves, absenteeism decreases, there are fewer sick days and health costs go down. There's also evidence to support claims that retail sales jump into stores where there's more natural light, and hospitals with elements of sustainable design experience earlier discharges.

At Creative Management Consultants, we take pride in leading initiatives. We understand our relationship with the society; our efforts shall help our nation to grow by preventing loss of energy, enhancing resource utilization in a better way and protecting our 'Mother Nature'.

WHO GMP

A good manufacturing practice (GMP) is a production and testing practice that helps to ensure a quality product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Basic concepts of all of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products. In the U.S. a drug may be deemed adulterated if it has passed all of the specified tests, but is found to be manufactured in a condition which violates current good manufacturing guideline. Therefore, complying with GMP is a mandatory aspect in pharmaceutical manufacturing.

Although there are a number of them, all guidelines follow a few basic principles:

• Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
• Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
• Instructions and procedures are written in clear and unambiguous language (Good Documentation Practices).
• Operators are trained to carry out and document procedures.
• Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
• Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
• The distribution of the drugs minimizes any risk to their quality.
• A system is available for recalling any batch of drug from sale or supply.
• Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.

GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company sets up its quality program and manufacturing process, there may be many ways it can fulfil GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.