ISO 9001:2015 Quality Management System

ISO 9001:2015 specifies the requirements for a quality management system in situations where an organization must demonstrate its ability to consistently provide a product that complies with customer and applicable regulatory requirements, and aims to increase customer satisfaction through the system’s effective application, which includes processes for system improvement and conformity assurance.

It is now the only standard in the ISO 9000 family that allows an external agency to certify your quality system against its requirements. ISO 9001:2015 certification establishes a global standard for customer satisfaction, product quality, and defect reduction.

ISO 9001:2015 ensures that quality management is fully integrated and aligned with your organization’s business strategies. When applied to the management system, the standard acts as a corporate governance tool, assisting in identifying business risks and opportunities that contribute to profitability.

BENEFITS

External Benefits

• When a company has been assessed satisfactorily against ISO 9001, they will be able to display the certification Body’s logo on their correspondence, and an additional logo may be used if the Body is approved by the relevant agency. Benefits of Sales and Marketing:
• The logos will elevate the company’s profile in the marketplace and aid in the expansion of the customer base.
• It demonstrates to larger businesses that the company operates under a controlled system, resulting in fewer customer audits necessary to confirm the company’s ongoing commitment to getting it right the first time.
• It will remove one of the barriers to entry into a potential customer’s approved supplier list.
• ISO 9001 is a global standard, and compliance with it will open international doors in addition to domestic ones.
• Even though it is not required by the standard, the quality manual can be used as a sales and marketing tool, describing the company’s commitment to standards and customer requirements while also promoting the company to new customers.

Internal Benefits

• A properly implemented system reduces production errors and, in the long run, reduces the amount of rectification work required.
• Reduced rectification work, combined with a regularly updated list of suppliers and subcontractors, results in decreased warranty work as the product becomes more reliable.
• The initial implementation will provide the Company with a once-in-a-lifetime opportunity to conduct a comprehensive review of its management systems to ensure they are efficient and effective. It will enable staff to contribute to the system’s development. This results in staff subscribing to and treating the system as their own.
• Regular internal reviews would force the Company to examine itself more closely, ensuring that there are fewer areas where errors could occur.
• Staff members will be more aware of their responsibilities and the importance of demonstrating customer care.
• In certain areas, the implementation of a suitable system may indicate to an insurance company that there is a reduced risk of negligence, resulting in lower insurance premiums.
• It will enhance communication both internally and with customers.
• It enables management to implement procedures and other requirements that it has been attempting to implement for a long period of time but has been unable to do so due to employee resistance.

ISOmantra also provides advisory services for the following quality management standards that are sector-specific:

ISO 10002:2018 Quality management — Customer satisfaction — Organizational guidelines for handling complaints

ISO 10002:2018, published by the International Organization for Standardization, provides guidance on the process of handling complaints about products within an organisation, including planning, design, operation, maintenance, and improvement. The described process for handling complaints is suitable for inclusion as one of the processes within a larger quality management system.

ISO 10002:2018, on the other hand, is not applicable to disputes referred to a third party for resolution or to employment-related disputes.

ISO 10002:2018 specifies the following requirements for complaint handling:

Enhancing customer satisfaction through the establishment of a customer-focused environment that is receptive to feedback (including complaints), the resolution of received complaints, and the organization’s capacity to improve its product and customer service

• Top management commitment and involvement through appropriate resource acquisition and deployment, including personnel training;
• Recognizing and meeting the needs and expectations of complainants; Providing a transparent, effective, and simple-to-use complaints process for complainants;
• Analyzing and evaluating complaints in order to improve the product’s and customer service’s quality; Auditing the complaints-handling process; Conducting a review of the complaints-handling process’s effectiveness and efficiency.

ISO/TS 29001:2010 – Requirements for product and service supply organizations in the petroleum, petrochemical, and natural gas industries It establishes a quality management system for organizations that supply products and services to the petroleum, petrochemical, and natural gas industries.

ISO 29990:2010 – non-formal education and training learning services – Basic requirements for service providers

ISO 9001:2015 QMS FOR AGILE SOFTWARE DEVELOPMENT

• Agile software development may be the answer to the customer’s ever-changing needs.
• ISO 9001 certification will assist software development companies in establishing and managing their internal processes.
• Any organization that designs, develops, replicates, installs, and/or services software/software products can use ISO 9001:2015. Numerous prospective customers, both government agencies and private businesses, require an ISO 9001 certification before awarding a contract to a software development company.
• The Advantages of ISO 9001 Certification in Software Development
• Provides your business with a competitive edge by increasing the marketability of your products and services.
• Customer satisfaction and loyalty are increased.
• Contributes to process improvement in areas such as project management, software development life cycle management, quality assurance and testing, and configuration management.
• Contributes to the identification of competency requirements and actions for achieving competence.
• Define and implement quality-related internal and external communications.
• Reduce throughput and time costs by requiring little or no rework.
• Engages you in a process of continuous improvement.

ISO 9001:2015 Healthcare Quality Management System

• By implementing the ISO Family of Standards, an organization can establish a comprehensive Quality/Business Management System that: The logos will help to elevate the company’s profile in the market and expand its customer base.
• Facilitates increased employee awareness of their roles and responsibilities, as well as improved communication and coordination between departments.
• Establishes measurable improvement objectives and holds individuals accountable for meeting those objectives through monitoring, measuring, and reporting.
• As a result, systems, processes, and outcomes are improved.
• Why should healthcare organizations seek ISO 9001:2015 certification?
• ISO 9001:2015 certification is used in a variety of ways to assist healthcare organizations in identifying systemic risks and breakdowns and addressing gaps or loopholes.
• Identify critical interfaces between processes, departments, and employees.
• Streamline your workflow and make the best use of available resources.
• Prevent problems before they occur.
• Provide mechanisms for detecting and resolving errors and problems.
• Ensure that documented processes are followed and are effective.
• Concentrate on the needs and expectations of both patients and providers.
• Sustain a high level of customer satisfaction.
• Facilitate compliance with quality certifications, accreditation standards, and regulatory requirements in healthcare.
• The advantages of ISO 9001:2015 as a quality management system for healthcare
• ISO 9001:2015 establishes a framework for evaluating organizational processes. Additionally, it enables the organization to define organization-specific quality management objectives and methods. Finally, ISO 9001:2015 includes a system for monitoring and auditing the healthcare quality management system.
• If a healthcare provider is ISO 9001 certified, any subsequent survey process for healthcare quality certifications will be significantly simpler and less expensive in terms of preparation and demonstration of compliance. Provides a firm foundation for meeting all imposed requirements and healthcare quality certifications (e.g., JCAHO, Central, State and Municipal regulations).
• Recognize and address systemic risks and breakdowns.
• Developing hospital-wide processes that adhere to “best practices,” with reference to supporting documentation.
• Assures that documented processes are followed and are effective.
• Patient Care, Satisfaction, and Safety are the primary objectives.
• Reduce errors caused by “hand-offs.”
• Increase the quality of documentation and records.
• Sustain a high level of customer satisfaction.
• Enhance employee comprehension of their respective roles and responsibilities within the healthcare quality management system.
• Convince and build relationships with customers, the community, and insurance companies.
• The foundation for an ongoing initiative of improvement.
• What distinguishes ISO from other standards is that it places a premium on an organization’s ability to establish, document, implement, and maintain a quality management system, as well as continuously improve its effectiveness.

ISO 13485:2016 For Medical Devices

A successful implementation demonstrates a company’s capability to provide medical devices and related services to customers while adhering to regulatory requirements. ISO 13485 is not a product-oriented standard; rather, it focuses on the processes used to develop medical devices. Bear in mind that you must also adhere to all applicable technical standards and regulations pertaining to products and services in this area of expertise.

BENEFITS

• Is globally recognized as the industry’s best quality practices by organizations involved in the medical device industry.
• Allows you to work in a wide variety of countries where it is a regulatory requirement, such as the CE Mark in Europe, and with a wide variety of organizations where it is a contractual requirement or expectation.
• Contributes to the establishment of a systematic framework for monitoring, measuring, and analyzing business processes and customer feedback.
• Contributes to the establishment of a framework for the implementation of actions ns (as necessary) to ensure the achievement of intended results and the continued effectiveness of those processes in accordance with applicable customer, quality, and regulatory requirements.
• Can result in increased performance in key metric areas such as increased sales, increased timeliness in bringing products to the global marketplace, cost savings, fewer errors, less waste, more efficient use of time and resources, and fewer product failures.

The International Standardization Organization – ISO – is one of the oldest and most experienced organisations in the field of industry standardisation, with expertise ranging from quality management to food safety. ISO has established itself as a global benchmark for standardisation, affecting businesses, organisations, policymakers, and various regulations worldwide.

ISO 21001 – Management Systems for Educational Organizations is one of its most recent standards (EOMS). This standard is applicable to educational organisations and the services and products they provide. Although its primary objective is to increase learner and other beneficiary satisfaction, its principles clearly state that being more socially responsible and providing accessible and equitable educational services are also core components of ISO 21001.

ISO 21001 Content Organization

In terms of content organisation, those familiar with ISO management systems will recognise the standard Annex SL structure in ISO 21001. However, this standard contains specific requirements for educational providers and their services and products, and, unlike other ISO standards, Annex A of ISO 21001 (normative) includes additional requirements for early childhood education.

Additionally, its annexes, particularly Annex A, B, and E, are quite lengthy and contain a wealth of information and guidance on ISO 21001 requirements and education-related concepts.

Terminology and Perspectives on ISO 21001

When considering the standard and its requirements from the educator’s or researcher’s perspective, it must be emphasised that the standard does an excellent job of providing a comprehensive document that includes detailed requirements for educational service design and development controls. These are stated explicitly in clause 8 Operation and its subclauses: 8.3.4.4 Controls for the design and development of summative assessments; 8.3.4.3 Controls for the design and development of curricula; 8.3.4.2 Controls for the design and development of educational services; and so forth.

Education for Individuals with Disabilities

What makes this standard particularly impressive is the language used and the emphasis placed on special needs education.

It should be noted that they took special care not to use the term “deficiency,” which implies that students have a deficiency, but rather terms such as “students with special needs,” “exceptionalities,” and so on, which are more consistent with current disability studies in education. This is reinforced further by emphasising the importance of a special education focus from the leadership perspective (clause 5), the requirements for accessible facilities that “ensure that the dimensions of the facilities are adequate to the requirements of those using them” (clause 7.1.3.1), and the requirements for curriculum and instruction modification/adjustment.

Although not explicitly stated, as is customary for ISO/standardization documents, it is clear that the requirements for special needs education are well-developed and reflect – to a degree – the work of Universal Design (UD) and Universal Design for Learning (UDL) principles – whose primary goal is to provide accessible educational opportunities to all students (regardless of their dis/abilities, background, etc.).

Primary packaging materials for medicinal products – Specific requirements for the application of ISO 9001:2015 in conjunction with Good Manufacturing Practice (GMP). It establishes requirements for a quality management system that demonstrates an organization’s ability to provide primary packaging materials for medicinal products that consistently meet customer requirements, including regulatory requirements and applicable international standards. ISO 15378:2011 is a design, manufacture, and supply standard for primary packaging materials for medicinal products. It is also applicable for the purpose of certification.

What is ISO 18788?

ISO 18788 establishes requirements and guidelines for organisations that conduct or contract security operations. Additionally, it establishes, implements, operates, monitors, reviews, maintains, and improves a Security Operations Management System. It enables continuous development of security services while also ensuring customer safety and human rights compliance. This standard demonstrates compliance with applicable laws and regulations, adherence to human rights, and the establishment of professional security operations in order to better serve the needs of customers and stakeholders.

Why is it critical for you to have a Security Operations Management System?

ISO 18788’s significance is based on an organization’s ability to identify appropriate legal and regulatory guidelines while also supporting business functions and the supply chain. This standard is applicable to any organisation that conducts or contracts for security operations. ISO 18788 certification aides in the establishment, implementation, maintenance, and improvement of a Security Operations Management System while also ensuring that the organisation has implemented effective management controls.

Additionally, it demonstrates the organization’s commitment to providing consistently high-quality services that meet customer needs and safeguard both the customer’s and the organization’s reputation, all while adhering to applicable laws and human rights standards.

The ISO 18788 Security Operations Management System has several advantages:

• Assure dependability and establish sound corporate governance
• Ensure the quality and professionalism of security organisations by enhancing credibility and protecting reputation
• Consistently improve customer satisfaction
• Instil trust in customers, governments, and communities
• Enhance the likelihood of operational success

ISO IEC 20000-1 can be used by any information technology service provider to demonstrate its ability to meet the unique service requirements of its customers. Meeting this standard’s requirements demonstrates that an IT service provider is capable of designing, delivering, and improving its services.

A service management system for information technology is a collection of interconnected or interacting elements that service providers use to direct and control their service management activities.

These elements encompass all policies, objectives, processes, procedures, documents, and resources necessary for service providers to direct and control how services are planned, designed, implemented, deployed, monitored, measured, reviewed, maintained, and improved.

• It aids in the alignment of information technology services with business strategy.
• It is structured according to the Plan-Do-Check-Act cycle. Which represents a paradigm shift away from ad-hoc processes toward managed processes. It assists you in identifying and mitigating risks, resulting in cost savings.
• It establishes a formal framework for roles, responsibilities, and accountability at all levels, as well as for establishing, implementing, and monitoring organisational process assets and ensuring continuous improvement.
• With the assistance of this standard, you can establish a baseline for comparison to industry best practises.
• Implementing and certifying to this standard will assist your organisation in gaining a competitive edge by deploying consistent and cost-effective services, thereby enhancing your bottom line and reputation.

Food Safety Management Systems — Requirements for all food-related organisations. ISO 22000 is a new International Standard that aims to ensure the safe supply of foodstuffs worldwide throughout the entire supply chain. The standard primarily addresses food safety concerns and includes requirements for HACCP in accordance with the Codex Alimentarius principles:

• A system of management.
• Manufacturing best practices (pre-requisite Programmes).
• Interactions within the supply chain.
• Insurance premiums are reduced.
• Advantage in the marketplace.
• Enhance your standing.

The requirements are intended to be universally applicable to all activities, including crop and primary source producers, transport and storage operators, retail and food service outlets, and their suppliers, which may include manufacturers of equipment and packaging, among others.

Due to the fact that the standard applies to such a broad range of activities, regardless of their size or complexity, it is by definition generic.

ISO 22000 OR BRC CERTIFICATION?

While both ISO:22000 and BRC Global Standards are designed to be audited by accredited Third Party Certification Bodies, the BRC standards were developed specifically to comply with the United Kingdom’s “due diligence” laws. As a result, they have been divided into several distinct sectors and their requirements are extremely prescriptive. As a result, it appears improbable that ISO.22000, with its generic format, will supplant BRC in this market.

However, retailers outside the United Kingdom are likely to be interested in adopting a common standard that can be applied at all levels of their supply chain, supplementing or replacing ISO 9001, which had previously been the only viable alternative.

System Prerequisites

Businesses wishing to implement the standard must first identify the risks inherent in their specific process using the established HACCP principles defined by Codex Alimentarius. These would need to be incorporated into a formalised management system such as ISO.9001, along with any applicable industry codes of good practise and legal requirements. ISO.22000 contains cross references to these standards to assist in the application of requirements. ISO/TS 22004 provides additional guidance.

BENEFITS

• By complying with the requirements of ISO 22000, an organisation should be able to: Plan, implement, operate, maintain, and update a food safety management system aimed at providing safe products for their intended use.
• Demonstrate compliance with all applicable statutory and regulatory requirements pertaining to food safety.
• Evaluate and assess customer requirements and demonstrate compliance with food safety regulations.
• Interactions within the supply chain.
• Communicate food safety issues effectively to their suppliers, customers, and other relevant stakeholders in the food chain.

Consider the ramifications for an organization if its business were lost, destroyed, corrupted, burned, flooded, sabotaged, or misused. In many cases, it can (and has) resulted in the demise of businesses. The objective of the ISO 22301 Business Continuity Management System (BCMS) is to enable the organization to respond effectively to threats such as natural disasters or data breaches and to safeguard the organization’s business interests. ISO 22301 is applicable to organizations of any size, whether large or small, and in any industry sector.

ISO 22301, a business continuity management system, emphasizes the importance of understanding continuity and preparedness requirements, as well as the necessity of establishing business continuity management policies and objectives, implementing and operating controls and measures for managing an organization’s overall continuity risks, and monitoring and reviewing the business continuity management system’s performance and effectiveness.

Disaster recovery, business recovery, crisis management, incident management, emergency management, and contingency planning are all covered by ISO 22301.

BENEFITS

• It increases contracting opportunities: For many years, both the public and private sectors recognized the benefits of ISO 22301 and began requiring it of their suppliers. By requiring ISO 22301 compliance in all tenders and contracts across the business supply chain.

• It increases the confidence of stakeholders and customers: Confidence in stakeholders and customers is a critical component of ISO 22301. It instils confidence in your business continuity controls system among customers and stakeholders.

• Identification of Potential Risks: Business continuity management systems assist organizations in gaining a clear picture of how they operate, what and where potential internal and external risks to their assets may exist, and where and how their systems, processes, and people may fail.

• Due Diligence: Management frequently uses compliance with, or certification against, an international standard to demonstrate due diligence.

• It can increase employee motivation and participation: When proper processes are in place, employees will feel more at ease in their job roles, resulting in increased job satisfaction and motivation, especially when they are made aware of the critical role they play in the business’s continuity and overall success. Certification to an internationally recognized business continuity management standard is an accomplishment worth celebrating, so certification should be a cause for celebration!
• Continuous enhancement: Continuous improvement is a critical component of all ISO management standards, compelling you to strive for improvement year after year. Thus, the benefits mentioned previously are amplified.

Why is Information Security Needed?

Information is now globally accepted as being a vital asset for most organizations and businesses. As such, the confidentiality, integrity, and availability of vital corporate and customer information may be essential to maintain competitive edge, cash-flow, profitability, legal compliance and commercial image. ISO 27001 is intended to assist with this task. It is easy to imagine the consequences for an organization if its information was lost, destroyed, corrupted, burnt, flooded, sabotaged or misused. In many cases it can (and has) led to the collapse of companies.

ISO 27001 is a specification for the management of Information Security. It is applicable to all sectors of industry and commerce and not confined to information held on computers. It addresses the security of information in whatever form it is held.

The information may be printed or written on paper, stored electronically, transmitted by post or email, shown on films, or spoken in conversation. Whatever form the information takes, or means by which it is shared or stored, ISO 27001 helps an organization ensure it is always appropriately protected. 

Information security can be characterized as the preservation of: 

• Confidentiality- ensuring that access to information is appropriately authorized.
• Integrity- safeguarding the accuracy and completeness of information and processing methods.
• Availability- ensuring that authorized users have access to information when they need it.

 ISO 27001 contains a number of control objectives and controls. These include:

• Security Policy Management
• Corporate Security Management
• Personnel Security Management
• Organizational Asset Management
• Information Access Management
• Cryptography Policy Management
• Physical Security Management
• Operational Security Management
• Network Security Management
• System Security Management
• Supplier Relationship Management
• Security Incident Management
• Security Continuity Management
• Security Compliance Management

The following is a list of potential benefits. As with many items on this website, this is an ongoing project. Please feel free to add further points via the comments option below:

• Interoperability: This is a general benefit of standardization. The idea is that systems from diverse parties are more likely to fit together if they follow a common guideline.
• Assurance: Management can be assured of the quality of a system, business unit, or other entity, if a recognized framework or approach is followed.
• Due Diligence: Compliance with, or certification against, and international standard is often used by management to demonstrate due diligence.
• Bench Marking: Organizations often use a standard as a measure of their status within their peer community. It can be used as a bench mark for current position and progress.
• Awareness: Implementation of a standard such as ISO 27001 can often result in greater security awareness within an organization.
• Alignment: Because implementation of ISO 27001 (and the other ISO 27000 standards) tends to involve both business management and technical staff, greater IT and Business alignment often results.

ISO 26000, or simply ISO SR, is an International Standard developed by the International Organization for Standardization. It provides guidelines for social responsibility (SR). It became available on 1 November 2010. Its mission is to contribute to global sustainable development by encouraging businesses and other organisations to embrace social responsibility in order to mitigate their negative impacts on their workers, natural environments, and communities.

ISO 26000 is a voluntary guidance standard; it does not include any of the requirements associated with standards that are offered for “certification.” There is a learning curve associated with implementing ISO 26000, as there is no explicit external reward – certification – associated with the standard. ISO recommends that users include statements such as “we used ISO 26000 as a guide to integrate social responsibility into our values and practises.”

ISO 26000’s Fundamental Principles and Core Subjects

The Seven Key Principles, which are argued to be the bedrock of socially responsible behaviour, are as follows:

• Accountability
• Transparency
• Ethical conduct
• Respect for stakeholder interests (stakeholders are individuals or groups who are impacted by an organization’s actions or have the ability to influence them).
• Observance of the rule of law
• Respect for international behavioural standards
• Human rights observance
• The Seven Core Subjects that every ISO 26000 user should consider are as follows:
• Governance of organisations
• Rights of the individual
• Workplace customs
• Environment
• Ethical business practises
• Consumer concerns
• Participation and development of the community

SA8000 Accountability to the Public

SA8000 is an auditable certification standard that encourages businesses to develop, maintain, and implement socially responsible workplace practises. It was developed in 1997 by Social Accountability International, formerly the Council on Economic Priorities, with the assistance of an advisory board comprised of representatives from labour unions, non-governmental organisations, civil society organisations, and businesses. The SA8000 standard simplifies the process of navigating industry and corporate codes by providing a common language and measurement standard for social compliance. It is an extremely useful tool for measuring, comparing, and verifying social accountability in the workplace because it can be applied globally to any company in any industry.

Criteria for performance

Additionally, it requires compliance with eight performance criteria, which are detailed on the website of Social Accountability International.

Child Labor: No use or support of child labour; policies and written procedures for resolving situations in which children are found working; adequate financial and other support to enable such children to attend school; and employment of young workers is conditional.

Forced and Compulsory Labor: No use or support of forced or compulsory labour; no required ‘deposits’ – financial or otherwise; no withholding of salary, benefits, property, or documents to compel personnel to continue working; personnel right to leave premises after workday; personnel free to terminate employment; and no use or support of human trafficking.

Health and Safety: Maintain a safe and healthy work environment; prevent occupational accidents; appoint a senior manager to oversee OSH; train all personnel on OSH; implement a system to detect, avoid, and respond to risks; document all accidents; provide personal protective equipment and medical attention in the event of a work-related injury; eliminate or reduce risks to new and expectant mothers; hygiene—toilet, shower, etc.

Associational Freedom and the Right to Collective Bargaining: Respect the right to organise and join trade unions, as well as the right to collective bargaining. All employees have the right to organise trade unions and bargain collectively with their employer. A company must respect workers’ rights to organise unions and bargain collectively; refrain from interfering with workers’ organisations or collective bargaining; educate employees about these rights and their protection from retaliation; allow workers to freely elect representatives where applicable; ensure no discrimination against employees who participate in worker organisations; and ensure representatives have access to workers at all times.

There shall be no discrimination on the basis of race, national or social origin, caste, birth, religion, disability, gender, sexual orientation, union membership, political beliefs, or age. There shall be no discrimination in hiring, compensation, training, promotion, termination, or retirement. There shall be no interference with the exercise of personnel tenets or practises; there shall be no threatening, abusive, exploitative, or coercive behaviour on the job or in company facilities; and there shall be no pregnancy or virginity tests under any circumstances.

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

Hours of Operation: Compliance with applicable laws and industry standards: a normal workweek, excluding overtime, shall not exceed 48 hours; one day off following every six consecutive work days, with certain exceptions; overtime is voluntary, not regular, and limited to 12 hours per week; required overtime is only negotiated in the collective bargaining agreement.

Respect for personnel’s right to a living wage; wages sufficient to meet basic needs and provide discretionary income; deductions not for disciplinary purposes, with certain exceptions; wages and benefits clearly communicated to employees; paid in a convenient manner – cash or check; overtime paid at a premium rate; prohibited use of labor-only consortia.

Its purpose is to help improve the security of supply chains. ISO 28000 can help organizations protect people, products, and property. ISO 28000 applies to any organization that is part of a local, national, or international supply chain. And since almost all organizations belong to a supply chain, it applies to virtually all organizations. It doesn’t matter what size they are or what they do. ISO 28000 applies to both exporters and importers. It applies to airports, seaports, and terminals as well as to organizations that move products by air, sea, rail, or road. It applies to logistics, storage, transportation, and service companies as well as to manufacturers, shippers, wholesalers, and distributors.

ISO 28000 defines a set of security management requirements. If your organization is part of a supply chain, ISO 28000 expects you to establish a security management system (SMS) that complies with 
these requirements. It then expects you to use this system to protect people, products, and property.

A SMS is a network of interrelated and interacting elements that combine to resist, fend off, or withstand unauthorized acts that are designed to cause intentional harm or damage to a supply chain. 
These elements include a security management policy as well as the many objectives, targets, programs, procedures, plans, practices, processes, controls, documents, records, roles, relationships,
responsibilities, authorities, and resources that are used to implement this policy.

ISO 37001 is a certification standard for Anti-Bribery Management Systems that was published in 2016. DQS is the preferred partner for a value-adding certification experience, with highly qualified ISO 37001 auditors located throughout the world.

No organisation can afford to take the risk of bribery lightly in the age of transparency. Investors, business associates, employees, and shareholders all want to know that management has taken every precaution to avoid bribery at all levels of the organisation. Implementing ISO 37001 and obtaining certification from a third-party independent auditor enables you to do just that.

ISO 37001 is a standard that was created to assist organisations in establishing and maintaining a proactive anti-bribery system. The standard, which supersedes British Standard 10500, contains a number of requirements that represent internationally recognised anti-bribery best practises. The standard is applicable to organisations of all sizes.

BENEFITS

• The standard establishes minimum requirements for the implementation of an anti-bribery management system and provides supporting guidance.
• ISO 37001 certification demonstrates to management, investors, business associates, employees, and other stakeholders that an organisation has taken appropriate anti-bribery measures.
• By implementing the standard’s measures, the risk of malpractice is reduced.
• Implementation and certification can be used to demonstrate due diligence in the event of a disagreement.
• ISO 37001 is structured similarly to ISO 9001, ISO 14001, and ISO 45001 and can be easily integrated into existing management systems.
• Our auditors identify areas for improvement and make recommendations to help your anti-bribery system function more effectively during the certification audit.

ISO 44001:2017 defines the requirements for effectively identifying, developing, and managing collaborative business relationships within and between organisations. ISO 44001 is applicable to any organisation regardless of its type, size, or location.

“As [businesses] increase their reliance on external parties to deliver solutions and increase their use of outcome-based contracting, the emphasis on collaborative working will grow,” the Institute for Collaborative Working states about the standard’s significance.

ISO 44001 is based on the British Standard BS 11000 and conforms to the ISO High Level Structure.

 ISO 44001 addresses eight stages of the life cycle, which are based on BS 11000. They are as follows:

• Operational consciousness
• Knowledge
• Internal evaluation
• Selection of a partner
• Collaborating
• Creating value
• Remaining united
• Execution of the exit strategy

Business relationships come in a variety of shapes and sizes. From long-term partnerships to one-off transactions, ISO 44001 enables organisations to maximise the value of each relationship.

Of all the standards within the ISO 14000 series, ISO 14001 is the standard that specifies the requirements for an organization’s EMS. The Environmental Management System (EMS) document is the central document controlling the interaction of the core elements in the organization, and provides a third-party auditor with the key information necessary to understand the environmental management systems in place. It is a “tool” that enables an organization of any size or type to control the impact of its activities, products or services on the environment. As in the case of ISO 9001, the key to a successful ISO 14001 EMS is having documented procedures that are implemented and maintained so that they describe environmental goals and their place in all other company-wide activities. ISO 14001 standards require sites to document and make an Environmental Policy available to the public. In addition, procedures should be established for a continuous review of the environmental aspects and the impacts of products, activities, and services. Based on these environmental aspects and impacts, then goals and objectives are established that are consistent with the environmental policy. As with a QMS, Internal Audits of the EMS should be conducted routinely to ensure that non-conformances in the system are identified and addressed. In addition, the management review process must be in place to ensure top management’s involvement in the assessment of EMS.

BENEFITS

• Providing your company with assurance that you meet, and will continue to meet, your legal and corporate policy requirements.
• Providing potentially fewer surveillance visits from regulatory agencies.
• Showing your business partners, regulatory agencies, and community that you are environmentally responsible.
• Increasing competitiveness.
• Increasing profits through potential process improvements.
• Reducing your environmental liability.
• Reducing costs as a result of potentially lower insurance rates.
• Complying with environmental laws and regulations.
• Improving relationships with regulators – organizations that implement an ISO 14001 EMS often report improved relations with government regulatory agencies, find that regulators are quicker to provide technical support, and find that the regulators are much more supportive in general.
• Capturing institutional knowledge – ISO 14001 ensures this information is properly documented, communicated and retained. The cyclical nature of this management system further ensures all system information is reviewed and updated at least annually.
• Streamlining operations – organizations often realize monetary savings as a result of greater operational efficiency and energy conservation.
• Increased awareness and participation – organizations benefit from better communication about environmental issues inside and outside the organization.  ISO 14001 gives people an avenue to raise environmental issues and makes it clear that environmental performance is an important part of the corporate culture.
• Safety benefits : by reviewing the procedures for controlling significant operations, including a review of emergency preparedness and response procedures, organizations are able to identify and implement significant safety improvements.

ISO 45001:2018 gives clearer direction to an occupational health and safety management system. ISO 45001:2018 is an audit/certification specification, not a legislative requirement or a guide to implementation. It should be noted that ISO 45001:2018 does not state specific performance criteria, or give detailed specifications for the design of a management system. Instead, the system is geared towards reducing and preventing accidents and accident-related loss of lives, resources, and time.

ISO 45001:2018 has been developed to be compatible with the ISO 9001 (Quality) and ISO 14001 (Environmental) management systems standards. It is its hope that any organization that implements OHSAS 18001:2007 can easily integrate it with other quality, environmental or occupational health and safety management systems. The ISO 45001:2018 Specification follows the Plan-Do-Check-Review cycle, with a concurrent emphasis on continual improvement. This model aligns well with the structure of other management system documents such as ISO 14001, thus aiding the progress of integrated management systems.

The elements of ISO 45001:2018 includes Policy and commitment, Hazard identification, risk assessment & risk controls, Legal requirements, Objectives and Programs, Organization and personnel, Training, Communication and Consultation, Documentation and records, Operational Controls, Emergency Readiness, Measurement and monitoring, Accident and incident investigation, corrective and preventive action, Audit and Review, and Application and

BENEFITS

Most organizations pursue ISO 45001:2018 certification to qualify for a tender or to achieve preferred supplier status: e.g. for a Local Authority. However, there are many other benefits that can be gained, including:

• Reduced risk to employees, customers and suppliers.
• Reduction in the costs associated with accidents at work.
• Enhanced staff morale and motivation.
• Demonstrate legal compliance.
• Reduced insurance premiums.
• Competitive advantage.
• Enhance status.

In a competitive market, your customers are looking for more than just keen pricing. Organizations need to demonstrate that their delivery is managed efficiently and responsibly and that they can provide a reliable service: free of the downtime associated with work-related accidents and incidents.

An effective occupational health and safety management system promotes a safe and healthy working environment by providing a framework that allows your organization to identify and control its health and safety risks, reduce the potential for accidents, aid legislative compliance and improve overall performance.

In addition, ISO 45001:2018 is designed to be compatible with other management system standards such as ISO 9001 (Quality), ISO 14001 (Environmental) and ISO 27001 (Information Security). All or any combination of these complementary standards can be integrated seamlessly. They share many principles, so choosing an integrated management system can provide you with outstanding value for money.

It can be used by any organization at a strategic or organizational level regardless of its type, activity or size. It can be applied towards the achievement of any and all types of objectives at all levels and areas within an organization related to the risk. It can be used to help manage processes, operations, functions, projects, programs, products, services, and assets. ISO 31000 defines a set of guidelines.

ISO 31000 is used by a wide range of  stakeholders, including people who need to:

• Establish a risk management policy.
• Ensure that risk is managed properly.
• Manage and control risk within an organization.
• Evaluate risk management practices and processes.
• Develop risk management procedures and guides.

BENEFITS

When properly implemented and applied, ISO 31000 will help you to:

• Better organizational  ability to identify threats and opportunities.
• Encourage personnel to identify and treat risk.
• Help you allocate and use risk treatment resources.
• Develop your risk management controls.
• Improve loss prevention and incident management activities.
• Improve the overall resilience of your organization.
• Increase the likelihood that risk related objectives are achieved.
• Improve operational efficiency and effectiveness.
• Improve the effectiveness of your governance activities.
• Improve  your organization’s enviromental, health and safety performance.
• Encourage and support continuous organizational learning.
• Comply with legal and regulatory requirements.
• Improve the trust and confidence of your stakeholders.
• Enhance both mandatory and voluntary reporting.

The standard specifies the requirements for establishing, implementing, maintaining and improving an energy management system, whose purpose is to enable an organization to follow a systematic approach in achieving continual improvement of energy performance, including energy efficiency, energy security, energy use and consumption. The standard aims to help organizations continually reduce their energy use, and therefore their energy costs and their greenhouse gas emissions. The system is modeled after the ISO 9001 Quality Management System and the ISO 14001 Environmental Management System (EMS).

Governments increasingly want to reduce the Greenhouse Gas Emissions of their citizens and industries, and are imposing legislative mechanisms to compel carbon reduction more and more frequently. A significant feature in ISO 50001 is that there is no quantitative targets specified – an organization chooses its own then creates an action plan to reach the targets. With this structured approach, an organization is more likely to see some tangible financial benefits. Furthermore, Organizations of all types and sizes increasingly want to reduce the amount of energy they consume

BENEFITS

• Reduce costs,
• Reduce the impact of rising costs,
• Meet legislative or self-imposed carbon target, and
• Enhance the organization’s reputation as a socially responsible organization.

According to WHO – Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product.

According to the International Pharmaceutical Excipients Council (IPEC) of Europe The supply chain of a pharmaceutical excipient starts at the point of manufacture and continues until used by the finished product manufacturer. Apart from the manufacturer, other parties may be involved in the chain, including distributors, transporters and warehousing companies, forwarding agents, traders, and brokers. Although some of these parties do not have direct contact with the product (e.g., transporters), those that do (e.g., re-packagers, processers, samplers, testers) require a higher level of control and Good Distribution Practice (GDP) to be applied.

ISOmantra offers a comprehensive simulated Inspection. We identify the areas where the current compliance status needs to be improved. The Audit Report will summaries the GAP between the requirements laid down in the different legislations and Guidance documents and contains recommendations to close the GAP.

According to the International Pharmaceutical Excipients Council (IPEC), as IPEC-Americas and IPEC Europe and the Pharmaceutical Quality Group (PQG), the quality of excipients is critical to assure the safety, quality and efficacy of medicines. Excipients have a wide range of applications and are essential components of the drug product formulation. Characteristics that excipients impart to formulated drug products include cosmetic appearance, stability and delivery of the active ingredient. Therefore, applying appropriate Good Manufacturing Practice (GMP) principles to excipients is essential. In contrast to finished dosage forms and Active Pharmaceutical Ingredients (APIs), there are no specific GMP regulations for excipients. In addition, there are a large number of applications of this diverse range of materials which makes the development of excipient GMP guidelines challenging. However, there is a general expectation that excipients are manufactured to recognised GMP principles.

IPEC – PQG Good Manufacturing Practice Guidelines FOR PHARMACEUTICAL EXCIPIENTS proposes GMP appropriate for the manufacture of excipients. The text of the guidelines aligns with the corresponding clauses in ISO 9001:2008. This Guide proposes to make an essential contribution to the wider understanding and attainment of good manufacturing practice appropriate for the excipient supply industry. Excipient manufacturers and their customers can be assured that excipients manufactured according to this Guide will meet internationally accepted good manufacturing practice principles.

ISOmantra offers a complete conformity assessment solution for IPEC – PQG GMP for Pharmaceutical Excipients including training, auditing and certification services. It is also possible to integrate your existing management systems of other standard such as ISO 9001 and ISO 14001, and saving you valuable time and resources.

Cosmetics – Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices

·   Good Manufacturing Practices (GMP) – ISO 22716

·   Council Directive 76/768/EEC

The European Union’s new Regulation (EC) No 1223/2009 requires cosmetic products to be manufactured according to Good Manufacturing Practices (GMP).

A manufacture of cosmetics can demonstrate compliance with GMP by implementing the International Standard ISO 22716:2007.

ISO 22716 presents a management systems approach to documenting and regulating the production, control, storage, and shipment of cosmetic products. The standard’s guidelines will provide your organization with practical methods for managing the many factors that can affect product quality. These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the personnel engaged in the plant, nor do they cover aspects of protection of the environment. The guidelines in ISO 22716:2007 are not applicable to research and development activities and distribution of finished products.

This is an asset management system standard designed to assist businesses in managing their assets and their usage more effectively. This standard was created primarily to give organisations greater control over their daily operations by allowing them to earn a higher rate of return on their assets while minimising risk.

ISO 55001:2014 directs an organization’s efforts toward enhancing overall asset management in order to meet business and legal requirements while also satisfying stakeholders. It not only saves time and money, but also optimises asset utilisation while adding value to your business.

This standard is intended to assist businesses and organisations in enhancing their current and future performance. This assists the business in aligning its objectives with the pre-defined asset management objectives, thereby assisting the business in achieving its objectives. Assets are not only an investment for the business; they can also become a drain on the business’s resources at times. This highlights the critical importance of a business keeping a close eye on how its assets are managed.

ISO 55001:2014 enables a business to demonstrate significant organisational growth by efficiently carrying out the following activities:

• Asset management that is effective
• Risk management
• Enhancing the financial performance of the organisation as a whole
• ISO 55001:2014 is critical in demonstrating an organization’s ability to run a streamlined operation that is both asset-light and efficient. The following are some of the benefits of ISO 55001:
• Possessing a demonstrated ability to manage assets effectively can give you an edge over competitors and assist you in meeting the conditions and compliance requirements of prospective partners and clients.
• It provides the business with comprehensive information and control over the assets’ lifecycle.
• It enables process improvement by maximising asset utilisation.
• It improves operational efficiency through cost savings from redundancies and more efficient asset utilisation.
• increases the business’s overall profitability.
• assists the business in determining how legal and regulatory compliance can be improved.

Capturing both the costs and revenue associated with physical infrastructure investment is critical. When assets are overused, they will fail, resulting in delays, repairs, and replacements. However, if the asset is idle, valuable capital is being held in an inefficient manner. By implementing an asset management system effectively, organisations can reduce their total cost of ownership over the asset’s lifecycle and increase the efficiency and effectiveness of investment, maintenance, and disposal decisions. This would contribute to the growth of the business by coordinating initiatives, processes, resources, and functional contributions. Additionally, it would mitigate the risk of interruptions or delays caused by safety incidents.

Concerning R2v3 and RIOS Responsibly Recycled Materials. The Rv3 standard complies fully with the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal (the “Basel Convention” or “Convention”). R2v3 mandates practises that go beyond current international legal requirements for the export of used electronic equipment for material recovery or reuse in a number of areas.

• Under a slew of international agreements, including the Basel Convention, legal requirements governing the classification, collection, and management of used equipment and e-waste are evolving in a number of countries and at the global level.
• R2v3 requires recyclers to develop, implement, and maintain a legal compliance process that complies with all applicable environmental, health, and safety, and data security requirements.
• An R2v3 electronics recycler must implement and maintain an Environmental, Health, and Safety Management System (“EHSMS”) that is certified to an accredited management system standard, such as RIOS or a combination of ISO 14001 and ISO 45001.
• R2v3 requires recyclers to positively identify, document, and track all international shipments of end-of-life (“EOL”) and untested equipment that contains Focus Materials. EOL equipment containing Focus Materials would be considered hazardous waste under the laws of some countries.

Taken together, these requirements ensure that R2v3 certified recyclers have the information and management system infrastructure necessary to ensure compliance with applicable local, national, and international legal, regulatory, and/or statutory requirements.

ISOmantra provides R2:v3 and RIOS Responsible Recycling Advisory Services. These services include the following:

• A comprehensive front-end analysis of your facility
• Management Systems for the Environment, Health, and Safety
• Strategies for Reuse, Recovery, and Disposal
• Compliance with all applicable environmental, occupational health and safety, and data security laws
• Best Practices to ensure worker protection as well as the health and safety of the general public
• Effective supply chain management of downstream focus materials
• Reliable repair and maintenance of reusable equipment and components
• Establishment of an R2v3-compliant data tracking and destruction process
• Establishing the documentation systems required to demonstrate compliance with the R2v3 Standard.

IATF 16949:2016 is a global quality management standard for automobiles. Curated by members of The International Automotive Task Force (IATF) in 1999, the International Organization for Standardisation (ISO) has since approved three editions of this certification for industry use, the most recent of which was published in 2016.

This management certification programme aims to develop a standardised set of methods and techniques for processes and product development in collaboration with manufacturers in the global automotive industry. The IATF 16949 certification programme is focused on continuous improvement, waste reduction, variation reduction, and defect prevention in automotive processes, ensuring that everything manufactured meets exceptionally high customer standards and supply chain efficiency.

The IATF 16949 standard covers nearly every aspect of automotive processes, including the design, development, production, installation, and servicing of automotive products and devices.

When used in conjunction with ISO 9001, this quality management system maintains close communication with the ISO 9001 platform and is capable of bridging the gap between automotive processes and customer-specific automotive requirements.

WHO ARE THE INTERNAL AID TRAFFIC FORCES (IATF)?

The International Automotive Task Force is a group of automotive manufacturers who work together to enhance and improve their processes and production lines for global consumers of their products.

Their goals are as follows:

• To define and develop consensus on international fundamental quality system requirements, primarily for direct suppliers of production materials, product or service components, or finishing services to participating companies (e.g., heat treating, painting and plating).
• To develop policies and procedures for the IATF’s third party registration scheme in order to ensure global consistency.
• To provide appropriate training to meet the requirements of ISO/TS 16949 and the IATF registration scheme.
• To develop formal relationships with appropriate bodies in order to further the IATF’s objectives.

WHICH ENTITIES REQUIRE IATF 16949 CERTIFICATION?

If your organisation is a part of the automotive supply chain, your contractors, clients, or governing bodies may expect you to adhere to IATF 16949 regulations. Existing certification holders must reapply every three years to ensure their processes continue to meet the required quality management standard.

A quality management system certified to IATF 16949 will assist you in continuously monitoring and managing quality throughout your business, allowing you to identify areas for improvement and ensure that everything runs smoothly. This is the quality system required by international automotive businesses to operate at the highest level.

A sustainability report is an organizational report that gives information about economic, environmental, social and governance performance. Sustainability reporting is not just report generation from collected data; instead it is a method to understand, internalize, measure, improve and communicate their economic, environmental, social and governance performance and an organization’s commitment to sustainable development in a way that can be demonstrated to both internal and external stakeholders

What we offer:

• In-house training on sustainability reporting
• Workshops on preparing sustainability reports including: stakeholder identification, materiality testing for indicators
• Consulting on data management and sustainability reporting monitoring systems
• Consulting on authorship of sustainability reporting
• Sustainability report preparedness audits – ensuring that reports are ready for external assurance
• Independent third party assurance on sustainability reports

Compliance management systems — Requirements with guidance for use

ISO 37301 is a management system standard of Type A that specifies the requirements and guidelines for establishing, developing, implementing, evaluating, maintaining, and continuously improving a compliance management system (CMS). A CMS enables organisations to take a structured approach to meeting all compliance obligations, including those that are mandatory, such as laws, regulations, court rulings, permits, and licences, as well as those that are voluntary, such as internal policies and procedures, codes of conduct, standards, and agreements with communities or non-governmental organisations.

ISO 37301 is applicable to all organisations regardless of their size, nature, or degree of complexity. CMS is founded on the values of integrity, sound governance, proportionality, openness, accountability, and sustainability.

As is the case with the majority of management system standards, ISO 37301 adheres to the ISO-developed high-level structure (HLS). The HLS structure defines the commonly used terminology and definitions, as well as the clause sequence (1–10), in which the CMS requirements are defined in clauses 4–10. The HLS enables organisations to integrate multiple management systems, which means they can use a CMS as a stand-alone management system or integrate it with other existing management systems.

Why is ISO 37301 critical for businesses?

Consistent compliance with compliance obligations is a requirement, not an option, for organisations seeking growth and long-term success. A CMS built on the ISO 37301 requirements and guidance provides organisations with a set of tools (policies, processes, and controls) for establishing and maintaining a compliance culture.

Organizations that use an ISO 37301-compliant content management system (CMS) commit to sound corporate governance standards, best practises, and ethical behaviour. The CMS, on the other hand, cannot entirely eliminate the risk of noncompliance. ISO 37301’s requirements and guidance assist organisations in identifying and responding to noncompliance in this regard. In some jurisdictions, the presence of a CMS can be interpreted as an indication of an organization’s diligence and commitment to compliance, which can aid in mitigating legal liability and reducing penalties for violations of applicable laws.

ISO 37301 establishes requirements for competence, communication, and awareness. By adhering to these requirements, organisations ensure that top management’s vision is translated and ingrained in the behaviour of managers and employees. ISO 37301 also requires and encourages the establishment of succinct and effective policies, procedures, and controls that establish a compliance culture and high ethical and integrity standards within organisations.

ISO 37301 outlines the path to compliance, which begins with the top-down setting of the organization’s tone. The organization’s governing body and top management demonstrate their commitment to a strong compliance culture through a compliance policy and the establishment of compliance objectives at various levels. Additionally, the governing body and top management must demonstrate leadership and commitment by allocating necessary resources, establishing a compliance function, and clearly defining roles and responsibilities. Above all, the governing body and top management should demonstrate their commitment to the CMS in a proactive and visible manner through their actions and decisions.

The advantages of implementing ISO 37301 in a business

By implementing a content management system (CMS) based on ISO 37301, organisations can:

• Conduct a formal third-party assessment of their CMS’s conformance
• Create a positive compliance culture
• Address compliance concerns expeditiously and effectively
• Maintain their reputation and integrity by preventing and detecting unethical behaviour.
• Enhance commercial opportunities and sustainability
• Consider the requirements and expectations of internal and external stakeholders.
• Establish strong and mutually beneficial relationships with regulators
• Increase third-party confidence in the organization’s ability to sustain success
• Increase customer confidence and loyalty