Industry Standards Normative

A standard is a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose. For businesses, they are strategic tools that reduce costs by minimizing waste and errors, and increasing productivity. They help companies to access new markets, level the playing field for developing countries and facilitate free and fair global trade.

Tuning Fork will help you ensure that products and services are safe, reliable and of good quality, and that your business is operating, as a minimum, in conformity to the regulations, legislation, industry norms, statutory requirements and standards that the particular field of business operation entails. This is done through standards such as ISO 9001, ISO 14001 and other certifications.

ISO 9001 Quality Management System

ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001.

This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. These principles are explained in more detail in the pdf Quality Management Principles. Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefit.
Get an overview of ISO 9001 in this powerpoint presentation>

Preview revisions of ISO 9001:2015 watch >
https://www.youtube.com/embed/Lp6xP-We5yY?fs=1&autoplay=1&rel=0

ISO 14001 Environmental Management System

The ISO 14000 family of standards provides practical tools for companies and organizations of all kinds looking to manage their environmental responsibilities.

ISO 14001:2015 and its supporting standards such as ISO 14006:2011 focus on environmental systems to achieve this. The other standards in the family focus on specific approaches such as audits, communications, labeling and life cycle analysis, as well as environmental challenges such as climate change.

Get an overview of ISO 14001 in this powerpoint presentation>

Preview revisions of ISO 14001:2015 watch>
https://www.youtube.com/embed/_hs54V3x1VQ?fs=1&autoplay=1&rel=0

OHSAS 18001 Occupational Health, Safety & Security Management System

OHSAS 18001 sets out the minimum requirements for occupational health and safety management best practice. Work with us to bring work health and safety (h&s) into your business and you can achieve the maximum return for your employees, your operations and your customers.

OHSAS 18001 is a framework for an occupational health and safety (ohs) management system and is a part of the OHSAS 18000 (sometimes incorrectly identified as ISO 18000) series of standards, along with OHSAS 18002. It can help you put in place the policies, procedures and controls needed for your organization to achieve the best possible working conditions and workplace health and safety, aligned to internationally recognized best practice.

ISO 45001 Occupational Health & Safety Management System

The burden of occupational injuries and diseases is significant, both for employers and the wider economy, resulting in losses from early retirements, staff absence and rising insurance premiums.

To combat the problem, ISO is developing a new standard, ISO 45001 Occupational health and safety management systems - Requirements, that will help organizations reduce this burden by providing a framework to improve employee safety, reduce workplace risks and create better, safer working conditions, all over the world.

The standard will follow other generic management system approaches such as ISO 14001 and ISO 9001. It will take into account other International Standards in this area such as OHSAS 18001, the International Labour Organization's ILO-OSH Guidelines, various national standards and the ILO's international labour standards and conventions. The standard is expected to be published in December 2017.

ISO 22301 Business Continuity Management System

This International Standard specifies requirements for setting up and managing an effective Business Continuity Management System (BCMS). Understand and prioritize the threats to your business with the international standard for business continuity. ISO 22301 specifies the requirements for a management system to protect against, reduce the likelihood of, and ensure your business recovers from disruptive incidents.

A BCMS emphasizes the importance of:
— understanding the organization's needs and the necessity for establishing business continuity management policy and objectives,
— implementing and operating controls and measures for managing an organization's overall capability to manage disruptive incidents,
— monitoring and reviewing the performance and effectiveness of the BCMS, and
— continual improvement based on objective measurement.

ISO 26000 Corporate Social Responsibility

ISO 26000 outlines international recommendations for making your organization more socially responsible. It will guide you in building and delivering a long-term social responsibility strategy, whatever the nature of your business. ISO 26000 can help you address everything from working practices to environmental policies, sustainable development and the communities that you impact.

Social responsibility has become one of the most important factors to measure your organization’s performance and this is true of all sectors of society. Social responsibility is an organization’s legal and voluntary duty to consider its social and environmental impact of its decisions and activities. A corporate responsibility strategy outlines the ways that an organization contributes to sustainable development, engages with its stakeholders and behaves ethically.

ISO/IEC 27001 Information Security

You simply can’t be too careful when it comes to information security. Protecting personal records and commercially sensitive information is critical. ISO/IEC 27001 helps you implement a robust approach to managing information security (infosec) and building resilience.

Internationally recognized ISO/IEC 27001 is an excellent framework which helps organizations manage and protect their information assets so that they remain safe and secure. It helps you to continually review and refine the way you do this, not only for today, but also for the future. That’s how ISO/IEC 27001 protects your business, your reputation and adds value.

ISO 31000 Risk Management System

ISO 31000 is the international standard for risk management. By providing comprehensive principles and guidelines, this standard helps organizations with their risk analysis and risk assessments. Whether you work in a public, private or community enterprise, you can benefit from BS ISO 31000, because it applies to most business activities including planning, management operations and communication processes.

Whilst all organizations manage risk to some extent, this international standard’s best-practice recommendations were developed to improve management techniques and ensure safety and security in the workplace at all times.

By implementing the principles and guidelines of BS ISO 31000 in your organization, you’ll be able to improve operational efficiency, governance and stakeholder confidence, while minimising losses. This international standard also helps you to boost health and safety performance, establish a strong foundation for decision making and encourage proactive management in all areas.

ISO 55001 Energy Management System

The purpose of this International Standard is to enable organizations to establish the systems and processes necessary to improve energy performance, including energy efficiency, use and consumption. Implementation of this International Standard is intended to lead to reductions in greenhouse gas emissions and other related environmental impacts and energy cost through systematic management of energy.

This International Standard is applicable to all types and sizes of organizations, irrespective of geographical, cultural or social conditions. Successful implementation depends on commitment from all levels and functions of the organization, and especially from top management.

ISO 22000 Food Safety

ISO 22000 is an international standard that defines the requirements of a food safety management system covering all organisations in the food chain from “farm to fork”.

The benefits of ISO 22000 FSMS to your business are manifold and include:
* Introduce internationally recognized processes to your business
* Give suppliers and stakeholders confidence in your hazard controls
* Put these hazard controls in place across your supply chain
* Introduce transparency around accountability and responsibilities
* Continually improve and update your system so it stays effective

BRC Food Safety

Developed by the British Retail Consortium (BRC), a UK trade organization that represents the interests of UK retailers, the BRC's Global Standard for Food Safety was created to establish a standard for due diligence and supplier approval to:

Improve your food safety management systems
Demonstrate your commitment to food safety standards
Increase confidence in the quality and safety of your products
Make sure your suppliers also follow good hygiene practices
Monitor your system to achieve continuous improvement.

HACCP Food Safety Analysis & Control

Hazard Analysis Critical Control Point (HACCP) is a management system to uphold food safety through the analysis and control of physical, microbiological, chemical and allergenic hazards across the entire process from procurement and receipt of raw material to manufacturing, distribution and consumption of finished product. This is a mandatory requirement for all European food processing entities as per Regulation EC 852/2004 on the hygiene of foodstuffs.

ISO 29990 Non-formal Education & Training

BS ISO 29990 would benefit anyone offering or procuring non-formal education and training such as vocational training, lifelong learning and in-company training (either outsourced or in-house).

If you provide learning services in non-formal education and training, this specifies the basic requirements for delivering services. This new standard is also intended to provide reassurance for organizations and individuals buying learning services in the global market.

BS ISO 29990 is intended to provide a generic model for quality professional practice and performance, and a common reference for learning service providers (LSPs) and their clients in the design, development and delivery of non-formal education, training and development. This International Standard uses the term “learning services” rather than “training” in order to encourage a focus on the learner and the results of the process, and to emphasize the full range of options available for delivering learning services.

IATF 16949 Automotive (Replaces ISO/TS.16949)

This is the global technical specification and quality management standard for the automotive industry. Based on ISO 9001:2015, it was published in October 2016 and replaces ISO/TS 16949. It is designed to be used in conjunction with ISO 9001:2015 and contains supplemental requirements specific to the automotive industry rather than being a standalone QMS.

It brings together standards from across Europe and the US. IATF 16949:2016 outlines everything you need to know about achieving best practice when designing, developing, manufacturing, installing or servicing automotive products.

ISO 13485 Medical Devices

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

With over 150 BSI QMS assessors globally supported by BSI product experts, our ISO 13485 certificates are known and trusted in the medical device industry by authorities, suppliers and manufacturers around the world.
ISO 13485:2016 is here

The world’s most popular standard for medical devices quality management has been revised for the first time since 2003.

Good Distribution Practice (GDP)

Good Distribution Practices (GDP) is based on Directive 92/25/EEC and EU 2013/C 68/01 guidelines on GDP of medicinal products for human use. These requirements provide worldwide-accepted practices for the proper distribution of medicinal products for human consumption.

This standard can help you identify the gaps of your current system to achieve compliance and/or certification, establish procedures and implement them, giving your customers the confidence in a quality assured service and a secure supply chain.

Good Manufacturing Practice (GMP)

The EU governs medicinal products via the EudraLex rules and regulations. Volume 4 of EudraLex specifically addresses Good Manufacturing Practice (GMP) and presents the guidelines to ensure that pharmaceutical products are consistently produced and controlled and do not pose any risk to the consumer. GMP covers all aspects of production, training and personal hygiene of staff controlled via detailed, written procedures.

This standard will help you identify the gaps of your current system to achieve compliance and/or certification, establish procedures. Understanding and implementing these regulations will add to your credentials providing evidence that procedures are consistently followed throughout the manufacturing process.

PS 9000 Pharmaceuticals Packaging

This guide aims to assist suppliers of pharmaceutical packaging materials to
understand and implement the Quality Management System (QMS) of ISO
9001 and the application standard of PS 9000. It supplements the following
documents:
• ISO 9001 which specifies the requirements of the international QMS
standard
• ISO 9004 gives guidance on ISO 9001
• PS 9000 is an application standard written by the PQG for suppliers of
pharmaceutical packaging materials that integrates ISO 9001 and ISO
9004 together with additional Good Manufacturing Practices (GMP)
requirements particular to these suppliers.

Companies complying with PS 9000 will comply with ISO 9001 and also the
additional GMP requirements endorsed by the highly regulated pharmaceutical
industry.

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