ISO 9001

Quality Management System


Introduction

The ISO 9000 family of standards relate to quality management systems and are designed to help organizations ensure they meet the needs of customers and other stakeholders. The standards are published by ISO, the International Organization for Standardization and are available through National standards bodies.

ISO 9000 deals with the fundamentals of quality management systems, including the eight management principles on which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard have to meet.

Independent confirmation that organizations meet the requirements of ISO 9001 may be obtained from third party certification bodies. Over a million organizations worldwide are independently certified making ISO 9001 one of the most widely used management tools in the world today.

ISO 9001 specifies the basic requirements for a quality management system (QMS) that an organization must fulfil to demonstrate its ability to consistently provide products (which include services) that enhance customer satisfaction and meet applicable statutory and regulatory requirements.

Overview

The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines relating to quality management systems and related supporting standards.

It helps organizations to improve customer satisfaction and to continually improve its management system through internal audits and management reviews.

    The ISO 9001 series of standards consist of:
  • ISO 9000– Fundamentals and Vocabulary: this introduces the user to the concepts behind the management systems and specifies the terminology used.
  • ISO 9001– Requirements: this sets out the criteria you will need to meet if you wish to operate in accordance with the standard and gain certification.
  • ISO 9004– Guidelines for performance improvement: based upon the eight quality management principles, these are designed to be used by senior management as a framework to guide their organizations towards improved performance by considering the needs of all interested parties, not just customers.
  • Internal quality processes will improve productivity and efficiency.
  • Cost savings can be made through improved efficiency and productivity, as product or service deficiencies will be highlighted.
  • Improvements can be developed, resulting in less waste, inappropriate or rejected work and fewer complaints.
  • Communication, resource planning and quality administration continually improve.
  • Increasing customer expectations and confidence can be achieved through improve productivity, efficiency and communication
  • Implementing continual quality improvement initiatives will improve the organizations’ quality management systems
  • ISO certification can be a positive marketing tool in a competitive marketplace
  • Enables quality measurement

Benefits

  • Implementing a Quality Management System will motivate staff by defining quality terminology, processes their key roles and responsibilities.
  • Staff will gain more quality knowledge and be better trained due to documented policies and procedures.

ISO 14001

Environmental Management System


Introduction

After the adoption of QMS Standards – which eventually lead to ISO 9001 - it was recognised that the same Plan Do Check Act elements could be applied to environmental management systems.

From the 1970s onwards there was greater international awareness of modern society’s impact on the environment and what we know call sustainability. BSI introduced BS 7750 in 1992 and early versions of ISO 14001 were developed from 1992 onwards.

The current version is ISO 14001:2004. It is key to remember that this is an environmental management system (EMS) for environmental policy, compliance, training, improvement and operational controls.

ISO 14001 is not evidence of any particular scientific or technological standards or approaches being used by an organisation to manage their environmental impact - as is sometimes mistakenly believed - although it can be adapted by organisations who have such processes and want to manage their development through an EMS framework.

ISO 14001 is used for certification/registration although there is no necessity to have this third party approval unless an organisation desires it or is required by customers to do so i.e. an organisation can implement an ISO 14001 EMS without having a third party assessment.

Overview

    The main requirements of ISO 14001:2004 are categorized into the following subjects:
  • Policy (which includes a commitment to prevent pollution)
  • Environmental aspects and impacts; environmental planning
  • Management review
  • Evaluation of legal and other requirements
  • Implementation and operation
  • Training and competency of staff and contractors
  • Emergency preparedness and response to pollution and other unplanned environmental events
  • Performance assessment
  • Improvement

ISO 14001 can be implemented alongside ISO 9001:2008, BS OHSAS 18001 or other Standards e.g. Excellence Model, PAS 99. The trend is towards integrating management systems and there is strong commonality in certain areas such internal audit and management review as well as operational controls. Guidance on implementation can be found in books published by ISO amongst others.

Benefits

    These depend on an organisations direct and indirect impact on the environment and their sustainable goals but would include:
  • Improved business focus
  • A more holistic approach to managing environmental risks including reputational and financial risks to the organisation of non-compliance
  • Reduced bureaucracy and parallel processes; yes, this is true! Management systems lead to less bureaucracy if they are properly implemented
  • More effective and efficient audits both internally and externally

Of course, at least some reduced impact on the environment, be it through less energy consumption, less emissions or waste and less wasteful business processes. Some organisations can also support biodiversity protection through their EMS. Whilst not part of ISO 14001 some organisations will implement their Corporate Social Responsibility (CSR) policies and activities alongside their EMS. Synergies can be drawn between the two.

OHSAS 18001

Occupational Health and Safety Management System


Introduction

OHSAS 18001 is a requirement standard that is finding wide application throughout the world (about 55,000 organizations were certified in 2009). The drafting Committee on the OHSAS Project Group represented national standards bodies, regulators, safety practitioners and certification bodies from around the world including the USA, South America, Europe, Malaysia, Japan, Indonesia and China. A number of countries have formally adopted it, such as the UK, as a national standard (BSOHSAS 18001) because it reflects the management principles used in the country for occupational health and safety and is consistent with the way organizations manage their risks.

The BS Committee consisting of HSE, CIEH, TUC, IOSH, BSC, RoSPA, ABI and many industrial Trade Associations including the Federation of Small Businesses were consistent with HSG65 and advanced the management approach to occupational health and safety.

All the documents follow the Plan Do Check Approach (PDCA) as used in ISO 14001 on environmental management which is in line with the EU requirement given in the Framework Directive of 1989 – hazard identification, risk assessment and control of risks that are unacceptable without some preventive measure being applied. The risk based approach has been adopted in many countries throughout the world.

Overview

OHSAS 18001 represents an international consensus on what organizations should manage with respect to occupational health and safety, no matter where they are in the world or what sector they operate in. It focuses equally on occupational ill-health as much as safety as it recognises that increasingly, occupational ill-health is becoming an equally significant cause of human misery and cost to organizations, society and the economy of the country.

It recognises that most countries in the world have laws and regulations in place that must be complied with and the standard must take this into account and not conflict with these requirements. It adopts the risk based approach of identifying what harm could occur and the likelihood of such an event or events happening. The organization is required to control all those that are of concern by establishing a management system to continually improved performance.

    The suite of standards is:
  • OHSAS 18001:2007 Occupational health and safety management systems – Requirements
  • OHSAS 18002: 2008 Occupational health and safety management systems - Guidelines for the implementation of OHSAS 18001:2007
  • BS 18004: 2008 Guide to achieving effective occupational health and safety performance
  • PAS1010: 2011 Guidance on the management of psychosocial risks in the workplace

Requirement standards such as OHSAS 18001 are fairly short and identify what must be in place – the clauses of the document use the term “shall” whereas the international support document OHSAS18002, talks in terms of “should” giving

Benefits

  • Implementing an Occupational Health and Safety Management System can motivate staff as it shows commitment to their welfare – employees then can feel greater commitment to the organization.
  • The reduction in injury to workers is of benefit to both employees and
  • Cost savings can be made through reduced business interruptions and absenteeism and greater motivation.
  • Customers take confidence when seeing organizations managing occupational health and safety as they are more confident that there will be no business interruptions and regulatory action against their supplier.
  • Reduction in insurance premiums can be obtained by improved risk management and improved performance

ISO 22000

Food Safety Management System


Introduction

The ISO 22000 family of standards relate to food safety management systems and are designed to help organizations of any size and at any stage in the food chain to ensure they meet the needs of customers and other stakeholders. The standards are published by ISO, the International Organization for Standardization and are available through National standards bodies.

ISO 22000 deals with the fundamentals of food safety management systems. ISO 22000:2005 deals with the requirements that organizations wishing to meet the standard have to meet. It has been designed to be compatible with other management system standards such as ISO 9001 and can be implemented within an integrated management system.

Independent confirmation that organizations meet the requirements of ISO 22000:2005 may be obtained from third party certification bodies.

ISO 22000:2005 specifies the basic requirements for a food safety management system (FMS) that an organization must fulfil to demonstrate its ability to consistently produce food products which are safe for the end consumer.

The standard can be used for certification/registration and contractual purposes by organizations seeking recognition of their food safety management system. ISO 22000:2005 delivers safe product, and covers all organizations in the food chain, both direct and indirect food chain.

ISO 22000 has been developed to aid harmonisation of approaches to managing food safety, not for just one part of the food chain, but for all organizations in the food chain and for those organizations supplying to the food chain, materials and services that could impact on the safety of food.

The standard combines the key elements to enable management of food safety along the food chain including: integrating the principles of HACCP and application sequence developed by Codex Alimentarius Commission; system management; control of food safety hazards through pre-requisite programmes and HACCP plans; interactive communication with suppliers, customers, regulators and consumers and, continual improvement and updating of the management system.

The standard has been developed as a food safety management system applicable to all organizations in the food chain and to suppliers of services and products to the food chain, and has been designed to enhance communication on food safety issues within the food chain to help raise standards of food safety within the food industry and thus harmonise approached to managing food safety globally.

Overview

ISO 22000 describes the requirements for operating an effective food safety management system integrating the use of the Hazard Analysis and Critical Control Point (HACCP) techniques and defined prerequisites for the safe production of food.

The ISO 22000 model is a systematic approach to developing, planning, validating, establishing, implementing, monitoring, verifying and improving the food safety management system.

    Implementation is split down into several distinct stages including:

  • Management responsibility

    This section of the standard is designed to enable top management to establish and maintain commitment to the development and improvement of a food safety management system. The need for measurable objectives is intended to support top management understanding how the food safety management system is performing and therefore what improvements and updating may be required to enable the ongoing production of safe food.

    • Food Safety Policy: Establish a policy that is appropriate to the role of the organization in the food chain ensuring it conforms to both statutory and regulatory requirements and agreed food safety requirements of customers.
    • Objectives: Establish measurable objectives relating to food safety in support of the food safety policy.
      • System definition:
      • Define the scope of the food safety management system in terms of products, activities and sites.
      • Documented food safety management system.
      • Development of internal and external communication on food safety issues with relevant interested parties.
      • Development of a food safety management system that enables all food safety hazards to be identified and controlled.
      • Establish procedures to manage potential emergency situations that can impact food safety.
    • Responsibilities: Responsibilities and authorities defined and communicated. Appointment of a food safety team leader and establish a food safety team.
    • Review the continued suitability, adequacy and effectiveness of the food safety management system at planned intervals and identify opportunities for improvement and updating of the system.
    • Resources: Provide adequate resources for the development, maintenance, updating and improvement of the food safety system.

  • Planning and realization of safe products

    • All relevant information needed to conduct the hazard analysis shall be collected, maintained, updated and documented.
    • The food safety team shall conduct a hazard analysis to determine which hazards need to be controlled.
    • A combination of control measures shall be put in place and managed through pre requisite programmes and/or by HACCP plans.
    • Traceability systems will need to be implemented to enable the identification of product lots/batches back through to raw materials and delivery records in the event that recall or withdrawal is warranted.
    • There shall be procedures in place to handle potentially unsafe products, withdrawals, disposal.
    • The food safety team shall plan and implement the processes needed to validate control measures and/or control measure combinations before their implementation to test that they will work in practice. They will also need to verify the effectiveness of the system after implementation.
    • Internal audits shall be conducted at planned intervals to determine whether the food safety system conforms to planned arrangements and is effectively implemented and updated.
    • The food safety team shall evaluate the individual results of planned verification and shall analyse the results ,which are then formally reviewed by top management.
    • ISO 22000:2005 Food safety management systems - Requirements for any organization in the food chain
    • ISO 22003:2007 Food safety management systems - Requirements for bodies providing audit and certification of food safety management systems
    • ISO 22004:2005 Food safety management systems -Guidance on the application of ISO 22000:2005
    • ISO 22005:2007 Traceability in the feed and food chain -General principles and basic requirements for system design and implementation

Benefits

  • Applies to all organizations in the global food supply chain.
  • Internationally recognized standard
  • Complies with the Codex HACCP principles.
  • An auditable standard which provides a framework for third-party certification.
  • The structure aligns with the management system clauses of ISO 9001:2008 and ISO 14001:2004.
  • System approach, rather than product approach.
  • Improved documentation.
  • Systematic management of prerequisite programs.
  • Increased due diligence.
  • Dynamic communication on food safety issues with suppliers, customers, regulatory bodies and other interested parties.

HACCP

Hazard Analysis Critical Control Point


Introduction

HACCP, or the Hazard Analysis Critical Control Point system, is a process control system that identifies where food safety hazards may occur in a food production process and puts into place stringent controls to prevent the hazards from occurring. By strictly monitoring and controlling each step of the process, there is less chance for hazards to occur and in this way a food business is able to assure the safety of the food products they produce.

HACCP is used internationally and has been adopted by the joint FAO/WHO Food Standards Programme as the best approach to take to control food borne disease. The Codex Alimentarius Commission was been created under this Programme to develop food standards, guidelines and related texts, one of which is the Codex Basic Food Hygiene Texts which contain the 7 Codex Alimentarius HACCP Principles, and details how they can be applied through the adoption of a 12 step logic sequence. Essentially, it is a food safety system consisting of two main components: the pre-requisite programs and the HACCP plan. HACCP can be applied to all businesses throughout the food chain and forms the basis of a proactive food safety management system. When effectively implemented, HACCP will control biological, physical, chemical and allergen hazards within a food operation.

Implementing a HACCP plan helps assure regulatory authorities and customers that the food business is taking every reasonable precaution to assure food safety. As a proactive approach to managing food safety, it also helps reduce contamination-related food losses and associated costs, and will protect and enhance brands and private labels.

There is no internationally recognized auditing standard for HACCP and while all seven HACCP principles are included in the ISO 22000 standard, HACCP can be implemented as a separate risk management system, or as part of a certification to ISO 9000.

Overview

HACCP is a science based systematic system which identifies specific hazards and measures for their control to ensure the safety of food. HACCP is a tool to assess hazards and establish control systems that focus on prevention rather than relying mainly on end-product testing. Any HACCP system must be capable of accommodating change, such as advances in scientific knowledge about food safety hazards, equipment design, processing procedures or technological developments.

HACCP can be applied throughout the food chain from primary production to final consumption and its implementation should be guided by scientific evidence of risks to human health. As well as enhancing food safety, implementation of HACCP can provide other significant benefits. In addition, the application of HACCP systems can aid inspection by regulatory authorities and promote international trade by increasing confidence in food safety.

The successful application of HACCP requires the full commitment and involvement of management and the work force, along with the implementation of Pre-requisite programmes and HACCP. A HACCP system splits down into 4 distinct stages: Design and development of the plan, validation, verification and review.

Before implementing HACCP, food businesses must already be operating to standards of good hygiene practice by having in place appropriate pre-requisites. HACCP can then be used to control steps in the business which are critical in ensuring the preparation of safe food.

    Prerequisites include measures to control the following basic environmental operating conditions:
  • Cleaning and Disinfection
  • Maintenance
  • Personnel Hygiene and Training
  • Pest Control
  • Plant and Equipment
  • Premises and Structure
  • Services (compressed air, ice, steam, ventilation, water etc.)
  • Storage, Distribution and Transport
  • Waste Management
  • Zoning (physical separation of activities to prevent potential food contamination)

Once the Pre-Requisites have been developed and implemented, the Codex 12 step logic sequence can be used to apply the & Codex HACCP Principles. The codex approach is to identify significant food safety hazards which may occur in the food process and control them.

    The 12 step logic sequence is as follows:
  • Assemble a HACCP team, with a team leader to lead in designing and implementing HACCP. The team must have a good knowledge of the business. Initially, the team will be required to spend a reasonable amount of time and effort to develop and implement the HACCP system.
  • Describe the product(s)
  • Define the intended end user
  • Draw up a flow diagram to show each step of your operation.
  • Validate the flow diagram by walking through the operation to confirm that the flow diagram is correct and check that it covers all the products produced in the particular process being studied.
  • Identify the hazards - Look at each step (e.g. purchasing, delivery, storage, preparation, thermal processing, chilling etc.) in the food process and identify what can go wrong e.g. Salmonella in a cooked chicken product due to cross contamination with raw meat (microbiological hazard), contamination of uncovered food with detergent (chemical hazard) or a piece of broken glass falling into uncovered food (physical hazard).
  • Determine the critical control points (CCPs) - Once hazards have been identified the team must ensure that they are adequately controlled. In general, the majority of hazards are controlled by effective prerequisite programmes, i.e. good hygiene practices. A Critical Control Point (commonly referred to as ‘CCP’) is a step in food processing where a control procedure must be applied to prevent a food safety hazard occurring or reduce it to a safe level. It is the last chance to control a hazard in the process. For example, cooking chicken to a minimum core temperature of 70°C for 2 minutes or equivalent (e.g. 75°C instantaneously) will kill Salmonella and other vegetative pathogens.
  • Establish critical limit(s) - Set limits to identify when a CCP is out of control e.g. the temperature at the centre of the chicken following cooking must reach a minimum 70°C for 2 minutes, or equivalent (e.g. 75°C instantaneously).
  • Establish a system to monitor control of the CCP - When CCPs and critical limits have been identified it is important to have a way to monitor and record what is happening at each CCP. Typically, monitoring will involve measuring parameters such as temperature and time. Monitoring should in all cases be simple, clear and easy to use e.g. recording the final cooking temperature and time for cooking chicken.
  • Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control When monitoring indicates that a CCP is not under control, corrective action must be taken (e.g. the temperature of cooked meat in a refrigerator rises to >10°C for over 24 hours due to a technical fault in the refrigerator. The cooked meat is destroyed and the refrigerator is repaired by the manufacturer to maintain new cooked meat supplies at the correct temperature of >5°C).
  • Establish procedures for verification to confirm the HACCP system is working effectively - The system must be audited regularly and reviewed and whenever changes are made to the operation. If necessary the system may need updating or correcting.
  • Establish documentation concerning all procedures and records appropriate to these principles and their application - For the successful implementation of HACCP, appropriate documentation and records must be kept and be readily available. e.g. cooking temperatures, delivery or cleaning records. It is unrealistic to operate HACCP or to demonstrate compliance with the current legislation without providing evidence such as written records. As with HACCP itself, the complexity of the record keeping will very much depend on the nature and complexity of the business. The aim should be to ensure control is maintained without generating excessive paperwork. The application of HACCP is compatible with the implementation of quality management systems, such as the ISO 9000 series, and is the system of choice in the management of food safety within such systems if ISO 22000 has not been adopted.

Benefits

  • Improved food safety
  • Increased business awareness of food risks
  • Greater product and raw ingredient traceability
  • Increased buyer and consumer confidence
  • Consistency in inspection criteria
  • Promotion of internal review of processes
  • Supports business leadership through the direction of resources to safety critical elements of the process
  • Compliance with food law
  • Reduction in complaints
  • Reduced risk of negative publicity
  • Improved responsiveness to problems through devised corrective action

ISO 50001

ISO 50001 is the new ISO standard for energy savings, is important for the reduction of energy intensiveness of a company’s operation. It is intended to help organisations of all types and sizes manage energy. Certification to ISO 50001 benefits not only manufacturing companies, but also service providers.

Benefits

  • saves energy, and therefore costs
  • assists compliance with legal requirements
  • prevents financial losses in the form of fines

ISO 27001

The ISO 27001 standard was published in October 2005, essentially replacing the old BS7799-2 standard. It is the specification for an ISMS, an Information Security Management System. BS7799 itself was a long standing standard, first published in the nineties as a code of practice. As this matured, a second part emerged to cover management systems. It is this against which certification is granted. Today in excess of a thousand certificates are in place, across the world.

The objective of the standard itself is to "provide requirements for establishing, implementing, maintaining and continuously improving an Information Security Management System (ISMS)". Regarding its adoption, this should be a strategic decision. Further, "The design and implementation of an organization's information security management system is influenced by the organization's needs and objectives, security requirements, the organizational processes used and the size and structure of the organization".

The 2005 version of the standard heavily employed the PDCA, Plan-Do-Check-Act model to structure the processes, and reflect the principles set out in the OECG guidelines (see oecd.org). However, the latest, 2013 version, places more emphasis on measuring and evaluating how well an organisation's ISMS is performing. A section on outsourcing was also added with this release, and additional attention was paid to the organisational context of information security.

    The content sections of the standard are:
  • Context Of The Organization
  • Information Security Leadership
  • Planning An ISMS
  • Support
  • Operation
  • Performance Evaluation
  • Improvement

ISO 10001:2007

Customer satisfaction

Guidelines for codes of conduct for organizations

ISO 10001:2007 provides guidance for planning, designing, developing, implementing, maintaining and improving customer satisfaction codes of conduct. ISO 10001:2007 is applicable to product-related codes containing promises made to customers by an organization concerning its behaviour. Such promises and related provisions are aimed at enhanced customer satisfaction.

ISO 10001:2007 is intended for use by organizations regardless of type, size and product provided, including organizations that design customer satisfaction codes of conduct for use by other organizations. Annex C gives guidance specifically for small businesses.

ISO 10001:2007 does not prescribe the substantive content of customer satisfaction codes of conduct, nor does it address other types of codes of conduct, such as those that relate to the interaction between an organization and its personnel, or between an organization and its suppliers.

ISO 10001:2007 is not intended for certification or for contractual purposes, and it is not intended to change any rights or obligations provided by applicable statutory and regulatory requirements.

ISO 10002:2004

Customer satisfaction

Guidelines for complaints handling in organizations

ISO 10002:2004 provides guidance on the process of complaints handling related to products within an organization, including planning, design, operation, maintenance and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system.

ISO 10002:2004 is not applicable to disputes referred for resolution outside the organization or for employment-related disputes.

It is also intended for use by organizations of all sizes and in all sectors.

    ISO 10002:2004 addresses the following aspects of complaints handling:
  • enhancing customer satisfaction by creating a customer-focused environment that is open to feedback (including complaints), resolving any complaints received, and enhancing the organization's ability to improve its product and customer service.
  • top management involvement and commitment through adequate acquisition and deployment of resources, including personnel training.
  • recognizing and addressing the needs and expectations of complainants.
  • providing complainants with an open, effective and easy-to-use complaints process.
  • analysing and evaluating complaints in order to improve the product and customer service quality.
  • auditing of the complaints-handling process.
  • reviewing the effectiveness and efficiency of the complaints-handling process.

ISO 10002:2004 is not intended to change any rights or obligations provided by applicable statutory or regulatory requirements.

ISO 10003:2007

Customer satisfaction

Guidelines for dispute resolution external to organizations

ISO 10003:2007 provides guidance for an organization to plan, design, develop, operate, maintain and improve an effective and efficient dispute-resolution process for complaints that have not been resolved by the organization.

    ISO 10003:2007 is applicable to:
  • complaints relating to the organization's products intended for, or required by, customers, the complaints-handling process or dispute-resolution process.
  • resolution of disputes arising from domestic or cross-border business activities, including those arising from electronic commerce.
    ISO 10003:2007 is intended for use by organizations regardless of type, size and product provided, and deals with
  • • guidance on determining when and how organizations can participate in dispute resolution.
  • • guidance on the selection of providers and use of their services.
  • • top management involvement in, and commitment to, dispute resolution and deployment of adequate resources within the organization.
  • • the essentials for fair, suitable, transparent and accessible dispute resolution.
  • • guidance on management of an organization's participation in dispute resolution, and monitoring, evaluating and improving the dispute-resolution process.

ISO 10003:2007 is not intended for certification or for contractual purposes. It does not apply to the resolution of other types of disputes, such as employment disputes. It is not intended to change any rights or obligations provided by applicable statutory and regulatory requirements.

ISO 10003:2007 does not apply to complaints handling within an organization.

ISO 10004:2012

Customer satisfaction

Guidelines for monitoring and measuring

ISO 10004:2012 provides guidance in defining and implementing processes to monitor and measure customer satisfaction.

ISO 10004:2012 is intended for use by organizations regardless of type, size or product provided. The focus of ISO 10004:2012 is on customers external to the organization.

ISO 10006:2003

Quality management systems

Guidelines for quality management in projects

ISO 10006:2003 gives guidance on the application of quality management in projects.

It is applicable to projects of varying complexity, small or large, of short or long duration, in different environments, and irrespective of the kind of product or process involved. This can necessitate some tailoring of the guidance to suit a particular project.

ISO 10006:2003 is not a guide to "project management" itself. Guidance on quality in project management processes is discussed in this International Standard. Guidance on quality in a project's product-related processes, and on the "process approach", is covered in ISO 9004.

Since ISO 10006:2003 is a guidance document, it is not intended to be used for certification/registration purposes.

ISO 10015:1999

Quality management

Guidelines for training


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SAFER FOOD , BETTER BUSINESS

Planning and realization of safe products

  • All relevant information needed to conduct the hazard analysis shall be collected, maintained, updated and documented
  • The food safety team shall conduct a hazard analysis to determine which hazards need to be controlled.
  • A combination of control measures shall be put in place and managed through pre requisite programmes and/or by control plans.
  • Traceability systems will need to be implemented to enable the identification of product lots/batches back through to raw materials and delivery records in the event that recall or withdrawal is warranted.
  • There shall be procedures in place to handle potentially unsafe products, withdrawals, disposal.

Validation, verification and improvement of the food safety management system

  • The food safety team shall plan and implement the processes needed to validate control measures and/or control measure combinations before their implementation to test that they will work in practice. They will also need to verify the effectiveness of the system after implementation.
  • Internal audits shall be conducted at planned intervals to determine whether the food safety system conforms to planned arrangements and is effectively implemented and updated.
  • The food safety team shall evaluate the individual results of planned verification and shall analyse the results ,which are then formally reviewed by top management.

5S

5S is Nippon concept for workplace keeping; the name derives from five words that in Japanese start with letter “S”. The decision-making process usually comes from a dialogue about standardization, which builds understanding among employees of how they should do the work. The original concept of 5S has been twisted and partially lost: at first its real meaning was referred to five “good qualities” of a virtuous person or company, the transliteration or translation altered them as step of a process, and for this reason strongly within the framework of standard ISO.

The list describes how to organize a workplace for efficiency and effectiveness by identifying and storing the items used, maintaining the area and useful items, and sustaining the new order, passing through 5 steps:

  • Seiri – Sorting, remove what is not needed and keep what is needed.
  • Seiton – Straightening, arranging properly tools, parts and instructions in such a way that the most frequently used items are the easiest and quickest to locate.
  • Seiso – Sweeping, keep things clean and polished; no trash or dirt in the workplace.
  • Seiketsu – Standardizing, maintain cleanliness after cleaning – perpetual cleaning.
  • Shitsuke – Sustaining, maintain and review standards and do not allow a gradual decline back to the old ways.

Benefits:

  • • successful and continuous improvement
  • • collective collaboration
  • • sense of belonging
  • • participation for one goal

ISO TS 29001

ISO/TS 29001:2010 defines the quality management system for product and service supply organizations for the petroleum, petrochemical and natural gas industries.

The ISO/TS 29001 standard is based on ISO 9001 and incorporates supplementary requirements emphasising defect prevention and the reduction of variation and waste from service providers.

These requirements have been developed separately to ensure that they are clear and auditable. They also provide global consistency and improved assurance in the supply quality of goods and services from providers. This is particularly important when the failure of goods or services have severe ramifications for the companies and industries involved.

This standard is for all organizations working within the oil and gas industry supply chain. Certification to ISO/TS 29001 ensures standardization and improvement within the sector.

    What are the benefits?
  • Gain your licence to trade to increase contracts and prospects
  • Demonstrate your commitment to industry best practice to stakeholders
  • Improve the way you manage risk and increase performance
  • Streamline your operations to improve quality and reduce waste
  • Better communication and regular assessment leads to continual improvement

HSE

HSE Integrated is one of the largest National occupational and industrial safety service companies providing cost effective worker safety solutions, and a comprehensive suite of top professional health, safety, and environmental monitoring services to protect industry workers, corporate assets. Our specialized teams include medical & emergency response services for oil and gas well blowouts fire control & recovery, oilsands mining and heavy oil drilling, maintenance of petroleum refineries and chemical processing facilities, and skilled training and equipment to protect high risk construction workforces. We’ve brought together the best people, equipment and work safe procedures from 20 regional, private industrial safety companies, and consolidated them into an all inclusive workplace site safety service provider and certified industrial health and safety course training systems .

Mission Statement

HSE Integrated's mission is to provide the best safety services in the world.

Core Values Statement

The following values are the guiding principles by which we operate our business and treat our co-workers, clients, and the community:

  • We always work safely
  • We keep our promises
  • We invest in our people
  • We operate with mutual respect, trust and integrity
  • We strive for continuous improvement
  • We know our customers are our future

GMP

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act . These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

Good manufacturing practices (GMP) are the practices required in order to conform to guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a drug product is safe for human consumption. Many countries have legislated that pharmaceutical and medical device manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.

    All guidelines follow a few basic principles:
  • Hygiene: Pharmaceutical manufacturing facility must maintain a clean and hygienic manufacturing area.
  • Controlled environmental conditions in order to prevent cross contamination of drug product from other drug or extraneous particulate matter which may render the drug product unsafe for human consumption.
  • 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.

Practices are recommended with the goal of safeguarding the health of patients as well as producing good quality medicine, medical devices, or active pharmaceutical products. In the United States, a drug may be deemed "adulterated" if it has passed all of the specifications tests, but is found to be manufactured in a facility or condition which violates or does not comply with current good manufacturing guideline. Therefore, complying with GMP is mandatory in pharmaceutical manufacturing.

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 is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.

GLP

In the experimental (non-clinical) research arena, the phrase good laboratory practice or GLP specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.

GLP was first introduced in New Zealand and Denmark in 1972, and later in the US in 1978 in response to the Industrial BioTest Labs scandal. It was followed a few years later by theOrganisation for Economic Co-operation and Development (OECD) Principles of GLP in 1992; the OECD has since helped promulgate GLP to many countries.

GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals) to man, animals and the environment. An internationally recognized definition of GLP can be found as:

  • Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals (only preclinical studies), agrochemicals, cosmetics, food additives, feed additives and contaminants, novel foods, biocides, detergents etc.... GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.

GLP, a data quality system, should not be confused with standards for laboratory safety - appropriate gloves, glasses & clothing to handle lab materials safely.

ISO 20000

Information technology -- Service management

SO/IEC 20000-2:2012 enables organizations and individuals to interpret ISO/IEC 20000-1 more accurately, and therefore to use it more effectively. The guidance includes examples and suggestions to enable organizations to interpret and apply ISO/IEC 20000-1, including references to other parts of ISO/IEC 20000 and other relevant standards.

This includes guidance on the use of an SMS for the planning, design, transition, delivery and improvement of the SMS and services. At a minimum this includes service management policies, objectives, plans, service management processes, process interfaces, documentation and resources. The SMS provides ongoing control, greater effectiveness, efficiency and opportunities for continual improvement of service management and of services. It enables an organization to work effectively with a shared vision.

ISO 27001

Information security management

The ISO 27000 family of standards helps organizations keep information assets secure.

Using this family of standards will help your organization manage the security of assets such as financial information, intellectual property, employee details or information entrusted to you by third parties.

ISO/IEC 27001 is the best-known standard in the family providing requirements for an information security management system (ISMS).

What is an ISMS?

An ISMS is a systematic approach to managing sensitive company information so that it remains secure. It includes people, processes and IT systems by applying a risk management process.

ISO 26000

Social responsibility

Business and organizations do not operate in a vacuum. Their relationship to the society and environment in which they operate is a critical factor in their ability to continue to operate effectively. It is also increasingly being used as a measure of their overall performance.

ISO 26000 provides guidance on how businesses and organizations can operate in a socially responsible way. This means acting in an ethical and transparent way that contributes to the health and welfare of society.

ISO 26000:2010 provides guidance rather than requirements, so it cannot be certified to unlike some other well-known ISO standards. Instead, it helps clarify what social responsibility is, helps businesses and organizations translate principles into effective actions and shares best practices relating to social responsibility, globally. It is aimed at all types of organizations regardless of their activity, size or location.

The standard was launched in 2010 following five years of negotiations between many different stakeholders across the world. Representatives from government, NGOs, industry, consumer groups and labour organizations around the world were involved in its development, which means it represents an international consensus.

ISO 31000

Risk management

Risks affecting organizations can have consequences in terms of economic performance and professional reputation, as well as environmental, safety and societal outcomes. Therefore, managing risk effectively helps organizations to perform well in an environment full of uncertainty.

ISO 31000:2009, Risk management – provides principles, framework and a process for managing risk. It can be used by any organization regardless of its size, activity or sector. Using ISO 31000 can help organizations increase the likelihood of achieving objectives, improve the identification of opportunities and threats and effectively allocate and use resources for risk treatment. However, ISO 31000 cannot be used for certification purposes, but does provide guidance for internal or external audit programmes. Organizations using it can compare their risk management practices with an internationally recognised benchmark, providing sound principles for effective management and corporate governance.

ISO/TS 16949:2009

Quality management systems -- Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations

ISO/TS 16949:2009, in conjunction with ISO 9001:2008, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products.

ISO/TS 16949:2009 is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured.

Supporting functions, whether on-site or remote (such as design centres, corporate headquarters and distribution centres), form part of the site audit as they support the site, but cannot obtain stand-alone certification to ISO/TS 16949:2009.

ISO/TS 16949:2009 can be applied throughout the automotive supply chain.

ISO 13485:2003

Medical devices

ISO 13485:2003 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 13485:2003 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 13485:2003 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 13485:2003 reflect exclusion of design and development controls.

If any requirement(s) in Clause 7 of ISO 13485:2003 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 13485:2003, 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's quality management system.

ISO 10668

Brand valuation

Requirements for monetary brand valuation

ISO 10668:2010 specifies requirements for procedures and methods of monetary brand value measurement.

ISO 10668:2010 specifies a framework for brand valuation, including objectives, bases of valuation, approaches to valuation, methods of valuation and sourcing of quality data and assumptions. It also specifies methods for reporting the results of such valuation.

ISO 10668 is a specification by the International Organization for Standardization (ISO) for the procedures and methods of measuring the value of a brand.

    ISO 10668 applies to brand valuations commissioned for all purposes, including:
  • Accounting and financial reporting
  • Insolvency and liquidation
  • Tax planning and compliance
  • Litigation support and dispute resolution
  • Corporate finance and fundraising
  • Licensing and joint venture negotiation
  • Internal management information and reporting
  • Strategic planning and brand management
    The last of these applications include:
  • Brand and marketing budget determination
  • Brand portfolio review
  • Brand architecture analysis
  • Brand extension planning

Under ISO 10668 the brand valuer must declare the purpose of the valuation as this affects the premise or basis of value, the valuation assumptions used and the ultimate valuation opinion, all of which need to be transparent to a user of the final brand valuation report.



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