ISO Consultancy Services
(Available in Malaysia)
ISO Management System
What is Quality Management Systems (ISO 9001)?
ISO 9001 is a series of Quality Management Systems (QMS) Standard created by the International Organization for Standardization (ISO), a federation of 132 national standards bodies. The ISO 9001 Quality Management Systems standards are not specific to products or services, but apply to the processes that create them. The standards are generic in nature so that they can be used by manufacturing and service industries anywhere in the world.ISO 9001 is an internationally-recognized standard for business management, which ensures that businesses are operating to the same standards of meeting customers requirements. Its purpose is to define, identify and confirm quality benchmarks within organizations. It applies to the processes that create and control the products and services an organization supplies. It prescribes systematic control of activities to ensure that the needs and expectations of customers are met. It is designed and intended to apply to virtually any product or service, made by any process anywhere in the world.
Benefit of Quality Management Systems
A well designed and implemented Quality Management Systems has been shown to provide organizations with the following benefits:- Organizations implementing ISO 9001 and obtain registration will assures customers that the company has a good Quality Management Systems in place. An organization with an effective QMS will typically meet customer expectations better than an organization that does not have an effective QMS.
- An ISO 9001 certificate enhances organization image in the eyes of customers, employees and shareholders alike.
- ISO 9001 certified organizations experience increased productivity and improved financial performance, compare to uncertified organizations.
- An organization with ISO 9001 certification has a competitive edge over nonqualified companies. They can make claims about quality; ISO 9001 certified companies have proof of their commitment to quality and continuous improvement.
- Mutually beneficial supplier relationships are one of the key attractions to ISO 9001 certification. Many organizations require their suppliers to have ISO 9001 Registration.
- ISO 9001 can help organization to manage their processes to become more efficient and cost-effective. From this, improvements can be developed, resulting in less waste, inappropriate or rejected work and fewer complaints. Customers will notice that orders are met consistently, on time and to the correct specification. This can open up the market place to increased opportunities.
What is Environmental Management Systems (ISO 14001) ?
ISO 14001 is a global series of Environmental Management Systems (EMS) standards, providing a framework for organizations to demonstrate their commitment to environmental responsibility. An EMS enables an organization to control the environmental aspects and impacts of its activities, products and services by establishing targets and objectives related to identify environmental management goals. Once implemented, an EMS will improve compliance with legislative and regulatory requirements, reduce exposure to liability, prevent pollution, reduce waste and create a more positive public image.A typical Environmental Management Systems (EMS) includes an environmental policy; looks at the environmental impact and aspect of products, activities, and services; sets environmental objectives; meets legal and regulatory requirements; provides training to employees; and provides for oversight and auditing procedures.
All the requirements in ISO 14001 are intended to be incorporated into any Environmental Management Systems. The extent of the application will depend on factors such as the environmental policy of the organization, the nature of its activities, products and services and the location where and conditions in which it functions.
The most important of organization registered to ISO 14001 is to demonstrate environmental management practices, able to prevent environmental disasters and government sanctions and experience fewer regulatory audits by correcting environmental problems.
Benefit Of Environmental Management Systems
By having an Environment Management Systems has been shown to provide organizations with the following benefits:- Organizations can reduce their costs by using fewer raw materials and producing less waste. This may also lead to reduced taxes and illegal bills.
- Poor environmental performance is likely to discourage potential customers; good performance will widen markets and improve public relations.
- The volume of environmental legislation is increasing. Organizations need to keep abreast of new legislation to avoid expensive legal and remediation costs. Implementing Environmental Management Systems will help by formalizing the methods for accessing relevant legislation and monitoring and measuring critical processes.
- Investors like green portfolios since they respond to ethical demands and show that a company cares.
- Building awareness of environmental concern among employees.
- Reducing environmental, health and safety risks.
- Organization having a system of continuous improvement.
- More efficient and less hazardous production processes.
What is Occupational Health and Safety Management Systems (OHSAS 18001)?
OHSAS 18001 developed by a group of European standards bodies, is an occupational health and management systems (OHSMS) standard designed to create a safer workplace. An Occupational Health & Safety Management Systems is a framework that allows an organization to consistently identify and control its health and safety risks, reduce the potential for accidents, aid legislative compliance and improve overall performance.OHSAS 18001 is the assessment specification for Occupational Health & Safety Management Systems. It was developed in response to the need for companies to meet their health and safety obligations in an efficient manner.
OHSAS 18001 is essentially a planned and documented approach to occupational health and safety. An organization that has implemented OHSAS 18001 has a clear management structure delegating authority and responsibility, a clear set of objectives for improvement, with measurable results and a structured approach to risk assessment. OHSAS 18001 also requires arrangements to be put into place to monitor health and safety management failures, audit performance and review organizations' policies and objectives. It is intended to address occupational health and safety rather than product and services safety.
OHSAS 18001 has been developed to be compatible with the ISO 9001 (Quality Management Systems) and ISO 14001 (Environmental Management Systems) management systems standards. It is its hope that any organization that implements OHSAS 18001 can easily integrate it with other quality or environmental management systems.
Benefit Of Occupational Health and Safety Management Systems
Since the early industrial age, the need to reduce and eliminate the occurrence and costs of occupational injuries, illness and fatalities has been a common goal for many organizations. Improved Occupational Health and Safety performance brings many benefits to your company, employees, business partners and key stakeholders. Key advantages and benefits to OHSAS 18001 registrations can include:- Commitment from the top required by OHSAS 18001 will lead an organization to be more health and safety focused.
- Demonstrate your commitment to health and safety to stakeholders.
- Demonstrated commitment to your employees, their families and all interested parties that you care about the health, safety & wellness of each person that may be exposed to the health and safety risks associated with the activities and operations of your organization.
- Reduced costs for insurance premiums, compensation or penalties for breach of legislation.
- Identification of new legislation in adequate time to address appropriate issues.
- Solid ground to establish sound assessment and control of the Occupational Health & Safety risks. Improved safety levels by controlling hazards and risks. Better management of health and safety risks, now and in the future.
- Integration of multiple Occupational Health & Safety programs under the umbrella of one common management system. Implement, maintain and continually improve an Occupational Health & Safety Management System.
- Maintain / improve organization's public reputation in the health and safety industry.
What is Food Safety System Certification (FSSC 22000)?
Food Safety System Certification (FSSC) 22000 contains a complete certification scheme for Food Safety Systems based on the food safety management standard ISO 22000: 2005 requirements for any organization in the food chain and the publicly available specification for pre-requisite programs on food safety for food manufacturing, BSI PAS 220: 2008. Manufacturers that are already certified against ISO 22000:2005 will only need an additional review against BSI PAS 220:2008 to meet this certification scheme.It is developed for the certification of food safety systems of food manufacturers that process or manufacture animal products (not including slaughtering and pre-slaughtering), perishable vegetal products, products with a long shelf life and (other) food ingredients like additives, vitamins and bio-cultures
The FSSC 22000 certification scheme has been given full recognition by the Global Food Safety Initiative Board of Directors. This follows an extensive benchmarking process using the requirements laid out in the GFSI Guidance Document Version 5, and an addendum which was issued in December 2009.Food Safety System Certification (FSSC) 22000 contains a complete certification scheme for Food Safety Systems based on the food safety management standard ISO 22000: 2005 requirements for any organization in the food chain and the publicly available specification for pre-requisite programs on food safety for food manufacturing, BSI PAS 220: 2008. Manufacturers that are already certified against ISO 22000:2005 will only need an additional review against BSI PAS 220:2008 to meet this certification scheme.
It is developed for the certification of food safety systems of food manufacturers that process or manufacture animal products (not including slaughtering and pre-slaughtering), perishable vegetal products, products with a long shelf life and (other) food ingredients like additives, vitamins and bio-cultures
The FSSC 22000 certification scheme has been given full recognition by the Global Food Safety Initiative Board of Directors. This follows an extensive benchmarking process using the requirements laid out in the GFSI Guidance Document Version 5, and an addendum which was issued in December 2009.
What is PAS 220:2008?
Publicly Available Specification (PAS) 220:2008 is a standard which specifies requirements for pre-requisite programs to assist in controlling food safety risks within the manufacturing processes of international food supply chains. This PAS is intended to be used in conjunction with ISO 22000:2005, which is the internationally recognized standard for food safety management systems.ISO 22000:2005 sets out specific food safety requirements for organizations in the food chain. PAS 220:2008 has been developed to be used to support management systems designed to meet the requirements specified in ISO 22000:2005 in a detailed manner.
Where and who developed PAS 220:2008?
The development of PAS 220:2008 was sponsored by the Confederation of the Food and Drink Industries of the European Union (CIAA) and the major food manufacturers, Danone, Kraft, Nestlé and Unilever, contributed to the development of the Specification. Representatives from the Food and Drink Federation (FDF), McDonald's, General Mills Europe (representing the FDF Food Hygiene Committee), the French National Association of Food Industries (representing CIAA) and certification bodies were part of the Steering Committee in the development of PAS 220.Benefits Of Food Safety System Certification 22000
By implementing it:- Harmonizes pre-requisite programs best practice for food manufacturing where it is supported by key manufacturers & trade associations.
- Complements and aligns with ISO 22000, the internationally recognized food safety management system standard.
- Meets the PRP expectations and requirements of food manufacturing stakeholders, including food retailers and food service providers.
- Auditable - in conjunction with ISO 22000 - so organizations can demonstrate independent compliance with industry best practice.
It applies to all organizations, regardless of size or complexity. It also applies to all who are involved in the manufacturing step of the food chain and wish to implement PRP in such a way as to address the requirements specified in ISO 22000.
With GFSI recognized FSSC 22000 (ISO22000 + PAS 220) which supported by pre-requisite program specified in PAS 220, it helps organizations that achieve FSSC 22000 certification to meet the requirements of several global retailers or major branded food companies under a single internationally recognized food safety management system. It also enables easy integration to be made with other management systems such as ISO 9001, ISO 14001 and OSHAS 18001.
What is Food Safety Management Systems (ISO 22000)?
ISO 22000 is an international standard that defines the requirements for Food Safety Management Systems. The increase in consumer demand for safe food has led the International Organization for Standardization (ISO) to develop the ISO 22000 standard. The purpose of the standard is to ensure that any organization working within the food chain establishes management systems that ensure food is safe. It applies to all organizations in the food chain.ISO 22000 is designed to provide a framework of internationally harmonized requirements for the global food industry. It allows every type of organization in the supply chain - from primary producers to food processors, storage and transportation companies, retail and food service outlets, and even makers of equipment used in food processing - to implement a Food Safety Management Systems.
The standard builds on generally accepted principles for food safety in the food chain and focuses on identifying and preventing food safety hazards through PRPs (Pre-Requisite Programs) and HACCP (Hazard Analysis and Critical Control Points) plans. It promotes communication, continual improvement and updating of the Food Safety Management Systems.
The benefit of ISO 22000 is that it extends the successful management system approach of the ISO 9001 quality management system standard which is widely implemented in all sectors but does not itself specifically address food safety. The development of ISO 22000 was based on the assumption that the most effective food safety systems are designed, operated and continually improved within the framework of a structured management system, and incorporated into the overall management activities of the organization.
Benefit of Food Safety Management Systems
Benefits of implementing Food Safety Management Systems include:- To plan, implement, operate, maintain and update a Food Safety Management Systems aimed at providing products according to their intended use and safe for the consumer.
- To demonstrate compliance with applicable statutory and regulatory food safety requirements
- To effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain
- To ensure that the organization conforms to its stated food safety policy.
- Clearer, more visible and widely understood reporting relationships, document control mechanisms, records control mechanisms and staff development processes.
- A control measure validation approach which gives confidence in the food safety controls implemented.
- Continuous improvement of an organization's Food Safety Management Systems
- Allows organization within the food chain to demonstrate their commitment to food safety.
- It is designed to be fully compatible with ISO 9001 and companies already certified to ISO 9001 will find it easy to extend this to certification to ISO 22000.
What is British Retail Consortium?
The British Retail Consortium (BRC) is the leading trade association representing all retailers from large multiples through to independents. The BRC's Global Standards support retailers and suppliers by providing a leading global product safety and quality certification program.In 1998 the British Retail Consortium, responding to industry needs, developed and introduced the BRC Food Technical Standard to be used to evaluate manufacturers of retailers, own brand food products. It is designed to assist retailers and brand owners produce food products of consistent safety and quality and assist with their 'due diligence' defense, should they be subject to a prosecution by the enforcement authorities. Under EU food Law, retailers and brand owners have a legal responsibility for their brands.
In a short space of time, this Standard became invaluable to other organizations across the sector. It was and still is regarded as the benchmark for best practice in the food industry. This and its use outside the UK has seen it evolve into a Global Standard used not just to assess retailer suppliers, but as a framework upon which many companies have based their supplier assessment programs and manufacture of branded products.
Following the success and widespread acceptance of the BRC Food Technical Standard, the BRC published the first issue of the Packaging Standard in 2002, followed by the Consumer Products Standard in August 2003 and finally the BRC Global Standard - Storage and Distribution in August 2006. Each of these Standards is reviewed, revised and updated at least every 3 years after extensive consultation with a wide range of stakeholders.
There are four BRC Global Standards:
BRC Global Standard - Food Safety
BRC Global Standard - Packaging And Packaging Materials
BRC Global Standard - Consumer Product
BRC Global Standard - Storage And Distribution
Benefit Of British Retail Consortium
There are a number of benefits to the implementation and certification of the BRC Global Standard:- Helps you to meet and focused on the safety, legal and regulatory obligations
- Addresses due diligence requirements between you and your customers
- Enhances your product quality and safety management system
- Shows your commitment to producing quality and safe products
- Increases your customers confidence in your product's safety and quality
- Reduces the number of supplier audits & meet supplier requirements
What is Hazard Analysis Critical Control Point (HACCP)?
HACCP stands for Hazard Analysis and Critical Control Point. HACCP is an industry-wide effort approved by the scientific community as well as regulatory and industry practitioners. The Hazard Analysis and Critical Control Point (HACCP) system is a preventative food safety system that can be applied throughout the food supply chain from primary production to the consumer. HACCP is an internationally recognized as the most effective way to produce safe food, providing a structure for objective assessment of what can go wrong and requiring controls to be put in place to prevent problems.The principles of HACCP are traceable to the Codex Alimentarius Commission, which was created to develop food standards, guidelines and codes of practice by the Joint FAO/WHO (Food and Agriculture Organization/World Health Organization) Food Standards Program for the United Nations. The Global Food Safety Initiative, made up of global food retailers, has recognized HACCP as a fundamental element of food safety system. HACCP is a key component of numerous food safety standards.
HACCP is a system for ensuring food safety in which adequate safety precautions are identified, put into place and regularly reviewed. It involves:
- analysing the potential risks to food sold from your premises e.g. risk of contamination from infected food handlers or from using raw eggs. A hazard has the potential to cause harm to your customer and can be due to germs, chemicals or physical objects in the food.
- identifying where along the food chain these hazards might happen e.g. cross contamination from raw foods to cooked foods.
- deciding which of these points are critical to the safety of the food. If a hazard makes food unsafe and if a subsequent step in handling the food will not eliminate the hazard or reduce it to an acceptable level, then this stage in handling the food is a critical control point e.g. cooking food thoroughly is critical to food safety.
- identifying and implementing ways to effectively control and monitor these critical points e.g. re-heating food thoroughly.
- reviewing the system on a regular basis to check that it is working well. It must also be reviewed if new products or equipment are introduced or if any food handling operation changes.
Benefit of Quality Management System
HACCP provides businesses with a cost effective system for control of food safety from ingredients through production, storage and distribution to sale and service of the final consumer. The preventive approach of HACCP not only improves food safety management but also complements other quality management systems. The main benefits of HACCP are:- Business will benefit from a clear definition of processes and procedures. Effective communication and continual process improvement are the cornerstones of a functioning management system.
- A controlled food operating environment and effectively implemented and applied food safety system will improve customer and consumer confidence in the safety of food.
- It uses a systematic approach covering all aspects of food production from raw materials, processing, distribution and point of sale to consumption and beyond. It moves a company from a solely retrospective end product testing and sampling approach towards a preventative approach that is designed to reduce product losses and liabilities.
- It enables management throughout a business to demonstrate their commitment to the production and supply of safe products and within facility environments that are favorable for the production or supply of safe food.
- Implementation of HACCP system can improve the relationship between food processors & food inspectors and food processors and consumers.
- Record-keeping enables a more efficient and effective government and customer oversight and allows. The availability of documentation facilities and inspection activities of food inspectors.
- It has been widely accepted that HACCP based system present the food industry with the most effective management tool to enable the production and supply of safe food. As such the adoption of this approach can offer a legal defense in the event of an outbreak of food borne diseases.
- HACCP based approaches are a benefit to companies seeking to meet customer and legal requirements whether in the domestic or for the export market.
What is Good Manufacturing Practices ?
"Good manufacturing practice" or "GMP" is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product.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.
GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix ups, 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.
GMP covers quality assurance programs and organization, buildings, equipment, components, production and process controls, packaging and label control, distribution and installation, device evaluation and records.
Benefit Of Good Manufacturing Practices
- Ensuring that products are consistently produced and controlled according to quality standards appropriate to their intended use and as required by the product specification.
- Increases the creditability and offers a competitive advantage in the marketplace for contract manufacturers
- A system is available for recalling any batch of products from sale or supply.
- Increases senior management confidence in the preparedness of manufacturing facilities for FDA inspection
- Demonstrates independent third-party verification of continuing conformance to GMPs
What is ISO Technical Specification 16949 (ISO / TS 16949)?
The ISO/TS 16949 standard is a worldwide automotive standard developed by the International Automotive Task Force (IATF) - a group of the world's leading automotive manufacturers (General Motors, Ford, BMW, PSA Citroen, Volkswagen, Renault and Fiat) and their respective trade associations. The ISO/TS 16949 standard brings together the various aspects of ISO 9001, AVSQ (Italian), EAQF (French), VDA6 (German) and QS-9000 (U.S.) into one standard. ISO/TS 16949 can be applied to company sites worldwide, wherever automobiles or their parts and components are manufactured.With ISO/TS 16949, suppliers and subcontractors in the automotive industry can use a single document to comply with these international quality management standards. ISO/TS 16949 applies to all internal and external suppliers of production or service parts; production materials; and heat treating, painting, plating or other finishing services directly relating to original equipment manufacturer (OEM) customers. International automotive suppliers no longer have to satisfy multiple national automotive quality standards, which were often contradictory and led to redundant audits.
Basically, ISO/TS 16949 specifies the quality system requirements for the design/development, production, installation and servicing of automotive-related products. There are 3 criteria need to be fulfilled by an organization that wishes to apply for ISO/TS 16949 certification, which are:
1. The organization supplies for ISO/TS 16949 subscribing customer
2. The organization is in the automotive supply chain
3. The organization is a potential supplier to company supplies for ISO/TS 16949 or in the automotive supply chain, or is being documented on the bid list
Benefit Of ISO / TS 16949 Automotive Quality Management
Certification to ISO/TS 16949 offers plenty of benefit, which includes:- ISO/TS 16949 satisfies automotive mandates of IATF members on a global basis, when complemented by fulfillment of customer-specific requirements.
- Promises more consistent auditing performance. Auditors of recognized ISO/TS 16949 registrars must undergo extensive training, testing and re-qualification to meet rigorous qualification requirements.
- Time and cost savings by avoiding multiple customer specific certification audits
- A clear focus on continual improvement, emphasizing defect prevention and reduction of variation and waste
- A commercial advantage during contract negotiations. The international recognition of the ISO/TS 16949 standard increases the credibility of your organization when bidding for global sourcing contracts or expanding your business locally.
- Greater emphasis on supplier quality improvement efforts
What is 5S Housekeeping ?
A long term obsession with cleanliness and order is the reason why The Five S's is a favorite improvement methodology. The 5S means SEIRI (Organization), SEITON (Neatness), SEISO (Cleaning), SEIKETSU (Standardization) and SHITSUKE (Discipline).The Five S methodology is easy to understand and relatively straightforward to implement (it's GMP and commonsense). Five S can add remarkable value as a standalone improvement technique and also establishes the essential prerequisites of working environment, practices and mind-set, which are the necessary foundations for supporting further improvement tools and techniques.
5S Certification is a set of techniques for businesses to optimize the organization of their workplace. 5S Certification may be as informal as making your own award when your workplace first passes its internal 5S Audit, but it is an important component in having a complete and successful 5S environment.
Following the principles involved ensuring that the service sites were laid out to enable efficient work flow, correct labelling for equipment going in and out, a designated red area for quarantined items, and that health and safety practices were outstanding. The purpose of performing 5S Certification is to visibly demonstrate both progress and compliance. This is especially important to make improvements in a large workplace with many employees.