Frequently Asked Questions
Aerospace - AS 9100
Automotive - ISO/TS 16949
Energy - ISO 50001
Environmental - ISO 14001
Food Safety - ISO 22000, HACCP, GMP
Information - ISO/IEC 27001
Integrated Management System
Laboratories - ISO/IEC17025
Medical Devices - ISO 13485
Pharmaceutical - PS 9000
Qil & Gas - ISO/TS 29001
Quality - ISO 9001
Safety - OHSAS 18001
Social Responsibility - SA 8000
Societal Security - ISO 22301
Supply Chain Security - ISO 28000
Telecommunication - TL 9000
|1.||How different is ISO 13485 from ISO 9001?|
As ISO 13485 is developed based on ISO 9001, it is quite similar. A fundamental difference, however, is that ISO 9001 requires the organisation to demonstrate continuous improvement, whereas ISO 13485 requires only that they demonstrate that the quality system is implemented and maintained. Other differences are requirements that are specific to the medical devices industry such as making management responsible for the promotion and awareness of regulatory requirements, controls to ensure product safety, specific requirements for inspection and traceability for implantable devices and specific requirements for documentation and validation of processes for sterile medical devices.
Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to EEC-decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The preferred method to prove conformity is the certification of the Quality Management System according ISO 9001 and/or ISO 13485, ISO 13488, or ISO 14971 by a Conformity Assessment Body (CAB). The result of a positive assessment is the authorisation for the CE-identification and the permission to sell the high quality medical device in the European Union.
|2.||Is ISO 13485 compatible with Environmental and Occupational Health and Safety Management System standards?|
As ISO 13485 is developed based on the ISO 9001:2000 model, it is also compatible with the Environmental and Occupational Health and Safety Management System standards of ISO 14001 and OHSAS 18001 that were similarly based on ISO 9001.
|3.||How do we establish the food safety controls that are required?|
ISO 22000 requires that all hazards that may be reasonably expected to occur in the food chain, including hazards that may be associated with the type of process and facilities used, be identified and assessed. Hazard analysis helps in establishing the hazards that need to be controlled and those that need not. Subsequently, the organisation is able to determine an effective combination of control measures and come up with the prerequisite programmes and the HACCP plan.
|4.||How different is ISO 22000 from ISO 9001?|
ISO 22000 has greater requirements pertaining to food safety. For instance, that the Food Safety Management System (FSMS) must conform to appropriate statutory and regulatory requirements, that food safety be supported by the business objectives, procedures such as emergency preparedness, product recall and withdrawal, and that analysis for food safety hazards be conducted as part of the process for planning the safe realisation of food production.
|5.||What is the relationship between HACCP and ISO 22000?|
HACCP plays a large role in ISO 22000. So, if your company already has HACCP in place, you are one step closer to ISO 22000. ISO 22000 strengthens the HACCP system in several ways. It is a management system standard and as such, has requirements for policy, planning, implementation and operation, performance assessment, management review and improvement. ISO 22000 is also compatible with other ISO management system standards such as ISO 9001.
|6.||Why is GMP important?|
Poor quality food is not only a health hazard, but is damaging to the reputation of the supplier and impacts upon the bottomline.
|7.||Can organisations afford to implement GMP?|
Yes. It is more expensive to find and fix mistakes after they have been made, than to prevent them in the first place. As mentioned, GMP is designed to ensure that mistakes do not occur. Implementation of GMP provides the assurance of good quality and safe food and is an investment in improving the credibility and standing of the manufacturer in the eyes of the market and the community.
|8.||What are the requirements for application of ISO 22000?|
| Food premises applying for ISO 22000 Certification shall fulfill the following requirements:|
• Food premises shall be licensed.
• Company is registered with the Registrar of Companies.
• Pre-requisite programmes shall be in place and documented.
• A HACCP Manual shall be available. The Manual shall be duly signed and dated by the company
management with executive responsibility.
• The HACCP system shall be developed based on the ISO 22000 and any other requirements imposed
by the importing country/countries.
• The HACCP system should have been implemented for a minimum of three (3) months.
|9.||How different is ISO AS 9100 from ISO 9001?|
For one, regulatory requirements are critical functions within the industry. The requirements within AS 9100 are complementary to contractual and applicable law and regulations. The requirements of customers, regulatory agencies (such as the FAA and the JAA) and local, state and national laws are also referenced within the system's documentation.
Another is the AS 9100 standard provides guidance for managing variation when a "key characteristic" is identified. Features of a material, process or part in which the variation has a significant influence on product fit, performance, service life or manufacturability are key characteristics and the organisation has to establish and document a configuration management process.
Given the complexity of aerospace products and customers' expectations for reliable performance during a protracted period of time, AS 9100 includes extensive supplementation in design-and-development functions. Design outputs are supplemented to provide identification of key characteristics, and the data essential for the product that will be identified, manufactured, inspected, used and maintained is detailed.
|10.||What are the AS 9100 family of standards?|
The AS 9100 QMS family comprise the following three standards:
AS 9100 - Quality Management Systems - Aerospace
The AS-9100 is a Quality Management System (QMS) standard defined specifically by and for the aerospace industry. Published in the late 1999, it was developed by the ISO Aerospace Technical Committee 20 in conjunction with the American Aerospace Quality Group (AAQG), the European Association of Aerospace Industries (AECMA) and other similar international bodies from Brazil, China, Japan, and Mexico.
AS 9110 - Quality Maintenance Systems - Aerospace
Requirements for Maintenance Organisations. AS9110 focuses on the maintenance, repair and overhaul aspects of the aerospace business. Aircraft are designed to perform for 50 years or longer, but properly maintaining them is essential for the product's total life cycle and continued safe operation. AS9110 is used to complement the expanded use of ISO 9001 by major aerospace repair stations worldwide.
AS 9120 - Quality Management Systems - Aerospace
Requirements for Stockist Distributors. AS 9120 focuses on organisations that deal directly with OEMs and accumulate aerospace materials and products for resale. These distributors or stockists while providing a useful service, can affect product performance if they fail to handle parts and materials correctly or lose a part's chain of custody from the OEM to the customer.
AS 9120 complements AS9100 and may be used by OEMs or others in the aerospace supply chain. This standard applies to "pass through" distributors (i.e., businesses that accumulate and distribute parts and materials rather than add value or work on the products themselves). Value-added distributors are subject to the appropriate requirements of AS 9100.
|11.||Does AS 9100 apply to you?|
AS 9100 certification can be used throughout the entire aerospace supply chain including the design and manufacture of airport and airline operations, replacement parts, supply and maintenance, cargo handling, overhaul and repair depots and flight operations. If you provide the above mentioned services, it applies to your organisation.
|12.||Is certification to AS 9100 necessary ?|
Apart from the fact that major aircraft engine manufacturers, such as General Electric's Aircraft Engine division (GEAE), Boeing, Rolls-Royce Allison and Pratt & Whitney, are requiring their suppliers to be certified to AS 9100, Certification to the AS 9100 standard provides:
• Qualification to be considered as an aerospace supplier
• Public recognition
• Internal validation
• Independent feedback to foster continual improvement
|13.||How different is TL 9000 from ISO 9001?|
TL 9000 is based on ISO 9001, so an organisation that is already certified to this quality management system standard has fulfilled part of the requirements. An added element in TL 9000 is a focus on performance measurements for the telecommunications industry. QuEST Forum has published two handbooks to guide the implementation of the TL 9000 quality management system. They are the TL 9000 Requirements Handbook and the TL 9000 Measurements Handbook.
The TL 9000 Requirements Handbook contains all of ISO 9001 plusadditional requirements specifically addressing the needs of quality management system in telecommunication organisation.
The TL 9000 Measurements Handbook is a comprehensive guide to measurements processing, usage, responsibilities and requirements. It identifies performance measurements in the key areas of hardware, software, common, outage and service quality.
|14.||Is ISO/PAS 28000 compatible with the ISO 9001 Quality Management System standard?|
Yes it is. In fact, the ISO/PAS 28000 standard integrates the ISO 9001 quality management system’s process-based approach, its Plan-Do-Check-Act (PDCA) cycle and requirement for continual improvement, with the risk management concept of ISO 14001.
ISO/PAS 28000 requires the user organisation to establish, document, implement, maintain and continually improve on its security management system, to identify security risks and control and mitigate their consequences.
|15.||What is ISO/TS 16949?|
ISO/TS 16949 is an ISO Technical Specification which aligns existing American, German, French and Italian automotive quality system standards within the global automotive industry. ISO/TS 16949 specifies the quality system requirements for design/ development, production, installation and servicing of automotive-related products.
|16.||Who are the originators of ISO/TS 16949?|
The ISO/TS 16949 document was developed by the International Automotive Task Force (IATF) and the Japan Automobile Manufacturers Association(JAMA), with the support of the ISO technical committee, ISO/TC 176. The IATF committee consists of an international group of vehicle manufacturers: the BMW Group, DaimlerChrysler, Fiat Auto, Ford Motor Company, General Motors Corporation, PSA Peugeot-Citroen, Renault SA and Volkswagen, plus national trade associations, AIAG (America), VDA (Germany), SMMT (UK), ANFIA (Italy) and FIEV (France). The Japanese Automobile Manufacturers Association (JAMA) is a Tokyo-based trade association representing 13 Japanese car, truck, bus and motorcycle manufacturers.
|17.||What is the relationship between ISO 9001 and ISO/TS 16949?|
The ISO/TS 16949 Automotive Sector requirements defines international automotive quality system requirements and is written in consistent with the ISO 9001 standard. Additional customer specific requirements are required by individual subscribing vehicle manufacturers and are provided separately.
|18.||What are the eligibility requirements for ISO/TS 16949?|
| - ISO/TS 16949 is relevant to automotive production and service part organisations only.|
- It is applicable only to sites where production or service parts are manufactured. (A site is defined as: a
location in which value added manufacturing processes occur assemblies, or heat treating, painting, plating
services.) Any tier within the supply chain is eligible.
- A potential supplier can only be accepted for registration to the scheme if they have a documented request
for quotation or is in the bid list of a subscribing customer.
|19.||Will ISO/TS 16949 be accepted in addition to current automotive standards?|
| YES. |
Along with customer specific requirements, ISO/TS 16949 has been accepted as equivalent to the following automotive quality standards:
• VDA (Germany)
• AVSQ (Italy)
• EAQF (France).
|20.||Will the certification body which my company is registered to need to be accredited by UKAS for ISO/TS 16949 ?|
ISO/TS 16949 will not be accredited by UKAS or any national accreditation body. Witness audits of office activities and field assessments will be performed by IATF, to verify a certification body’s competence and compliance to requirements. The UKAS symbol will not be displayed on any ISO/TS 16949 certificates; instead the IATF logo will be displayed.
For latest information on accreditation by IATF, consult the customer service department of the certification bodies.
|21.||What is Lean?|
Lean is a way of working which utilises minimum resources to achieve more output. In other words, to do more with less. How it this possible ? Through the relentless elimination of wastes that can be found in all types business processes. Customer satisfaction are not compromised as a result of a lean initiatives but, greatly enhanced in terms of higher Quality, lower Costs, and shorter Delivery lead time.
|22.||Why should organizations implement Lean ?|
Organizations are facing tough competition and environment where products, services and technology are so easily replicable. Organizations need to improve and distinguish themselves by being able to provide products/services faster, better and at lower cost. Lean provide the method on how to make improvement quickly and consistently to achieve better profitability and growth.
|23.||Is Lean relevant to non-manufacturing organisations?|
Yes. Non-manufacturing organisations (such as Lockheed Martin) are also implementing Lean. The Lean management principles and approach are relevant both to manufacturing and non-manufacturing organizations. What are different for non-manufacturing organisations are the tools that are used for analyzing and improving processes. Data analysis tools are generally more suitable for manufacturing processes whereas process mapping and analysis tools are more suitable for non-manufacturing processes.
|24.||What types of ‘wastes’ are we talking about?|
| Waste is any activity which absorbs resources but creates no value. There are 7 classic wastes in manufacturing:|
These ‘wastes’ contribute to the cost of manufacturing and they are not seen as ‘value’ in the eyes of the customers.
|25.||What do you mean by ‘value’?|
“Value” is seen from the customer’s point of view. A feature or characteristics of a product is of value if the customer wants it and is willing to pay for it. In Lean Manufacturing, the organisation eliminates, as much as possible, the activities that do not contribute to “value” from the customer’s point of view.
|26.||What are the 5 Principles of Lean?|
| Principle 1: Specify value of specific product|
Principle 2: Identify Value Stream for each product
Principle 3: Make Value flow without interruption
Principle 4: Let customer pull value from the producer
Principle 5: Pursue perfection
|27.||What kind of organisations can implement Lean?|
| Any organisations that faces one or more of the following problems can benefit from lean|
• High inventory
• Long lead times
• Not flexible to meet small orders
• High defects, reject and rework rate
• Extensive material movement due to poor work flow
• Extensive movement of personnel due to poor layout of work area
• Increasing number of customer with orders that are high mix and low volume
• Long machine downtimes
• Long machine set-up and changeover times
|28.||Is Lean Manufacturing only for Manufacturers? Is it applicable to Services?|
Lean Manufacturing concepts are equally applicable to Services. There are activities in Service organisations that are ‘wastes’ and considered ‘non-value’ by the customers. Implementation of Lean Concepts result in:
• Lower operational cost
• Less queuing time
• Shorter service cycle time
• Less redundant paper work
• Less errors
• More effective dissemination
• Greater capability using existing resources
• Happier customers
|29.||Is Lean about applying statistical methods?|
Lean is about implementing a lean principles and tools to improve processes. They are many elements in Lean improvement management system and statistical method is a minor part of the elements. Statistical method is necessary to translate raw data into information for making decision about the process. Not all Lean improvement projects require the application of complex statistical methods.
|30.||What are the other elements of Lean ?|
| They include: |
1. How to identify what is important that need improvement (Value Stream Map).
2. How to identify which process to improve (set up projects).
3. How to manage the improvement projects.
4. How to create the infrastructures to support the improvement activities.
|31.||What is the difference between ISO 9000 and Lean ?|
1.The previous version of ISO 9000 did not emphasise improvement. The new version emphasizes the
improvement aspect. ISO 9000 tells you "What You Need To Do" while "Lean teaches you How To Do
2. ISO 9000 comes with the need to get certification at the organisation level.
In Lean, it is not a practice at the present moment to certify organisations.
|32.||How do I know whether my organisation and management is ready for or need Lean ?|
You can conduct a one-day Lean Awareness for the management team for them to obtain a clear picture of what is Lean and how Lean can help an organisation to achieve excellence. This will help them to make an informed decision. Next, you can get a consultant to conduct an assessment on your organisation and give you an independent feedback on the potential areas for reducing Waste and Cost. This may also help to the organisation to evaluate the costs and benefits of implementing Lean.
|33.||How long does it take for a typical Lean Programme to achieve results?|
The entire Lean Programme typically takes about 3 to 12 months depending on the requirements and the size of each company. Generally, the company will see return on their investment when the first wave of projects are completed (around 6-9 months).
|34.||How do I get started?|
We would recommend you to start the Lean Awareness and the initial assessment to educate the management and to provide a more accurate proposal. The objective is to ascertain the training requirements so that we can customise the training programme and to determine the extent of consultancy support required. This will have an impact on the investment required as training takes up a major portion of it.
|35.||What are the benefits of Lean?|
I will summarise them in five key words that is Cheaper, Faster and Better leading to Improved Profitability and Organisational Excellence.
• Lower operational cost
• Less Inventory
• Shorter lead times
• Less rejects and rework
• More effective utilisation of resources
• Greater capacity using existing resources
|36.||What is Six Sigma?|
Six Sigma is a management approach focusing on making improvement effectively in an organisation to meet customer requirements. Six Sigma is about asking tougher and tougher questions until we receive quantifiable answers that change behavior.
[Note: Six Sigma is a management tool for the management to manage the improvement aspect. It is not just a problem-solving tool for engineers or officers]. As a statistical term, Sigma is a Greek alphabet that describes variation from the average.
|37.||Why should organisations implement Six Sigma?|
Organisations are facing stiff competition and a situation where your products, services and technology are so easily replicable. Organisations need to improve and differentiate yourself by able to provide your products/services faster, better and at lower cost. Six Sigma provide the method on how to make improvement effectively to achieve better profitability and growth.
|38.||Is Six Sigma relevant to non-manufacturing organisations?|
Yes. Non-manufacturing organisations (such as Federal Express, Citibank) are also implementing Six Sigma. The Six Sigma management principles and approach are relevant both to manufacturing and non-manufacturing organisations. What are different for non-manufacturing organisations are the tools that are used for analysing and improving processes.
|39.||Is Six Sigma about applying statistical methods?|
Yes. Non-manufacturing organisations (such as Federal Express, Citibank) are also implementing Six Sigma. The Six Sigma management principles and approach are relevant both to manufacturing and non-manufacturing organisations. What are different for non-manufacturing organisations are the tools that are used for analysing and improving processes.
|40.||What are the benefits of implementing Six Sigma?|
Six Sigma can be summarised into 5 key words; Cheaper, Faster and Better leading to Improved Profitability and Organisational Excellence. Immediate benefits include:
• Improve product and service quality performance
• Reduce cycle time (ie time when order is in to time when order is met by company)
• Identifies and eliminate cost that has no value to customers
• Improve customer satisfaction
• Focuses on defect prevention (reduce waste)
• Increase efficiency, effectiveness
|41.||What is the difference between the Black Belt and the Green Belt?|
Even though both Black Belt (BB) and Green Belt (GB) are trained in the DMAIC approach and the Six Sigma tools and techniques to improve products/services and processes, BB is different due to the following:
• Trained on a wider array and more advanced set of tools and techniques.
• Able to work with and advice management on the identification and subsequent implementation of
• Mentor to Green Belt.
• Develop skills that will enable them not only to improve existing processes but also to design new
products/services to Six Sigma quality levels.
|42.||Where and how does Six Sigma fit into my business?|
Six Sigma is a methodology for improving processes. Because almost everything in business consists of processes, Six Sigma can be applied in almost all areas. It links with other programs, enhancing and building upon work already carried out. Six Sigma methodology has been proven to succeed in almost all business environments.
|43.||How does Six Sigma help me focus my business operations?|
Six Sigma brings a structure to how we do things: Firstly, identification of the business strategy and what the key elements for success are. This is followed by identification of the gaps that will prevent this success. Projects are chosen to close these gaps. Through rigorous methodology, data collection and analysis, real root causes are identified affecting process performance. Improvements to these root causes are implemented. Finally, robust controls are put in place to ensure improvements are sustained.
|44.||How do I know whether my organisation and management is ready for or need Six Sigma?|
You can conduct a one-day Top Executive Briefing for the management team for them to obtain a clear picture of what is Six Sigma and how Six Sigma can help an organisation to achieve excellence. This will help them to make an informed decision. Next, you can get a consultant to conduct an assessment on your organisation and give you an independent feedback on the potential areas for reducing Cost Of Poor Quality. This may also help to the organisation to evaluate the costs and benefits of implementing Six Sigma.
|45.||How long does it take for a typical Six Sigma Programme to achieve results?|
The entire Six Sigma Programme typically takes about 9 to 12 months depending on the requirements and the size of each company. Generally, the company will see return on their investment when the first wave of projects are completed (around 6-9 months).
|46.||How do I get started?|
We would recommend you to start the Top Executive Awareness and the initial assessment to educate the management and to provide a more accurate proposal. The objective is to ascertain the training requirements so that we can customise the training programme and to determine the extent of consultancy support required. This will have an impact on the investment required as training takes up a major portion of it.
|47.||What is Design for Six Sigma(DFSS)? |
DFSS is a specific approach to design and develop new products. In the industry, product design and development is often called New Product Introduction (NPI) process. Many companies have recognised the benefits of this approach and are incorporating DFSS concepts and tools into their new product introduction process. They include General Electric, Samsung, Philips, Siemens, and Seagate.
|48.||What is special about this DFSS approach?|
| • This approach is based on a methodology called DMADV (Define-Measure-Analyse-Design-Verify). |
• In a nutshell, the DMADV methodology helps to assure market success of a new product by doing the
a) Make sure the new product idea is well defined and product development project is properly planned
and kicked-off (Define).
b) Diligent efforts are put into understanding customer requirements so that product is designed
according to important customer requirements (Measure).
c) Effective identification and evaluation of various design alternatives/solutions to meet customer
d) The functional performance of the design is optimised (Design).
e) The new product is checked to make sure it meets defined customer requirements before launching
the product in the market (Verify).
f) Along the product development process, conscious efforts are made to identify potential design
problems and resolve these problems during the design and development stage.
|49.||How to implement DFSS?|
| Listed below are the key success factors for implementing the DFSS approach.|
• The management team understands the concepts of DFSS, what the DMADV methodology is, and
what resources are needed to implement DFSS. With this understanding, the management team
carefully thinks through the decision to adopt the DFSS approach.
• When the decision to adopt the DFSS approach is made, a DFSS deployment committee is formed to
take on the responsibility to implement DFSS. An influential member from the management needs to
be appointed for the role of the chairman of DFSS deployment committee.
• The DFSS deployment committee under the leadership of the chairman develops a comprehensive
DFSS deployment plan.
• For holistic implementation of DFSS, it is necessary to review the current state new product
introduction process to identify and prioritise the opportunities to apply DFSS concept and the design
quality tools. A work plan is then developed to realise these opportunities.
• Staffs involved in new product introduction are trained on the relevant design quality tools according to
|50.||Does ISO 9001 mean paperwork?|
NO. This standard only describes, “What the organisation needs to do” but not “How to comply”. Thus, the organisation always has the flexibility to determine the complexity and amount of documentation in its QMS.
|51.||How do I select my Certification Body?|
In selecting a certification body, it is important to consider if the certification body is accredited to provide certification services in your area of activity. On top of that, it may be important to find out from your customers as to the preferred certification body that they would want your organisation to appoint.
|52.||Can the ISO 9001 Quality Management System be integrated with other systems?|
YES. This standard can be integrated with other systems such as ISO 14001, OHSAS 18001, ISO/TS 16949, ISO/IEC 17025, ISO 22000, HACCP, ISO 13485, and many others.
|53.||Is there a minimum number of employees that I must have to implement ISO 9001?|
The number of employees is not a requirement to implement ISO 9001. One may be a 5-man organisation or a 5,000 strong organisation. Size does not matter.
|54.||Why should my company implement ISO 9001?|
Implementing ISO 9001 provides uncountable benefits - both tangible and intangible. This standard provides a systematic approach for an organisation to control all its processes. By adopting this systematic approach, the organisation may be able to increase its market share, reduce second party audits, and have better control on quality.
|55.||What is ISO/TS 29001?|
| ISO/TS 29001 defines the quality management system requirements for product and service supply organisations for the petroleum, petrochemicals and natural gas industries. |
|56.||Why ISO/TS 29001 is needed for the oil and natural gas industry?|
Due to the critical needs of the international oil and gas industry, this sector requires rigorous conformity to engineering, user and regulatory requirements. The industry handles fluids (liquids and gases), often at high pressures, through a variety of products and processes. Considerations for the safety of personnel, including the public, are of paramount importance.
|57.||What is the difference between ISO 9001 and ISO/TS 29001?|
| A technical specification, ISO/TS 29001 incorporates the verbatim text of ISO 9001 and includes detailed, sector-specific requirements for design, development, production, installation and service of products. To assist users of the document, the requirements of ISO 9001 are given in boxed text, followed by specific guidance and supplementary requirements for its implementation within the industry.|
|58.||Who can, or will, provide third party certification to ISO/TS 29001?|
| Any Certification Body can offer and provide ISO/TS 29001 certification. On top of that, it may be important to find out from your customers as to the preferred certification body that they would want your company to appoint.|
|59.||How many audits are needed in order to satisfy the full requirements of the oil and gas industry?|
| One audit can cover both ISO/TS 29001 and ISO 9001, because ISO/TS 29001 includes ISO 9001 unaltered and in its entirety.|
|60.||What are the PS 9000 standards?|
| These are standards produced by the Pharmaceutical Quality Group (PQG) which is a specialist group from the Chartered Quality Institute (CQI) based in London.|
The two main standards are PS 9000 which applies good manufacturing practices to pharmaceutical packaging and printed components such as labels and patient information leaflets (PIL) and PS 9100 which does the same for excipients. PS 9100 at the highest level of GMP is equivalent to ICH Q7.
There are also a number of specialist guides including a very good guide to implementing PS 9000 using a risk based approach and another for supply chain risk management.
Why not visit www.pqg.org for the full list of publications.
We supply many of these for use on the course and also have full audit checklists for PS 9000 and PS 9100.
|61.||What is the regulator’s position on these standards?|
| We cannot speak for the local regulators views, but we can quote the Medicines and Healthcare Products Regulatory Agency in the UK who have been endorsing and supporting the use of these standards for over a decade. The following is from the foreword to PS 9004 which is a guide to implementing PS 9000. The current head of the MHRA Inspection and enforcement division is preparing a similar foreword and endorsement for the revised PS 9000 which had been launched in September 2011.|
The EU Guide to Good Manufacturing Practice (GMP) emphasises the need for pharmaceutical manufacturers and assemblers to ensure that the packaging materials are of the appropriate quality. Not only is this in the interests of patient safety, but also in the pharmaceutical industry where the increasing use of automated packaging processes relies heavily on the consistent quality of packaging components.
Each year the Medicines and Healthcare products regulatory Agency (MHRA) receives and investigates a number of reports of quality defects concerning medicinal products. A significant proportion of these concern packaging errors, some of which are attributable to the use of packaging materials not of the desired quality.
The introduction of PS 9000 in 2001 by the Pharmaceutical Quality Group of the Institute of Quality Assurance was a key step in promoting the understanding of GMPs relevant to the suppliers of packaging materials to the pharmaceutical industry. PS 9000 focussed on the development and implementation, by suppliers, of a quality management system designed to provide assurance of the quality of their products and to enhance customer satisfaction.
Its contribution was welcomed by both industry and the Regulator. PS 9004 is aimed at increasing the awareness of the quality management system requirements embodied in PS 9000. This comprehensive and easy to follow guide explains further the GMP requirements of PS 9000. It adopts a risk assessment approach to the identification and implementation of preventive action and uses case studies to illustrate areas of GMP risk.
The MHRA encourages the introduction of PS 9004 designed to improve product and service quality in the supply of packaging materials for medicinal products, for the benefit of patients and the pharmaceutical industry as a whole.
|62.||What is ISO 15378?|
| ISO 15378 is a complete, integrated quality management system standard combining ISO 9001:2000 and Good Manufacturing Practices for Primary Pharmaceutical Packaging Materials. |
In addition to the complete requirements of ISO 9001:2000, ISO 15378 contains relevant GMPs for the design, manufacture and supply of packaging materials for medicinal products.
These GMP’s are based on a scientific, practical and cost effective balance, agreed following wide consultation and comment.
In line with current developments world-wide, the standard also contains guidance annexes on Risk Management and Validation.
The standard was published in 2006 as a full ISO, European Norme (EN) and British Standard (BS) and is an invaluable tool for Purchasing, Packaging Development, Supply Chain Management, Quality Assurance and Control and, more importantly, suppliers!
ISO 15378 can be used for quality improvement, training, auditing and certification purposes. Accredited Certification can lead to formal recognition and Certified Supplier status.
|63.||Who is IPAC-RS?|
| PQG Partners have collaborated with IPAC-RSon the production of PS 9000:2011 Pharmaceutical packaging materials to incorporate specific requirements for higher risk applications such as orally inhaled and nasal drug products.|
IPAC-RS are an international association of innovator and generic companies that develop, manufacture or market orally inhaled and nasal drug products for local and systemic treatment of a variety of debilitating diseases such as asthma, chronic obstructive pulmonary disease and diabetes.
IPAC-RS are committed to advancing consensus-based, scientifically driven standards and regulations for these products, with the purpose of facilitating the availability of high-quality, safe, and efficacious drug products to patients.
|64.||What is Rx-360?|
| Rx-360(International Pharmaceutical Supply Chain Consortium) is a consortium which aims to enhance the security of the supply chain and improve the quality of products by providing audits of suppliers of raw materials, components, excipients and active pharmaceutical ingredients carried out to various standards, including excipact, provided by other organisations.|
|65.||What are the prerequisites of implementing BCMS : ISO 22301?|
| A good foundation of any management system will be helpful depending on what risks are prevalent. It is best that the company have all the four components of managing risks for quality, environment health and safety, and information security to set the good foundation for its integration and implementation maturity.|
|66.||What are the typical risks covered?|
| Risks that may lead to significant disruptions to the businesses are identified so that preparedness around such risks be managed?|
|67.||What is the need for business impact analysis?|
| It important to conduct a business impact analysis to identify critical business functions so as to provide focus on what matters to the business with regards to set criteria such as customer requirements, regulatory compliance, and financial impact.|
|68.||What are the measureable standards and requirements that needs to be established?|
| The system requires for maximum period of tolerable disruption ( MTPoD ) and recovery point objectives ( RPO ) around the various steps within the critical business functions.|
|69.||Who is the rightful department to be accountable for the Business Continuity Management System?|
| There is no fixed department to possibly handle BCMS, it all depends upon the dominance and prevalence of risks. It is best for that coordinating unit to have knowledge on operational risk, and other such risks as strategic, hazard and even financial risks. |
|70.||What is the difference between Enterprise Risk Management and Business Continuity Management System?|
| It will be an advantage if an organisation has a framework for enterprise risk management to facilitate the drive for preparedness against the risks that have been considered. The output of the ERM will come in very useful along with the business impact analysis as required by BCMS to facilitate the consequence analysis to the business and the need for standards in the effort to minimize its impact of disruptive events. |
|71.||Who are the intended users of ISO 50001? |
| This is a generic standard for any scale of organisations, large and small; both public and private sectors; manufacturing and service industries. |
|72.||What is ISO 50001? |
| ISO 50001 is an international standard developed by ISO (International Organisation for Standardisation) specifies the requirements for Energy Management Systems. |
|73.||How does it work? |
| This standard is based on PDCA (Plan – Do – Check – Act). An organisation implements this standard will have to perform energy review, establish baseline, energy performance indicators (EnPIs), objectives, targets, implement action plans, measure and monitor energy performance against set criteria and take actions to make continual improvement. |
|74.||What kind of impact will ISO 50001 have? |
| ISO 50001 is intended for widespread use by industrial facilities, buildings, and other organisations. If widely adopted, it could influence up to 60% of the world's energy use across many economic sectors.|
|75.||Can the ISO 50001 be integrated with other Management Systems? |
| YES. This standard can be integrated with other systems such as ISO 9001, ISO 14001, OHSAS 18001 and many others.|
|76.||Why implement ISO 14001 EMS?|
Improved environmental awareness brings a world-wide focus to the environment, encouraging a cleaner, safer and healthier world. Facts have shown that companies need an environmental management certification to compete in the global marketplace. In addition, ISO 14001 provides a framework for continual environmental performance and this helps in ensuring compliance to regulatory requirements as well as to reduce business risks.
|77.||We already have a compliance programme – why do we need an ISO 14001 EMS?|
An EMS can help you to comply with regulations more consistently and effectively. It can help you to identify and capitalise on environmental opportunities that go beyond compliance.
|78.||How will an EMS affect my existing compliance obligations?|
An EMS will not result in a more or less stringent legal compliance obligation. But an EMS should improve your efforts to comply with legal obligations, and in some cases, lead to a more flexible compliance requirements.
|79.||What types of organisations does the ISO 14001 EMS apply to?|
| It applies to organisations of all types and sizes with the intent to improve the environmental aspects that they have control over.|
|80.||Can the ISO 14001 EMS be integrated with other Management Systems?|
YES. This standard can be integrated with other systems such as ISO 9001, OHSAS 18001 and many others.
|81.||What is the purpose of being OHSAS 18001 certified?|
OHSAS 18001 certification proves that your management system has been measured against a best practice standard and found compliant. Issued by a third party accreditation body/registrar, the certificate lets employees and other stakeholders know that you proactively protect the health and safety of your work force.
|82.||Is OHSAS 18001 an International Standard?|
NO. It is not an international standard. The OHSAS 18000 series was developed by a group of national bodies, certification bodies and specialist consultancy firms rather than the International Organisation for Standardisation (ISO). Published by the British Standards Institution, United Kingdom, ownership and copyright of this specification is still retained by them.
|83.||What types of organisations does the OHSAS 18001 apply to?|
In general, all industries need to have an OH&S Management System. It applies to any organisation that wishes to eliminate or minimise its OH&S risks, assure itself of its stated OH&S Policy and comply to applicable OH&S Laws.
|84.||How is OHSAS 18001 different from ILO-OSH and MS 1722?|
Both OHSAS 18001 and the Malaysian Standard, MS 1722 Part I are specifications for OHSMS that can be used for certification. Organisations can opt to be certified to either one or both. MS 1722 Part I has additional stipulated requirements compared to OHSAS 18001; namely in operational control.
On the other hand, ILO-OSH 2001 by the International Labor Organisation – Occupational Safety & Health and Part II of the Malaysian Standard, MS 1722 are Occupational Safety and Health Management System guidelines for the implementation of OHSMS and are compatible with the OHSAS 18002 guidelines. These guidelines cannot be used for certification.
|85.||Does certification to OHSAS 18001 ensure compliance to national legislation or other legal requirement?|
NO. Being certified does not in itself confer immunity from legal obligations. However, as a management system, OHSAS 18001 provides a useful framework for the organisation to address applicable legislative requirements. The concept of compliance to legal requirements and continual improvement are minimum requirements of OHSAS 18001.
|86.||Can the OHSAS 18001 be integrated with other Management Systems?|
YES. The standard has been developed to be compatible with the ISO 9001 QMS and ISO 14001 EMS. It is recommended that the three systems be integrated into a single one for better business management and performance.
|87.||What types of organisations does the ISO/IEC 17025 apply to?|
Laboratories that test products and samples as well as those that calibrate precision instruments may use this standard.
|88.||Is this an industry-specific standard? Can the laboratory at my manufacturing concern implement this standard?|
This standard is not an industry-specific standard per se though most who implement it tend to be organisations in the business of testing and calibration. A laboratory at a manufacturing concern or a laboratory at a hospital that find it useful to assure others of its technical competence may also use it.
|89.||How does this fit in with a Quality Management System? If I have ISO 9001 certification, what else do I need to do to achieve certification to this standard?|
ISO/IEC 17025 is divided into two principal parts, i.e. Management requirements and Technical requirements. The management requirements are similar to the ISO 9001 Quality Management System. Hence, an organisation with prior ISO 9001 certification would fulfil this component and would only need to put in a bit more work on demonstrating that it is technically competent and able to generate valid results.
|90.||Is this an industry-specific standard? Can the Information Technology (IT) Department at my organisation implement this standard?|
This standard is not an industry-specific standard per se though most who implement it tend to be organisations in the business of information security or managing information. An IT or an Information Security (IS) Department in a manufacturing facility or a bank may find it useful as well to assure others that it has a system in placed for information security.
|91.||Does the standard just apply to IT?|
Information security is not just IT security. Information may exist in many other forms - written, printed, verbalised or in images. The underlying principle of this standard is that information in any form, whichever means it is stored, shared or used, must always be appropriately protected.
The ISMS assists organisations to carry out the day-to-day management of information in a systematic way and to improve on the protection of this very crucial resource in all organisations ie information.
|92.||What are the management systems that can be integrated ?|
An organisation can choose to integrate any combination of management systems. The common ones include: ISO 9001, ISO 14001, OHSAS 18001, HACCP, ISO/TS 16949, ISO 22000, ISO 13485, ISO/IEC 17025, TL 9000, AS 9100, ISO/PAS 28000, ISO/IEC 27001 and ISO 20000.
|93.||Why do we need to integrate the various management systems?|
| By integrating all the systems into one, the organisation will be able to enjoy many benefits including better utilisation and management of resources, clarity of purpose and responsibilities, and overall improvement of the system.|
|94.||What are the common areas that can be integrated?|
An organisation can integrate the following processes commonly found in management systems: Document Control, Records Control, Internal Audit, Management Review, Training and the Corrective and Preventive Actions. In so doing, the organisation can combine some of the documentation, reduce the amount of documentation and simplify its document management.
|95.||Which certification body can conduct an integrated audit?|
Any certification body, which has auditors from multi-disciplines and experience in the various management systems, will be able to perform the integrated audit upon a client’s request.
|96.||What is covered under SA 8000?|
Amongst the areas covered by SA 8000 are: child labour, forced labour, health and safety, freedom of association and collective bargaining, discrimination, disciplinary practices, working hours, compensation and management systems and workers’ rights.
SA 8000 embraces existing international agreements, including International Labour Organisation (ILO) conventions, the Universal Declaration on Human Rights, and the UN Convention on the Rights of the Child. SA 8000, is a way for retailers, customers, suppliers and other organisations to maintain a just and decent work condition throughout the supply chain.