An overview of the possible changes in ISO 9001:2015

ISO 9001 or also known as Quality Management System (QMS) was first published its standard in 1987, and later published an updated version in 1994. In an effort to address the constant changing needs of its users, ISO has updated its ISO 9001 standard in 2000 and again in 2008. The current version is known as ISO 9001:2008 whereby the changes were consider to be at a minimum level when compare to the previous version (ISO 9001:2000)

The upcoming ISO 9001 standard in 2015 would involve more changes when compare with the upgrading works needed to be in compliance with 2008 version. For more info, please refer to the links below:

http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref1633

http://www.mapwright.com.au/New-version-ISO-9001_2015.html

http://www.irca.org/en-gb/resources/iso-90012015/

http://www.lrqa.co.uk/standards-and-schemes/ISO-9001/ISO-9001-Revision.aspx

ISO 22000—Standards Without Profitability Are Doomed by Thomas R.Cutler

Regulatory and standards compliance is a requirement that meets with regular resistance from CFOs and CEOs who must justify the expense. Brand protection from recalls and costly litigation is essential; ultimately avoiding catastrophic business outcomes proves less of a driver for actionable traceability than seeking enhanced profitability.

The paradigm has shifted from traceability as a necessary evil to a quantifiable lean-enhanced profitability process.

With food safety at the highest levels of concern by the average customer, the ISO 22000 (and Publicly Available Specification (PAS) 220) standard developed by the International Organization for Standardization, complying with food safety regulations has never been more important than it is today. Communication in the food chain is essential to ensure that all relevant food safety hazards are identified and adequately controlled at each step within the food chain.

This interactive communication is the first step in the ISO 22000 international standard, which specifies the requirements for a food safety management system includes system management and utilizes hazard analysis and critical control points (HACCP) principles.

HACCP is a systematic preventive approach to food safety and pharmaceutical safety that addresses physical, chemical, and biological hazards as a means of prevention rather than finished product inspection. HACCP is used in the food industry to identify potential food safety hazards so that key actions can be taken at critical control points to reduce or eliminate the risk of the hazards being realized. The system is used at all stages of food production and preparation processes, including packaging and distribution. The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) use mandatory juice, seafood, meat, and poultry HACCP programs as an effective approach to protecting public health. Meat and poultry HACCP systems are regulated by the USDA, while seafood and juice are regulated by the FDA. The use of HACCP is currently voluntary in other food industries.

Quality assurance professionals understand the importance of planned and systematic production processes that provide confidence in a product's suitability for its intended purpose. The set of activities intended to ensure that products (goods and/or services) satisfy customer requirements in a systematic, reliable fashion cannot absolutely guarantee the production of quality products, which is unfortunate, but it does make the intended outcome more likely. The challenge is that the technology selection process to support these standards is rarely made by a quality assurance (QA) professional. While a decision-influencer in such technology solutions, the QA or quality control manager must find a way to justify the expense and demonstrate profitability, not merely brand protection and catastrophe avoidance.

ISO 22000 users

ISO 22000 is written as a food safety management standard that may be used by any organization involved in the food chain. Businesses of any size or type may utilize the ISO 22000 standard to help ensure the safety of its food or food related products.

According to ISO “ISO 22000 may apply to all types of organizations within the food chain ranging from feed producers, primary producers through food manufacturers, transport and storage operators and subcontractors to retail and food service outlets—together with inter-related organizations such as producers of equipment, packaging material, cleaning agents, additives and ingredients.” In short, ISO 22000 covers the food supply chain from farm to fork and everything in between.

While there’s efficacy in the standard, persuading the key financial decision-makers to implement these technology tools continues to meet with resistance. There are many software solutions for traceability, some installed, others offered as software as a service (SaaS, which require less up-front capitalization and therefore are often better received). The greatest limitation for these traceability technologies is that few of them use the collected traceability data to examine and derive increased profitability throughout the supply chain. There are exceptions.

“Most people equate traceability with material movement—that’s a last-century concept," says Gary Nowacki, president of TraceGains, a brand protection and promotion solutions provider. "You also have to collect all the surrounding information, and then analyze that information to make good business decisions."

Traceability can no longer remain an insurance policy that only pays off when something goes wrong, Nowacki explains. Payoff typically in that case is usually only compliance with the Food Bioterrorism Act. By monitoring their supply chain, companies avoid recalls, which has little to do with traceability but everything to do with profitability and brand protection. The Reasons for ISO 22000

“While the media is quick to report the latest lysteria contamination, or salmonella outbreak, and how a company was lax it meeting a standard, the thin margins of these organizations must ensure that beyond simply reacting to the Food Bioterrorism Act, HACCP requirements, GAP/GMP best practices, or the ISO 22000 standard," Nowacki adds. "The vast data collected by an advanced traceability solution informs better, leaner, and more profitability throughout the supply chain while improving product safety and quality.”

Management Commitment: It’s not all about delegating by Bretta Kelly

ISO 9001 says in subclause 5.1, "Executive management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by:

a) Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements 

b) Establishing the quality policy 

c) Ensuring that quality objectives are established 

d) Conducting management reviews 

e) Ensuring the availability of resources"

The standard also says in subclause 5.5.2, “Executive management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes:

a) Ensuring that processes needed for the QMS are established, implemented, and maintained, b) Reporting to executive management on the performance of the QMS and any need for improvement, and c) Ensuring the promotion of awareness of customer requirements throughout the organization."

The above section of the standard is where executive management often gets confused and is under the perception that the extent of their participation is to pick a person to be a management representative for their ISO system. Every paragraph in section ISO 9001 clause 5 of the standard begins with, “Executive management” and not with “the management representative.” Management commitment refers to all of the executive management (management team) and not to an individual or department.

There are many reasons why executive management needs to be continually committed and involved in implementation and maintenance of the business management system besides it being a requirement of clause 5 of ISO 9001. The main reason is that if commitment isn’t evident to the employees then the system will never truly be implemented throughout the organization. Employees at all levels of an organization won’t be committed to a system that’s not driven, supported, and believed-in by upper management.

Don’t confuse promotion, advertising, or mandating of a QMS with the “management commitment” of a QMS. Telling the company that you’re going to be registered to a standard and expecting them to do what they perceive is required is very different than executive management driving, participating, and flowing the QMS down to their employees through their actions and not just their words.

A company implements a business management system (ISO 9001, AS9100, ISO 14001, RC 14001, and others) to define how they do business, collect data from their activities, and analyze that data to improve their processes and ultimately become more profitable. The basic programs that all of these standards require is:

• Define a quality policy.
• Set measureable objectives at all levels of the organization with customer focus and requirements in mind.
• Conduct audits of your process.
• Conduct management reviews of your processes, programs, and data.
• Based on analysis of all of these topics, assign corrective and preventive action to continually improvement your processes/company.

Communication of these programs is the key to illustrating management commitment to a business management system. To accomplish this, commitment must be illustrated through action(s). When an employee submits a suggestion for improvement to management, management reviews the suggestion and chooses to take action or not. Either way, communicating to the employee the decision that was made and providing them with a clear explanation is how to illustrate commitment.

By providing continuous feedback to employees, management will ensure that suggestions will continue, even if a few aren’t accepted. Without clear communication from management, employees will eventually become discouraged and employee’s suggestions for improvement will decrease dramatically. Executive management must define all of the company’s measureable objectives. These objectives should be a unified goal that defines what is best for the company. Objectives cannot be unrealistic or standard (everyday) goals that the employees perceive they should track for quality improvement (such as SPC). Every company has customer requirements.

The management must define what processes and how best to conduct these processes to meet the customer requirements with the required quality at the lowest possible cost. It’s in this arena that the management must set measurable objectives for each process. When laid out clearly and accurately, management will illustrate their commitment to the employees. The objectives must be directed toward improvement of quality, performance, and cost reduction.

Cost reduction is included because it really is a catchall to every process. For example, accidents that happen during a process affect the overall cost and employee turnaround requires additional training and therefore affects costs. Hence, process cost reduction may encompass a wide variety of elements within a process. When audited by a third-party auditor (registrar), management commitment is measured in several ways. Executive management must be available, ready, prepared, and excited to participate in the opening and closing meetings.

This illustrates management’s commitment to the registrar and illustrates their total support for the management team. When the auditor audits clause 5 of the standard, they’re required to interview the executive management (many registrars require that the auditor document the names of executive management interviewed). If the auditor only speaks to the management representative (MR) and the MR shows them all of the records of audits and management review, it is difficult for the auditor to find evidence of management commitment.

This isn’t to say that executive management cannot delegate responsibilities and authorities of their management system. Executive management must define the objectives of the company, review the data/outputs of processes, and make decisions based on these reviews of what actions to take and what the extent of those actions should be. Actually collecting the data, summarizing the data, or reporting of the data can be delegated freely.

Executive managers are concerned with

• Profit margins and reducing expenses
• Increasing the company value
• Not becoming obsolete in their industry
• Opportunities for growth
• Not having to deal with personnel issues
• Not having to defend their company in legal battles (liability and personnel issues)
• Becoming the best in their industry
• Less stress and more golf

What tools are available to properly address executive management’s concerns?

• Management review meetings
• Departmental meetings
• Internal audits
• Strategic planning using quality objectives
• Training, seminars, and having the opportunity to share ideas with external experts in a similar career
• Having access to company information in a timely manner

Currently, executive management in companies often perceive that their QMS is costs money, causes personnel issues, and requires additional resources (commitment) that they feel is unnecessary to simply get the work done. These managers may say things like:

• "Why do we have to have these meetings?"
• "Why do we have to do audits?"
• "Why do we need to train so much?"
• "We fully understand our challenges, we have been in business forever…"

Very rarely do you hear …

“Our QMS system has saved us thousands of dollars a year—we love it!” We don’t hear this very often because we don’t communicate the results of our ISO standards programs effectively, or we don’t use our ISO standard in a way to clearly measure cost savings, risk management, and improvements.

The responsibility is with the management team

As managers in a company, we have the responsibility to recognize and understand the executive management’s concerns, focus, strategic plan, and objectives and to take actions to ensure that they’re realized. We may not always agree with the executive management’s focus, but as managers, we must ensure that we are all on the same page.

Communication is the key

When communicating audit results to executive management, we must consider their interests in the operation:

• Provide a summary of the audit.
• Highlight opportunities for improvement (avoid zero opportunities).
• If audit actions aren’t taken or effective, executive management needs to know.
• Include cost savings or cost overruns as a result of the QMS.
• Include potential cost savings and associate them with opportunities for improvement.

Communicating to executive management correctly

• Identify processes to audit based on data; e.g. scrap, rework, or cycle time.
• Baseline the current performance of each process.
• Set objectives for each process.
• Identify opportunities for improvement for each process, including cost savings.

Management review—the heartbeat of the organization Executive management doesn’t want to waste time in a meeting to have a record in order to satisfy an ISO requirement. In a management review, executive management wants to see a picture of the company and have the information and data available complete and accurate so they can make effective decisions and improvements. Specifically, executive managers need to:


Review and establish new company objectives.
Determine what actions we’re taking or need to take to achieve company objectives.
Determine when they’ll be achieved and at what cost.
Understand where nonconformities are originating.

How much are they costing?
How many are there?
Why and when will they go away?
What is the customer’s perception?

Positive and negative customer feedback
How much is negative customer feedback costing us?

What are the trends?
Will we lose customers?
What indicators do we have that show if our corrective and preventive action programs are effective?

Are nonconformities and negative customer feedback trending down in the areas where we have implemented action?
If not, why not? What are we doing about it?

Internal audit program—the engine driving improvement How to put your executive management to sleep when reporting on an internal audit:

• Report that an internal audit was done and a checklist completed. It says that our processes match our procedures and we have a record to show the auditor. In other words, we are telling them that we are perfect when in fact the executive management knows very well that we aren’t.

How to keep your executive management glued to their seats and not thinking about golf


We conducted an internal audit of the “X” process and found four opportunities for improvement:

1. John Doe suggested we do this, and it will save us 20 hours a week.

2. We eliminated a nonvalue-added process step that will save us X-dollars/month. 3. We identified a breakdown in communication between one department and another. 4. We identified a process in this department that has improved their efficiency by X-percentage resulting in X-dollars savings per year. If we implement this process in other areas, we can improve their efficiency as well.

How do we implement this approach? The simple part about this approach is that the internal auditor has no pressure to identify these steps. The internal auditor simply has to know what type of questions to ask. Audit the process and take notes of all of your observations (mini process map):

How do you do this (inputs/outputs)?
While you’re observing, pay attention to what does and doesn’t make sense, and then ask these questions:

Why do you do it that way?
Is there a better way?
What problems have occurred in the past?

Pay attention to the answers. The following answers indicate that further investigation into the process is required and may require input from other managers more qualified to identify opportunities for improvement. Furthermore, these types of answers indicate a lack of effective training:

• We’ve always done it this way.
• I don’t know.
• That’s how I was trained.

Asking the right questions The people you are auditing are a wealth of information. They know what will make their processes better; the auditor’s job is to get this information from them. By asking the right questions, the auditor will get all of the opportunities needed to report to management.

How to change Another way to identify opportunities for improvement in a process is to try and do the process. Simply take the work instructions and do the process according to the instructions with the help of the person you are auditing. By doing this you can gather information by asking, “Why do you do it this way? Wouldn’t it be easier if ...?” This gets the person you’re auditing to look at their process in a whole new light and all of the sudden they’re working with you to come up with ways to improve their process.

Where are the opportunities? Most opportunities for improvement have to do with communication between departments or effective communication of the company objectives.

Ask, “What are the objectives in this process?”

If none why not?
If yes how are they measured?
When they aren’t achieved what happens?
Ask, “What is the communication?”
Who do you communicate with?
What is the biggest breakdown in communication?
How do you communicate? (verbal, forms, electronic, etc.)

If forms or electronically, do you get all the information required to do your process effectively?

The art of questions What data have been collected within this process to provide management with information for continual improvement opportunities?

• Has action been taken based on them?
• Do they align with company objectives?
• Are there any opportunities for preventive action in this process?
• What will be prevented (risk or cause analysis)?
• What are the advantages of preventing this?

As managers, we must accept a large responsibility in driving the future development, improvement, and success of an organization. It isn’t a responsibility that can be taken lightly. To succeed as managers, we must put in the effort and work to ensure that executive management’s objectives are achieved. (It’s our job.) Every manager should strive to make a difference in the organization. Management isn’t only about completing paperwork to pass an audit. Management is about managing—taking proactive steps to avoid problems and improve the organization. Management skills can be learned (continual training is required).

A final note about improvement Many managers seem to feel that there is a limit to improvement. In fact, we’ve heard comments such as:

• "These types of problems are associated with the process and can‘t be removed (acceptance)."
• "We’re better than industry standards and in fact, achieving 97.5 percent is excellent (perception of excellence)."

Acceptance I attended a management seminar presented by my colleague Peter Sanderson, who presented some interesting examples about acceptance and attitudes of management. (A copy of this seminar may be obtained by from peter@cisssoftware.com.) In 1993, Sanderson went into a circuit-board manufacturer to quote an ISO 9001 quality system. The quote was $ 19,500.00, which the owner felt was far too much money. During the tour of the operation, Sanderson noticed a large table in the inspection that was piled high with scrap boards under a sign that said “scrap of the month.” Before leaving without an order, Sanderson questioned the owner about this scrap table and was told that manufacturing circuit boards was a tough and dirty business that inherently produced scrap. Sanderson asked about the value on the scrap table and was told that the typical monthly scrap was about $ 30,000.00. Sanderson told the owner that he’d do the ISO 9001 system for free and see it through to certification with one condition. That condition was that we benchmark the scrap table today, and that after the ISO 9001 system was implemented, the company would issue a monthly check payment for any difference between the $ 30,000.00 typical scrap amount per month and the savings after certification for the rest of his life. Sanderson explained to the owner that if he was willing (accepted the fact as a standard) to have $30,000.00 worth of product scrapped each month and that it was acceptable to him, why would he object to simply putting the money in Sanderson’s pocket rather than on the scrap table? After all, he would get a free ISO system. Sanderson left with a $8,000.00 deposit to do the management system and the owner agreed to the $19,500.00 price tag. In six months, the monthly scrap was less than $4,000.00.

Perception of excellence In this example from the same seminar, Sanderson said, “If I were to give you a brand new 2008 Ford Mustang right now, how happy would you be?” But before he delivered the Mustang, he would take a key and scratch the car all over each side including the roof, trunk, and hood. “Would that make you angry? Even though the car was free, wouldn’t you have the scratches repaired?” The Mustang has approximately 25,000 square inches of surface area. The surface area of the scratches would be about 33 square inches, 0.00132 of the car’s surface. In fact, the car is still 99.9868 percent scratch-free. Well, isn’t 99.9868 percent perceived as perfect? Can’t we live with that? If not, why are we so willing to live with it in our organizations’ processes?

The bottom line is attitude The attitude of solving a problem alone vs. having a team approach to problem solving may be a change.

• The attitude of working together to meet customer’s performance requirements on a daily basis may be a change.
• The attitude of planning together to survive into the future instead of only fighting today’s battles may be a change.
• The attitude of insisting on performing the job right the first time to a standard process may be a change.
• The attitude of measuring performance, effective process auditing, and taking preventive actions to avoid potential errors and initiate improvement may be a change.
  But there is no change to the QMS.

Final notes No nonconformities, variations from the standard, or mistakes are acceptable, no matter how small the ratio of output to errors can be. Continuous improvement only becomes effective when all management buy into this methodology. ISO 9001 emphasizes the importance of management leadership to meet the customer’s needs and quality objectives. Without leadership, the company achieves zero improvement and simply reacts to problems.

Customer Relationship Management and ISO 9001 by Thomas R.Cutler

Customer relationship management (CRM) usually refers to sales activities, and CRM software is commonly purchased, and occasionally used, to track potential customers, existing customers and sales activities.

“Contract manufacturing is unquestionably a relationship business. CRM must manage the relationship bringing maximum value to both parties; CRM is and has been key to successful long-term partnerships. Customers rely on their contract manufacturer for the core of their business, and quality validation, corroboration, open communications and the supplier-customer relationship are critical for success,” says Larry Caretsky of Commence Corp.

According to ISO 9001, manufacturing companies seeking a product definition or answers to service and marketing questions must get such information from their customers. The ISO standard requires companies to establish processes for identifying customer requirements and communicating those requirements throughout their organization, as well as processes for tracking and analyzing customer satisfaction. The standard has direct application for CRM, particularly for contract manufacturers.

Since its first release in 1987, the ISO 9001 quality management standard has been accepted worldwide as a baseline for organizational performance. First embraced by manufacturing companies around the world, this standard quickly became the most widely used of the more than 8,000 standards published by the International Organization for Standardization. Because the original set of standards were based on existing national quality standards, they were nonprescriptive in nature and were designed to ensure compliance with written procedures.

The main criticisms of the first version of ISO 9001 was that compliance wasn’t sufficient to move a company to world-class status and that management’s role within a company’s quality system was considered minimal. Just as lean manufacturing has the core principle of continued process improvement, ISO 9001 needed to push companies beyond their maintenance mode.

Responsibility for the quality management system has now shifted from the quality assurance department to top management. ISO 9001 includes management requirements that are designed to ensure that customer needs and expectations are determined and fulfilled, that an awareness of customer requirements is promoted throughout the organization and that customer feedback is included in management reviews.

When the current ISO standard was released, the changes ranged from greater customer focus to integration to measurement processes and continual improvement. For contract manufacturers, the ability to determine customer needs and satisfaction were paramount.

Whether industries are yet compliant to ISO 9001 or not, to thoroughly understand customers’ needs is to actively seek out customer feedback and create solutions to meet those needs. Good performance leads to customer satisfaction, and strong relationships lead to customer loyalty. Customer satisfaction is great if it results in customer loyalty. Satisfied customers feel good and still may be lured by a competitor. Loyal customers will stick with their suppliers over the long term.

Commence Corp. has conducted intensive financial analyses regarding the cost of customer acquisition vs. the cost of retention. The results have shown that keeping customers is always a more profitable strategy. Caretsky notes that one of the critical roles of cost-effective CRM solutions for the mid-range manufacturing organization is creating “. . . [L]oyal customers, which lead to lower marketing costs, increased revenues, more referrals and a better understanding of how the company can improve performance.”

CRM evaluation criteria must provide the basis for a meaningful and objective CRM software comparison. The comparison factors may include sales force automation, marketing and customer support, as well as functionality requirements, technology utilization, user support, price and value criteria to demonstrate company requirements based on the quantifiable measures that are established as part of the documented ISO 9001 procedures.

CRM functionality and ISO 9001 are increasingly integrated as both promote a better understanding of customer requirements through open communication, as well as establishing processes for the measurement and analysis of customer satisfaction and loyalty.

Coca-Cola and management systems by Garry Lambert

Introduction

Coca-Cola’s new bottling plant in Russia will be run in conformity with an integrated ISO 9001, ISO 14001, ISO 22000 and OHSAS 18001 based management system being rolled out across all 75 plants in 28 countries, operated by major bottler Coca-Cola Hellenic.

Coca-Cola Hellenic, a major bottler of Coca-Cola Company products, has opened its largest beverage plant in Russia to target a market of some 140 million consumers. The new plant in the city of Rostov-on-Don is the result of a USD 120 million investment programme, creating over 400 jobs, and is part of a plan to invest more than USD 3 billion in the Russian economy over the next five years for long-term sustainable growth.

In constructing the new plant, Coca-Cola Hellenic’s main goal was to minimize its impact on the environment by implementing an environmental management system in conformity with ISO 14001 to improve water efficiency, save energy, recycle more production waste and send less to landfill. Among many such measures designed into the new plant is a 1 600 m2 water cleaning facility, reportedly the most powerful in Russia, to gather water for repeated use after backwashing through sand filters, and reduce total consumption.

Standards integration

Coca-Cola Hellenic operates 75 plants in 28 European countries, serving approximately 560 million people, and achieves annual sales of more than two billion unit cases of famous brands including Coca-Cola, Fanta, Sprite, Nestea and Schweppes. The company is rolling out a multi-faceted management system across the organization that integrates the ISO 9001 quality, ISO 14001environmental, ISO 22000 food safety and OHSAS 18001 (non-ISO) operational health and safety standards, and is currently looking at aligning with ISO 26000guidance on social responsibility.

Company-wide environmental improvements achieved since implementing ISO 14001 have been impressive. To ensure water sustainability, each bottling plant conducts risk assessments of water resources, and as a result absolute water use has dropped despite increased production volume. By the end of 2010, 99 % of all plant wastewater was being treated.

The organization’s energy-savings initiatives, including its commitment to construct 20 on-site combined heat and power units, have improved plant energy efficiency by 23 % since 2004. 

Also, CO2 emissions are expected to fall by 25 % by 2015, compared to 2004.

Total waste to landfill has dropped by 58 % since 2004 and 85 % of production waste is recycled, with much of the PET plastics reused in making new bottles. In addition, PET bottles are 16 % lighter than in 2004 and consume less raw material.

ISO publishes new standard for business continuity management

For more info:
http://www.iso.org/iso/pressrelease.htm?refid=Ref1587&utm_source=ISO&utm_medium=RSS&utm_campaign=News

New Edition of ISO 19011

ISO 19011 provides guidance on auditing management systems, including the principles of auditing, managing an audit programme and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process, including the person managing the audit programme, auditors and audit teams

ISO has just announced on publication of the 2011 edition of ISO 19011. There are some changes to the new version 2011 compare with the previous version back in 2002.Hereby, i would like to that this opportunity to hightlight the main differences compared with the first edition in 2002 are as following:

(A) The scope has been broadened from the auditing of quality and environmental management systems to the auditing of any management systems;

(B) The relationship between ISO 19011 and ISO/IEC 17021 has been clarified;

(C) Remote audit methods and the concept of risk have been introduced;

(D) Confidentiality has been added as a new principle of auditing;

(E) Clauses 5, 6 and 7 have been reorganized;

(F) Additional information has been included in a new Annex B, resulting in the removal of help boxes;

(G) The competence determination and evaluation process has been strengthened;

(H) Illustrative examples of discipline-specific knowledge and skills have been included in a new Annex A;

More info:

http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=50675

Defination of RoHS Compliance

The RoHS directive aims to restrict certain dangerous substances commonly used in electronic and electronic equipment. Any RoHS compliant component is tested for the presence of Lead (Pb), Cadmium (Cd), Mercury (Hg), Hexavalent chromium (Hex-Cr), Polybrominated biphenyls (PBB), and Polybrominated diphenyl ethers (PBDE).

For Cadmium and Hexavalent chromium, there must be less than 0.01% of the substance by weight at raw homogeneous materials level. For Lead, PBB, and PBDE, there must be no more than 0.1% of the material, when calculated by weight at raw homogeneous materials. Any RoHS compliant component must have 100 ppm or less of mercury and the mercury must not have been intentionally added to the component. In the EU, some military and medical equipment are exempt from RoHS compliance.

Risk Management Standards Dilemma ? AS/NZS 4360 vs ISO 31000 : The Comparison

APPLICATION:
AS/NZS 4360:2004 – Universal across all organisations, recognized in Australasia but also widely accepted internationally
ISO 31000:2009 - Universal across all organisations, recognized internationally

RISK MANAGEMENT
AS/NZS 4360:2004 – An organisation’s objectives
ISO 31000:2009 - An organisation’s objectives

PRINCIPLES FOR MANAGING RISK
AS/NZS 4360:2004 – Mainly implicit and included as part of risk management culture ISO 31000:2009 – Clearly explicit in Clause 3– common business management principles

FRAMEWORK FOR MANAGING RISK
AS/NZS 4360:2004 – Covered in details
ISO 31000:2009 – Clearly explicit in Clause 4– Expands on 4360

RISK MANAGEMENT PROCESS
AS/NZS 4360:2004 – Core of the standard
ISO 31000:2009 – Explicit in Clause 5 (similar as 4360)

ENHANCED RISK MANAGEMENT
AS/NZS 4360:2004 – Not covered
ISO 31000:2009 – Annex A. Informative only

GUIDE FOR ESTABLISHING AND IMPLEMENTING
AS/NZS 4360:2004 –Covered in details in HB 436:2004
ISO 31000:2009 – ISO 31004 document under development, due in 2014 or earlier

DEFINITION OF RISK
AS/NZS 4360:2004 –Chance of something happening that will impact on objectives
ISO 31000:2009 – Effect of uncertainty on objectives

DEFINITION OF RISK MANAGEMENT
AS/NZS 4360:2004 – Culture, processes and cultures that are directed towards realizing potential opportunities whilst managing adverse effects of uncertainty on objectives
ISO 31000:2009 – coordinated activities to direct and control an organization with regard to risk

DEFINITION OF RISK MANAGEMENT FRAMEWORK
AS/NZS 4360:2004 – Set of elements of an organisation’s management system concerned with managing risk
ISO 31000:2009 – set of components that provide the foundations and organizational arrangements for designing, implementing monitoring, reviewing and continually improving risk management throughout the organization

DEFINITION OF RISK MANAGEMENT POLICY
AS/NZS 4360:2004 – Not definedISO 31000:2009 – statement of the overall intentions and direction of an organization related to risk management

DEFINITION OF RISK MANAGEMENT PLAN
AS/NZS 4360:2004 – Not defined
ISO 31000:2009 – scheme within the risk management framework specifying the approach, the management components and resources to be applied to the management of risk

DEFINITION OF RISK MANAGEMENT PROCESS
AS/NZS 4360:2004 – Not defined
ISO 31000:2009 – scheme within the risk management framework specifying the approach, the management components and resources to be applied to the management of riskIn

SUMMARY :
Whilst the fundamentals of the risk management process in ISO 31000 remain the same as in AS/NZS 4360, there are a number of important changes organisations must consider when adopting ISO 31000.

ISO 31000 is a true international risk management standard and serves as “an umbrella” for other ISO or non-ISO standards referring to risk. It is critical for the many organisations wanting a consistent risk management approach globally.There are changes to important terms and definitions, some new definitions are introduced and some definitions are removed.

The relationship between the principles for managing risk, the framework for managing risk and the risk management process are better explained and illustrated in ISO 31000. There are 11 principles introduced in ISO 31000 that need to be considered to help make risk management effective.ISO 31000 now lists and describes five attributes of an enhanced risk management framework.

Fore More info:

www.safa.sa.gov.au/documents/ins_ISO_3100.pps

Requirements Medical Devices Manufacturers in Singapore By Siew En

Medical Devices Manufacturers in Singapore are required to be certified to ISO13485 standard prior to applying for a Manufacturer’s license from the Health Sciences Authority.Companies that are involved in distribution or importing Medical Devices in Singapore are required to obtain the GDPMDS certificate prior to applying for Importer or Wholesaler’s License.

In order to be certified by the certification body, companies are required to have implemented a quality management system that adheres to current good distribution practices. Medical devices companies are required to implement quality management system, procedures and with suitable facility and transportation to handle, store and transport the medical devices in accordance to current Good Manufacturing or Distribution Practice of Medical Devices.

Good Distribution Practice (GDP) is that part of quality assurance which ensures that products are consistently stored, Transported and handled under suitable condition as required by the marketing authorization or product specification.Companies who are currently certified to ISO 9001:2008 will find that they have partially fulfilled the GDPMDS requirements.

However there are differences between ISO 9001:2008 and GDPMDS or ISO13485:2003 which companies will need to reconcile before going for certification. To provide with assurance, companies will require quality manuals, comprehensive system to give assurance via proper procedures, qualified personnel, correct processes/ facilities /equipment.

Singapore’s Health Sciences Authority (HSA) released new guidelines on the preparation of a Site Master File (SMF) for pharmaceutical Good Distribution Practice (GDP) certification.

Introducing ISO 26000 – Guidance on Social Responsibility by Eugene Tay

The latest International Standard ISO 26000:2010 – Guidance on Social Responsibility, was launched yesterday by SPRING Singapore at a seminar to introduce the new standard to the business community.

What is ISO 26000

ISO 26000 provides social responsibility guidance for all types of organisations, such as MNCs and big corporations, SMEs, non-governmental organisations and government agencies.

As the world moves towards an age of radical transparency, organisations and stakeholders become increasingly aware of the need for socially and environmentally responsible behaviour. ISO 26000 is thus a timely and relevant guide to help organisations understand what social responsibility is and what they need to do to operate in a socially responsible way.


For more info:
http://www.greenbusinesstimes.com/2011/03/16/introducing-iso-26000-guidance-on-social-responsibility/

Benefits of Implementing ISO/IEC 17025 by SAMM

Implementing ISO/IEC 17025 provides both laboratory and business benefits such as:
Gaining more contracts for testing and/or calibration. All ISO 9001 certified companies will prefer to engage a laboratory that is accredited with ISO 17025 as this will be a requirement that is looked into by the certification body auditor during re-assessment or surveillance audit.

Improved national and global reputation and image of the laboratory.
Having a basis for most other quality systems related to laboratories, such as Good Manufacturing Practices and Good Laboratory Practices.

The main difference between accredited and non-accredited laboratory is that the competency of staff and reliability of test/calibration results have been proven and verified.

Technical requirements were updated to include the addition of formal personnel training plans and detailed records, method development and validation procedures, measurement of method uncertainty, equipment calibration and maintenance program. In addition, a stronger definition of the sample preparation process was documented to maintain consistency in sampling, and a more rigorous quality control monitoring program was implemented. Management quality improvements focused on document control to maintain consistent analytical processes, improved monitoring of supplier performance, a contract review process for documenting customer requirements, and a system for handling customer comments and complaints, with continuous improvement through corrective and preventive action procedures and audits.

Quarterly management review of corrective actions, nonconforming testing, and proficiency testing aid in determining long-term trending. The practical benefits of these technical and management quality improvements are seen on a daily basis in the laboratory. Faster identification and resolution of issues regarding methods, personnel or equipment, improved customer satisfaction, meeting quality requirements of specialized customers, and overall increased laboratory business are all the result of implementing an effective quality system.

Accreditation is an effective marketing tool for testing, calibration and measurement organizations, and a passport to submit tenders to contractors that require independently verified laboratories.

Laboratory accreditation is highly regarded both nationally and internationally as a reliable indicator of technical competence. Many industries, such as the construction materials industry, routinely specify laboratory accreditation for suppliers of testing services.

Unlike certification to ISO9001, laboratory accreditation uses criteria and procedures specifically developed to determine technical competence, thus assuring customers that the test, calibration or measurement data supplied by the laboratory or inspection service are accurate and reliable.

Many accreditation bodies also publish a directory of their accredited laboratories, which includes the laboratories’ contact details plus information on their testing capabilities. This is another means of promoting a laboratory’s accredited services to potential clients.

Finally, through a system of international agreements (see later in this brochure) accredited laboratories receive a form of international recognition, which allows their data to be more readily accepted in overseas markets. This recognition helps to reduce costs for manufacturers and exporters that have their products or materials tested in accredited laboratories, by reducing or eliminating the need for retesting in another.

Note:
SAMM - Malaysian Lab Accrediation Scheme