ISO 9001 Revision 2015 Is Coming

The ISO 9001 Revision 2015 timetable for development is as follows:

July 2015 – Final Draft International Standard ballot opens
August 2015 –  Final Draft International Standard ballot closes
9 September 2015 – ISO 9001:2015 International Standard is published
 According to the draft design specification, the revised ISO 9001:2015 standard should:
  • Provide a stable core set of requirements for the next 10 years or moreISO
  • Remain generic, and relevant to all sizes and types of organization operating in any sector
  • Maintain the current focus on effective process management to produce desired outcomes
  • Take account of changes in quality management systems practices and technology since the last major revision in 2000
  • Reflect changes in the increasingly complex, demanding and dynamic environments in which organizations operate
  • Enhance compatibility and alignment with other ISO management system standards
  • Facilitate effective organizational implementation and effective conformity assessment by first, second and third parties
  • Use simplified language and writing styles to aid understanding and consistent interpretations of its requirements

Seven Significant Changes in ISO 9001 Revision 2015 Committee Draft

  1. The term “product” has been replaced by “goods and services”.
  2. Two new clauses related to the context of the organization:
    4.1 Understanding the organization and its context
    4.2 Understanding the needs and expectations of interested parties.
  3. The requirement to use the “process approach” has been more explicit by adding a new clause.
    4.4.2 Process approach
  4. The standard does not include a specific clause for “Preventive Actions”.
  5. The terms “document” and “records” have been replaced with the term “documented information”.
  6. of external provision of goods and services address all forms of external provisions.
  7. The term “continual improvement” has been replaced with “improvement”.

 

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ISO 9001 Process Flow

ISO 9001 Process Flow:

iso9001-process-flow

Total Quality Management Strategies: Advantages & Disadvantages

Total Quality Management Strategies: Advantages & Disadvantages

Total Quality Management is a system of continuous improvement that involves all workers in a business from upper management to production line workers. The focus of the improvement program is to improve customer service and reduce waste in the business. Quality improvement teams use problem-solving techniques and analysis to identify and eliminate weaknesses in the company.
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Production Disruption

Implementing a Total Quality Management system in a company requires extensive training of employees. The employee training includes instruction in problem solving techniques and the tools to evaluate a process and identify weaknesses such as statistical process control, Pareto diagrams and brainstorming techniques. During the initial training period, productivity can decline. Meetings for quality improvement teams also take workers away from their duties, which also reduce productivity. While the improvements do reduce lead time, eliminate waste and improve productivity, the beginning stages of implementing Total Quality Management in an organization can reduce worker output.

Lowers Production Costs

A Total Quality Management program eliminates defects and waste, which reduces production costs in a business. As teams gather to identify and eliminate weaknesses in the business, the company continues to enjoy reduced costs and higher profit. Quality improvement teams can eliminate defects, reduce lead time and identify redundancies in the production process that can significantly add to the profit the company earns.

Employee Resistance

Total Quality Management requires change in mindset, attitude and methods for performing their jobs. When management does not effectively communicate the team approach of Total Quality Management, workers may become fearful, which leads to employee resistance. When workers resist the program, it can lower employee morale and productivity for the business. Total Quality Management uses small incremental improvements to move the business forward. It can take years for a company to enjoy the benefits of the program.

Employee Participation

Once workers understand their participation and involvement in Total Quality Management is essential to its success, morale and productivity improve. Workers become empowered through participation on quality improvement teams. Businesses can improve morale further by recognizing improvement teams that make meaningful changes in the production process to reduce or eliminate waste.

source: http://smallbusiness.chron.com  by  Luanne Kelchner, Demand Media

Continuous Improvement – Way of Developing New Products

Continuous Improvement – Way of Developing New Products

Many companies pursuing lean transformation and continuous improvement are focusing on the customer fulfillment operations to improve quality and delivery while reducing costs.

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Organizations are working to reduce lead time, improve quality, and make their manufacturing and distribution operations more efficient in an effort to cut costs. While these improvements are important, they are not sufficient in today’s globally competitive manufacturing world.

In many companies today, direct labor is a single-digit percentage of the cost of goods sold (COGS), with purchased materials and overhead burden making up over 90% of their COGS. Even with these cost breakdowns, many continuous improvement efforts still focus on trying to eliminate waste in the manufacturing process to use labor more efficiently to reduce labor content. These efforts will produce some small incremental improvements in the COGS, but a much better opportunity exists early in the new product design cycle.

It is estimated by some product development experts that 80% of the final cost of a new product is determined in the first 20% of the design cycle where the product concept and initial design philosophy are chosen. If you involve your manufacturing organization and your suppliers at these very early stages of the cycle and form a concurrent engineering design team, you have the opportunity to design products for manufacturing and assembly, both at your suppliers and in your own operations as well as using their expertise in your designs. Using such design-for-manufacturing techniques as reduced parts count, substitution of molded plastics or pressed and sintered powdered metal parts for machined metal and poka-yoke designs to eliminate assembly errors, your new products can be developed with a radically lower final cost of goods sold.

People from your manufacturing operations are a great resource to use with your product design teams to offer suggestions on how designs can be manufactured and how costs can be reduced by making products easier to assemble, with less chance for quality issues and their resultant scrap and rework costs. Manufacturing engineers can plan how to produce a new product while it’s still in design when options for processing methods and equipment are still available. Operators can evaluate their ability to assemble new products and can offer suggestions on visibility and accessibility of components before designs are frozen.

Manufacturing personnel who are familiar with existing products can suggest part substitutions to increase commonality of parts rather than having all unique components. A unique fastener that is out of stock will shut down a product operation just as surely as a custom casting or machined component, but common fasteners can often be designed in from the start.

Your suppliers, working with your product development teams, can suggest design alternatives that often reduce a product’s material cost by up to 50%. Rather than just giving them a component specification to quote, use their expertise to suggest alternate materials, design options, different fabrication techniques, and tolerances that really matter to reduce your product’s component costs. Too often, suppliers are not trusted and not involved until the design is complete and your organization has lost the opportunity to exploit the supplier’s expertise to minimize component costs by being involved with the design team from the very beginning.

There are a number of organizations utilizing concurrent engineering design teams today to incorporate the knowledge and unique experience of suppliers, manufacturing engineers, quality professionals, production and distribution personnel, accounting/finance folks and marketing/sales people to bring increased knowledge and expertise to the team to get better designs at a lower product cost. These teams are part of the design process from the very beginning, at the ideation phase, to develop new products that are better quality and lower cost than those designed exclusively behind the curtain of new-product engineering. Don’t forget to involve your suppliers and operations organization in your new product-development process at the very start.

source: http://www.industryweek.com

Revised ISO 9001 Standard Moves Closer to Completion

Revised ISO 9001 Standard Moves Closer to Completion

The revised standard will retain its strong focus on a process-based approach to quality management systems.

quality management

There is change afoot with respect to the ISO 9001 standard on quality management systems.

It is not unexpected change. All ISO standards are reviewed every three to five years to determine whether revisions are needed to keep the standards current and relevant in the marketplace, according to the International Organization for Standardization.

ISO 9001 is in the late stages of the revision process, with a new edition expected in 2015.

There are several changes outlined in the ISO 9001: 2015 edition, although the standard will retain its strong focus on a process-based approach to produce desired outcomes, explained Nigel Croft, chair of the ISO subcommittee revising the standard, in a Web update. “…which in the case of a quality management systems means, of course, consistent products and services consistently meeting customer needs and expectations.”

The changes focus on three concepts:

  1. The process approach will strongly emphasize that the quality management system has to be woven into and fully aligned with an organization’s strategic direction.
  2. Superimposed on the system of processes is the PDCA (plan-do-check-act) methodology, which will apply both to individual processes as well as the quality management system as a whole.
  3. An overall focus on risk-based thinking aimed at “preventing undesirable outcomes,” such as non-conforming products and services.

A recent vote approved the latest draft of the revised ISO 9001 standard, which has since moved to the next stage – Final Draft International Standard. In his update, Croft explained that the subcommittee will review comments that came in during the last vote and produce a final draft, which then will be voted on.

While ISO itself does not certify organizations to ISO standards, Croft noted that there would be a three-year transition period for companies to migrate to the updated standard once the new edition is published.

He also suggested that organizations may want to review the draft rather than wait until the new edition of the standard is published.

https://www.youtube.com/watch?v=1JIMyvpP0tw#t=319

Source: http://www.industryweek.com

Internal Auditing – How Often ?

Any organisation/business is required to conduct internal audits to maintain its ISO9001 standard. The audit involves testing out company processes and procedures to determine the standard at which they operate when compared to how they should work. Audits are designed to help employees but the mere mention of the word can see your staff sent into a panic, scrambling around to make everything look perfect. However, communicating yourself well to your staff on the benefit of the audits, and letting them know that this is not a finger pointing exercise, can serve well to make these audits more positive.

Internal audits should be viewed in a positive light, a chance to take a step back and have your process reviewed by a fresh set of objective eyes. They are an ideal way to prepare for external assessment too. In some ways internal assessments can be more thorough as processes are examined more closely, more frequently and in greater detail than external auditors.

ISO 9001 does not specify how often internal audits should be conducted. Instead, the requirements are that organisations audit based on how important a process is, the risks involved and whether there is an existing record of previous concerns. Consideration should also be given to quality objectives as these can dictate audit frequency. At the least, internal audits should be carried out annually. There are two ways around this – auditors may decide to review processes in one go, or they may portion off aspects and have a plan which details the schedule over a number of months. Complex processes may require more frequent assessment and this should be built into an internal audit plan.

The audit plan removes the need for panic and helps eliminate an atmosphere of mistrust. It lets everyone know what will be happening and when, as well as allowing process owners time to complete any improvements that may be taking place. Although the audit plan is made general knowledge, the detail relating to timings should be confirmed with respective process owners as soon as is possible.

The internal audit should not be seen as second string to an external audit and for that reason it needs to be as thorough as possible. Appointed auditors may benefit from some training and development to support them in getting the best out of the process. Auditors should apply a variety of methods to test the process including talking to employees, reviewing data and relevant documentation as well as and perhaps most importantly observing the process in practice. Part of being thorough is keeping accurate documentation that is a true reflection of the findings, for both management and future audits.

The aim of the audit should not be to purely report non-conformance, but auditors should also use the opportunity to highlight areas of a process which may benefit from change. Therefore as important as the audit is the follow up. Follow ups are critical to ensuring that the audit cycle is closed off, and they are also a great motivating factor for further improvements.

source: http://synergosconsultancy.co.uk

TRAINING PLAN AND TRAINING REALIZATION – TRAINING NEED ANALYSIS,

choose-personIntroduction

The Quality management principles underlying the ISO 9000 family of standards (of which the ISO 10000 series form a part) emphasize the importance of human resource management and the need for appropriate training. They recognize that customers are likely to both respect and value an organization’s commitment to its human resources and its ability to demonstrate the strategy used to improve the competence of its personnel.

Personnel at all levels should be trained to meet the organization’s commitment to supply products of a required quality in a rapidly changing market place where customer requirements and expectations are increasing continuously.

This International Standard provides guidelines to assist organizations and their personnel when addressing issues related to training. It may be applied whenever guidance is required to interpret references to “education“ and “training“ within the ISO 9000 family of quality assurance and quality management standards. Any references to “training“ in this document includes all types of education and training.

An organization’s objectives for continual improvement, including the performance of its personnel, might be affected by a number of internal and external factors including changes in markets, technology, innovation, and the requirements of customers and other stakeholders. Such changes may require an organization to analyse its competence-related needs. Figure 1 illustrates how training could be selected as an effective means of addressing these needs.

Training Need Analysis, Training Plan and Training Realization

Training can be described as “the acquisition of skills, concepts or attitudes that result in improved performance within the job environment”.

Training is process to provide and develop knowledge, skills and behaviours to meet requirements” (ISO 10015 Clause 3.2)

Training analysis looks at each aspect of an operational domain so that the initial skills, concepts and attitudes of the human elements of a system can be effectively identified and appropriate training can be specified.

Training analysis as a process often covers:

  • Training Analysis is most often used as part of the system development process. Due to the close tie between the design of the system and the training required, in most cases it runs alongside the development to capture the training requirements

Training Analysis (sometimes called Training Needs Analysis (TNA)) is the process of identifying the a gap in employee training and related training needs.

Training Needs Analysis (TNA) is defined as the “Identification of training requirements and the most cost effective means of meeting those requirements”.

A TNA should always be performed where a major new development in policy, equipment acquisition or procedures is deemed to have potential impact upon the current training regime.

What is ISO 10015?

The ISO 10015 Quality Standard for Training is a sector specific quality assurance system. It focuses on training processes at the workplace.

ISO 10015 complements ISO 9001 Standard and further elaborates on the clause 6.2.2 — “Awareness, Competence and Training” and gives clear guidance for its implementation.

The role of this ISO 10015 International Standard is

  • to provide guidance that can help an organization to identify and analyse training needs,
  • design and plan the training,
  • provide for the training,
  • evaluate training outcomes,
  • and monitor and improve the training process

in order to achieve its objectives.

It emphasizes the contribution of training to continual improvement and is intended to help organizations make thier training a more effective and efficient investment.

Scope of ISO 10015

This standard cover the development, implementation, maintenance, and improvement of strategies and systems for training that affect the quality of the products supplied by an organization.

This International Standard applies to all types of organizations.

It is not intended for use in contracts, regualtions, or for certification.

It does not add to, change, or otherwise modify requirements for the ISO 9000 series.

This International Standard is not intended to be used by training providers delivering services to other organizations.

Training providers may use this International Standard when addresing the training needs of their own personnel.

Source: www.ngusuyasa.wordpress.com

Main Steps to Improve Manufacturing Quality

There is no better cost to eliminate than the cost of poor quality.

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Good managers seek to contain costs in the manufacturing environment. There is no better cost to eliminate than the cost of poor quality. Scrap material and lost labor hours add no value to the operation.

In order to best eliminate these wastes, a strategic approach to quality improvement is essential. By following these five steps, quality can be improved in a meaningful, sustainable way.

Use a team mindset

Quality won’t be sustainably improved by individuals. To really make lasting and meaningful change in manufacturing processes, it will take a team-based approach. By involving multiple disciplines in the search for improved quality, a variety of perspectives is obtained. Also of importance is knowledge of process history. Why is the process the way it is today? There must be a reason or cause, and that reason should be considered so as not to repeat a problem of days gone by. By considering history and group perspective, solid improvements can be obtained.

Define quality from the customer perspective

Too often, staff within a manufacturing environment want to make a product “better” but don’t really know what better means. With additional cost, we almost always can make a product better. But is additional cost desirable by the customer even if it means better product life? Someone in the organization should serve as the customer advocate. Typically this voice can come from the sales or marketing departments. Use the customers’ perspective to define what the best-in-class product would be and meet those requirements while minimizing cost.

Develop understanding of the Cost of Quality

The cost to fix a defect in the field once it reaches a customer is dramatically higher than the cost to fix the source of the problem before it is created. It is essential that the manufacturing staff be trained to understand the cost multipliers involved with warranty repair or replacement and cost of damaged reputation. Once the staff take this perspective, a desire to find root cause for problem solving is inherently developed.

Solve problems completely

All too often, manufacturing quality improvements fix the symptoms of failure rather than the root cause. This can be done by adding quality inspection steps or rework stations that make it more efficient to fix defects. Instead, a true understanding of root cause should be developed within the teams. When teams develop the ability (through Ishikawa, fault tree, or five-why analysis) to ascertain root cause of defects in the manufacturing process along with a “killer test” that verifies the ability to turn-on and turn-off the problem in the manufacturing process, true solutions to problems will be created that will not allow the return of the issue.

Employ strong process discipline

Throughout the quality improvement process, it is essential that strong process discipline is employed. Depending on the product that is being manufactured, deviation without proper team cooperation and anticipation of the change could have dire quality repercussions. While the organization should avoid cumbersome bureaucracy that inhibits innovation, it is essential that some structure be employed to maintain consistency and an understanding of the way the product is produced during that time period so that root cause can also be identified later if new problems arise as a consequence of the change.

By following these above steps, good management teams can develop great quality programs within their organizations.

source: http://www.industryweek.com

Why register your company to ISO 9001 .

Benefits of ISO 9001ISO 9001

ISO 9001:2008 aims to provide a practical and workable Quality Management System for improving and monitoring all areas of your business.

Achieving the standard is not about establishing a set of procedures that are complicated and difficult to manage. With the right support and the knowledge of your employees, you will end up with a system that will improve all areas of your organisation.

Implementing an effective and robust Quality Management System (QMS) will help you to focus on the important areas of your business and improve efficiency. The management processes that are established throughout your business will provide a sound foundation, leading to increased productivity and profit. This in turn will improve your customer acquisition and retention.

Some of the main benefits include:

  • Suitable for both small and large organizations
  • Better internal management
  • Less wastage
  • Increase in efficiency, productivity and profit
  • Improved customer retention and acquisition
  • Consistent outcomes, measured and monitored
  • Globally recognised standard
  • Compatible with other ISO standards

A valid ISO 9001:2008 certificate will be a prerequisite for some of your customers and a “nice to have” for others, when they are considering suppliers.

It gives your customers confidence that you are working to standards and procedures that will provide them with a high standard of customer service.

Benefits to your customers:
The ISO 9001:2008 standard is recognised worldwide and your customers will understand the benefits of working with companies that are ISO 9001:2008 certified. In fact, some of your customers will only do business with certified companies because it gives them assurance that you management systems are constantly assessed and approved.

They will know from experience that working with ISO 9001:2008 certified companies provides many advantages:

Minimizes mistakes:
Improves reporting and communications
Better quality products and service
More reliable production scheduling and delivery
Standards maintained by annual assessments

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