Steps to Implement ISO 9001:2008 QMS Without Seeking Consultant’s Help

- Dr. Divya Singhal & Keshav Ram Singhal

A few days back one of the authors of this write-up received a phone call from an executive of an organization stating that his organization wishes to implement ISO 9001:2008 QMS standard and asked whether engaging a consultant was necessary to implement the standard and how his organization could implement ISO 9001:2008 standard without engaging a consultant.

Due to high cost involved in implementing any of the management systems standards, organizations generally hesitate to implement management systems standards. Although appointing a consultant may be worthwhile investment for an organization, however appointing a consultant to implement any management systems standards is not necessary. Many organizations in the world have implemented ISO 9001 QMS standard without engaging consultants and successfully got ISO 9001 certification. However, many organizations find it difficult to implement the standard without consultant. It depends on the level of competency available in the organization. An organization, wish to implement any management systems standards, should determine whether a consultant is required. Why organizations generally engage consultants? We find, there may be following reasons:

1. Consultants have the experience, expertise and time that employees may not. Organizations generally engage consultants to fill the knowledge and time gaps.
2. Consultants provide flexibility of time. Consultants work any time, including nights, weekends and holidays.
3. Consultants offer the latest and objective point of view. Consultants bring the latest and unbiased ideas from their vide experience.
4. Consultants are more efficient and focus on assigned project with sincerity. So they help you fast track your way to an effective QMS.

If competency level in the organization is adequate and people are well aware of the organization’s systems, then organization can think implementing ISO 9001:2008 QMS standard without consultant. One should be very clear that ISO 9001:2008 standard is a generic standard in terms of its requirements, but not generic in terms of its implementation. So, while implementing the standard, the emphasis should be on the objectives and processes of the organization.

When organization plans to implement ISO 9001:2008 QMS Standard without consultant, the top management of the organization has important and relevant role in implementation. Through leadership and their actions, the top management is able to create an environment in the organization – (i) where people are fully involved, and (ii) in which a quality management system can operate effectively. The top management should demonstrate its commitment and determination to implement ISO 9001:2008 QMS Standard by involving themselves actively in the following tasks –

(i) Ensuring people in the organization understand the importance of meeting customer requirements and also statutory and regulatory requirements.
(ii) Defining organization’s quality objectives and commitment to quality and ensuring that everyone in the organization understands the ‘quality policy’ and how it applies to their work.
(iii) Performing ‘management reviews’ regularly to see the continuing suitability, adequacy and effectiveness of the quality management system.
(iv) Providing necessary resources to all quality activities.

The following step-by-step approach may be useful in implementing ISO 9001:2008 QMS Standard –

Step 1 – Appointing management representative

Management representative is important personnel in quality management system structure, who should have responsibility and authority to (i) implement the requirements of ISO 9001:2008 QMS, (ii) report back to the top management on the performance of the quality management system, and (iii) promote awareness of customer requirements throughout the organization. ISO 9001:2008 QMS Standard also requires appointment of a management representative (clause 5.2.2). Accordingly, the top management should appoint a member of organization’s management as management representative. It should be noted that the responsibility and authority of management representative cannot be assigned to an outside person.

Step 2 – Setting up a steering committee

When organization is thinking to implement ISO 9001:2008 QMS without consultant, it is better if the top management set up a steering committee. The chief executive or a senior officer of the organization should head the steering committee. Functional heads and management representative should be the members of the steering committee. The committee should be responsible for the overall planning of ISO 9001:2008 QMS implementation process, giving directions and allocating resources. The committee should also decide the scope for ISO 9001:2008 QMS.

Step 3 – Setting up a task force

The top management or steering committee should set up a task force. The management representative should be the coordinator of the task force. Persons having good knowledge of the organization’s processes and good communication-writing skills should be included as members of the task force. The task force should be allocated the timeframe task of developing documentation, such as, quality manual, procedures, work instructions etc.

Step 4 – Obtaining information about ISO 9001 QMS

The management representative should collect information about ISO 9001:2008 QMS and related standards. For general information, it is better to visit ISO website and IAF website. Purchase of the following may be useful –

• ISO 9000:2005 Quality management systems – Fundamental and vocabulary,
• ISO 9001:2008 Quality management systems – Requirements,
• ISO 9004:2009, Managing for the sustained success of an organization – A quality management approach,
• ISO 19011:2002, Guidelines on quality and/or environmental management systems auditing,
• Various others publications / literatures providing knowledge on ISO 9001:2008 QMS.
Internet is useful source for obtaining information on ISO 9001:2008 QMS for which various websites and blogs may be visited.

Step 5 – Organizing awareness programme

ISO 9001:2008 QMS awareness programme should be organized to communicate to the employees the aim of ISO 9001:2008 QMS, the advantage it offers (to employees, customers and the organization), how it will work, and employees’ roles and responsibilities within the system. This programme may be conducted by the management representative, any of the task force members or outside faculty.

Step 6 – Training

Training is important for improving the competency level of employees. Training programmes should be organized for different categories of employees – senior managers, supervisors and workers. It will be better if the top management also attend ISO 9001:2008 QMS related training, seminar or presentation.
The training should cover the basic concepts of quality management systems and their overall impact on the strategic goals of an organization, quality management principles, the processes, requirements and the likely work culture implications of the system.

Initial training may also be necessary on developing documentation, QMS auditing, laboratory management techniques, statistical tools, calibration, measurement and testing procedures etc.

The steering committee can decide organizing such trainings as in-house programmes or alternatively personnel may be nominated to external training programmes.

It is suggested that a few people of the organization (including the management representative) should undergo Lead Auditor Training. A few people selected as internal auditors should be provided internal audit or lead auditor training.

Step 7 – Formulating action plan

The steering committee should formulate a timeframe action plan for implementation of ISO 9001:2008 QMS. The action plan should define the responsibilities of different departments and personnel and set target dates for the completion of activities.

Step 8 – Carrying out initial status survey

It is better to know the gaps between the systems of the organization and the requirements of the ISO 9001:2008 QMS Standard. A self-assessment initial status survey may be carried out by the management representative or any other personnel who have undergone QMS auditor training or lead auditor training. After conducting initial status survey, the organization will be in a position to know the gaps and what is required to do for implementation.

Step 9 – Developing documentation

ISO 9001:2008 QMS Standard requires developing QMS documentation and developing documentation is the most important activity in the implementation process. Members of the task force should be given training on developing documentation. It will be better if a few of them are trained as lead auditors. They should be well versed with the requirements of ISO 9001:2008 QMS Standard and also with the processes of the organization. As earlier pointed out, members of the task force involved in developing documentation should have good communication-writing skill. While developing documentation, reference to ISO 9001:2008 QMS, ISO 19011:2002 (on auditing) and ISO 10013 (on documentation) Standards would be better.

Organizations implementing ISO 9001:2008 QMS need to develop and establish documentation (including quality policy, quality objectives, quality manual, procedures etc.) and also to keep records of information that is useful in operation and assessment of the organization’s quality management system.

The quality management system documentation of the organization needs to include the following documents:

i. Documented statement of quality policy,
ii. Documented statements of quality objectives,
iii. A quality manual,
iv. Documented procedures required by the Standard,
v. Documents (= including documented procedures, work instructions, forms) determined by the organization,
vi. Records required by the Standard,
vii. Records determined by the organization.

Out of the above first five types of documents are required to be developed and rest two types are records of information that is useful in operation and assessment of the organization’s quality management system.
For developing organization’s quality policy, quality objectives and quality manual, compliance to requirements mentioned in clauses 4.2, 5.3 and 5.4.1 of ISO 9001:2008 QMS Standard should be adhered to.

QMS documentation is the basis for establishment, implementation and maintenance of the quality management system of the organization. An organization can combine all documentation in one manual or can have more manuals.
As stated earlier developing QMS documentation is the most important activity in the implementation process. A list of documents to be prepared should be drawn up and the the responsibility for writing the documents should be assigned to members of the task force concerned with various functional departments. This will lead to better understanding of requirements and also provide a sense of responsibility (including the involvement and ownership by personnel involved in developing documentation). The responsibility to develop QMS documentation (for example: procedures, work instructions) should be given to those persons, who are involved in the processes and activities. This will lead to ownership of documents and better understanding of the organization’s processes.

As the coordinator of the task force, the management representative should follow following steps –

• Make a list of all existing QMS related documents and obtain a copy of each documents for reference,
• Study each process and prepare a flow chart of activities,
• Examine interfaces and lack of interfaces between the processes,
• Review the process flow charts and identify duplication or omissions in the information or process flow,
• Map out what is to be written,
• Verify the presence of all the required elements (requirements) of ISO 9001:2008 QMS Standard in the current system,
• Allocate responsibilities for preparing drafts of relevant parts to various members of the task force,
• Circulate the completed drafts to persons concerned for comments,
• Consider comments received and incorporate necessary corrections,
• Take action to prepare final manuscript of the documentation

Step 10 – Implementation

The organization needs to close the gaps as identified in step 8 (initial status survey), the steering committee should allocate resources to perform actions and implementation, assign responsibilities and establish a final time-frame to complete the needed actions.

It will be good practice to implement the procedures being documented, as the documentation is developed, although this may be more effective in larger organizations. In small size organizations, the implementation of the QMS documentation is done at once throughout the organization. When phased implementation takes place, the effectiveness of the system in selected area can be evaluated. It would be a good idea initially to evaluate areas where the chances of positive evaluation are high, to main confidence of both management and staff in the merits of implementing the quality management system as per ISO 9001:2008 QMS Standard. Make efforts for effective implementation and make sure that what has been written in QMS documentation is being carried out.

Step 11 – Internal audit

As per the requirement of ISO 9001:2008 QMS Standard, the organization needs to conduct internal audits at planned intervals. The purpose is to ensure that the quality management system of the organization conforms to the planned arrangements, to the requirements of the ISO 9001:2008 QMS Standard and to the requirements established by the organization. A few staff members should be trained to carry out internal auditing. Even after the system stabilizes and start functioning, internal audits should be planned and performed as a regular strategy.
Make sure that non-conformances pointed out in the internal audit are resolved by ensuring corrective actions and turned to conformances. Make sure to maintain records of the audit and its results.

Step 12 – Management Review

When implementation of the documented QMS has been operating for three to six months and an internal audit has been conducted, a management review should be conducted by the top management of the organization by considering following inputs:

• Internal audit results,
• Customer feedback,
• Process performance,
• Product conformity,
• Status of corrective and preventive actions,
• Changes that could affect the QMS and recommendations for improvement.

Management review forms an integral part of the quality management system and it should be conducted at planned intervals. Make sure to maintain records from the management review.

Conclusion

Accordingly, by carrying out above steps an organization can implement ISO 9001:2008 QMS Standard without seeking consultant’s help, however, it is important to note that the training and awareness is very important in implementing management systems standards.

Certification is not a requirement of ISO 9001:2008 QMS Standard and many organizations in the world are implementing the standard without obtaining certification. However, if an organization wishes to obtain certification, then a pre-assessment audit should be arranged with an independent and qualified auditor that would provide a degree of confidence in the implementation. When the quality management system as per ISO 9001:2008 QMS Standard has been in operation for a few months and has stabilized, the organization can go for the process of third party certification.

Courtesy - Quality World, New Delhi - November 2010



Where can I get more articles?
This article is included in ‘Awareness Series on QMS’ containing more than 50 articles edited by KESHAV RAM SINGHAL. You can get this series by sending your subscription that is very nominal. You should send an email to keshavsinghalajmer@gmail.com asking subscription details of the Awareness Series on QMS.

I need Training or Consultancy help. Can you help?
Yes, we can certainly help you. We are expertise in implementation steps and can help you fast track your way to an effective and profitable QMS. We can provide you online training and/or consultancy help. If you need help in developing or implementing your ISO 9001:2008 QMS, please email us at keshavsinghalajmer@gmail.com giving details of your requirements.

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Let us learn from a Quality Guru - Philip Crosby

Philip Crosby
18 June 1926 – 18 August 2001)

American Quality Guru Philip Crosby contributed to management theory and quality management principles. He was the person, who initiated ‘Zero Defects’ programme at the plant of Martin Company, Florida, USA. He was the person, who put the belief among the industrial world that quality is free. ‘Doing it right the first time’ is his principle to respond to any quality crisis.



Education – Graduated (1944) from Triadelpha High School, Honorary Law Degree from Wheeling College, Honorary Law Degree from Rollins College, Honorary Doctor of Corporate Management from the University of Findlay

Crosby work life details

Crosby served in World War II and the Korean War. After serving in WWII and the Korean War, he worked for Closley, Martin-Marietta and ITT. He was the corporate vice president of ITT for 14 years. In the Korean War he served as a Marine Medical Corpsman.

1952 – Crosby started his career as a quality professional. Joined Croseley Corporation (Richmond, Indiana) as a junior electronic test technician, where he was directed to join the American Society for Quality Control and thus he entered in to the field of quality.

1955 – Moved to South Bend, Indiana and joined Bendix Corporation as a reliability technician, where he was associated with the work to investigate defects found by the testers and inspectors

1957 – Joined Martin Marietta Company in Orlando, Florida as a senior quality engineer and worked there for eight years. During this period, he developed his ‘Zero Defects’ concepts and also wrote many articles for various journals. He also started his speaking career.

1965 – He joined International Telephone and Telegraph as a vice president in charge of corporate quality.

1979 – Started a management consultancy organization ‘Philip Crosby Associates Inc.’ He published his first book ‘Quality is Free’.

1991 – Retired from Philip Crosby Associates and founded a new company named ‘Career IV, Inc.’ helping people to grow.

Crosby in Indian context

Philip Crosby visited India in 1996 and he talked with a few software folks at NIIT. As a nonexecutive chairman of ‘India Quality Management Foundation’, Crosby wrote a story about the eighth grade and quality management.

Crosby books

• Cutting the Cost of Quality (1967)
• Quality is Free: The Art of Making Quality Certain (1979)
• Quality Without Tears: The Art of Hassle-Free Management (!984)
• Running Things: The Art of Making Things Happen (1986)
• The Eternally Successful Organization (1988)
• Let’s Talk Quality (1989)
• Leading: The Art of Becoming an Executive (1990)
• Completeness: Quality for the 21st Century (1992)
• Reflections on Quality (1995)
• Quality IS Still Free (1996)
• The Absolutes of Leadership (1997)
• Quality and Me : Lessons of an Evolving Life (1999)

The Principle – ‘Doing it right the first time’

‘Doing it right the first time’ is Crosby’s principle to respond to any quality crisis. He defined following four quality absolutes:

i. Quality is conformance to requirements (requirements meaning both product requirements and customer’s requirements), not as ‘goodness’ or ‘elegence’
ii. The system of quality is prevention, not appraisal
iii. The performance standard must be zero defects (relative to requirements), not ‘that’s close enough’
iv. The measurement of quality is the price of nonconformance (PONC), not by indices

The above four absolutes originally coined by Crossby in his famous book ‘Quality is Free’. Four years after the death of Philip Crosby, Pilip Crosby Associates, a consulting organization founded by Philip Crosby, added another absolute, which states – “The purpose of quality is to ensure customer success, not customer satisfaction.”

Philip Crosby’s 14-Step Quality Improvement Process

Step 1 – Management commitment
Step 2 – Quality improvement teams
Step 3 – Measurement
Step 4 – Cost of quality
Step 5 – Quality awareness
Step 6 – Corrective action
Step 7 – Zero defects planning
Step 8 – Education
Step 9 – Zero Defects Day
Step 10 – Goal setting
Step 11 – Error cause removal
Step 12 – Recognition
Step 13 – Quality councils
Step 14 – Do it over again

‘Quality is Free’

‘Quality is Free’ communicates powerful messages
i. Senior management must commit to quality if things are to change
ii. Doing things right the first time adds absolutely nothing to the cost of a product or service
iii. Quality is free, but it is not a gift
iv. An organization that established a quality programme will see savings more than pay off cost of the quality programme.

With best wishes,

Keshav Ram Singhal

Let us learn from a Quality Guru - Joseph M. Juran

Joseph M. Juran
(24 December 1904 – 28 February 2008)

Joseph Moses Juran, a leading quality guru, who had written several influential books on quality and quality management. Born in Romania, but he spent most of his life in America. He is often known as ‘Father of Quality’.



A few awards received by Juran includes – (i) Second Order of the Sacred Treasure Award from the Emperor of Japan.

Education – B. S. in Electrical Engineering (1925) – University of Minnesota

Juran’s Work Life details

1925 – Started working with Western Electric in the Inspection Department of the Hawthorne Works, Chicago, USA.

1926 – Attended training programme designed to implement new tools and techniques, and thereafter, from a group of 20 trainees, Juran became one of two engineers for the Inspection Statistical Department.

1928 – Juran wrote a paper ‘Statistical Methods Applied to Manufacturing Problems’

1937 – Juran became the Chief of Industrial Engineering at Western Electric in New York. His work involved visiting other organizations and discussing methods of quality management. Juran created the ‘Pareto Principle’ which managers rely on to help separate the ‘vital few’ from the ‘useful many’ in their activities. This is now commonly referred as the 80-20 principle and also referred to as Juran’s Pareto Principle.

During World War II – Juran’s leave of absence from Western Electric for a period of four years, during this time he served as an assistant administrator for the Land-Lease Administration in Washington. By the end of the war, Juran was a well-known and highly-regarded Statistician and industrial engineering theorist in America.

1945 and thereafter – Left Washington and did not join Western Electric. Juran chose to devote the remainder of his life to the study of quality management. Joined New York University as Chairman of the Department of Administrative Engineering, where he taught for many years. He devoted his tome mostly in the development of his management philosophies. The Union of Japanese Scientists and Engineers invited Juran to Japan in 1954, where he taught them the principles of quality management and thus helped Japanese rebuilt their economy. In 1979 he founded Juran Institute.

Juran is famous for his quality management ideas known as Quality Trilogy. Quality Trilogy includes three distinct phases: (i) Quality Planning – Identify your customers, determine needs of your customers, translate their needs in your own language, and develop a product that can respond to customer needs, (ii) Quality Improvement – Develop a process which is able to produce a product, and optimize the process, (iii) Quality Control – Prove that the process can produce the product under operating conditions with minimal inspection, and transfer the process to operation.

Juran in Indian context

Indian Merchants’ Chamber (IMC) initiated an award named ‘IMC Juran Medal’, which has become a benchmark for quality leaders in India.

Famous work of Juran

• Juran’s Pareto Principle
• Quality Control Handbook (First released in 1951)
• Managerial Breakthrough – A collection of Juran’s lectures (1964)
• Juran’s Quality Trilogy (First published in 1986)
• Foundation of Juran Institute (1979)

Juran’s Pareto Principle

Juran’s Pareto Principle, suggested by Joseph M. Juran, is also known as the ’20-80 Rule’, ‘the law of vital few’ and ‘the principle of factor sparsity’. It emphasizes that for many phenomena 80% of consequences stem from 20% causes. Juran framed this principle after he adopted an idea from the Italian economist Vilfredo Pareto that stated the 80% of property in Italy was owned by 20% of the Italian population. Thus, Juran was able to frame that ‘20% of clients are responsible for 80% of sales volume’. The Juran’s Pareto Principle is helpful in future decision making. The 20-80 Rule means that in anything a few (20%) are vital and many (80%) are trival.

Juran’s definition for quality

Juran defines quality as ‘fitness for use’ (1988). Note: The customer defines the fitness.

Juran offers two definitions of quality in his must-have reference, Juran’s Quality Handbook:
• Quality means those features of products, which meet customer needs and thereby provide customer satisfaction.
• Quality means freedom from deficiencies – freedom from errors that require doing work again (rework) or that result in field failures, customer claim and so on.

Juran’s Quality Improvement Tools

Juran suggests following 10 steps to quality improvement:
i. Build awareness of opportunity to improve
ii. Set your goals for improvement
iii. Organize yourself to reach goals
iv. Provide training
v. Carry out projects to solve problems
vi. Report progress
vii. Give recognition
viii. Communicate results
ix. Keep score
x. Maintain momentum by making annual improvement plan of the regular systems and processes of the organization

With best wishes,

KRS

Let us learn from a Quality Guru - W. Edward Deming

W. Edward Deming (14 October 1900 – 20 December 1993)

W. Edward Deming was an American quality guru, who had significantly contributed in building Japan. He taught – (i) How to improve design (and thus product/service), (ii) Product quality, (iii) Testing, (iv) Sales through various methods, (v) Application of statistical methods.



A few awards received by Deming includes – (i) Second Order Medal of the Sacred Treasure (1960) awarded by the Emperor of Japan, for his contribution for improvement of quality and of Japanese economy through statistical quality control, (ii) Shewhart Medal (1955) from the American Society for Quality Control, (iii) Samuel S. Wilks Award (1983) from the American Statistical Association, (iv) Taylor Key Award, American Management Association (1983) (v) ‘National Medal of Technology’ (1987) awarded by the US President Reagan, (vi) ‘Distinguished Career in Science Award’ (1988) from the National Academy of Sciences, USA .

Deming was popularly considered as a hero in Japan.

Education – B. Sc. (Electrical Engineering) from the University of Wyoming (1921), M. S. from University of Colorade (1925), Ph. D. from Yale University (1928), Internship at Bell Telephone Laboratories while pursuing Ph. D.

Famous work of Deming:

(i) Book ‘Out of Crisis’ (1982-1986)
(ii) Book ‘The New Economics for Industry, Government, Education’ (1993)
(iii) System of Profound Knowledge
(iv) 14 Points for Management
(v) Foundation of W. Edwards Deming Institute in Washington (1993)


The Deming System of Profound Knowledge

The Deming System of Profound Knowledge teaches us –

i. The prevailing style of management must undergo transformation (change). A system cannot understand itself. The transformation requires a view from outside – a lens that Deming called it a system of profound knowledge.
ii. A map of theory by which to understand the organizations that people work in.
iii. The first step is transformation of individual. This transformation is not continuous. This transformation of individual comes from understanding of the system of profound knowledge.
iv. The individual transformed will perceive new meaning to his life, to events, to numbers of interactions between people.
v. Once the individual understands the system of profound knowledge, he will apply its principles in every kind of relationship with other people.
vi. Once the individual understands the system of profound knowledge, he will have a basis for judgement of his own decisions and for transformation of organizations that he belongs to.
vii. Once the individual is transformed, he will set an example, he will be a good listener but will not compromise, he will continually teach other people and he will help people to pull away from their current practices and beliefs and move into the new philosophy without a feeling of guilt about the past.

Deming advocated that all managers must to have a System of Profound Knowledge. A system of profound knowledge consists of four parts: (i) Appreciation of a system, (ii) Knowledge of variation, (iii) Theory of knowledge, (iv) Knowledge of psychology. Accordingly, a manager must have the understanding of the overall processes including suppliers, producers, and customers (or recipients or end users) of goods and services. He must have knowledge of the range and causes of variation in quality and use of statistical techniques in measurements. He must understand the concepts explaining different things and limits. He must have the knowledge of concepts of human nature, thus he should be an expert in psychology. Deming explained his concept on the system of profound knowledge and stated that one need be eminent neither in any part nor in all four parts in order to understand it or apply it. Deming puts the 14 points for management in industry, education and government to follow as application for transformation. The System of Profound Knowledge is the basis for application of Deming’s famous 14 points for management.

Deming in Indian context

Deming visited India as a delegate from the A. A. A. S. to the Indian Science Congress, New Delhi in January 1947. He worked as a consultant in sampling to the Government of India during January – February 1947, December 1951 and March 1971.


Deming’s 14 points for management

Deming’s book ‘Out of the Crisis’ mentioned Deming’s famous 14 points for management for transforming business effectiveness, which are as under:
1. Create constancy of purpose toward improvement of product and service, with the aim to become competitive, stay in business and to provide jobs.
2. Adopt the new philosophy. We are in a new economic age. Western management must awaken to the challenge, must learn their responsibilities, and take on leadership for change.
3. Cease dependence on inspection to achieve quality. Eliminate the need for massive inspection by building quality into the product in the first place.
4. End the practice of awarding business on the basis of a price tag. Instead, minimize total cost. Move towards a single supplier for any one item, on a long-term relationship of loyalty and trust.
5. Improve constantly and forever the system of production and service, to improve quality and productivity, and thus constantly decrease costs.
6. Institute training on the job.
7. Institute leadership. The aim of supervision should be to help people and machines and gadgets do a better job. Supervision of management is in need of overhaul, as well as supervision of production workers.
8. Drive out fear, so that everyone may work effectively for the company.
9. Break down barriers between departments. People in research, design, sales, and production must work as a team, in order to foresee problems of production and usage that may be encountered with the product or service.
10. Eliminate slogans, exhortations, and targets for the work force asking for zero defects and new levels of productivity. Such exhortations only create adversarial relationships, as the bulk of the causes of low quality and low productivity belong to the system and thus lie beyond the power of the work force.
11. a. Eliminate work standards (quotas) on the factory floor. Substitute with leadership.
b. Eliminate management by objective. Eliminate management by numbers and numerical goals. Instead substitute with leadership.
12. a. Remove barriers that rob the hourly worker of his right to pride of workmanship. The responsibility of supervisors must be changed from sheer numbers to quality.
b. Remove barriers that rob people in management and in engineering of their right to pride of workmanship. This means, inter alia, abolishment of the annual or merit rating and of management by objective.
13. Institute a vigorous program of education and self-improvement.
14. Put everybody in the company to work to accomplish the transformation. The transformation is everybody's job.

Deming’s Seven Deadly Diseases and Lesser Category of Obstacles

Deming described ‘Seven Deadly Diseases’ as under:

1. Lack of constancy of purpose
2. Emphasis on short-term profits
3. Evaluation by performance, merit rating, or annual review of performance
4. Mobility of management
5. Running a company on visible figures alone
6. Excessive medical costs
7. Excessive costs of warranty, fueled by lawyers who work for contingency fees

‘A Lesser Category of Obstacles’ include the following:

1. Neglecting long-range planning
2. Relying on technology to solve problems
3. Seeking examples to follow rather than developing solutions
4. Excuses, such as, ‘Our problems are different.’
5. Obsolescence in school that management skill can be taught in classes
6. Reliance on quality control departments rather than management supervisors, managers of purchasing and production workers
7. Placing blame on workforces who are only responsible for 15% of mistakes where the system designed by management is responsible for 85% of the unintended consequences
8. Relying on quality inspection rather than improving product quality

Deming modified PDCA Cycle

Plan-Do-Check-Act (PDCA) cycle was made popular by Dr. W. Edwards Deming, referring it as ‘Shewhart Cycle’, later he modified this cycle to ‘Plan-Do-Study-Act’ (PDSA) cycle because Deming felt that ‘check’ emphasized inspection over analysis.

With best wishes,

KRS

ISO 9001:2008 QMS Awareness Questions

Write ‘Yes’ for the statement you agree and ‘No’ for the statement you do not agree.

1. Quality is a fluid concept. - Yes / No
2. It is easy to manage quality. - Yes / No
3. W. Edward Deming says that quality is pride for workmanship. - Yes / No
4. According to the ISO definition of ‘quality’ means ‘degree to which a set of inherent characteristics fulfills customer expectations.’ - Yes / No
5. The fitness for purpose for quality can be judged by the customer, provider or an independent auditor. The independent auditor is the final judge. - Yes / No
6. The system of appraisal known as ‘quality control’ as a traditional method where ‘inspection’ is the king. - Yes / No
7. In order to remain in business, an organization has to provide goods and service of high quality, sale at the right price, meet delivery requirements and make a profit. - Yes / No
8. There can be two members from one country having ISO membership. - Yes / No
9. The objective of ISO is to promote the development of standardization and related activities in the world. - Yes / No
10. ISO 9000 is a mandatory system. - Yes / No
11. ISO 9001:2008 QMS Standard is a government regulation in India. - Yes / No
12. It is necessary to implement ISO 9001:2008 QMS Standard by organizations to seek SSI registration. - - Yes / No
13. Suppliers can establish standards of quality in their management systems and have assessed against ISO 9004:2009 international standard. - Yes / No
14. The quality management principles have been developed for use by the people of the organization in order to have better performance. - Yes / No
15. By predicting customer needs, an organization becomes customer focused organization. - Yes / No
16. Continual improvement is a requirement of ISO 9001:2008 QMS Standard and also a quality management principle. - Yes / No
17. Effective decision can be taken if an organization analyzes data and information in a proactive manner using ‘factual approach to decision making’ principle. - Yes / No
18. A desired result can be achieved more efficiently when all related resources and activities are managed as a process. - Yes / No
19. Appointing a consultant is necessary to implement ISO 9001:2008 QMS Standard. - Yes / No
20. The top management must appoint a ‘quality manager’ to coordinate QMS activities and also to give necessary directions to the people of the organization. - Yes / No
21. The responsibility and authority of ‘management representative’ can be assigned to an outside person. - Yes / No
22. It is necessary for the management representative to undergo lead auditor training. - Yes / No
23. An organization (in the absence of organization’s quality policy and quality objectives) can be granted ISO 9001:2008 QMS certification, if certification body finds the organization having met all other requirements of the ISO 9001:2008 QMS Standard. - Yes / No
24. If an organization has appointed a quality professional, then the organization is not required to appoint management representative for implementing ISO 9001:2008 QMS. - Yes / No
25. For implementing ISO 9001:2008 QMS, it is necessary to appoint a consultant. - Yes / No
26. International organization for Standardization (ISO) audit organizations and issues ISO 9001:2008 certificates. - Yes / No
27. International organization for Standardization (ISO) is the biggest certification body. - Yes / No
28. Management review forms an integral part of the quality management system and it should be conducted at planned intervals. - Yes / No
29. External audit and certification are mandatory requirements of ISO 9001:2008 QMS Standard. - Yes / No
30. An organization can implement ISO 9001:2008 QMS Standard only when it wishes to achieve its certification. - Yes / No
31. On implementing ISO 9001:2008 QMS Standard requirements, quality management system documentation of one organization cannot differ from another organization. - Yes / No
32. The ISO 9001:2008 QMS Standard lays down an emphasis on continual improvement of the quality management system. - Yes / No
33. Where an organization chooses to outsource any process that affects product conformity to requirements, the organization may relax control over such processes. - Yes / No
34. The intention of the ISO 9001:2008 QMS Standard is to imply uniformity in the structure of quality management system and uniformity of documentation. - Yes / No
35. Ensuring control over outsourced processes absolve the organization of the responsibility to fulfill all customer and legal requirements. - Yes / No
36. The quality management system documentation of an organization can be in any form or type of medium. - Yes / No
37. One copy of the quality management system documentation must be in hard copy. - Yes / No
38. It is mandatory for an organization to have documented procedure for control of documents, control of records, internal audit, control of purchasing, corrective action and preventive action. - Yes / No
39. All documents required by the quality management system of the organization are needed to be controlled as per requirements mentioned in clause 4.2.3 of ISO 9001:2008 QMS Standard. - Yes / No
40. Records required by the quality management system of the organization are needed to be controlled as per requirements mentioned in clause 4.2.4 of ISO 9001:2008 QMS Standard. - Yes / No
41. Approval of documents for adequacy may be obtained after issue of documents. - Yes / No
42. Reviewing documents means another look at the documents and this may be carried randomly or periodically. - Yes / No
43. Relevant versions of applicable documents along with obsolete documents must be available at points of use. - Yes / No
44. Management reviews is conducted at the convenience of the top management as and when they wish. - Yes / No
45. The detail and format of the quality manual of one organization cannot differ from another organization, if both organizations are implementing the same ISO 9001:2008 QMS Standard. - Yes / No
46. Quality objectives must be measurable. - Yes / No
47. ISO 9001:2008 QMS Standard stipulates that management review must be conducted at least once in a year. - Yes / No
48. ISO 9001:2008 QMS Standard stipulates that the organization must maintain appropriate record of human resources (such as attendance, leave records). - Yes / No
49. Personnel carrying out work affecting conformity to product requirements must be competent. - Yes / No
50. The organization must determine the necessary competence for all personnel. - Yes / No
51. The term ‘work environment’ relates to physical, environmental and other factors, human resources and also infrastructure facilities that organization has. - Yes / No
52. The term ‘work environment’ has been defined as a set of conditions under which work is performed. - Yes / No
53. No organization can take exclusion from design and development requirements as mentioned in clause 7.3 of ISO 9001:2008 QMS Standard. - Yes / No
54. If an organization is unable to conduct management review at defined intervals due to shortage of staff, then the organization can claim exclusion for management review requirements. - Yes / No
55. Internal audit is a one time activity. - Yes / No
56. An internal auditor is allowed to audit his/her own work. - Yes / No
57. The organization must conduct internal audit at defined intervals, however it is not necessary to maintain records of audit. - Yes / No
58. ISO 9001:2008 QMS Standard has defined the frequency of the internal audit. - Yes / No
59. If an organization has a good monitoring system and it conducts management review at defined intervals then there is no need to conduct internal audit. - Yes / No
60. It is mandatory to have a documented procedure for control of nonconforming product as per ISO 9001:2008 QMS Standard. - Yes / No
61. It is mandatory to have a documented procedure for analysis of data as per ISO 9001:2008 QMS Standard. - Yes / No
62. It is mandatory to have a documented procedure for continual improvement as per ISO 9001:2008 QMS Standard. - Yes / No
63. It is mandatory to have a documented procedure for corrective action as per ISO 9001:2008 QMS Standard. - Yes / No
64. It is mandatory to have a documented procedure for preventive action as per ISO 9001:2008 QMS Standard. - Yes / No

Do self assessment by reading different blog posts.

With best wishes,

KRS

A Short Course on ‘ISO 9001:2008 QMS Awareness’

Introduction
ISO 9001/2/3 standards series first published in 1987 and then revised in 1994.
Major revision in 2000 with publication of ISO 9001:2000 QMS Standard on 15 December 2000
Fourth edition – ISO 9001:2008 QMS Standard published on 15 November 2008

Overview
Clause 1 deals with scope including application
Clause 2 deals with references
Clause 3 deals with terms and definitions
Clause 4 to 8 deal with requirements of QMS
Clause 4 – Quality Management System
Clause 5 – Management Responsibility
Clause 6 – Resource management
Clause 7 – Product realization
Clause 8 – Measurement, analysis and improvement

Scope
ISO 9001:2008 QMS Standard specifies requirements for a QMS
Generic standard applicable to all organization regardless of its type, size and product
Exclusions are limited to requirements within clause 7 only.

References
Normative reference document
ISO 9000:2005, Quality management systems – Fundamental and vocabulary

Terms and definition
Terms and definitions as mentioned in ISO 9000 apply
Product include service

Quality Management System
General concept – Plan-Do-Check-Act (PDCA)
Determine processes, their application, sequence and interaction
Determine criteria and methods needed to ensure processes are effective
Provide necessary resources
Monitor, measure and analyze processes
Implement actions necessary to achieve planned results
Have continual improvement
Manage processes in accordance with requirements of ISO 9001:2008 QMS standard
Ensure control over outsourced processes

Quality Management System … Documentation
Remember – Say what you do, do what you say
Purpose – Effective planning, operation and control of QMS
Need documented quality policy
Need documented quality objectives
Need a quality manual
Need six documented procedures required by ISO 9001:2008 QMS standard
Need documents (procedures, work instructions etc.) determined by the organization
Maintain records required by ISO 9001:2008 QMS standard
Maintain records determined by the organization

Six documented procedures required by the Standard
- Control of documents
- Control of records
- Control of nonconforming product
- Internal audit
- Corrective action
- Preventive action

Management responsibility
Responsibility – Top management
Provide vision and commitment to quality
Communicate importance of meeting requirements (customer as well as legal)
Establish quality policy
Establish quality objectives
Conduct management reviews at planned intervals
Ensure availability of resources
Maintain customer focus
Ensure enhancement of customer satisfaction
Define duties and responsibilities
Assign someone from your management as management representative
Establish and use appropriate internal communication processes

Management responsibility …. Review the QMS
At planned (defined) intervals
Inputs to include from previous audits, customer, previous management reviews and information on process performance, product conformity, preventive action, corrective action, changes and recommendations in QMS
Output to cover decisions and actions on resource needs and improvement in QMS, processes and product.
Keep review records

Resource Management
Determine and provide resources (human and infrastructure including necessary equipment, tools and supporting services)
Engage competent work force
Determine necessary competence
Provide training or take other actions to achieve competence
Evaluate effectiveness of the training or action taken
Maintain records of education, training, skills and experience of your work force
Manage proper work environment


Product realization
Do proper planning
Determine and define – Product specifications, processes, documents and provide resources
Determine and define – Processes for verification, validation, monitoring, measurement, inspection and test activities for the product and product acceptance criteria
Determine and keep records needed

Product realization …
Determine what customer wants
Determine customer requirements, including requirements for delivery and after sales activities
Determine requirements not stated by customer but necessary for specified or intended use
Determine legal requirements applicable to the product and any additional requirements that you consider necessary
Make contract review that you can meet what customer wants
Keep contract review records
Determine and implement effective arrangements for customer communication

Product realization ….
Design and development of the product
Determine a design and development plan
Determine (define) design and development input requirements and maintain records
Verify that input requirements are met
Ensure that design and development output provide information on purchasing, production and service
Ensure that design and development outputs have product acceptance criteria and characteristics of the product for safe and proper use
Review the design and development process at suitable stages and keep records
Verify that design and development outputs meet design and development inputs and keep records
Validate the design and development process and keep records
Control changes to design and development and keep records

Product realization …
Purchasing activity
Purchase and use good product
Define what you want to purchase
Evaluate and select suppliers.
Maintain records of evaluation.
Communicate to your supplier what you want to purchase
Verify your purchase against what you ordered

Product realization …
Control your production and service activities
Plan and carry out production and service activities under controlled conditions
Validate processes where resulting output can’t be verified by subsequent monitoring or measurement
Identify product throughout product realization process
Where traceability is a requirement, control unique identification of the product and maintain records
If you use customer property, exercise due care. Report where customer property is lost, damaged or found unsuitable for use and maintain records.
Preserve the product during product realization and delivery to intended destination

Product realization …
Check the monitoring and measuring equipment
Determine the equipment
Control the equipment
Make sure the equipment is calibrated or verified
Keep records of calibration and verification


Measurement, analysis and improvement
Plan and implement monitoring, measurement, analysis and improvement processes to ensure product conformity with requirements, conformity of the QMS and improvement of the effectiveness of the QMS
Monitor information relating to customer perception
Carry out Internal audit at planned intervals and keep records of audits
Monitor and measure internal processes
Monitor and measure product
Control nonconforming product to prevent unintended use or delivery. Keep appropriate records of nonconformities and actions taken
Collect and analyze appropriate data and analyze
Continually improve the QMS effectiveness.
Take corrective and preventive actions and keep records of results of action taken

Suggested to refer to ISO 9001:2008 QMS and ISO 9000:2005 Standards

Thanks,

Keshav Ram Singhal



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