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Wednesday, April 25, 2012

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.


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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Devendra (SQA- CMMI for Dev 1.2 and ISO 9001:2008, MS SharePoint 2010) said...

This is WELL described about the Implementation part of ISO 9001:2008. This will really help me lot...
Thank You So Much Sir..

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