Implementing ISO 9001 QMS

There is no quick step-by-step for implementing iso 9001 according to ISO 9001 into any other serious standard. Many have publicized it, but there are too many steps to do and to go through thoroughly making the implementation process complicated.
In this approach, we claim that all the really needed elements are discussed. What is not needed is not discussed.
The implementation of a formal management system is best handled as a specific project with a professional project manager, who should be a key member of the organization’s management team and having sufficient authority and trust of the personnel involved.
In the ideal situation this person will also be the Management Representative, but skills in project management are essential. It is important that none of the stages in the flow chart are omitted.
The existing system of management and working practices must be known in some detail, before the framework of the formal QMS-documentation can be designed. The system is best designed around existing processes as the development of new systems that require additional resources may simply delay the implementation process.
The total flow chart for the implementation of the QMS is visualized.

On the following pages each step of the implementation process is described that have to be carried out before moving to the next step.
It is advised to get more people involved in decision making and not to leave the decision to move to the next step up to one person only. Everybody involved must feel comfortable that a part is under control and that the organization is ready to move on.
The total implementation process for QMS takes fourteen steps. Communicate with the employees what has done, what has to be done and when it is expected to be completely implemented. This creates interest and involvement and will speed-up the process of implementation.
STEP 1: Evaluate the organization’s objectives and targets for implementing iso 9001.

The need for a QMS may arise from repeated customer complaints, frequent warranty returns, delayed deliveries, too high inventories, frequent production hold-ups or a high level of rework or rejection of products or services.
Also it could be that the need for implementing iso 9001 comes from the market, that is demanding a certified QMS, or otherwise it is impossible to operate in this market, or supply this dominant customer.
Strong technological driven markets such as the aircraft and automotive business put this demand on their contractors and subcontractors for cost reasons but also for safety and liability reasons. This third party certification demonstrates the abilities of the organization to the potential customer.
At this stage, identify the goals and objectives which should be achieved through a QMS, such as an improved company structure, greater efficiency, better profitability, reliable supplier etc.
Introduce the Eight Quality Management principles to top management and get them motivated and committed to applying to these principles.
 Checklist at this stage:
1.Check that the management has adopted the 8 leadership principles and is motivated and committed to applying them.
2. Communicate the objectives and targets for the implementation of the QMS with all the staff.

STEP 2: Obtain knowledge about the ISO 9000 family and appoint a management representative

Decide on the responsibilities of the person who will be involved in developing and documenting the QMS, including the appointment of a management representative who will oversee the implementation of the QMS. The person made responsible for the process of implementing the QMS should understand the requirements of ISO 9000 and 9001 and read the contents of ISO 9004.
 Checklist at this stage:

    1. Check to see that the management representative should has been appointed at this stage.
    2. Check that the contents and the philosophy of ISO 9000 and 9001 have been made clear and have been accepted.

STEP 3:  Organize the resources

Decide on the responsibilities of the person who will be involved in developing an documenting the QMS, including the appointment of a management representative who will oversee the implementation of the QMS. Establishing a project or ISO-team may also prove to be useful to oversee progress and in providing resources wherever required. The ISO team should consist of involved employees from different levels. Some authority can be given by top management to speed up the process.
If within the organization no adequate competence is available, or no resources such as time and knowledge can be made available, then a consultant should be appointed.
Before doing so, it is good to realize that with subcontracting a part of the implementation process, a part of the knowledge and the commitment is lost. An organization can learn more and better from its mistakes and own developments, than from just doing what a consultant is recommending. Prepare a cost estimate and procure and allocate the resources for this project. Raise commitment from the top management.
Checklist at this stage:

    1. Check that the management has decided upon the individual who will develop the QMS and about its authority.
     2. At this stage, check that the supporting ISO-team is established and the objectives for the team should have been made clear.
    3. Check if commitment has been made at this stage to the implementation process, if not, it should be stopped here.
   4.  Don’t continue if there is no support group such as an ISO-team or a similar solution.
   5.  Check that the needed resources such as manpower, money and time have been made available to the Management Representative and the ISO-team.

STEP 4: Raise awareness and provide training:

Raise awareness about QMS requirements amongst all personnel performing activities and tasks that affect quality. Plan for and provide specific training on how to develop quality manual, procedures and work instructions. Besides that, it is important to instruct people how to identify and implement improvement processes and how to audit compliance with the QMS. Appoint a certain number of people to be the internal auditors and provide sufficient training. The ISO-team and/or the consultant should be resources for assistance during the training.
Checklist at this stage:

     1. Check that training has been provided to the people involved in the writing of procedures and work instructions. Make sure that the written documents reflect the actual situation and not the desired situation.
    2. Check if a number of people have been selected as internal auditors and that the internal auditor training has been provided.
    3. Check that the ISO-team assist in providing insight into the QMS to the other employees by means of presentations, newsletters and other ways of communication.
    4. Develop forms that can replace difficult status reporting and provide instruction on how to use them.

STEP 5:  Gap Analysis 
Evaluate the gaps between the existing QMS and the requirements of ISO 9001:2008. Prepare how to bridge these gaps, including the planning for any additional resources required. Gap analysis may be carried out through self-assessment, by the ISO-team or by an external consultant.
Checklist at this stage:

    1. Check that the gap analysis has been carried out and study the outcome.
    2. With this analysis it should be possible to identify the gaps when it is compared with the ISO 9001 QMS
    3. Check that a plan has been developed to bridge the found gaps. Make sure that the plan also contains a time schedule and that the actions are realistic and can be finished in time.
    4. Check that the results of the gap analysis and the actions to bridge the gaps have been reported to top management and that management is also committed.

STEP 6: Product realization processes

Review clause 7 of ISO 9000:2008 relating to Product Realization to determine how the requirements apply or do not apply to the company’s QMS.
The processes covered by this clause include:

    1. Customer-related processes.
    2. Design and development.
    3. Production and service provision.
    4. Control of measuring and monitoring devices.

Note that if the company is not responsible for preparing the design of the product, it can exclude the requirement for design and development from the QMS, as long as the reasoning is mentioned in the quality manual.
Flow chart each process in detail and discuss these flowcharts with the experts, in another words, the people that work with these processes. Draft the framework of the quality management system and identify the supporting documents. Then develop the QMS documentation.
Checklist at this stage:

    1. Check to see that all the processes have been properly documented.
    2. Have this documentation done by the experts, the people that are responsible for these processes.
    3. Check on the requirements of the standard and exclude the elements that are not applicable to the organization.
    4. Get the approval from top management for these exclusions

STEP 7:  Planning and time frame

In this stage the allocation of the resources for the QMS project should be defined. Prepare a complete plan including the plan to close the gaps identified in the Gap Analysis, to develop the QMS processes.
In the plan, include activities to be performed, resources required, responsibilities and an estimated completion time for each activity. Build in check point to assure in time completion.
Clause 4.1 and 7.1 of ISO 9000:2008 provide information that should be used when developing the plan.
The total time required for each phase (planning, documentation, implementation and evaluation) depends on the extent of the gaps in the existing QMS.
Communicate the master plan to all staff, but especially the ISO-team and the people involved.
Checklist at this stage:

    1. Check that the plan is complete, including the actions to bridge the gaps, a time schedule and the allocation of the resources such as manpower, money and time.
    2. Check that enough effort has been made to communicate the plan and the result of it to all staff. If needed provide extra information to key people and the ISO-team.

STEP 8: Draft a Quality manual and develop a Quality Policy

Draft the quality policy for the organization. Get the policy committed by top management.
Make sure that the policy is a strong statement, original and applies to the organization.
In the quality manual:

    1. Include how the QMS applies to the products, processes, locations and departments of the organization.
    2. Exclude any requirement with justification if applicable.
    3. Refer to or include documented procedures (if available already) for QMS.
    4. Describe the interaction between the processes of the QMS, e.g. the interaction between product realization processes and other management, measurement and improvement processes.

Checklist at this stage:

    1. Check that there is an adequate policy developed, that top management is committed and it is a strong statement. Do not continue without this policy statement.
    2. Check that everybody in the organization has seen it, understands it and can repeat it in his/her own words.
    3. Check that the QMS manual is ready. Don t continue without an approved manual.
     4. Check that the requirements from the standards are fulfilled and that reference is made to at least six procedures, but no more than that are needed.
    5. Keep it simple.
    6. If there is still not sufficient commitment from top management, don’t continue.

STEP 9: Draft the Documentation, design the QMS and implement it

The implementation has two parts. The implementation of the QMS, and that of the supporting paperwork. The implementation of the QMS is another way of working. Define the structure and get the people involved committed to work accordingly. Introduce the quality manual to the top management. Explain the document structure and how it fits in the QMS. After top management introduction, middle management should be made aware of the document structure. Top management should be showing that they are working according to the leadership principles.
After company wide commitment, procedures have to be written. ISO 9000 outlines clearly what has to be documented. What is not needed can be decided by the organization. In principle the employees that work with the documents must write these procedures. The procedures should reflect the actual situation, not the desired one. After the completion and implementation of the procedures, the next level will be the work instructions. Here the same system applies. Get the experts to describe their work and activities.
Finally a complete documentation set should be available. It should be noted that only six procedures are required by the standard. Key is that the people involved, work according to these documents. Maintain the QMS for three months before internal auditing should take place. Correct the QMS where needed.
Checklist at this stage:

    1. Check that the elements of the standards are implemented in the organization.
    2. Elements such as continual improvement, leadership principles and customer orientation.
    3. Check that all the needed procedures have been developed and that the work instructions have been written.
    4. Check that the process owners are involved in the development of the work instructions.

STEP 10:  Carry out internal audits

During the phase of implementation of some three to six months after the documentation has been written, the trained auditors should carry out one or two internal audits covering all activities for the QMS, and concerned management should take corrective action on the audit findings without delay.
Wherever required, revise the manuals, procedures and objectives. After each internal audit, the top management should review the effectiveness of the system and provide resources for corrective actions and improvements.
Checklist at this stage:

    1. Check that the responsible people have been trained for the internal auditor function.
    2. Record their training results and data.
    3. Check that internal auditors do not audit their own department or work area.
    4. Check that the results of the internal audits are fed back into the system and lead to improvement of the QMS, the processes and the documents.
    5. Check that the results of the internal audits are reviewed on top management level and that appropriate action has been taken.
    6. Check that there is a time schedule for internal audits and that it is maintained.

STEP 11:  Conduct a Management Review

It is important in this stage to have a formal management review that shows the commitment of all levels. The recommendations from this review have to be carried out.
Use the Management Review procedure developed for the organization.
Checklist at this stage:

    1. Check that the result of the management review is functioning well and that all people involved know what is expected from them. Check the involvement and commitment of the top management.
    2. Check that actions are taken and decisions are made.
    3. Check that the main focus is on the customer s satisfaction.
    4. Check that the decision makers are present.

STEP 12:  Pre-assessment. Apply for certification

Carry out a pre-assessment. Correct the QMS and the documentation where needed. Re-assessment can be done with the help of an external certification body, but also by local consultants or by consultants from the branch organization. On satisfactory completion of the previous step, and if the company decided to obtain third party certification, an application for certification should be made to an certification body.
Checklist at this stage:

    1. Carry out a pre-assessment to win trust and confidence among the people involved in the certification process.
    2. Check that actions are taken and decisions are made based on the results of the pre-assessment.
    3. Check that the right partner has been found to carry out the pre-assessment.
    4. Check that a certification body has been approached for the final assessment.

STEP 13: Conduct periodic evaluations and initiate corrective and preventive actions

After certification, the organization should periodically conduct internal audits to review the effectiveness of the QMS and see how it can be continually improved.The organization should evaluate periodically if the purpose and goals for which the QMS was developed are being achieved, including its continual improvement.
It is needed to look at the organization s overall systems performance and then decide when and where the most effective improvements can be realized. Then objectives have to be set for those improvements and a periodic evaluation has to be conducted to monitor achievements.
Improvements could be the reduction of cycle time within a process or the reduction of contamination in a manufacturing process.
Checklist at this stage:

    1. Check that periodically internal audits are planned and conducted.
    2. Check that the non-conformities from the final assessment will be solved as soon as possible.
    3. Check that the organization will review its goals and objectives on a regular basis.
    4. Check that management reviews are planned and conducted periodically

STEP 14: Evaluation

The certification is certainly not the last phase. The people involved need to measure the success of the implementation of the QMS during the implementation process and by the conclusion of the process. Measurements should be made against the original aims and goals and the key indicators of an effective QMS as stated below:
Checklist at this stage:

    1. Check that senior management is fully committed to the QMS and owns the appropriate processes.
    2. Check that the QMS is designed around business processes and not around ISO 9001 or any other standard.
    3. Check that staff knows how to access the QMS documentation.
    4. Check that visibility of processes and the clarity of the instructions in the QMS documentation set are clear, concise, readable and understandable. The people involved maintain their own documents
    5. Check that the organizational culture is a culture of opportunities, focused around continual improvement rather than a person-to-blame culture.
    6. Check that the quality management representative is a key organization person rather than a sideline person.
    7. Check that internal auditing is seen as adding value and part of the continual improvement of the QMS.
    8. Ensure that there is Continual improvement in system.
    9. Keep up with regular internal audits and Management Reviews.

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