Tags Posts tagged with "implementation"

implementation

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Developing an ISO 9001 Implementation Plan - ISO Update

Once companies have made the decision to implement a Quality Management System (QMS) like ISO 9001:2015, they are usually faced with a multitude of new considerations and issues to sort through. If you are currently running a successful business, chances are you are complying with a large percentage of the standard, it’s only a matter of being able to prove this to an auditor and document your processes effectively. By developing an implementation plan, you will give yourself goals and action points that will help you and your team efficiently tackle the objective of achieving certification. Working on a thorough implementation plan will not only help break the process down but will also give you a rough idea of the resources and time needed to start implementing the standard.

A bit of preplanning is also required. You will need to determine what your timeline and end goals are and whether they can reasonably be attained. Aim for realistic and practical goals and estimates and consider using generic checklists and “Gap Assessments” that will help you move in the right direction.

Team Approach

A supremely effective method of implementation of ISO 9001 for most companies, regardless of size or nature, happens to be the “Team Approach.” The sizes of these teams can vary from organization to organization, usually 1-2 people per team for smaller organizations vs 5-7 people per team for larger companies. The technique essentially utilizes the concepts of allocation of responsibility to more efficiently utilize resources like time and energy.

Amongst these teams there will be one Steering Team, this is the team chosen to lead the project. The make-up should consist of managers of relevant departments to ensure that the members have the appropriate knowledge and power to allocate further responsibilities within their respected departments. The steering team will be expected to meet regularly and discuss updates and plans. The steering team leader will be the project manager for the implementation and their responsibility will include scheduling meetings and preparing agendas etc.

The steering team will also be tasked with reviewing processes and monitoring the work of task teams. These task teams are expected to document required procedures, modify pre-existing processes and develop new ones according to the framework provided in the ISO standard. There is usually a task team for each system procedure that needs to be created and documented so that the work is efficiently allocated. If you are using a Gap Assessment checklist, it would be wise to indicate the responsible parties for each task on or beside each clause of the standard that they are responsible for. The steering team is also expected to choose a Certification Body for external audit purposes.

You can create any suitable number of task teams; just be sure they are well acquainted with already existing QMS procedures within the company and those outlined in ISO 9001. If this is not the case, consider looking into training courses specifically designed to give participants awareness into the specific standard you are looking to become certified to. Many organizations offer the option to bring their trainer into your office to have a whole team seminar or company-wide seminar to help your organization familiarize themselves with the standard and its purpose within your organization. It is important for your task teams to understand the standard because filling in any possible gaps and updating any outdated processes is a large part of their work. Some company processes will need to be tweaked or drastically changed in order to meet standard requirements; in addition to this, the task team will also be responsible for documenting these changes or any newly added procedures for the purpose of auditing for compliance.

Ideally, a task team will discuss any possible additions and changes during the first few meetings alongside the QMS procedure, any decisions will need to be recorded and sent for approval to the Steering Team.

Planning your ISO 9001 Planning Meetings

Overall, there are a few prime factors to consider before you start your meetings. The most important being to decide on desired procedure implementation according to project goals and setting time constraints for the entire process. Recall that the key to any effective meeting is preparation, this must be handled at both an individual and group level if you aim to see productive results.

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All management systems require organizations to conduct internal audits in order to obtain information that will evidence the degree to which requirements are being met. In other words, internal audits check practice against policies, processes and procedures and thoroughly document any differences.

Although internal audits are an important tool for organizations to evaluate their management systems and to uncover areas that are in need of attention, for many, this process induces an enormous amount of stress. For audits to serve as a means to identify gaps and effective solutions, it is essential that these are formal, planned and organized. Other key characteristics internal audits should have are:



They are scheduled
Surprise audits are not welcomed by anyone. A schedule should be set and communicated to everyone, preferably at the beginning of the year. There’s no need to audit all processes at once; different processes can be audited at different times throughout the year, organizations just need to make sure that at the end of the year all processes have been audited.

Auditors are competent
Auditors need to demonstrate in-depth knowledge of the standard which they are auditing against and they should have an understanding of the processes being audited. They should be objective and impartial; this means that they can’t audit a process which they manage or control. Large organizations usually have a team of trained auditors, but that is not necessary; an alternative is to hire the services of an external consultant to perform the internal audits.

They are planned
The audit needs to be confirmed with the process owner. At this stage the auditor should review procedures and previous findings or issues related to the audited process. A checklist with a pre-determined list of questions can be sought to be used during the audit; this checklist should be provided to the auditee so they have time to organize any information.

It’s conducted in an objective and friendly manner
An audit should start with an opening meeting with the auditor and the auditee(s). It’s recommended that the auditor works systematically through the checklist or procedure, while reviewing records, observing the process, analyzing process data and talking to employees. During the audit, the auditor must discuss the findings with the auditee before recording it.

Audit findings are recorded
A closing meeting with the auditee is fundamental so information is not delayed. Here the auditor should point out possible weaknesses and areas for improvement. Findings and their details (these include non-conformities, positive areas and improvement areas) need to be recorded and communicated to the auditee(s) and management.

Findings are monitored
The auditor is responsible for ensuring that corrective actions have been taken to fix any problems found during the audit.

If everyone takes advantage of the positive results internal audits can bring, and if these aid organizations to improve their processes and management system- whether is a quality, environmental or any other system- an internal audit can be considered a success.



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Even if you have an informal quality management system within your business it is often difficult to implement the requirements of ISO 9001:2015. Depending on the size of your business this could be a task that may take six to twelve months to complete depending on the established current systems. It is vital that your staff are fully trained and engaged to make any implementation a success. The following 10 tips are vital to smoothly and effectively implementing an ISO 9001 management system:

  1. Get senior management commitment; while this may sound a little cliché, without the full commitment of your management team throughout the business it is going to be very difficult to drive home the changes and improvements that are required.
  1. Provide training at all levels in the business. Your staff needs to understand not only about the requirements of ISO 9001 but also the different quality principles that they should strive to implement within their every day work. Training should be provided on an ongoing basis according to perceived needs.
  1. Ensure that you have effective internal communication. Without this you are not going to be able to maintain the constancy of purpose that is required.
  1. Establish an implementation team with the authority to make things happen. You cannot just implement an ISO 9001 management system by assigning a management representative and expecting them to do everything in isolation. You need to identify the staff that will be required at all levels throughout the business to craft your system.
  1. Conduct a Gap Analysis; you need to fully understand where your current system meets or fails to meet the expectations of ISO 9001:2015 so that you can allocate resources accordingly.
  1. Involve customers and suppliers in analyzing your current systems. It is important to understand how others view the effectiveness of what you currently do and what they expect from you to improve things.
  1. Plan your implementation fully; responsibilities, roles and schedule. As with any project, the better that you plan it the more likely you are to have success.
  1. Create clear and concise policies and objectives for quality to provide the company with a common direction. Well communicated and understood these will help your company to move forward together.
  1. Encourage everyone to question and improve. It is not enough to only have auditors looking for issues with the systems; everyone should continually seek better ways to do things.
  1. Conduct regular reviews of your ISO 9001 management system through your auditing process to ensure that you are continually improving how your systems function.

In addition to the above, foster a good relationship with your certification body. Your auditor is not there to catch you out. They will want to help you to develop and grow a system that will significantly benefit your business, so use them fully.

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Measuring Supplier Performance

Implementing and seeking certification for ISO 9001 is an important decision many organizations make to improve their quality management system (QMS) and increase their competitiveness within their market. After the decision is made, one of the first concerns is: how long will this process take? Will it take three months? six months? a year maybe? or two years?

This question does not have a definite answer, implementing and seeking certification for ISO 9001 requires time, money and effort and the overall time spent will depend on several factors:

  • The size and complexity of the organization.
    Is it a small or medium-sized organization? Is it a single site organization or a multinational? Does the organization have complex processes such as design, manufacture, installation, test, etc.?
  • The maturity of the quality system that is in use.
    Does the organization have a well developed and structured QMS? Does it have a simple one with deficiencies?.
  • The resources available (money and time).
    Does the organization have a team dedicated exclusively on the implementation of ISO 9001? Do employees have only a couple of hours a week to dedicate to this project? Will the organization be able to hire a consultant to guide them through all the process?

The major time consuming activities organizations need to consider when implementing ISO 9001 are:

  • Understanding ISO 9001. Time will need to be spent in studying and training the people responsible for the implementation.
  • Conducting a gap analysis. This analysis will allow organizations to identify exactly what needs to be done to meet ISO 9001 requirements.
  • Getting busy with the documentation. A number of documents (policy, manual, procedures and forms) need to be developed.
  • Implementation and training. Employees need to know and understand key ISO 9001 requirements, and their work needs to be aligned with what is required.
  • Preparing and conducting an internal audit. At least one internal audit needs to take place before the certification audit.
  • Correcting non-conformities. Audit findings need to be addresses with an action plan to permanently correct them.
  • Selecting the certification body (CB). A registrar or CB needs to be selected to undertake the audit certification.
  • The certification audit. After all the hard work, a certification audit is scheduled with the CB and if the audit is a success, the organization is certified.

Carrying through all these activities can take an organization from 9 to 18 months; however, it will all depend on the organization and its specific situation.

It is recommended that organizations take the time needed to effectively implement ISO 9001; a well established and implemented QMS will provide organizations with a valuable tool to improve their quality performance and continuously meet their client’s expectations.

 

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In order for organizations to successfully implement an ISO 9001 Quality Management System (QMS) that provides confidence to customers and serves as an instrument for continuous improvement, the implementation process should be taken up as a project, following these steps and recommendations:

Step 1: Nominate a Team.

  • A small team consisting of a senior person from each department should be appointed by management for system development.
  • A coordinator must be designated.
  • The team should undergo awareness and documentation training on the ISO 9000 family of standards with a professional training organization.

Step 2: Carry out a gap analysis

  • Start with a flow chart showing how information currently circulates, from order placement by the customer to delivery of the product or service.
  • Follow with a flow chart of activities in each department.
  • Formulate a list of existing procedures and work instructions for the most relevant activities in each department.
  • Other activities and processes that are considered relevant at this point can be added.
  • Identify gaps throughout this process.
  • A time-bound action plan to close the gaps identified during this exercise should be prepared and action taken as planned.

Step 3: Prepare documentation

  • Procedures should be limited the documentation that is required.
  • Additional procedures and records should be devised only if they add value to the system.
  • Involve all personnel concerned in the development of the procedures and work instructions applicable to their areas.
  • Documentation should reflect current practice and not ideas of what should be implemented.
  • New forms and checklists should be created if necessary; otherwise adopt existing ones to the extent possible.

Step 4: Train and implement

  • Train all employees. Everyone should know their responsibilities in order to successfully implement and maintain the QMS.

Step 5: Conduct Internal audit and improvement

  • Some managers and staff members should be trained by a professional trainer to carry out internal auditing.
  • Conduct the first internal audit approximately three months from implementation.
  • Correct any gap found during the audit.
  • Once the system stabilizes, internal audits should be conducted at planned intervals.
  • To improve the system internal audits, customer feedback data, process and product monitoring data, evidence of the attainment or not of quality objectives, corrective actions taken, etc. should be used.
  • Management should provide financial and other resources for improvement projects and monitor the progress of improvement.

Step 6: Management review

  • Top management should review the QMS.
  • As a result of this review, management may decide to set new targets for quality objectives and to make the improvements needed in the QMS.

Step 7: Certification

  • Certification is voluntary; therefore the need for it should be decided by management.
  • Once the system has been in operation for a few months, organizations may consider making an application for certification.

An action plan for developing QMS covering the above activities should be prepared. The plan should define the responsibilities of team members and management and set target dates. Full implementation may require six to nine months.