ISO 9001 Implementation Guide

Here, we will provide practical guidance, including tips and tricks on implementing ISO 9001.

This is written for the Project Manager. We aim to help you deliver a smooth ISO project and avoid mistakes along the way.

If you are looking for specific steps in a project plan, please see: What Are The Steps For ISO 9001 Certification?

Introduction

As anyone who has experienced the implementation process can attest, developing an ISO 9001 quality management system can seem intimidating. However, knowing how to address the implementation challenges in advance makes developing a successful management system much more realistic and will save unnecessary or costly problems in the future.

You should develop a project plan that includes all the actions necessary to create a process-based quality management system that can be used to manage risk, satisfy customers, add value, and prevent defects while conforming to the relevant ISO standard.

Where to Begin?

Begin with the assumption that you are already doing most of what ISO requires; you probably are! Start by reviewing your existing quality systems, policies, procedures, and processes that you have in place at the moment.

Then, compare those with what ISO 9001 asks for. You may be surprised how much you already do. The standard will allow you to keep the things that work for you while refining those that do not.

Many people talk about the high cost of implementing management systems, but this is a false assumption. If you do it right and understand the standards, then implementation should not be a problem since 75% of your management system is already in place in some form.

A culture shift will start during the early development and implementation phase. By involving and consulting with employees and stakeholders at this early stage, you can more easily secure their buy-in by assigning responsibility and utilizing their skills, knowledge, and experience to help develop the QMS.

How Long Does It Take?

Many factors can affect the time required to implement a management system.

The size and complexity of your organization, the extent to which the quality management system will be introduced within the business, whether the implementation is assisted by a consultant or done in-house, the maturity of existing processes and documentation, the availability of resources, and the commitment of Top management and staff.

Experience suggests that, due to these factors, 12 to 18 months is a realistic and achievable time frame to develop a management system.

N.B. This time period includes the time to gather necessary documented evidence that should clearly demonstrate successful implementation to an External Auditor.

Managing the Change

The organizational migration from a pre-certification state to one that operates within the rigors of an ISO-based management system is not a casual task. Processes must be tightened, and staff interactions, responsibilities, and accountability often change. Such changes are unlikely to succeed without the dedicated support of executive and operational management.

The greatest resource of any company is its people, so strategies for managing both real and perceived change or concerns and attitudes should be addressed during the initial planning of the management system.

It is likely that during the first few months, top management will need to reinforce its requirements positively on a routine basis to ensure that staff maintain motivation and do not lapse back into old habits.

Iterative adjustment of new or existing management system documentation should also be expected as staff become accustomed to the requirements and suggest usability improvements. Instant business or operational improvements may initially be observed.

Top Management Commitment

Top management commitment is 100% essential. We cannot stress this enough.

Implementation takes time, money, and other resources. Make sure you have the commitment of top management before continuing the project. Be sure that top management is solidly behind in developing the quality management system; without that commitment, the implementation process becomes almost impossible.

Top management should demonstrate their initial commitment to the implementation project by ensuring that:

• The implementation mandate is communicated and understood
• Appropriate resources are made available
• An appropriate budget is made available

Understand why your organization is implementing a quality management system.

Is it because a client or the market requires you to register? Is it for internal benefits? Is the motivation coming from top management?

Whatever the reasons for implementation, keep them visible during the implementation project. This will help retain commitment and focus on the end goal.

Top management can consist of one or more people. Still, they must have cross-functional influence to integrate the quality management system with current business processes and ensure compatibility with your organization’s strategic direction.

The Implementation Team

Top management should consider creating an Implementation Team to assist in developing the new management system. This decision should be based on the size of the organization or facility wimplementing the quality management system.

This implementation team should consist of key individuals from various divisions, departments, and operating work areas within your organization who are familiar with the facility and its processes. Diversity among team members will bring together a pool of expertise and ideas to develop and implement the management system.

One key moment in the implementation process is defining the individual responsibility of management and employees for introducing different elements into the current working process. That is why the company's most experienced employees should be involved in this process.

Following this methodology, a team of experienced and engaged key personnel should be formed at the beginning of the implementation process. The Implementation Team should include personnel with the authority to devote resources to the project and remove roadblocks.

The Implementation Team should meet on an ‘as needed’ basis according to the project timeline. When the team meets, they must address the items on their action/task list.

Management Review Meetings

There are no specified time periods for conducting management review meetings. However, they are essential during the management system's initial development and implementation stages and should be conducted on an as-required basis. Our 18-step implementation methodology takes advantage of three separate management reviews.

There is much merit in conducting management review meetings following internal and external audits to review the findings and plan for follow-up/corrective actions. Some organizations may also find it beneficial to perform a management review meeting before an external surveillance or certification audit to identify gaps that can be filled before the external audit(s) are conducted.

A member of top management must chair the management review meetings. The meetings provide helpful insight into the implementation processes and enable management to respond accordingly. It is imperative that the management fully understand and appreciate the management review requirements under clause 9.3.

The Project Manager typically undertakes the secretarial duties.

The attendees of management review meetings should include senior managers and other staff who operate within the boundaries of the occupational quality management system. The internal auditor(s) should also attend.

Choosing your Registrar

The registrar is a third-party certification auditor who will formally assess your management system and issue a certificate if the system meets the requirements of ISO 9001:2015. When choosing a registrar, you should consider their industry experience, geographic coverage, price, and service level offered.

The key is to find a registrar who can meet your requirements and certify against the standards.

Your registrar selection criteria should include:

• Must have clients from our industry (i.e., your competitors)
• Must offer resumes of their auditors for your review
• Must deliver well-crafted nonconformity statements (seek examples)
• Must not offer advice (seek objective evidence of system weakness instead)
• Must protect your intellectual property

Organizations view their registrations differently. Some prefer having multiple business units or locations on a single certificate. You can register one department or the entire organization.

The scope of certification must precisely and clearly reflect the activities covered by your organization's quality management system. No single business-related activity should exist outside of the scope.

Overcoming Obstacles

Many organizations experience some expression of negativity about the intention to implement a quality management system. This can come from management, employees, or other interested parties such as shareholders. Such concerns can jeopardize an ISO 9001 management system even before implementation has begun.

‘We don’t know what a management system is’.

It is important to explain any management system's fundamental aims and benefits to all interested parties early in the process—perhaps by giving a presentation to the management teams or placing the information on a notice board, featuring it on your organization’s intranet, or in a newsletter.

‘We don’t have the time or the resources to implement a management system.’

This is a common concern, and there is no single, straightforward answer. However, a management system will help your organization become more efficient by reducing defects and avoiding risk.

The time and resources needed to implement a management system should be viewed as an investment that will produce high yields in terms of cost savings and thus make the organization more profitable. Many organizations have already invested in a management system and are reaping the benefits.

Does the management system have to be implemented across the whole organization? It does not have to be implemented across the whole organization. It can be piloted or implemented in one part and then rolled out to other sites/facilities or operational areas as and when required.

What about training?

Whether carried out by external parties or undertaken in-house, training can be relatively inexpensive and can be scheduled to avoid any operational disruptions. This is particularly true where a ‘train the trainer’ approach is applied (i.e., a person or small group is trained to carry out further training within the organization).

Will it cost money?

Implementing a management system almost invariably entails some costs. These vary considerably and depend upon the organization's size, the number of sites involved, the number of employees, and the level of in-house expertise.

If costs are a major concern, a simple cost-benefit analysis will help estimate potential savings. A walk around your site will probably highlight a number of no-cost or low-cost opportunities that will produce significant cost savings and thus offset the initial cost of implementing the management system.

Communicate Regularly

Everyone in your organization is key to its success, and their full involvement enables their skills to be used to the maximum benefit for themselves and you. Make sure you have good internal communication channels and processes within the organization. Staff need to be involved and kept informed of what is going on.

Clearly lay out a plan of activities and time scales. Make sure everybody understands them and their role in achieving them. Give some thought to how departments work together. The people within your organization must not work in isolation but work as a team for the benefit of the customers and the organization.

Do not ignore the impact of introducing a quality management system on your stakeholders, customers, and suppliers. Speak to them to understand how they view your business and how they feel improvements could be made.

Effective communication can ensure engagement and assist in embedding principles into working practices.

1. Before beginning your review, let employees know what is happening and encourage them to start thinking about the part they can play
2. Communicate with employees (e.g., using a notice board, internal memos, meetings, intranet, team briefings, and letters)
3. Ask employees for their ideas. Usually, those doing a job daily will have ideas about how things can be done more effectively. Ensure that these ideas are acknowledged and are not ignored
4. Be open, let employees know that some decisions are not set in stone
5. Provide feedback, both good and bad
6. Make sure employees understand and believe in any procedures introduced as part of the management system through suitable training
7. Set up short but frequent management team meetings and ensure line managers are brought into the process

Effective communication benefits everyone, professionally and personally. These skills should be embedded within your organization. It requires a commitment, but the return on the investment is well worth the time and energy.

Using an External Consultant

Asking an external consultant to help may significantly reduce the time spent on implementing your management system. The consultant will review your company’s existing practices, processes, controls, and documentation using the ISO 9001:2015 standard as the assessment criteria.

A consultant’s familiarity with the requirements of management system standards can save you time and money. It will ensure you achieve effective quality practices and successful management system certification.

You must provide the consultant with a clear brief as part of the written contractual agreement. There may be cases where you need to get specialist advice and assistance, particularly in the areas of compliance, risks, handling corrective action, and auditing.

When seeking outside help, ensure potential consultants have the necessary experience and qualifications.

Choose a management system specialist who is familiar with your sector's particular issues and understands staff needs.

Implementation Methodology

We recommend constructing a Project Plan broken down into high-level steps, and using Implementation Checklists to manage the sub-tasks and evaluate the completeness of the quality management system’s development.

Each of the steps is divided into separate sub-tasks in the Implementation Checklist that should be completed sequentially.

Benefits of Using a Project Plan

• Compliance Confidence: Ensure that all necessary steps are taken to meet ISO 9001 standards
• Enhanced Organization: Maintain a clear and structured approach to project management
• Improved Accountability: Assign roles and responsibilities to ensure everyone knows their tasks
• Clear Communication: Keep stakeholders and management updated with regular progress reports
• Stakeholder Engagement: Foster buy-in from stakeholders and management, ensuring their support throughout the process
• Certification Success: Increase your chances of successful ISO certification with a well-documented and organized approach