What Are The Steps For ISO 9001 Certification? [with Project Plan]

Developing an ISO 9001 management system requires a project management approach. For successful implementation, all staff should be involved in developing, deploying, and improving the quality management system.

Show progress as you meet the deadlines and take action if the implementation team is not meeting deadlines. If the team is not expected to meet deadlines, other tasks will soon take priority; the project will drag on and lose momentum. The implementation team must watch the timeline and milestones while coordinating and implementing the plan.

Step 1 – Commitment & Resources

The first step in implementation is to establish leadership and commitment to the quality management system (QMS).

• Obtain formal commitment and endorsement of top management
• Secure the required budget
• Necessary human resources

Management should appoint an Implementation Team representing all sections of your business.

A Project Manager who will take ownership of driving the implementation of the management system must be appointed.

A top-down approach to quality management is critical. Management should review the ISO implementation project and management system at regular intervals to ensure it is relevant and fit for purpose.

Step 2 – Adopt the Standards & Define Scope

Ensure that the contents and philosophy of ISO 9001:2015 have been made clear and accepted. Clearly defining what the management system will include enables its implementation to be project-managed.

You can establish your management system when top management has made the appropriate commitments. When you have determined the scope of the quality management system, make sure that you document it, usually in a few statements or paragraphs contained in the quality manual.

Step 3 – Training & Awareness

All employees should receive awareness training about the new elements of the management system and how they might affect their work. Training on the structure and content of the management system should be mandatory for all staff.

Provide an overview (presentation or seminar) of the ISO 9001:2015 requirements to key personnel who will be taking the lead roles in implementing the quality management system. The identified members of the Implementation Team must attend.

Attendance of the Executive and top management members is necessary.

All key stakeholders should be aware of the management system's purpose, structure, and implementation strategy. Employees should also be made aware of the quality management system policy and its objectives.

After training, employees should be comfortable using the quality management system. They will demonstrate their knowledge by locating and using the documented information related to their work.

Employees should know:

• Types of documented information that applies to their work
• Which forms to use, how to complete and process them
• Know how the safety policy relates to their work
• Know how the objectives relate to their work
• How to report nonconformances and issues for corrective action
• Understand the context of the organization
• Understand the risks and opportunities that affect their work

Step 4 – Select & Train Internal Auditors

Based on education and experience, internal auditors should undertake Certified Auditor training in person from an external provider or via online courses.

Train the internal auditors. The training provider should provide the required initial training and refresher training at specific intervals, e.g., every 2 to 3 years.

Establish a team of management system auditors comprising staff from different functional areas and levels within the unit. Schedule auditor training and provide ongoing refresher courses when necessary to maintain qualification.

Step 5 – Gap Analysis & Action Plan

The next step for the implementation team members is to benchmark the current situation. A gap analysis can be conducted to see where you currently are and where you would like to be and to identify the steps needed to get there.

Conducting an initial gap analysis is a critical step. A gap analysis is a survey instrument used to determine the differences (gaps) between your organization’s management system and the requirements of standards like ISO 9001. A gap exists when current quality policies, processes, practices, or procedures do not fully meet the stated requirements.

Prepare the gap analysis results, draft an Action Plan detailing the tasks, actions, deliverables, owners, and timeframes, and submit to the Project Manager for approval before proceeding.

Step 6 – Management Review 1

Once the gap analysis has been completed and the action plan has been documented, it should be presented to top management for formal review and approval at a management review meeting.

Top management should review the following:

• Results of the gap analysis
• The recommendations from the action plan
• Results of training and awareness
• Commitment to time-scales
• The resources necessary to fill gaps
• Defined scope and adoption of requirements

It is essential a member of Top management chair the management review meeting.

The Project Manager is the secretary, and the Implementation Team are active members of the meeting.

Step 7 – Begin Closing the Gaps

The outcomes of the gap analysis, which were discussed at the management review meeting, will provide a priority for rectifying identified gaps.

Once the gap analysis is complete, the Action Plan should include all identified actions. The Action Plan should be used as a central repository for all quality-related activity.

It should outline the required activity, the person responsible, the timeframe, the source of the activity, and the proposed action.

It is crucial to monitor progress and document the actions and results that must be considered at the next Management Review meeting.

The Action Plan should be monitored and reviewed at every Implementation Team meeting.

Step 8 – Strategic Direction & Stakeholders

Your organization must establish a vision consistent with its mission and identify the strategic directions relevant to its context. As the main objectives of quality management are reducing pollution and continual improvement, it is vital to define who the stakeholders are and what services they provide.

Ensure that internal context of the organization reviews consider your organization's values, culture, knowledge, and performance and capture these in a matrix. Where required, SWOT analysis should further understand these issues.

Ensure that external issues are captured using the matrix. Where required, further understanding of these issues should be acquired by PESTLE analysis.

Step 9 – Define the Policy & Objectives

The management system policy states your business’s commitment to managing quality issues. It must be clearly defined and communicated to all stakeholders. The quality policy should include understanding what quality means to your organization and its commitment to continual improvement.

The overall intention and direction concerning quality must be established. Your company will also need to set SMART objectives for each key activity and identify measurable performance indicators to track the achievement status properly.

Step 10 – Document Processes & Procedures

Meet and discuss the standard's requirements and document the management system’s processes. The quality manual should briefly overview your business and its commitments. The primary purpose of the quality manual is to outline how your organization meets the requirements of the standard.

The main functions/activities carried out and services provided by the unit (‘what we do’) are your business’s key processes. A detailed set of operational procedures should underpin each high-level business process.

Identify the processes that comprise your management system; there are two main types of processes that you should focus on.

The key processes are steps you go through to give the customer what they want, e.g., from order acceptance to design through to delivery. In contrast, support processes are those processes that do not contribute directly to what the customer wants but do help the key processes to achieve it. Support processes include human resources, training, facilities maintenance, etc.

A set of operational procedures (‘how we do it’) should be documented to support each key business process. Operational procedures outline the specific steps involved in undertaking the activity (i.e., a process) and are more granular in detail than the documented process.

Step 11 – Management Review 2

Once the quality management system has been documented and all components are in place, it should be presented to the top management team for formal review and approval. It should then be reviewed regularly at the next management review meeting.

Top management should review the following:

• Feedback from interested parties
• Follow-up actions from management review 1
• Results of the gap closures and actions
• Define and disseminate metrics/measures
• Discuss feedback from necessary changes to documents
• Approve the quality manual

It is important that members of top management chair the management review meeting. The Project Manager is the secretary, and the Implementation Team are active members of the meeting.

Step 12 – Begin Internal Auditing

Internal auditing is a vital component of any quality management system. It is both a mechanism to determine whether the system is performing as intended and a means of checking the functionality of the documented processes and procedures.

Perform internal audits of selected functions, areas, and processes. Each department should compile its own internal audit schedule. This should outline the process being audited, the assigned auditor and a specified timeframe.

The Project Manager should approve audit schedules.

The results of the reviews and the internal audits must be documented, and the related records must be maintained. Prepare the audit results, draft the Internal Audit Report detailing the tasks, actions, deliverables, owners, and timeframes, and submit it to the Project Manager for approval before proceeding.

Step 13 – Implement Corrective Actions

The process owners should implement corrective actions to address the audit findings. The Project Manager should assist the process owners in determining causes and finding solutions through training. The company’s key process owners should determine actions to be taken to address the audit findings.

Communicate the corrective actions and the action plan to relevant stakeholders (including internal and external customers). Once the problem is properly characterized, contained, analyzed, and corrected, the organization should gather key information inside a lesson-learned record for knowledge sharing within the organization.

Step 14 – Management Review 3

Once the quality management system has been documented and all components are in place, it should be presented to top management for formal review and approval.

Step 15 – Conduct a Readiness Review

Once you have implemented the quality requirements and have dealt with any corrective actions from the previous steps, it is suggested that the Project Manager carry out at least one other internal (element-based) audit in readiness for the Certification Body’s 1st stage audit.

If needed, you may conduct additional internal audits and management review meetings during the preparation to ensure that any previously identified nonconformances have been closed.

It is essential to ensure that a significant body of documented evidence has been gathered, demonstrating the successful implementation of the management system, before an external certification of compliance audit (for example, levels of customer satisfaction).

If there is a lack of confidence in the ability of the management system to undergo an external third-party audit successfully, then the audit should be delayed until such time it is ready. Otherwise, doing so would be setting up the management system for failure, which is unacceptable.

Step 16 – Certification Body 1st Stage Audit

If you plan to have your quality management system certified, it is essential to conduct thorough internal audits, management reviews, activities in the PDCA process, and evidence of responses taken as the result of those reviews and audits.

The 1st Stage Certification Audit is an initial assessment by the Certifying Body. Your company should address the issues raised by the Certifying Body to ensure a successful Stage 2 Audit.

Minor nonconformances are not negative; they identify potential risks of the management system and should be addressed promptly.

Step 17 – Certification Body 2nd Stage Audit

At this stage, you will receive a letter of Recommendation for Certification to ISO 9001:2015. If there are any issues, the company shall prepare a plan of action to address the 2nd stage audit findings. The documented corrective actions must be submitted to the Certifying Body for approval.

The findings of the external audit need to be reviewed, and the appropriate actions need to be taken to address any remedial actions.

Step 18 – Certification & Success

Celebrate the success! Recognition for a job well done helps to improve staff morale. As all staff members are involved in the implementation and the ongoing improvement of the management system, it is essential to recognize their efforts and celebrate their success.

Once the quality management system has been formally approved, the key components should be published on your business’s website for internal and external distribution.