Preparing for an ISO certification, surveillance, or recertification audit can be daunting stress filled task, but with proper preparation and organization stress levels can be significantly reduced.
Preparing the Management Team
The person hosting the audit usually the Quality Manager or Quality Director should ensure the facilities management team is aware of the audit date to ensure the team is available to support the process. The audit notification should be made well in advance of the audit so those supporting team members have ample time to rearrange their schedules.
Once the audit agenda is received, the management team should be made aware of the audit purpose, criteria, scope, topics, schedule, duration, and the importance of successfully completing the audit is to the organization. Regular meetings should be scheduled with the management team to ensure everyone is ready or if assistance is needed.
The audit host should ensure internal audits, management reviews, calibrations, maintenance activities, supplier audits, supplier scorecards, customer satisfaction surveys, and training activities are up to date. Any deficiencies should be addressed as soon as possible, or a corrective action initiated to document the issue. Ideally, there should not be any gaps if the Quality Management System is functioning as planned!
Any findings and supporting documentation from the last ISO certification, surveillance, or recertification audit should be thoroughly reviewed for completeness and effectiveness to ensure a repeat finding is not issued.
Preparing the Facility
Make sure the facility is clean, neat, and orderly! This applies to the inside and outside of the facility. The first impression is a lasting impression! Make sure the equipment has been properly cleaned, cobwebs and dust bunnies removed, floors swept, broken pallets and packaging materials hauled to the dumpster, and other similar items removed. Also, remember to look up!
At one week and one day out, perform a facility walkthrough to ensure all old procedures, work instructions, forms, and templates are removed. Samples and nonconforming parts should be tagged and quarantined or scrapped as appropriate.
If procedures and work instructions are available on the production floor in binders, ensure the binders are up to date with the latest revision of all the required documentation.
Preparing the Employees
The employees should be made aware of the audit purpose, criteria, scope, topics, schedule, duration, and the importance of successfully completing the audit is to the organization. Assure the employees the auditor(s) are there to assess conformance to standards, policies, and procedures with the overall intent of making your organization better.
Review the Quality Policy and ensure the employees know where it is located and understand what the Quality Policy means to them. There is no need for employees to memorize the policy, but they should be able to paraphrase the basic elements of the policy and what it means to them.
Additionally, the employees should have an awareness of the Quality Objectives and how they contribute to the achievement of the objectives.
Ensure the employees know where and how to access procedures, work instructions, forms, and templates. Employees should also know what to do if something is wrong, how to document the issue, and who to notify.
Encourage the employees to be positive, polite, courteous, and above all truthful when interacting with the auditor(s). Assure the employees that audits are ‘fact-finding missions and not faultfinding safaris’ and that generally, quality issues are with the system and not the people.
Encourage the employees to answer the auditor(s) questions to the best of their ability, not guess, and tell them it is ok to ask for clarification, ask to talk with their supervisor, review a procedure or work instruction, or just say I do not know.
Let the employee know that it is ok if they are in the middle of a critical task and need to remain focused it is ok to let the auditor(s) know and ask them to come back later.
Final Preparation
Final audit preparation should include communicating any special personal protective equipment requirements (PPE) to the auditor(s). This is especially important if special clothing is required. Another important question is to ask if there are any dietary restrictions or meal preferences to avoid any uncomfortable situations.
The auditor(s) should also be provided any special information about parking, entering the facility, or mandatory safety training that may be required. Additionally, if the organization requires a nondisclosure agreement (NDA) this should be addressed well in advance of the audit as the auditor(s) may not have the authority to sign such a document depending on the auditing organization’s policies.
Ensure the room where the auditor(s) will be housed has reliable internet access, power outlets, bottled water, coffee, tea, soft drinks, fruit juices, and assorted snacks available.
Print name badges or tents for the management team with titles to make it easier for the auditor(s) to identify the individuals participating in the audit. Also, have an updated organizational chart available with names and functional roles available to help the auditor(s) understand the responsibilities and reporting structure of the organization.
Prepare a brief presentation about your organization. Make sure to include the Quality Policy in one of the first slides! The presentation should include a history of the organizations, the number of employees, overview of the processes, major equipment, capabilities, types of products and/or services offered, and anything other information that may be useful to the auditor(s).
It may also be helpful, depending on the size and complexity of the organization to print copies of the quality manual and high-level procedures and place them in a binder for the auditor(s).
Final Thoughts
Be prepared, be relaxed, and be confident! Every audit is an opportunity to learn and improve!