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Internal Audits
Internal audits according to ISO 9001 & ISO 13485
Ensure Successful Audits
Internal audits based on ISO 9001 and ISO 13485 can offer a high added value thanks to neutral evaluation of quality management and successful audit planning. When the results of these audits are viewed as opportunities for improvement, they can greatly benefit the company.
Our quality management (QM) team handles internal audits following ISO 9001 and 13485 for industrial companies, medical device manufacturers, and pharmaceutical companies, ensuring smooth audits of your products. Learn more about how this process works below.
ISO 9001 AND ISO 13485 INTERNAL AUDIT SERVICES
For internal audits according to ISO 9001 & ISO 13485, trained internal auditors from our QM team offer various services to industrial companies, medical device manufacturers and pharmaceutical companies. Our internal auditors review quality management systems for product development for compliance with standards and effectiveness and take care of audit planning.
Compliance (or non-compliance) is determined based on adherence (or failure to adhere) to the requirements outlined by ISO 9001 or ISO 13485.
How do internal audits, including audit planning for products, typically work? We’ve outlined the process for you below:
When conducting internal audits, companies should adopt a systematic and methodical approach. Thorough audit planning is crucial for success.
- Scheduling an audit at least once a year
- Defining the objectives of the internal audit together with your company
- Plan the audit scope and focus, specifying which company divisions will be audited on your chosen date
- Determine the audit methodology, such as using predefined checklists, reviewing error databases, or examining technical documentation
- Develop an audit plan
- Inform the relevant employees about the audit dates, objectives, plan, scope, methods, and the audit team’s composition
As soon as the audit planning is completed, our auditors will start the detailed audit preparation for you.
- Examination of quality management documentation, if it is not known to our auditors or if significant changes have been made
- Composition of the audit team: internal auditor and process owner in the company
- Coordination with the company and the divisional management of the company divisions to be audited, as well as concrete organization and scheduling of internal audits
- Informing all persons involved in the audit about the aim and purpose of the planned audit
- Compilation of all relevant documents (audit criteria) by the audit team that are necessary for the audit to be carried out, such as quality policy, quality objectives, QM manual, process descriptions, work and test instructions
Audit execution must ensure objectivity and impartiality of the audit process.
- Audits are usually carried out on site at your company, but sometimes also online
- Start of the audit with an opening meeting with the auditor, the top management and the divisional heads to coordinate all audit activities defined in the audit plan
- Auditing of real practice through audit samples in your company's processes: Review of company material, such as process descriptions, (quality) management documentation and customer surveys
- Identification of deviations from the norm, which are discussed in a final meeting with the top management and the divisional management
- Joint derivation of improvement and corrective measures
The internal audit report presents the findings and conclusions drawn from the audit.
- Highlight significant and minor deviations from the standard requirements
- Drafting conclusions based-on audit objectives and audit findings
- Conduct one-on-one quality control with our internal auditors
- Submission of the audit report to your company
- This report may also be shared with a notified body to assist in preparing for external audits
An internal audit is considered completed when:
- All planned audit activities have been carried out as agreed with your company
- The audit report has been submitted and accepted by the relevant parties
The audit follow-up involves developing and implementing an action plan to address the findings.
- Prepare the action plan based on identified major/minor findings and areas for improvement
- Your company will review and approve the action plan, which will be implemented within an agreed timeframe
- Our internal auditors can assist with the implementation until completion
- Test the effectiveness of the implemented measures
- Conduct a management review
What are internal audits according
to ISO 9001 and ISO 13485?
Internal audits of quality management systems, based on ISO 9001 and ISO 13485, involve auditing individual processes and systems within a company following a pre-defined audit plan.
Internal audits are at least once a year a must
Internal audits must be carried out at least once a year and audit planning must be carried out for them. Both ISO 9001 and ISO 13485 standards require that the process flow be systematically audited at least once a year during an internal audit and that negative findings are recorded. It is important to derive and implement any corrective measures so that a continuous further development of processes and management system can be guaranteed.
All company divisions and processes should undergo internal audits at least once every three years.
What is the goal of internal audits according to ISO 9001 and 13485?
Internal audits according to ISO 9001 and 13485 aim to determine:
- the extent to which the standard requirements of ISO 9001 or ISO 13485 are met, which are prerequisites for initial or re-certification,
- whether processes and activities are carried out in accordance with the planned specifications in the quality management system,
- and to what extent the existing self-defined regulations continue to be expedient and effective in uncovering weaknesses and optimization potentials in the QM system.
Thus, an internal audit promotes compliance with the company's goals and ensures that process control functions smoothly. Our internal auditors will be happy to support your company in this.
DO YOU NEED SUPPORT WITH INTERNAL AUDITs?
