ISO 9000 / ISO 9001 - Based Internal Auditing Service
ISO 9001, TS 16949, TL 9000, AS9100, ISO 13485
Internal Auditing is a crucial element of your ISO 9001, TS 16949, TL 9000, AS9100, or ISO 13485 based quality management system (QMS). Consistent and effective internal audits assure continual effectiveness, compliance, and improvement of your QMS. However, many companies that tackle this responsibility alone must overcome the following obstacles:
- Difficulty in developing and maintaining the skills for part-time Internal Auditors,
- Lack of experience, independence, and objectivity of Internal Auditors, and
- Internal resource constraints.
Internal Auditors are Management's eyes and ears for monitoring the effectiveness and efficiency of the QMS. Expert Internal Auditors are more likely to be the first to discover a system that has broken down, needs attention, or is improving. While known problem areas might be deliberately avoided during a regulatory, accreditation, customer, or certification audits, Internal Auditors are required to focus both on problem areas and on areas demonstrating improvement. The training and skills needed to do this well are vital. Trained and experienced Internal Auditors are a crucial part of the QMS.
Pinnacle Enterprise Group's (Pinnacle) Internal Auditing Service is for companies that wish to outsource or augment the resources needed to maintain and improve their ISO 9001, TS 16949, TL 9000, AS9100, or ISO 13485 based QMS with Pinnacle's experts. Given the level of change most organizations undergo and their already strained resources, Pinnacle serves as a valuable source of expert support without the time and investment needed to develop and maintain such resources internally. Pinnacle possesses the experience and expertise to deliver a custom-tailored Internal Auditing program. Pinnacle's experience in implementation and certification of ISO 9001, TS 16949, TL 9000, AS9100, and ISO 13485 based QMS adds great value to this difficult process - beyond simply maintaining certification.
- Reduction or elimination of costly time and training of Internal Auditors.
- Reduction or elimination of resources and cost needed to perform internal audits.
- Minimal disruption of operations and internal resources.
- Expert assessments and advice through objectivity, experience, and independence of Pinnacle's experts.
- Increased efficiency and higher quality results through consistent and continual focus of Pinnacle's business process and Lean QMS® approach.
- Continual evolution and improvement of your QMS.
Complete Customization & Set-Up:
The first step is for Pinnacle to achieve a thorough understanding of your organization and its ISO 9001, TS 16949, TL 9000, AS9100, or ISO 13485 based QMS. For this you are asked to provide your complete QMS documentation package, as well as the latest Internal Audit and Management Review results. A Pinnacle expert then visits your facility(ies) for an on-site tour. Customization and set-up is completed when we jointly decide on topics such as:
- Which areas or functions of your organization should get greater attention than others,
- Whether to use your established internal auditing forms or Pinnacle's,
- The annual Internal Audit Schedule,
- Whether Pinnacle will be your internal auditor team or will augment your current staff, and
- Internal Audit objectives - compliance and/or business performance and improvement.
Pinnacle serves as your internal audit team and performs your Internal Audits. The frequency and length of each internal audit depends on the size and complexity of your organization, as well as your organizational objectives. However, two Internal Audits per year is a typical minimum.
To begin, Pinnacle's expert prepares and provides an Internal Audit Plan well in advance of each Internal Audit. The Internal Audit Plan details the schedule of activities for each Internal Audit. This assures that your staff has ample notice and time to prepare. The Internal Audit Plan also assures that disruption to your staff's daily activities is minimized.
To conduct each Internal, Audit Pinnacle uses a customized checklist and Pinnacle's exclusive Process Auditing Guide. The checklist assures a consistent assessment of compliance with ISO 9001, TS 16949, TL 9000, AS9100, or ISO 13485. The Process Auditing Guide assures continual focus on business processes. Any deviations (non-conformances), observations, and recommendations are detailed in a formal Internal Audit Report.
Pinnacle recommends that one or two of your Internal Auditors accompany and assist Pinnacle's expert during each Internal Audit. This allows for the skills of your Internal Auditors to be developed, improved, and/or maintained.
- QMS documentation review
- Program customizations and set-up.
- At least two customized Internal Audits per year.
- Annual Internal Audit Schedule.
- Tailored Internal Audit Plans.
- Documentation of Internal Audit results with a formal Internal Audit Report.
- Formal Internal Audit result presentation to management - Executive Briefing.
- Support of corrective, preventive, and improvement action development and implementation.
- Certification Maintenance Program - includes management of corrective, preventive, and improvement actions, Surveillance Audit and Registrar management, training of two Internal Auditors, facilitation of Management Review, and unlimited technical support.
Contact Pinnacle to schedule your Internal Auditing needs.Next Topic: Certification Maintenance Service
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