ISO 9001 - Based Certification Maintenance Program
ISO 9001, TS 16949, TL 9000, AS9100, ISO 13485
Maintaining and continually improving your ISO 9001, TS 16949, TL 9000, AS9100, or ISO 13485 based quality management system (QMS) requires a sustained focus and vision. Maintaining certification underscores this fact. Companies often loose momentum, focus, and commitment after achieving initial certification. The result is a scramble to prepare for Surveillance Audits, stress and anxiety during the Surveillance Audit, and an unplanned commitment of resources to deal with the aftermath.
The Pinnacle Enterprise Group's Certification Maintenance Program 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, this Pinnacle serves as a valuable source of expert support without the time and investment needed to develop and maintain such resource internally. Pinnacle has the experts and experience to deliver a custom-tailored 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 of resources and cost needed to perform internal audits and effectively closeout resulting corrective actions.
- Elimination of the stress, anxiety, and cost of preparing for, managing, and completing a registrar's Surveillance 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 business Management System.
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, and 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.
Internal Auditing is a crucial element of an ISO 9001, TS 16949, TL 9000, AS9100, or ISO 13485 based 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.
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 to assure 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, while 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.
One of the Internal Audits is scheduled in advance of your registrar's Surveillance Audits. In addition to the thorough assessment of your QMS, this Internal Audit has the added objective of assuring that you are prepared for the Surveillance Audit. Pinnacle then mentors your staff through the development and closeout of all corrective, preventive, and improvement actions. Furthermore, to ensure that you are always prepared for your Surveillance Audit, this approach is a driver of continual improvement.
Surveillance Audit Management:
Pinnacle coordinates all activities related to the Surveillance Audit, including communication and scheduling with the registrar. Typically, Pinnacle's expert arrives a day before the Surveillance Audit. With the Internal Audits completed and corrective, preventive, and improvement actions reviewed and implemented, Pinnacle's expert helps facilitate a Management Review meeting to assure that it is performed properly before the Surveillance Audit. Pinnacle's expert then facilitates the Surveillance Audit. Following the audit, Pinnacle expert mentors the development and closeout of corrective, preventive, and improvement actions in response to any non-conformances, observations, or suggestions noted by your registrar.
In addition to the above support activities, your staff has direct and unlimited telephone, e-mail, fax, and on-line meeting access to Pinnacle's experts for the term of the Maintenance Program. This support will include:
- Interpretation of ISO 9001, TS 16949, TL 9000, AS9100, or ISO 13485 requirements, including any revisions,
- Review of any changes or improvements to your QMS, and
- Advise on best practices and continual improvement initiatives.
- 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.
- On the job training and development of two Internal Auditors.
- Support of the development and closure of Corrective, Preventive, and Continual Improvement Actions.
- Facilitation of Management Review prior to Surveillance Audits.
- Preparation, management, and facilitation of Surveillance Audits.
- Unlimited access and technical support.
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