Practical Implementation of ISO for Pharma and Medical Device Manufacturers?

PharmOut’s QUALITY APPROACH

Quality Objectives and Policy - By working with the client’s ISO project team and senior management, we will define the Company Quality Objectives and formulate a Quality Policy for Executive approval.

GAP Analysis - Dependant on the company size, a one or two day GAP analysis is performed to define the current situation. This is dependant on the complexity of the organisation’s products, processes and existing documentation.

Once the GAP analysis has been completed, a detailed proposal and MS Project plan is submitted to the client for consideration. The scope of the project is clearly defined, as well as the schedule and key milestones. Finally, a detailed cost estimate is prepared for client approval.

Once management approval has been granted the following six step implementation plan is followed to ensure compliance.

1. Training

PharmOut will train, and where necessary, coach the ISO project team members and other staff as needed, in the fundamental principles, documentation, internal auditing and how the ISO requirements apply to their operation. Prior to the training, PharmOut will forward pre-read materials and training workbooks to be distributed to the ISO project team members.

We will instruct and demonstrate to the ISO project team members and other staff how to prepare and maintain ISO documentation to ensure registration and streamline the system to minimize maintenance costs.

In addition, PharmOut will run a Technical Document Writing component to the course, ensuring that a consistent technical standard will be applied to all documents.

PharmOut will equip the ISO project team members and other staff with the skills and knowledge required to design, install, maintain, audit and improve an ISO 9001 , ISO 13485 compliant quality system.

2. Detailed Review

PharmOut Consultants work with key client staff to develop and install a quality system and prepare for ISO 9001 / ISO 13485 registration.

In the absence of any Quality System, we propose that the client uses the PharmOut templates, formats and structure. We provide additional advice in the form of training, consulting and mentoring. Then, working closely with the client’s ISO project team, we apply the ISO standard to your business processes to ensure cost effective compliance.

If you have an existing Quality System, PharmOut will carry out an in depth, detailed review of the existing quality documentation and practices to identify changes and additions required for ISO 9001 / ISO 13485 registration.

3. MS Word Integrated (Optional)

PharmOut can provide an option of installing an integrated Quality Management System based on customised templates driven from MS Word. By using a proven Microsoft technology platform like Server 2003 for Small Business, PharmOut can provide the templates, validation, training and ongoing support for this system. As the technology platform is a Commercial Off The Shelf (COTS) system, validation effort and future risk is greatly reduced.

4. Implementation

During the implementation, the client’s team is encouraged to review and write as many of their own documents as possible. This encourages ownership and forces a questioning attitude of the systems, rather than simply accepting them. Documents written by PharmOut’s Technical Document Writers will ensure a high level of engagement by time-poor line managers, without the drag of actually spending hours doing the slog.

PharmOut experience will ensure that the project remains on track and ensure that the end objective is achieved and will not be lost in other, more pressing daily issues.

5. Audit Readiness

If the client believes that they are ready for an external audit, PharmOut can be invited to perform an Audit Readiness audit. Any last minute gaps can be remedied before the external body arrives. We instill confidence by reducing your risk and ensuring compliance with the requirements of ISO 9001 / ISO 13485 and any other TGA requirements, as outlined in PIC/S.

6. Surveillance Audits

We all know documenting your business processes and then complying with them 100% is extremely difficult in the practical, real world that we work in. Inevitably, staff may be tempted to shortcut systems to get the product out the door! Unfortunately, time is quality’s greatest enemy, and we may need to retrain staff or tweak systems prior to an audit. PharmOut can conduct a surveillance audit before your first regulatory audit to ensure compliance.