ISO Implementation

With a number of years experience working in the food and medical device sector, we can help you with your ISO implementation. We have capabilities of implementing successful systems for  ISO 9001 & ISO 13485.

Our aim is to implement a Quality Management System tailor-made for your company.

• We will complete a gap-analysis to identify what systems are currently in place and assess what needs to be completed to ensure your company is audit ready.
• We will work closely with the external certification body to ensure a seamless certification process.
• Once certification has been approved, we will complete a monthly audit to ensure your QMS is correctly maintained.

QCServices will guide you through the whole process from start to finish to ensure successful ISO implementation. We will work closely with you and the auditor on-site on the day(s) of the audit. Should any non-conformances be identified during the auditing process, QCServices will work closely with you to implement any corrective / preventive actions.

The process of implementing an ISO System depends on the sophistication of any existing quality programs already in place, the size of your organisation and the complexity of your processes. No ISO System will ever be successful unless top management show commitment for its implementation.

The following are some of the steps taken by QCServices to help with the implementation of a successful ISO System or Integrated System.

Gap Analysis

A gap analysis is completed to identify what systems are already in place, what systems are not in place and what systems need to be tweaked a little to satisfy requirements.

Management Representative & Management Reviews

A management representative will need to be appointed. This person will be required to have the necessary authority and ability to liaise with QCServices to co-ordinate and monitor the  implementation of ISO. It is also a requirement of an ISO QMS to conduct a management review at least annually. QCServices can guide the Management Representative through this process.

Documentation

QCServices will work with the Management Representative to build a documentation system that suits your company. There are many different types of documentation systems available to assist with the organisation and storage of such documents. QCServices can talk you through all options available to you.

ISO documentation systems are made up of four tiers:

1. Quality Management System Manual
2. Standard Operating Procedures (SOPs)
3.  Work Instructions
4.  Records

Implementation

Once the required documentation is in place, all personnel will receive awareness training. This will ensure that all employees are aware of the company changes as part of ISO Implementation. QCServices have the ability to complete this training with all personnel and can adapt the training to meet each employees needs.

Internal Audits

Internal audits will commence once the ISO Quality System is fully implemented. Internal auditing is a method used to ensure that all employees are following SOPs & Work Instructions correctly. QCServices will implement an internal audit schedule and all documentation to support this. Where non-conformances are identified, QCServices will work with the Management Representative to ensure that all corrective and preventive actions are implemented successfully to avoid re-occurance.

Improvement

The ISO system is based on the Plan, Do, Check, Act (PDCA) Cycle. QCServices can provide you with the service to ensure that your company ACTS on the continuous improvement process to ensure an effective Quality Management System. See Lean Six Sigma.