One of our most frequent requests is for re-certification to ISO 9001:2015
This sample demonstrates a typical scenario from an actual re-certification project being completed for a local business.
- Project Background and Description
The Company’s certificate had expired due to a number of factors including organisational restructure, Covid pandemic, staff moving onto other projects etc.
- Project Scope
The business has decided to resurrect the Quality Management System (QMS) process and controls to meet the requirements of ISO 9001:2015. This project will focus on the revision of the QMS and the development of new processes and refresher training of all the staff. However, the business will also consider the application of processes and procedures to meet ISO 14001:2015 Environment and ISO 45001:2018 Health and Safety requirements.
- High-Level Requirements
Description of high-level activities to be achieved or implemented.
The new quality system will:
- Have direct involvement from the most senior management to decide on the resources required and to show full commitment from top to bottom of the organisation.
- Use the existing process and procedures where applicable and will involve all levels of management to design new processes and forms to help develop a useful constructive system.
- Be auditable by any interested party, open for scrutiny and will be used for continual drive to improve the business success and deliverables to customers.
List agencies, stakeholders or divisions which will be impacted by this project and describe how they will be affected by the project.
All staff will be impacted by the QMS as it will require changes in working practices, new disciplines to be applied and review of working practices to achieve certification and continual improvement.
Clients, suppliers, and other external interested parties will be affected as changes in the processes will require additional information to be supplied by the clients to ensure full understanding by the business.
Suppliers may be affected as they will need to adapt to changes on delivery schedules, documentation and certification required by the business and improved communication lines.
Regulators will see improvements within the business and will hopefully welcome the improvements in the business to drive a safer more environmentally friendly approach and to achievement of ISO 9001:2015.
- Implementation of the Plan
To understand where the company’s system is regarding compliance to the ISO 9001:2015 requirements, the business will commence a complete review of the QMS by completing a full audit of the current system against the ISO 9001:2015 standard. Following the audit, the results will be discussed with the top management and a plan for the development of improvements generated with roles and responsibilities allocated.
- In all cases the Quality Policy will be re-written and checked for full compliance to the Standard requirements as well as the business needs. Raining and awareness on the policy, its availability and location will be issued to all staff. The policy will be signed by the Managing Director or CEO.
- All areas of the business will be explored to include business internal and external issues that could affect the ability to supply our services to our customers on time every time, leading to a business risks and opportunities review to reduce risks and achieve opportunities. Health and Safety and Environmental considerations will also be part of the review.
- Resources, training and competence will be reviewed and the training matrix and records revised improved and updated.
Detailed skills required will be noted and training programme established to achieve competence and improvement to individuals as well as to the company.
- A review of the production / warehouse / office layout is to be considered to ensure the most efficient ways of achieving customer and other interested parties requirements and the most efficient ways to achieve this are in place.
- Operational controls will be fully reviewed and will include Sales and Customer communications methods, recording of requirements, dealing with concerns etc. Service / production provision will be totally reviewed to ensure adequate controls are in place and any “bottle necks” are removed.
Design and development will be included in the review. Due to changes and interpretation of the ISO 9001:2015 Standard, the design of processes and procedures will be checked against the design clause requirements and verification confirmed of suitability and application.
- Review the selection process for our suppliers, along with the supplier credentials such as any ISO certification, environmental programmes or considerations, Health and Safety incidents etc.
The process for monitoring and re-evaluating the suppliers will be reviewed and controls considered and implemented.
Issue questionnaires to suppliers to obtain up to date information.
- Updating of the non conformance / improvement log to be useful and productive. The disciplines of fully utilising the information to improve the QMS will be considered as part of the training programmes to be set up and delivered.
- Internal Auditing
A check that the system is working correctly to ensure that the business is moving in the right direction, the system will be audited by our internal audit team and/or external consultant (QSC).
The findings should deliver positive results once all of the improvements identified from the initial audit have been implemented and had time to settle into the business.
If there are any areas of nonconformity identified, this will give the business the opportunity to make improvements and build an even stronger QMS.
- Management Review
Time for an overall review by the senior management
The ISO standards require that the total QMS is reviewed by the top management to ensure the system is achieving the desired results, audits are being completed and any deficiencies are being addressed. Customer complaints and feedback is reviewed along with other interested parties demands and requirements.
The key business risks and opportunities will be reviewed to ensure progress is made to reduce the risks and improve the opportunities.
To drive improvement, targets are to be set and resources considered, along with review periods to monitor progress.
As the policy statement is the corner stone of the entire system, the suitability of the policy and how it is communicated will be discussed and minuted.
The meeting will be fully minuted and relevant information discussed with the staff.
- Recommendations and Timescales
It is highly recommended that the QMS is fully reviewed and brought in line with the current business controls and methods. It can only be a benefit to the business.
Timescales from start to finish approximately 6 months to a year.
This will include the external ISO 9001:2015 Audit.
Achieving ISO 9001 involves a logical steps starting with a review of the standard against the system you are currently operating and noting strengths and weaknesses. We can help you review this area to build a program of improvements to meet the requirements of ISO 9001:2015.
Achieving ISO14001 does not have to be hard work. With the right approach and with top management commitment we can guide you every step of the way to ensure that your procedures are fully compatible with the requirements of the standard.
QSC Consultancy can offer a full Health & Safety System compliant with ISO 45001 the Occupational Health & Safety Management System. This system will assist you in managing Health & Safety Risks and facilitate legal compliance.
Quality Systems Consultancy
Quality Systems Consultancy Ltd