Her experience so far, in taking PSP to the next level of their quality management system, is to keep things as simple as possible. Not having procedures and work instructions for the sake of it. Ensuring everything that is documented is relevant to the company as a whole and keeping everything stream lined and cross referenced where appropriate.
Fiona Verde states “As a business you need to be aware of the six standard quality procedures required by an organisation undertaking ISO 9001:2008 for the first time, this is how we tackled it”.
The six procedures required by the QMS
The minimum six standards required for Quality Management System are:
1. Document Control
This procedure describes the format, preparation, numbering, revision, distribution and administration of all procedures and attachments, applicable to the quality and operating systems within a company.
This procedure should also be used as an example of how a procedure, or work instruction and/or form templates shall be prepared, formulated and presented within a company.
This procedure shall apply to all documents which identify the activities and functions of a department or group and shall be observed by all Departments within a company.
2. Control of Quality Documents
This procedure details the method for identifying and numbering of all documents applicable to the quality and operating systems. This procedure shall apply to all documents for incorporation into the Quality Manual, Departmental procedures and associated attachments.
This procedure shows you how to manage your quality documents, departmental procedures, work instructions, forms and templates.
3. Internal Audits
The purpose of this procedure is to establish an independent system for verification of the implementation of a quality system by means of a uniform and controlled method for planning, scheduling, co-ordinating and performing quality audits, raising and processing deficiencies and to assign responsibility for these activities.
This procedure applies to Internal; External and Extrinsic quality audits performed by suitably trained, independent, and experienced personnel, to verify implementation of the respective quality systems and procedures. It also establishes the requirements for planning, preparation, performance, reporting, follow-up and close out of the quality audit.
Any deficiency identified during a quality audit shall be addressed by a Corrective Action Request (CAR) or Non Conformance Report and shall be processed in accordance with the requirement of this procedure.
This procedure should be read by all employees, to ensure understanding of why and how we audit internally and promote continuous process improvements.
4. Non-compliance and complaints
The purpose of this procedure is to define a system for the control of non-conforming products or services, to prevent inadvertent use, shipment or mixing with conforming products. The controls provide for the recording, identification, segregation, collection, disposition and recall of non-conforming products.
The procedure shall also define the person(s) responsible for reviewing and authorising the disposition of non-conforming products.
This procedure shall apply to all non-conforming products found upon receipt from Suppliers, during manufacture, in storage or in transit and items returned as a result of a Customer complaint. If necessary, the scope shall include recall of any goods that have been sent out to a Customer or returns.
5. Corrective Action and Preventive Action
This procedure describes how a company intends to continually monitor and improve the quality management system.
This procedure shall cover all areas of the quality management system, it shall include quality policy, quality objectives, audit results, nonconformities and a defect arising from Supplier rejects internal issues and Customer complaint data analysis. It shall also cover the analysis of complaints and non-conforming products in order to identify any trends that exist.
6. Quality Management System Review
The purpose of this procedure is to ensure that the Quality System shall be periodically reviewed by management to assess its continuing suitability and effectiveness.
This procedure applies to all areas of the quality system within the company without exception.
The Quality Manual
The Quality Manual does not have to replicate the ISO 9001:2008 standard booklet. The quality manual should reflect the personality of the company. You can achieve this as we did.
When reviewing our quality manual, we found that by introducing a process flow map, highlighting quality documentation, reduced our quality manual from 30 pages to just 6 pages long. We feel that this gives a customer, who requests to see our Quality Manual, a brief but detailed insight to our QMS, this gives them an overview of what we expect our employees to attain to and accomplish our mantra of ‘Do it right, first time, every time’.
Process Flow Maps
When reviewing our quality procedures – it was found to be just as effective to show a process flow map of the procedure. This demonstrates the whole process flow, then summarize each step referring to the work instructions’ or forms where necessary for the step by step how to complete a particular process – by doing this we found that it could reduce a lot of duplication.
How to make your Quality Management system successful:
- The six QMS procedures should be read by all employees, to ensure understanding of the Quality Management System and why the company takes quality so seriously and promotes continuous improvement.
- Ensure that you motivate people contributing to the QMS, making sure that they understand the importance of applying the quality standard.
- Make sure that all quality documentation is assessable – we keep our quality documentation on our SharePoint document management system, we designed the Quality area to enable specific views for each department – so each department is not over run with every procedure and work instruction – just those that are instrumental for a specific department.
We welcome any questions or comments on how you manage quality procedures within your business.