Quality Management System
ISO 9001 Quality Management Systems have been around since the 1980’s. Back then it was BS5750 and overtime the standard has gone through many changes and updates. 2015 saw the standard have a new look with new clauses and requirements and a much more risk-based approach being taken with more emphasis on top management being involved.
BLE has been ISO 9001 Accredited since September 2013 and has implemented the following in order to meet the requirements of the standard and offer a service which fulfils the requirements and expectations of all its customers.
The cycle for an ISO 9001 system has 10 clauses with additional sub-clauses built into the standard. The actual nuts and bolts of the system and the clauses which are audited by a Notified Body and internally are surrounding sections 4 to 10.
There is a cycle which is common with anyone associated with ISO 9001 Quality Management System and that is the PLAN, DO, CHECK, ACT cycle.
Firstly, all staff must be aware of what is expected of them and where their areas of responsibility lie to achieve ISO 9001 Accreditation. A Documented Quality Management System (QMS) is required together with policies and some procedures. However, more emphasis is to have documented evidence. This documentation should then define the organisation structure.
A Quality Management System requires someone to have overall responsibility for the system i.e., an Owner, Director or CEO of a company and then a Quality Manager to handle the day to day ownership and management of the system. All employees must be aware of the standard and how they contribute to the success of the QMS. Further to this the ISO 9001:2015 standard is now more of a risk base system and involves top management to have more of an input into the system.
A person who has had specific training is required internally to audit the quality management system. This normally being the Quality Manager or someone who has been trained to carry out Internal Audits.
The ten clauses of the standard are listed below.
Section 0: Introduction
Section 1: Scope
Section 2: Normative References
Section 3: Terms and Definitions
The following clauses 4, 5 & 6 are the PLANNING part of the system and the actual nuts and bolts of the system, whereby top management lead the organisation and put together documentation such as SWOT and PESTLE Analysis and Management Review.
Clause 4: Context of the Organisation – Understand the Organisations Context, Clarify Expectations of Interested Parties, Define Scope of the Quality Management System, Develop the Quality Management System.
Clause 5: Leadership – Provide Leadership by focusing on Quality and our Customers, provide leadership by establishing a Quality Policy, Provide Leadership by Defining Roles with Quality Management Systems and Responsibilities
Clause 6: Planning – Define actions to manage Risks and Opportunities, Set Quality Objectives and Develop Plans to Achieve them, Plan and Control changes to the Quality Management System
Sections 7 & 8 in the cycle are the DOING part of the system.
Clause 7: Support – Provide the required resource to for the Quality Management System, Encourage and Expect Competence, ask personnel to help with the Quality Management System, Manage QMS communications Control QMS Information.
Clause 8: Operation – Develop Processes, Determine Requirements, carry out Design, Monitor Suppliers, Manage Production, Control Products, Document Actions
Clause 9 in the cycle is the CHECKING part of the system.
Clause 9: Performance Evaluation – Monitor, Measure and Analise the Quality Management System (QMS), Set up an Internal Audit Programme to monitor the performance of the QMS. (Auditors must be trained to carry out these types of audits).
Clause 10 in cycle is the ACTING part of the system.
This section of the standard is where you review the QMS and see where improvements can be made and control non-conformities and to take suitable corrective actions, enhancing the Quality Management System.
BLE Lighting and Power Ltd is very proud to be accredited with ISO 9001 and we endeavor to continue to provide excellent service and quality to all our customers.
Find out more about our Quality Management System.