According to ISO 9000: ‘A quality management system (QMS) is a system to establish a quality policy and quality objectives and to achieve these objectives.’
A QMS defines the policy, organization and responsibilities for the management of quality within a business. It ensures that all activities comply with an agreed set of rules, regulations and guidelines and that the end product conforms to the customer’s contractual requirements (see figure 1).
With the publication of ISO 9001:2000, there is now a single quality management ‘requirements’ standard that is applicable to all organizations, products and services.
ISO 9001 is the only standard that can be used for the certification of a QMS. Its generic requirements can be used by any organization to:
- address customer satisfaction
- meet customer and applicable regulatory requirements
- enable internal and external parties, including certification bodies, to assess the organization’s ability to meet these requirements
For certification purposes, an organization will have to possess a documented management system that takes the inputs and transforms them into targeted outputs. Something that effectively:
- says what the organization is going to do
- does what they have said they are going to do
- keeps records of everything that they do (particularly when things go wrong).
The basic process to achieve these targeted outputs will encompass:
- the client’s requirements
- the inputs from management and staff
- documented controls for any activities that are required to produce the finished article
- delivering a product or service that satisfies the customer‘s original requirements
Aims of ISO 9001
ISO 9001 aims to assist its users in producing a QMS with the following characteristics:
Flexibility
fitting any sort of organization, a flexible approach to quality documentation, works in tandem with other management systems
Structure
features a process management model, includes process capability studies, relies on process measurements and audits and requires configuration management. Also documents how a product is measured and evaluated using a quality control plan
Customer orientation
has an emphasis on the identification of stakeholders and how the organization plans to meet their needs, requires a formal system of measuring customer satisfaction and emphasises the need to identify and review customer requirements and expectations
Verification and validation
verifies purchased products, validates the output of processes and includes the requirement for regular revalidation of products and/or services to ensure that they continue to meet customer expectations
Corrective action
gives an assertive definition of corrective and preventive action
Continuous improvement
provides for continually reviewing the work environment and its effect on quality
Workforce
defines responsibilities and authorities within the process areas and enables an organization to assure that its infrastructure can meet quality objectives
Reviews
sets a requirement for the regular review of quality objectives
requires a formal policy on continuous improvement
Summary of requirements
ISO 9001 includes the following requirements:
QMS
An organization shall have a documented QMS that defines the processes necessary to ensure that a product and service conforms to customer requirements – specifically:
- the QMS shall be implemented, maintained and continually improved by the organization
- the quality manual shall be established and maintained as an organizational ‘rule book’
- the control of documents shall be established and maintained via a documented procedure, ie for the control of QMS documents
- quality records shall be controlled and maintained
Management responsibility
This is broken down into the following sub-clauses:
- management commitment – to the development and improvement of the QMS
- customer focus – determining, understanding and documenting customer requirements; ensuring compliance with identified statutory legislation
- quality policy – ensuring that it is appropriate for the purpose, understood by everyone and reviewed for continued suitability
- planning – clearly stating management’s quality objectives and quality policy in a fully documented QMS
- responsibility, authority and communication – identifying and planning the activities and resources required to achieve quality objectives
- management representative – someone responsible for the implementation and improvement of the QMS
- management review – regular reviews of the QMS to ensure that it continues to function correctly
Resource management
- provision of resources – identifying the resources required to implement and improve the processes that make up the QMS
- human resources – assigning personnel with regard to competency, education, training, skill and experience
- infrastructure – identifying, providing and maintaining the workspace, facilities, equipment (hardware and software) and supporting services to achieve conformity of product
- work environment – identifying and managing the work environment, eg health and safety
Product realisation
- planning of realisation processes – clearly defining and documenting the processes used to ensure reliable and consistent products, eg verification and validation activities, criteria for acceptability and quality records
- customer-related processes – identifying customer, product, legal and design requirements
- design and development – controlling the design process, eg design inputs, outputs, review, verification, validation and change control
- purchasing – having documented processes for the selection and control of suppliers and the control of purchases that affect the quality of the finished product or service
- production and service provision – having documented instructions that control the manufacture of a product or delivery of a service
- customer property – identifying, verifying, protecting and maintaining customer property provided for use or incorporation with the product
- control of monitoring and measuring devices – their control, calibration and protection
Measurement and improvement
The elements you then require to ensure this all words effectively are as follows:
- control
- monitoring and
- internal audits
- measurement and monitoring of processes and
- control of non-conformity
- data analysis
- improvement
- corrective and preventative action
How to select a certification body
• think initially about why you want certification and what is important in the service you expect to receive
• ensure your certification body is accredited for your activity
• get quotes from a range of various organizations
• ask for references in your area or line of business
• ask your certification body about its assessment process – you will quickly get a feel for its way of working
• don’t be afraid of challenging your certification body early on – it will be a good test of how well it listens
Do you need a consultant?
• are you capable of identifying performance gaps as they arise?
• do you have a performance gap?
• does something need to be done about the performance problem?
• do you have the right internal resources to solve the problem?
• should these internal resources be used on it?
• is it wise to combine internal resources with external help?
What you need to know… ISO 9000 FAQs
What is the difference between being certified and being registered?
There is no difference.
What is the difference between being certified and being compliant?
When an organization claims that it is ISO 9000 certified, it means that an independent auditor has assessed its QMS, certified that it meets the requirements of ISO 9001, and given a written assurance that the standard has been met. When an organization says that it is ISO 9000 compliant, it usually means that it has met ISO‘s QMS requirements but has not been formally certified by an independent auditor.
What is the difference between being certified and being accredited?
Auditors audit and certify organizations who wish to become ISO 9000 certified. Accreditation bodies like UKAS evaluate and accredit the auditors and certification bodies.
What is the difference between quality control and quality assurance?
Quality control is:
- the operational techniques and activities that are used to fulfil quality requirements
- the amount of supervision that a product is subjected to so as to be sure that the workmanship associated with it meets the quality level required by the design
- the control exercised by the manufacturer to verify that all aspects of its activities during the design, production, installation and in-service stages are to the desired standards
- exercised at all levels
Quality assurance is:
- all those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality
- a declaration given to inspire confidence that a product has achieved the highest standards and that its manufacture, modification or repair has been completed in an efficient and timely manner
What is the difference between a process and procedure?
A procedure:
- describes how the policy objectives of the quality manual can be met in practice and how these processes are controlled
- contains the basic documentation used for planning and controlling all activities that impact on quality
There are two types of procedure: system level procedures that are used to detail the activities needed to implement the QMS; and procedures that describe the sequence of processes necessary to ensure the conformity of a product or service.
A process:
- describes the sequence of events or activities used to complete a task
- is an activity that receives inputs and converts them to outputs
There are two types of process: core business processes which describe the end-to-end activities involved in producing a deliverable; and supporting processes, which describe the whole infrastructure required to manufacture or supply a product or service.
What is a quality manual?
It describes the interrelationships between:
- a process – an outline of its objective, scope and key performance indicators
- quality procedures – an enlargement of the process explaining how it is controlled
- work instructions – the ‘fine print’ required to perform a specific activity
How should a quality manual be structured?
A company’s quality manual is the formal record of the organization’s QMS. It:
- is a rule book by which an organization functions
- is a source of information from which the client may derive confidence
- provides consistent information, internally and externally, about the company’s QMS
- defines the responsibilities and interrelated activities of every member of the company
- is a vehicle for auditing, reviewing and evaluating the company’s QMS
- describes documents and records inspections
- describes how the goods inwards facility operates
- comprehensively describes how the company monitors quality
What is a QMS?
A QMS is a system that contains all the things that are used to regulate, control and improve the quality of a product and/or service.
It is a network of interrelated processes with each process being made up of people, work, activities, tasks, records, documents, forms, resources, rules, regulations, reports, materials, supplies, tools, equipment etc that are required to transform inputs into outputs.
What is the difference between a quality manual and a quality system?
A quality manual is all about paperwork and is just a document whereas a quality system is about a network of processes.
Your quality manual is not supposed to be your quality system, it merely documents your quality system. It is an organizational structure of responsibilities, activities, resources and events that together provide procedures and methods of implementation to ensure the capability of an organization to meet quality requirements.
What should be included in work instructions?
Work instructions describe:
- the physical operating practices and controls within each process
- how individual activities are to be carried out
- They provide examples of the various forms and documentation used by the manufacturer or supplier. For example:
- production control forms
- inspection sheets
- documents used to purchase components from subcontractors
What should be included in quality records?
Records such as QMS audit reports, calibration of test and measuring equipment, inspections, tests, approvals, concessions etc ensure that a company is capable of proving the effectiveness of its QMS. Quality records provide objective evidence of activities performed or results achieved and should:
- establish methods for making changes, modifications, revisions and additions to these records
- establish methods for accounting for the documents
- show their retention time
- establish methods for the disposal of out-of-date records
- show how they should be stored