Quality procedures according to the ISO 9001 Standard requirements – examples, samples, and solutions
What is the meaning of quality procedures? What is so qualitative about them? Ah! A key question. These quality procedures are the heart and soul of your quality management system. These procedures establish processes that make sure everything is performed according to the ISO 9001 Standard requirements.But first, let’s review shortly and understand what a procedure is.
Important notice – the ISO 9001:2015 does not require the maintenance of quality procedures anymore and the quality manual anymore. It does not mean that you will have to dispose of them – they can still be used in you QMS. I recommend to keep them but adapt them the new requirements of the ISO 9001:2015, for example no need for a procedure for preventive action anymore.
ISO 9001 – Working Procedures
One of the most important principles of the ISO 9001 Standard applies simply: “say what you do, do what you say”
That actually means that you must define first what you are required to perform and then perform it! One can also explain it differently; you will define in which cage (procedures and procedures hence requirements) you want to spend your time and work; the working processes and working instructions hence requirements. The purpose of the working instructions or procedures is to explain, very simply, what is required to do be done by employees in their everyday tasks. The instructions are highly important! Why? Who asked that? You are not serious! The explanation is very simple; When you define a working procedure you define a frame. This frame defines what has to be done and leave much less possibilities for questions, nonconformities and faults. Your employees need guidance. Naturally people would try to break the frame they are living and working in, in order to maintain more comfort for themselves or to promote interests that are no conformed to the organization’s objectives. This comes on behalf of efficiency and effectiveness. And when efficiency and effectiveness are declining, you can be pretty much sure that, in the not so long term, profitability and quality would decline as well.
Procedures give you the ability to examine where your employee tries short cuts. Straying from the procedures will create nonconformities. Nonconformities harm your profitability, even if you cannot realize it in the short term. In this case when you define a procedure, it is highly important to define the appropriate control over it as well. This issue is enforced by the ISO 9001:2015 Standard almost fanatically.In fact the requirement 4.4 Quality management system and its processes demands the establishment and maintenance of a method for planning, defining and documenting processes in the QMS. One of the means to eliminate nonconformities and defects is a clear procedure. A procedure must include:
- What is the purpose of the process? The objective or goal of the process.
- Who is responsible for maintaining and performing the process? In order for you to know exactly who is responsible for what had been done.
- What is the method? You must specify the steps, phases, or actions required to perform the process. We recommend being generous with details, specify within the most specific level and to explain with the simplest language what is to be done.
- What are the tools one needs to perform the process? Forms, software, working tools, etc. – This is actually the documentation and control over the procedure. By examining this tools we can decide whether the procedure was maintained and how well.
- What are the process outputs? The outputs expected at the end of the process (a price quote documented, a certificate of calibration, records of any kind, any form, etc).
ISO 9001 – Quality Procedures
After reviewing the meaning and importance of a procedure and understanding the link between a procedure and a process allow me to discuss to the quality procedures. The goal of these procedures is to make sure that the organization performs the minimum requirements of the ISO 9001 Standard that suit all kinds of organizations – from the low tech to the high-tech companies. These procedures are referred to as “quality procedures”. The procedures include the next:
- A quality manual. A document defining the scope of the quality management system, a general presentation of the organization activities, its organizational structure, the context of the organization, the needs and expectations of interested parties, a general description of the main process, a description of the relation between the working process and the quality management system (as shown below), a list of all procedures in the organization and list of exclusions –the ISO 9001 Standard requirements which are not applicable to the organization’s activity or nature. The quality manual is in fact not a procedure but a manual; it must not have the characteristics mentioned above. It describes no activities at all but it is required to maintain it documented as specified. As far for the description of the relation between the working process and the quality management system, I drew this diagram for example:
ISO 9001 quality procedures – the quality management relation diagram
- Control of documents. Specification of the process of controlling documents that are included under the quality management system. The requirements are specified in these articles. In the procedure you must define how to achieve the requirements
- Control of records. Specification of the process of controlling your records that are included under the quality management system. The requirements are specified in this article. In the procedure you must define how to achieve the requirements. This procedure will include or refer to a list of all documentation included in the quality management
- Internal audits. A procedure specifying how the internal audit should be performed within the organization. You may refer to this article for the specific requirements. In the procedure you are required to define how to achieve
- Control of nonconformity. Procedure specifying how one should handle nonconformity when he detects it
- Corrective action. A procedure specifying how one implements a corrective action. Read this article to learn about the ISO 9001 Standard requirements for corrective action
This is the list of the required quality procedures. They must be documented and maintained. That means that it’s not enough to document the procedure, you must also prove that you follow what you defined with evidence day by day – perform the quality management activities.
Quality procedures according to the ISO 9001 Standard – Summary
- The quality procedures are the heart and soul of your quality management system
- These quality procedures ensure that you maintain a quality management system according to the ISO 9001 Standard
- Say what you do, do what you say – One of the most important principles of the ISO 9001 Standard
- The purpose of a working procedure is to explain what is required to be done in order to reach a specified result or objective.
- A procedure must include: purpose of the process, the responsible party, the method, the tools and process outputs
- The purpose of quality procedures is to ensure that the organization performs the minimum requirements of the ISO 9001 Standard
- Quality procedures include: quality manual, procedure for the control of documents, procedure for the control of records, procedure for the performance of internal audits, procedure for the control of nonconformity, and procedure for the for integrating and controlling corrective action and preventive action.
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FAQs
What are quality procedures as per ISO 9001? ›
Six procedure are- Control of Documents, Control of Records, Internal Audit, Corrective Action, Preventive Action, Control of Non Conforming Products."
What are the quality system procedures in ISO 9001 2015? ›ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements.
What is ISO 9001 standard requirement? ›The ISO 9001 standard requires, through clause 7, that your organisation provides adequate resources to operate an effective Quality Management System. This includes providing resources for: Robust infrastructure. Efficient working environments.
What are the quality procedures? ›A quality management process consists of four main components: Quality Planning, Quality Assurance, Quality Control, and Continuous Improvement. As mentioned before, a quality management process is a collection of procedures, which most companies generally follow to ensure the quality of the deliverables.
How many procedures are there in ISO 9001? ›The 2015 revision of the ISO 9001 standard only lists 4 mandatory documents as opposed to the six mandatory procedures required in the 2008 version. ISO 9001 does however also require many records that have to be maintained. These records are generated by the QMS processes.
What are the 10 principles of ISO 9001? ›- Customer Focus. ...
- Leadership. ...
- Involvement of People. ...
- Process Approach. ...
- System Approach to Management. ...
- Continual Improvement. ...
- Factual Approach to Decision-Making. ...
- Relationship Management.
ISO Procedures. The ISO standards were developed by the International Organization for Standardization (ISO) to help create best practices for public and private sector businesses. The ISO procedures can be found within the standard and are what a company must follow to comply.
What are the four required documented procedures in the ISO 9001 standard? ›Procedure for document and record control (clause 7.5) Sales procedure (clause 8.2) Procedure for design and development (clause 8.3) Procedure for production and service provision (clause 8.5)
What are the 7 principles of ISO 9001? ›- Engagement of people.
- Customer focus.
- Leadership.
- Process approach.
- Improvement.
- Evidence-based decision making.
- Relationship management.
Quality management standards are details of requirements, specifications, guidelines and characteristics that products, services and processes should consistently meet in order to ensure: their quality matches expectations. they are fit for purpose. they meet the needs of their users.
What is the ISO 9001 definition of quality? ›
The term "quality" has a relative meaning. This is expressed by the ISO definition: "The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs".
What is the main purpose of ISO 9001? ›ISO 9001 is a standard that sets out the requirements for a quality management system. It helps businesses and organizations to be more efficient and improve customer satisfaction.
What are the five important components focused in ISO 9001 documents? ›- Scope. The first three clauses of ISO 9001:2015 are scope, normative references and terms. ...
- Terms and Definitions. The terms and definitions section outlines the rudimentary vocabulary and definitions from ISO 9001:2015. ...
- Leadership. ...
- Planning. ...
- Enforcement.
Customer service reviews, questionnaires, surveys, inspections, and audits are a few examples of quality testing procedures that can be used in non-manufacturing businesses. A company can use any procedure or technique to ensure that the final product or service is safe, compliant, and meets consumer demands.
Why are quality procedures important? ›It's about safety, delivering on a promise and meeting the very basics of customer expectations. But, by meeting quality standards, companies often reap better profits and reduce losses. Those that exceed quality standards stand out above their competitors and further their potential for profit and consumer loyalty.
What are the 4 types of quality? ›There are four types of quality control: process control, acceptance sampling, control charts, and product quality control.
What is an ISO 9001 explain its purpose and the procedures in getting the certification? ›ISO 9001 is the world's most recognised Quality Management System (QMS) standard. It aims to help organisations meet the needs of their customers and other stakeholders more effectively. This is achieved by building a framework to ensure consistent quality in providing goods and/or services.
What are the 10 major clauses of ISO 9001:2015 quality management system? ›The core concepts of the new clause structure include management, customer, requirements, policy, procedure, planning, performance, objective, control, monitoring, measurement, auditing, decision making, corrective action, and nonconformity.
What are standards of procedures? ›A standard operating procedure is a set of written instructions that describes the step-by-step process that must be taken to properly perform a routine activity.
What is the difference between quality procedure and work instruction? ›Procedures outline the overall steps to finish tasks. Work instructions provide a detailed guideline for completing the tasks associated with each step.
What is the difference between a procedure and a process ISO? ›
Per ISO 9000:2005, a procedure is a “specified way to carry out an activity or a process,” a process is a “set of interrelated or interacting activities which transforms inputs into outputs,” and a system is a “set of interrelated or interacting elements”.
Why do we need quality procedures in the workplace? ›When employees follow procedures, they perform tasks correctly and provide consistent customer service. This enhances the quality of your organization's products and services. And, in turn, improves your company's reputation. Employees can know they are fulfilling their roles and take pride in their work.
What is ISO 9001 for dummies? ›What exactly is ISO 9001? ISO 9001 is a management system standard, which is voluntarily agreed on, and applied across the industry. This standard includes requirements for quality management. In order to implement ISO 9001, an organization should be able to meet customer requirements and enhance customer satisfaction.
Does ISO 9001 require a quality policy? ›ISO 9001:2008 requires top management to “establish” the quality policy (5.1), and to “ensure” that it is reviewed for continuing suitability. It requires top management to “establish, implement and maintain” a quality policy.
What are the benefits of ISO 9001 for employees? ›The Five Main Benefits of ISO 9001 for Employees Include:
Bring More Clarity to Your Processes. Reduce Inefficiencies and Improve Work-flow. Increase Employee Engagement. Improve Customer Experience.
Per ISO 9000:2005, a procedure is a “specified way to carry out an activity or a process,” a process is a “set of interrelated or interacting activities which transforms inputs into outputs,” and a system is a “set of interrelated or interacting elements”. Click here to learn more about ISO 9000.
What is the ISO definition of procedure? ›The ISO 9001: 2015 says that a Procedure is: “specified way to carry out an activity or a process”. When you have a process that must happen in a specific way, and you specify how it happens, you have a procedure. The procedure is mandatoryand is necessary to develop any Quality Management System.
What are the three types of procedures? ›- Transform procedures.
- Source procedures.
- Target procedures.
Broadly speaking, there are 4 distinct types of standards within our portfolio of 42,000 standards: product, service, process and management standards.
What is the difference between policy and procedure in ISO 9001? ›A policy puts your company's principles into a communicated document. A procedure helps you to build consistency. The primary difference between a policy and procedure is that policy focuses on a specific direction, while procedure focuses on the steps that are required to reach that direction.
What is the difference between process and procedure in ISO 9001? ›
A process is a series of actions or operations conducing to an end. It is a continuous operation or treatment, especially in manufacturing. A procedure is a particular way of accomplishing something. This is also defined as a series of steps in a regular definite order; a traditional or established way of doing things.
What are the 3 ISO standards? ›ISO 9001:2015, a standard for general organizational quality management systems (QMS), including vendor management. ISO comprises QMS standards for specific industries, too. ISO 27001:2013, a standard for Information Security Management Systems (ISMS) ISO 14001:2015, a standard for Environmental Management Systems.
What are ISO standards for quality management? ›ISO 9001 is the international Standard for Quality Management. It is part of the ISO 9000 family of Quality Management Standards and is used by over 1 million businesses today. It delivers a system of continual improvement that is driven by your customers' needs.
What is an example of an ISO standard? ›What Is an Example of an ISO Standard? Some examples of ISO standards include the calibration of thermometers, food safety regulations, and the manufacturing of wine glasses. ISO standards also cover shoe sizes, musical pitches, security management, and environmental management.