How Many Clauses Are In ISO 9001? (hint there are 10!)

How Many Clauses Are In ISO 9001?

ISO 9001 has 10 top-level clauses. Below those are 56 sub-clauses, defining over 300 individual requirements.

What Are The Ten ISO 9001 Clauses?

Scope
Normative References
Terms and Definitions
Context of the organization
Leadership
Planning
Support
Operation
Performance Evaluation
Improvement

The current 2015 revision of ISO 9001 contains ten headings or clauses, seven of which contain the 'mandatory' requirements (Clauses 4 to 10).

The first three clauses provide general information but are no less important.

1, 2 & 3 Scope, References, Terms and Definitions

1 Scope
2 Normative references
3 Terms and definitions

The first three clauses in ISO 9001:2015 are scope, references, and terms and definitions. These are informational clauses rather than clauses that outline actions or requirements, which we will discuss in later sections.

1 Scope Of The Standard

The scope of the standard highlights the two basic tenets of what quality management is intended to achieve.

The standard encourages businesses to implement processes and systems to ensure consistent product and service output while enhancing customer satisfaction through conformity and improvement.

2 Normative References

Normative references help readers better understand the terms used in ISO 9001:2015 by providing relatable comparisons to the vocabulary used in the ISO 9000:2015 standard.

3 Terms and Definitions

References for better understanding basic terms by highlighting vocabulary and definitions from ISO 9000:2015. Refer to ISO 9000:2015 Quality Management Systems Fundamentals and Vocabulary.

Other related and applicable standards that you could refer to might include, among others:

ISO 9004-2018 Quality management — Quality of an organization — Guidance to achieve sustained success
ISO 19011-2018 Guidelines for auditing management systems
ISO 10004-2018 Quality management — Customer satisfaction — Guidelines for monitoring and measuring

These were the informational clauses, rather than those that outline any actions or requirements. The following section will now focus on discussing the requirements in more detail.

4 Context of the Organization

4.1 Understanding Organizational Context
4.2 Understanding the needs and expectations of relevant stakeholders
4.3 Determining the scope of the management system
4.4 The quality management system and its processes

The fourth clause in ISO 9001 outlines the general requirements for the entire quality management system.

4.1 Understanding Organizational Context

Collate evidence to provide assurance that your organization is regularly, or as necessary, reviewing and updating information relating to its external and internal issues.

Although there is no requirement for documented information to define the context of the organization, your organization will find it helpful to retain the types of documented information listed below to help demonstrate compliance:

Business plans and strategy reviews
Competitor analysis
SWOT analysis for internal issues
PESTLE analysis for external issues
A list of external and internal quality issues and conditions
QMS action plans and objectives
Annual reports
Minutes of meetings (e.g., management review, design review minutes, etc.)
Process maps, tables, spreadsheets, and turtle diagrams, etc.

Reviewing your organization’s context should include interviews with senior management, questionnaires, surveys and research. Cross-functional input is essential for gaining the expertise to identify the full range of issues, such as finance, training, human resources, commercial, engineering and design, etc.

Learn more about 4.1 Context of the Organization.

4.2 Understanding the Needs and Expectations of Relevant Stakeholders

Similar to the context review discussed above, cross-functional input is vital, as certain functions will identify with particular stakeholders, such as procurement with suppliers and sales with customers.

We should encourage a workshop approach that can be undertaken independently or in conjunction with the context review workshop.

Once stakeholders and their requirements are identified, the next step is to consider which stakeholder requirements generate compliance obligations. Legal requirements should be determined before other requirements.

Adopting requirements will allow you to focus and coordinate on what’s important.

Learn more about 4.2 Understanding the Needs and Expectations of Relevant Stakeholders.

4.3 Determining the Scope of the Management System

You will need to verify that your organization’s scope exists as documented information (which may be contained in the quality manual) in accordance with Clause 7.5.1a.

Please verify that the organization’s scope has been established, considering its boundaries and the quality management system's applicability.

Look for confirmation that your organization has determined the boundaries and applicability of the quality management system to establish its scope concerning any external and internal issues referred to in 4.1 and the requirements of relevant interested parties referred to in 4.2.

The scope of your quality management system may include the whole organization, specific and identified functions within the organization, particular sections of the organization, or one or more functions across a group of organizations.

Learn more about 4.3 Scope.

4.4 The Quality Management System and its Processes

ISO 9001:2015 includes specific requirements for adopting processes when developing, implementing and improving a quality management system.

This requires your organization to systematically define and manage processes and their interactions to achieve the intended results in accordance with both the policy and strategic direction.

How well is the ‘process approach’ understood in the organization?
Is the quality management system in line with the organization’s context and the requirements of interested parties?
Is it likely the established quality management system will achieve its intended outcomes and enhance quality performance?
Does it include the enhancement of quality management system performance?
Does it include the desire to fulfill compliance obligations and objectives?

Existing operational procedures, work instructions and flow charts are valid examples of documented information and can be used to evidence the requirement for ‘documented information to support the operation of processes is being met’.

When an outsourced process is controlled through purchasing, there must be documented information to ensure that the processes are being controlled - using techniques like:

Auditing and inspections
Contractual agreements
Trend monitoring
Quality and commercial reviews
Process performance data review on an ongoing basis

Learn more about 4.4 Quality Management System and its Processes

5 Leadership

5.1 Demonstrating leadership and commitment, and customer focus
5.2 Establishing and communicating the quality policy
5.3 Establishing roles of authority and responsibility in the workplace

Management responsibility mainly concerns customer commitment requirements. This is the company’s commitment to serving the customer and building a more loyal following.

5.1 Demonstrating Leadership and Commitment

This section also establishes the company's general focus on the customer. In other words, the company pledges to always keep the customer happy and improve its products, services, and procedures accordingly.

You will not have a successful quality management system without solid management commitment. This is not a commitment in words; it is a continuous and active demonstration to everyone in the organization that meeting customers' expectations is vital.

The actions required of Top management include:

Supporting the quality management system and actively promoting the agenda
Encouraging the goal of meeting customer, regulatory and statutory requirements

Develop and support the quality management system by:

Defining and communicating the quality policy
Establishing organizational quality objectives
Ensuring appropriate resources are available

Implement and improve the quality management system by:

Encouraging employees to achieve requirements
Reviewing QMS performance
Ensuring resources are available to improve the QMS

Customer focus involves determining customer requirements and ensuring that processes exist to meet them and achieve customer satisfaction. Ensuring that customer requirements are identified and cascaded enhances customer satisfaction.

Learn more about 5.1 Leadership and Commitment

5.2 Establishing and Communicating the Quality Policy

Management responsibility also helps a company define a quality policy and objective guidelines and provides help with QMS planning as a whole.

ISO 9001:2015 requires an organization’s policies to be appropriate to both its purpose and context. This means that once your organization has determined its context and the relevant requirements of its interested parties, Top management must review the policies in light of that information.

ISO 9001:2015 also requires that the policies be maintained as documented information (refer to Clause 7.5.1a). You should check whether the policies have been established, communicated, and understood throughout your organization. The policies must also be available to any relevant interested parties.

A quick and convenient way to promote and communicate the policy might be to create a shortened version of the main policy; try condensing it to five keywords or even a couple of short sentences.

This can be posted on bulletin boards in each department. You could even add it to the reverse side of staff security passes or ID badges.

Learn more about 5.2 Quality Policy

5.3 Establishing Roles of Authority and Responsibility in the Workplace

The definition of authority and responsibility in the workplace is another vital aspect of ISO 9001.

To ensure successful implementation, operation, and maintenance, each employee needs to know who is responsible for the various elements of the quality management system.

You should develop and make available to all employees a list of personnel and their job descriptions, competence requirements, and responsibilities, along with an organizational chart of employees as they relate to the QMS.

Learn more about 5.3 Organizational Roles Responsibilities and Authorities

6 Planning

6.1 Actions to address risks and opportunities
6.2 Management system objectives and plans to achieve them
6.3 Planning for change/change management

Risks and opportunities flow directly from clauses 4.1 and 4.2. Determine, consider, and, where necessary, address any risks or opportunities that might impact the quality management system’s ability to deliver conformance.

Addressing the risks and opportunities will ensure the quality management system can achieve its planned objectives!

6.1 Actions to Address Risks and Opportunities

The risks and opportunities should be relevant to the context of your organization (Clause 4.1), as well as, any interested parties (Clause 4.2). You should ensure that your organization has applied this risk identification methodology consistently and effectively.

Understanding and managing the risks will enhance your organization’s ability to make better decisions, safeguard assets, provide products and services and achieve its mission and goals.

Although developing and implementing a formal risk management process is not a requirement, it is encouraged that the identification and management of risks and opportunities are formally undertaken and documented. Consequence and likelihood tables should be used with a risk level matrix.

Learn more about 6.1 Actions to Address Risk and Opportunities

6.2 Management System Objectives and Plans to Achieve Them

An effectively implemented quality management system aligns the policies with strategic and management system objectives and provides the framework to translate these objectives into functional targets and measures.

Establish and maintain documented quality objectives and indicators, at each relevant function and level within the organization. The objectives and indicators help establish an essential link between the quality policy and the management program.

The objectives and targets must be consistent with the quality policy. It is also important to ensure that the quality objectives and associated key performance indicators (KPIs) are mutually consistent.

It is important to ensure KPIs are meaningful to all key stakeholders including the customer(s), top management, supervisors and the staff who produce the products and services.

Properly designed and implemented, a management program should achieve the objectives and improve your organization’s performance. The management program must:

Address each objective and target
Designate personnel responsible for achieving targets at each function/level of the organization
Provide an action plan describing how each target will be achieved
Establish a time frame or a schedule for achieving each target

Establishing an action plan for each objective may require considerable effort from the personnel at relevant levels within your organization.

To ensure the progress of the action plan and a coordinated effort, a target leader should be selected for each target. This person will be responsible for ensuring that the target is achieved within the specified time frame.

Learn more about 6.2 Quality Objectives

6.3 Planning for Change/Change Management

Changes are intended to be beneficial but must be carried out when your organization determines they are relevant and achievable. In addition, newly introduced risks and opportunities should also be considered.

To achieve the benefits associated with changes, your organization should consider all types of change that may occur. These changes may be generated, for example by:

Processes and procedures
Documented information
Infrastructure
Tooling
Process equipment
Employee training
Supplier evaluation
Stakeholder management
Interested party requirements

Learn more about 6.3 Planning of Changes

7 Support

7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information

A business must have the proper resources for everyone involved. An organized and professional workplace is paramount to successfully implementing a quality management system.

7.1 Resources

Clause 7.1 has six sub-clauses, which include general (7.1.1), people (7.1.2), infrastructure (7.1.3), work environment (7.1.4), monitoring and measuring resources (7.1.5), and organizational knowledge (7.1.6).

Ensure that your organization has determined and provided the resources needed to establish, implement, maintain and continually improve the QMS. These resources will often include raw materials, infrastructure, finance, personnel and IT, all of which can be provided internally or externally.

Check that your organization has identified the resources and staff necessary to implement the QMS effectively and operate and control its processes.

Most organizations determine resource requirements during management review meetings; you should review the management review minutes for evidence of resource allocation.

Provide and maintain the infrastructure necessary to achieve product conformance:

Buildings and workspaces
Tools and process equipment, e.g., hardware or software
Supporting services, e.g., transport, I.T. and communication

Ensure that documented information is maintained to demonstrate the suitability of monitoring and measuring equipment. While this is not required, all equipment requiring calibration must be identified.

Sources of internal knowledge often include the organization’s intellectual property, knowledge gained from experience, lessons learned from failures and successes, capturing and sharing undocumented expertise and understanding, and the results of improvements in processes, products and services.

External knowledge sources often include other ISO standards, research papers, conferences, or knowledge gathered from customers or external parties.

Learn more about 7.1 Resources

7.2 Competence

Identifying employee training needs is typically the first step in developing a competency-based training program. In addition to existing workers, new hires, temporary workers, and outside contractors must be included when identifying training needs.

After developing a list of these employees, the management representative or human resources manager should establish the appropriate training program for each person based on the type of employee interaction with each significant impact, hazard or risk.

Even though some personnel may have the same job, the type or level of training may vary according to each person’s past education, training, and experience.

Training options may include on-the-job training administered by senior/experienced members, formal training, including classroom instruction, or training provided by external consultants. In some situations, commercially available training courses may be another alternative.

7.3 Awareness

The awareness training does not need to follow the format of classroom sessions; techniques can include short training segments supplemented with videos and hands-on demonstrations that address critical elements of the QMS.

Other methods of promoting and reinforcing the quality awareness training sessions include communication via electronic bulletin boards, posters, newsletters and informational meetings.

Awareness training will provide an overview of your organization’s policy, objectives and targets, and overall QMS.

In addition to briefing employees during introductory presentations, try using other methods to promote awareness, such as posters placed on notice boards, leaflets with pay slips, etc. Use training sessions to inform employees of the plan and how they will be expected to contribute.

7.4 Communication

Communications may relate to your organization’s ongoing compliance with various obligations, milestone achievements, or sustainable resourcing.

Communication is the key. Communicate goals, plans, progress and milestones. Listen first, then ask for feedback. Lack of communication seems to be one of the leading root causes of business errors.

Keep people informed of the project's progress, e.g., what’s been done, what’s to be done next and how the project is progressing against the plan.

Internally, your organization needs to communicate information relevant to the QMS amongst all levels and functions, including information on any change, and establish a mechanism to enable all persons performing work under the organization’s control to contribute to continual improvement.

7.5 Documented Information

A robust document control process invariably lies at the heart of any compliant management system; scrutinizing documented information determines almost every aspect of auditing and compliance verification.

With this in mind, it becomes apparent that the ongoing maintenance of an efficient document management system must not be overlooked!

Departmental managers should always be responsible for promoting good, documented information practices in their area while supporting overall compliance with the requirements.

Individuals and their line managers should be responsible for the information they create and for its retention and disposal in accordance with legislative requirements and organizational needs.

The terms ‘documented procedure’ and ‘record’ used in ISO 9001:2015 have been replaced by ‘documented information, ' defined as information required to be controlled and maintained by an organization and the medium on which it is contained.

Operational procedures, work instructions, flow charts, process maps, signs, placards, container markings, labels etc., are all examples of ‘documented information.’ Documented information can be in any format, media, or source.

Organizations should determine the level of documented information necessary to control their QMS. ‘Access can imply a decision regarding permission to view the documented information only or the consent and authority to view and change the documented information.

Learn more about 7.5 Documented Information

8 Operation

8.1 Operational planning and control
8.2 Determining requirements for products
8.3 Design and development of products and services
8.4 Control of external processes, such as suppliers and contractors
8.5 Production and service provision
8.6 Release of products and services
8.7 Nonconforming products or services

Clause 8 is comparable to the requirements from ISO 9001:2008 Clause 7.1 – Product Realization Planning. However, it has been extended to include implementation and control, planning, evidence of controls, acceptance criteria and resources to address risks and opportunities.

8.1 Operational Planning and Control

For those risks and opportunities your organization has identified, you should seek evidence that these actions have been integrated into the quality management system.

These actions should be verifiable at the process level – for example, evidence of controls, acceptance criteria and resources to address the risks and opportunities; this clause links to the following clauses: 4.4, 6 and 8.4.

8.2 Determining Requirements For Products

Meeting customers' identified needs is a key objective. Establish adequate arrangements for providing the customer with product information, handling inquiries and orders, and handling customer comments, including compliments and complaints. As such, this clause links to the following clauses: 5.1, 7.4 and 8.4.

Establish processes for communicating with your customers:

Develop a process to control communications with customers
Implement your customer communications process
Communicate with your customers
Maintain records

Identification of any applicable statutory and regulatory requirements regarding the products and services offered is crucial.

The sub-clause mandates that your organization should not issue a quotation or accept an order until it has been reviewed to ensure that requirements are defined and the organization can meet them.

It requires that records of the review and any subsequent actions be maintained.

Where changes in requirements occur, ensure that all relevant documented information relating to the changed product or service requirements is amended and those relevant personnel are made aware of the changed requirements.

If the customer’s requirements change, all related documents must be amended, and the relevant personnel must be informed.

Learn more about 8.2 What are the Requirements for Products and Services

8.3 Design and Development of Products and Services

This clause focuses on developing, implementing and maintaining a design and development process appropriate to the requirements for providing products and services.

Many companies enhance or minor reconfigure existing, mature designs; such organizations may have to introduce a comprehensive design system and related processes.

Design plans must specify the design and development stages, activities and tasks, responsibilities, timeline and resources, specific tests, validations and reviews, and outcomes.

You should also ensure that your organization has retained documented information to confirm the identified design and development requirements were met and that design reviews were undertaken.

Define which inputs are required to carry out the design and development process. The inputs should be determined according to the design and development activities, such as which employees are required or what information is required for every step of the development.

The verification could consist of calculations, simulations, prototype evaluation, tests or comparison against samples.

You must maintain records of design verification as these records will indicate the results of verifications and determine any necessary corrective actions.

Validation is similar to verification, except you should check the designed product under actual use conditions.

The design and development output results from the design and development process. It is a clear description of the product containing detailed information for production. Design and development outputs must be reconciled with design and development inputs.

Controlling design changes throughout the design and development process is equally important. It should be clear how these changes are handled and what their effects are on the product.

Ensure control over design and development changes; design changes must be identified, recorded, reviewed, verified, validated, and approved.

Learn more about 8.3 Design and Development of Products and Services

8.4 Control of External Processes, Suppliers and Contractors

organizations need to identify which materials and services they buy can affect the quality of their products. Then, they must establish criteria for selecting suppliers that can provide these materials and services.

A purchased product is any product procured by an organization from another source incorporated or used in producing the final product. Note that products need not be procured from an 'independent source'; sometimes, sister companies supply each other and are not independent.

You could consider dividing your suppliers into groups based on the product or service they provide and its effect on the quality of your products or processes, e.g., level I/II/III/etc.

You can define the supplier evaluation and approval criteria based on those categories. You are free to define your supplier levels and approval parameters accordingly, but whatever rationale is chosen, it should be properly documented.

There is no ‘right way’ for vetting suppliers. To meet the intent of the clause, you need to establish a process with properly documented criteria based on customer requirements. ISO 9001 requires that the purchasing documentation contain the correct information before issuing it to a supplier.

Learn more about 8.4 Control of Externally Provided Processes, Products and Services

8.5 Production and Service Provision

You should seek and record evidence that your organization has controlled the conditions by which products or services are provided, for example, by ensuring that monitoring and measurement take place at appropriate points in the production process to ensure that both the processes themselves and the process outputs meet the organization’s acceptance criteria.

There are several ways of identifying products. The most obvious is using tags or stickers with part numbers, bar codes, job numbers, etc. The identification may be engraved in the product itself, or a color may mark the product.

Where traceability is a requirement, you should expect to see that your organization controls and records the product's unique identification.

Check that your organization communicates with its customers regarding handling and treating their property. You should also check that contingency plans and, where relevant, actions are undertaken when non-conformities occur with customer property.

Preserve the product during internal processing and delivery to the intended destination. Preservation, packaging, and other product-specific handling methods will likely be outputs of the product design process.

Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

Organizations must make changes thoughtfully and consider the potential impact on other processes, products and possibly the customer.

Responding to unplanned changes is essential to ensure that products or services meet their specified requirements and maintain conformity with requirements.

Learn more about 8.5 Product and Service Provision

8.6 Release of Products and Services

The release of a product or delivery of a service must not be completed until the planned requirements have been met. According to product planning and the verification stages, the product's release' may include release to the next operation, release to an internal customer, release to the final customer, etc.

8.7 Nonconforming Products or Services

Every once in a while, a company produces a product or service that does not meet the standard protocol defined by the ISO 9001:2015 standard. This is also known as a non-conforming product/service or a non-conformity.

If you have manufactured a product, inspected it and found it out of specification, it is most likely deemed nonconforming. In some instances, you will have to scrap the defective product, but in other situations, you may be able to do some remedial work and bring it back into specification.

Capture data on nonconformities and feedback information at the appropriate management level to effectively define and implement corrective actions.

Learn more about 8.7 Control of Nonconforming Outputs

9 Performance Evaluation

9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal auditing
9.3 Management review

The measurement, analysis, and improvement clause allows the company personnel to step back after executing their product or service and see how the customer has reacted to these positive changes.

9.1 Monitoring, Measurement, Analysis and Evaluation

Monitoring and measuring QMS operations and activities will establish a mechanism to ensure your organization meets its policies, objectives and targets. To meet this requirement, your organization must perform six steps:

Identify the activities that can have a significant risk
Determine critical characteristics of the activity to be monitored
Select the best way to measure the key characteristics
Record data on performance, controls and conformance with objectives and targets
Determine the frequency with which to measure the key characteristics
Establish management review and reporting

Establish the monitoring and tracking criteria for each activity with a significant risk and review the action plan. You should incorporate any monitoring and measurement information to cover these same activities.

Implemented a consistent and systematic approach to customer feedback and obtained information on customer perception. Collecting data on customer perceptions is insufficient; you should seek and record evidence that your organization has analyzed and evaluated customer data and that conclusions have been made regarding the effectiveness of the QMS.

Are there any trends?
Is the situation stable, improving, or deteriorating?
Are customer needs and expectations changing?

Ensure there are defined responsibilities for logging and tracking customer complaints, clearing issues, determining the root causes of problems, and taking action to address them.

Analyze and evaluate data from both internal and external sources such as quality records, monitoring and measuring results, process performance results, objectives, internal audit findings, customer surveys and feedback, 2nd or 3rd-party audit results, competitor and benchmarking information, product test results, complaints, supplier performance information, etc.

Learn more about 9.1 Monitoring Measuring & Analysis

9.2 Internal Auditing

These sub-clauses provide a clear framework for planning and conducting internal audits. The internal audit process is a primary tool to ensure the QMS operates effectively.

During the early stages of implementing ISO 9001:2015 or any other management system standard, the internal audit program often focuses on ensuring compliance issues or non-conformities are discovered and rectified before the Certification Body assessment. However, once your organization becomes certified, the audit program must evolve.

The internal audit program's focus should be redirected away from 'elemental' compliance with ISO 9001:2015 to an audit strategy that considers the 'status and importance' of each process comprising the quality management system.

If your current internal audit program has been developed on an annual calendar that merely forecasts which aspects of your quality management system will be audited, you should stop!

Begin programming your internal audits by basing the audit frequency on current process performance data, customer feedback, etc.

Learn more about 9.2 Internal Auditing

9.3 Management Review

Performance metrics should be monitored with varying frequencies: hourly, daily, weekly, and monthly. Management cannot wait six months to respond; it will be too late if they do.

Every time management convenes to review and react to performance, it is considered a management review. Whether they are reviewing an individual's performance, departmental programs and projects, etc., this should be regarded as a valid management review.

Some companies have multiple review levels, whereby each review may require multiple subjects and rely upon various metrics as inputs. Sometimes, subjects are reviewed at more than one level. For example, production teams might review production numbers during daily production meetings and then by senior management, possibly weekly.

Top management might conduct monthly or quarterly meetings to review performance, and other metrics against objectives to determine if corrective action is required.

Management review meeting minutes should be retained as documented information. The process owner is responsible for reporting close-out progress in the meeting.

Learn more about 9.3 Management Review

10 Improvement

10.1 Improvement
10.2 Nonconformity and corrective action
10.3 Continual improvement

The final clause in the ISO 9001:2015 standard focuses on improving the company and its products and services. While it is true that you can go through the entire ISO certification process to get the final stamp of approval from the organization, you won’t be able to keep it for long if you ignore the guidelines in this clause.

10.1 Improvement

Improvement often does not occur on a ‘continual’ basis. Sometimes, it can be affected reactively through corrective actions, incrementally over time.

Look for objective evidence that improvement is taking place. While improvement does not need to be continuous, it does need to be evidenced as occurring.

10.2 Nonconformity and Corrective Action

Your organization must take whatever action is necessary to control and correct the nonconformity and deal with any resulting impact by determining what caused it and considering whether the potential for a similar problem remains.

This is done by considering whether further action is required to prevent a similar nonconformity from arising at the same place or somewhere else at some point in the future and determining if similar non-conformities have occurred elsewhere and, consequently, whether it needs to take similar corrective action.

Taking appropriate action to address the effects of the problem may require a simple correction by the process owner or operator where it was discovered. If a major failure or defect exists, more significant resources would be needed for problem-solving and corrective action.

Learn more about 10.2 Corrective Action

10.3 Continual Improvement

Determine whether your organization identifies improvement opportunities and QMS underperformance using the data output from its processes, such as analysis and evaluation, internal auditing, management review, and the use of appropriate tools and methodologies to support validated findings.

Improving your business will include assessing everything, deciding how to improve it, and implementing those positive changes. This does not necessarily mean your actions are wrong; it is only that you want to improve daily.

The PDCA cycle is a perfect way of introducing continual improvement to your organization’s activities. Each step to improvement can be defined by four sub-steps: Plan, Do, Check and Act:

Plan: Establish a timetable for internal audits and management reviews. Establish the objectives and processes necessary to deliver results according to your customer’s requirements and your organization’s policies.
Do: Implement changes designed to solve the problems on a small scale first to see the effect. This minimizes disruption to routine activity while testing whether the changes will work or not.
Check: Monitor and measure processes and products against policies, objectives and requirements and report the results. Key activities should also be checked to ensure that the quality of the output conforms and is not influenced by changes.
Act: Take actions to improve process performance continually. If the experimental changes have proven successful, implement them on a larger scale. This means making the changes a routine part of the activity.

Learn more about 10.3 Continual Improvement

Are The ISO 9001 Clauses Also Requirements?

So, now that you have read through all ten ISO 9001 clauses and a brief explanation of what each one entails, you might be wondering if the clauses are also requirements?

If you know anything about ISO 9001, you probably understand how specific it can get.

Learn more about the ISO 9001 requirements - documents and records.