Tags Posts tagged with "QMS"

QMS

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ISO Terms Explained - ISOUpdate.com

To the novice quality manager, ISO jargon can be extremely overwhelming. What is an NCR? What do you mean by OFI? Are we certified or accredited? But before you go and pull out your hair, let’s take a moment to go over some of the most frequently used terms and their definitions with regards to ISO and Management System Certification.

Are you Accredited, Certified or Registered to an ISO Standard?

First things first. You are not certified to an ISO Standard, your company’s management system is certified. Individuals cannot be certified to an ISO Standard. However, individuals can receive training to become auditors to audit companies against an ISO Standard. For example, you may seek training and personnel certification to become an ISO 27001 Lead Auditor. You cannot be certified to ISO 27001.

The terms ‘’accreditation’’ “registration” and ‘’certification’’ are sometimes used interchangeably, but they don’t share the same meanings, technically.

CERTIFICATION:

An organization is considered certified to an ISO Standard if they have developed and maintained a compliant management system that has been audited by a third-party auditor from an accredited Certification Body (CB). To maintain certification, the organization will undergo annual audits from the CB to verify continuing compliance to the specific standard. A certification document or a certificate will be issued as an attestation of conformity of an organization’s management system to a specific management system standard or other normative requirements. Certification can be revoked if regular audits are not conducted, or if your management system persistently or seriously fails to meet certification requirements.

ACCREDITATION:

Accreditation is how an authoritative body provides formal recognition that an organization is competent to carry out specific tasks. Accreditation Bodies (AB) accredit Certification Bodies (CB) that demonstrate competence to audit and certify organizations conforming with management system standards. The accreditation process ensures impartiality and competence and fosters confidence and acceptance of the CB’s certifications by public and private sector end users. Accreditation provides assurance to customers that CB’s operate according to internationally accepted criteria.

REGISTRATION:

Registration is another term for Certification. The terms Registration and Registrar are not used much anymore in this industry and Certification is now the preferred term.

Audits, Auditing & Auditors

Auditing:

Auditing is the systematic process of collecting and evaluating information about an organization’s management system to determine their level of compliance with the standard they are being audited against.

Types of Auditors

Consultants:

Management system consultants provide organizations with specific advice, instructions or solutions towards the development, implementation, and maintenance of a management system. They may also prepare or produce manuals or procedures for the management system.

Internal Auditors:

An internal auditor is a company employee who independently and objectively evaluates the operations of an organization’s management system. Internal auditors perform internal assessments of the organization and prepare reports for management.

Note: Internal audits are required by ISO management system standards but cannot be used to grant certification to an organization.

Third-Party or External Auditors:

Individual(s) who conducts the audit(s) on behalf of the certification body. Unlike a consultant or internal auditor, third-party auditors are impartial. Their job is to collect and evaluate objective evidence to determine if the management system complies with the ISO Standard. Based on these findings, the CB will make a recommendation for certification.

Certification Body:

A Certification Body (CB) is an accredited third-party organization that audits and issues certificates to companies seeking certification to various ISO Standards. CB’s obtain accreditation to be able to certify to a specific ISO Standard(s). CB’s are audited by Accreditation Bodies (AB) to ensure impartiality and conformity of their work and processes.

Accreditation Body:

An Accreditation Body (AB) is an organization that provides accreditation services. AB’s provide formal, third party recognition that a Certification Body is competent to issue certification to specific ISO Standards.

The ISO Lingo – Commonly Used Term & Definitions:

The following Terms & Definitions are from ISO/IEC 17021-1

Certified Client

organization whose management system has been certified

Impartiality

presence of objectivity ; freedom from conflict of interest / bias

Note 1 to entry: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the certification body.

Client

organization whose management system is being audited for certification purposes

Auditor

person who conducts an audit

Competence

ability to apply knowledge and skills to achieve intended results

Guide

person appointed by the client to assist the audit team

Observer

person who accompanies the audit team but does not audit

Technical Area

area characterized by commonalities of processes relevant to a specific type of management system and

its intended results.

Note: The term “technical area” is applied differently depending on the management system standard being considered. For any management system, the term is related to products, processes and services in the context of the scope of the management system standard. The technical area can be defined by a specific certification scheme or can be determined by the certification body. It is used to cover a number of other terms such as “scopes”, “categories”, “sectors”, etc., which are traditionally used in different management system disciplines.

Nonconformity (NCR)

non-fulfilment of a requirement

Major Nonconformity (Major NCR)

a nonconformity that affects the capability of the management system to achieve the intended results.

Note: Nonconformities could be classified as major in the following circumstances:

  • if there is a significant doubt that effective process control is in place, or that products or services will meet specified requirements;
  • a number of minor nonconformities associated with the same requirement or issue could demonstrate a systemic failure and thus constitute a major nonconformity.

Minor Nonconformity (Minor NCR)

a nonconformity that does not affect the capability of the management system to achieve the intended results.

Technical Expert

person who provides specific knowledge or expertise to the audit team. Specific knowledge or expertise is that which relates to the organization, the process or activity to be audited.

Certification Scheme

conformity assessment system related to management systems to which the same specified requirements, specific rules and procedures apply

Audit Time

time needed to plan and accomplish a complete and effective audit of the client organization’s management system

Duration of management system certification audits (Audit Duration)

part of audit time spent conducting audit activities from the opening meeting to the closing meeting, inclusive.

Audit activities normally include:

  • conducting the opening meeting;
  • performing document review while conducting the audit;
  • communicating during the audit;
  • assigning roles and responsibilities of guides and observers;
  • collecting and verifying information;
  • generating audit findings;
  • preparing audit conclusions;
  • conducting the closing meeting.

Opportunity for Improvement (OFI)

Situations where the evidence presented indicates a requirement has been effectively implemented, but based on auditor experience and knowledge, additional effectiveness or robustness might be possible with a modified approach.

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ISO-Right-For-You

Product, Place, Price, Promotion. AKA, The Marketing Mix. This tool developed by J. McCarthy is a business basic model “used to pursue its marketing objectives in the target market”.

The Marketing Mix is one tool that can help you as an organization understand how to promote yourself and your product in a way that makes sense for your customer and their needs.

One thing you may learn during your analysis is your customers’ need for quality for example, or perhaps they care deeply about the environment and spending their dollars with environmentally conscious companies.

Researching your customer and their purchasing decisions can lead you to a new growth avenue – but can you achieve these?

In this article, you will learn how the adoption of standards, like ISO 9001, ISO 14001 or ISO 45001 can not only help your organization and its longevity, but it can also show your commitment to your customers through certification.

Why ISO Standards?

Part of ISO Guidelines is a framework for successguiding requirements that have been created by industry professionals and evaluated by a committee. They have been approved as an internationally adopted and recognized framework to build a business upon.

For example, if you work in the Aerospace industry, you have a different framework than those in the Automotive industry because you have different unique challenges.

The generic quality framework, ISO 9001:2015, was designed as a foundation for success with generic business principles and frameworks to allow organizations to create or improve an organization at its most basic roots to ensure efficiency and quality of work.

Implementing ISO 9001 into your business allows you to take time to look deep into the organization, and evaluate what you do great, what you do well, and what needs improvement.

Standards are not only a great foundation to grow a business upon though. These guiding requirements allow you to look within your organization, find your strength and allow them to shine and identify possible areas for improvement, places that need help to grow to their full potential.

The nature of ISO Standards audit processes allows unbiased reviews to truly see the organization without judgement. This is a great marketing opportunity to showcase your strengths.

Promote your certificate, your congratulatory statements from auditors, and what you are proud of.

Part of ISO 9001 is also measuring and monitoring. If you are interested in learning about how much productivity has gone up each quarter, or the number of sales per year, you are encouraged to do so in ISO 9001.

This is a great opportunity to learn real facts about your organization, in an effective manner, that you can then share with your customers. These are real, tangible numbers than can really impress prospective clients.

If you are looking to attract new people to your organization, you might want to look into obtaining ISO 14001:2015 certification. “Of those born between 1981 and 1996, 62% want to work for a company that makes a positive impact”. 

Companies with an active interest in sustainable practices, and the certification to prove that, can gain a lot of edge in the competitive hiring market place. Not only that but showcasing your commitment to sustainability and quality of goods and workplace safety with certification to ISO 45001, the standard for occupation health & safety, can prove to prospective hires how committed to their wellbeing you are.

Standards help you as an organization navigate best practises while allowing you to thrive as a unique organization and culture.

ISO Certification does not ask you to subscribe to a one size fits all approach to business. But it does show you how to eliminate inefficiencies and set you on a path for growth and longevity with a base set of tools for success.

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ISO 9001 as a Strategic Planning Model - ISO Update

Written by Kashif Mumtaz

Regardless of the other terms used in ISO 9001:2015, the term, Strategic Direction has not been defined in ISO 9000:2015 Quality Management Systems – Fundamentals and Vocabulary. However, ISO 9001:2015 contains the following strong linkages to the strategic direction of the organization:

  • Clause 4.1 – External and internal issues must be relevant to the Strategic Direction of the organization.
  • Clause 5.1 – The Quality Policy and Quality Objectives must be compatible with the Strategic Direction of the organization.
  • Clause 5.2 – The Quality Policy must support the Strategic Direction of the organization.
  • Clause 9.3 – Management Review Process must ensure the suitability, adequacy effectiveness and alignment of the Quality Management System with the Strategic Direction of the organization.

Strategic Direction as we believe is the organization vision of where the organization wants to be in the future and the development of an overall Strategic Plan is affected by various internal and external factors. Refer to the clause 4.0 of ISO 9001:2015 Context of the Organization which states that the organization shall determine external and internal issues relevant to its purpose and its strategic direction and those affect its ability to achieve the intended results of its Quality Management System. ISO 9001:2015 further elaborates in Notes (1 – 3) of the clause 4.1 that issues can include positive and negative factors or conditions for consideration – Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and international, national or regional economic environments. Understanding of the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.

The strategic planning process is a continual process and if we look at the traditional strategic planning process, it very much resembles with the Plan-Do-Check-Act (PDCA) Cycle of which ISO 9001:2015 is a big promoter to apply this cycle to all organizational processes and the Quality Management System as a whole to implement plans to achieve objectives including strategic.  In addition, various functions within the organization having their own strategies can closely be aligned and integrated within the Context of the Organization which is basically overall strategic plan of the organization highlighting all internal and external factors with their resulting impact on the organization along with the approaches to managing risk(s) at the functional and company-wide levels for the achievement of larger mission of the organization.

Having said that, we can say that framework provided by ISO 9001:2015 can be used by the organizations for strategic planning but when the management rejects QMS as strategic planning model and make intuitive decisions then ISO 9001:2015 cannot address or contribute in the overall strategic planning process.

About the Author

Kashif Mumtaz is serving as QA Manager at Omrania in Riyadh, Saudi Arabia and has more than 17 years’ experience in quality assurance & management systems. He is Chartered Quality Professional (CQP) and holds a master’s degree in Quality Management from UK

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Quality

Have you ever stood staring at a range of products in a supermarket trying to make up your mind which one to buy?  They all look quite similar, but one stands out and you buy it.  Why?  It’s got a sign on the shelf and a logo on the product to tell you that it’s won an award for quality.

So you’ve just based your purchase on Quality – Your customers are making the same decision every day!

Quality is more than just finished product, it’s the processes, systems and people that are behind the product.   Quality is everybody’s responsibility.



Quality is the pursuit of excellence, striving to be the best we can and getting ahead of our competitors.  It is meeting the needs and expectations of all stakeholders – our customers, our suppliers, our staff and the community at large.

How can we ensure that we are exploiting all avenues to be the very best?  A recognized standard such as ISO 9001 certification promotes the use of quality tools in business.   The ASQ (American society for quality) estimates that for every €1 spent on a quality management system, such as ISO 9001, returns €6 in revenue, €16 in cost reduction and €3 in profit – that’s €25 for every €1 spent!

93% of organisations agree that the implementation of a quality management system such as ISO9001 was a significant driver of success and most would agree that without it they could not justify their pricing to customers.

If you are looking at ways to improve your ROI by improving your quality then consider ISO certification.   Using an expert to help you implement a quality management system will ensure ISO 9001:2015 accreditation which will in turn help you make significant improvements and lead to significant growth.

 

This post has been a guest posting from Joann O’Brian over at our friends at CG Business Consulting Ireland .



ISO 9001:2015 represents a major change to the 9001:2008 version. One of these changes regards the Quality Management Systems (QMS) documentation.

The 2008 version of the standard, uses two separate terms “documents” and “records” to identify its documentation, whereas, in the recently published Draft International Standard of the new revision, both these terms are combined as “documented information”.



For those familiar with the 2008 version, it can be said that where it refers to “documented procedures” in the new revision it is expressed as a requirement to maintain documented information. Also, where the 2008 version refers to as “records” it is now expressed as a requirement to retain documented information. Below, there’s a list of the documented information that the new standard requires to be maintained and retained.

Documented information that is required to be maintained with ISO 9001:2015

  • The scope of the QMS, including the products and services it covers and the justification of those requirements that the QMS will not be able to apply.
  • Information that supports the operations of processes.
  • The quality policy.
  • Information that defines characteristics of products and services, activities to be performed, and the results to be achieved.

Documented information that is required to be retained with ISO 9001:2015

  • Information necessary to have confidence that processes are being performed as planned and conform to requirements.
  • Information on the quality objectives.
  • Information as evidence of fitness for purpose of monitoring and measurement resources.
  • Information as evidence of competence.
  • Information describing the results of the review of requirements related to products and services.
  • Information resulting from the design and development process.
  • Information on review of design and development changes.
  • Information of the results of the evaluation, monitoring of performance and re-evaluation of the external providers.
  • Information necessary to maintain traceability when required.
  • Information describing the results of the review of changes, personnel authorizing the change, and any necessary actions
  • Information providing traceability to the person(s) authorizing release of products and services for delivery to the customer.
  • Information on actions taken on nonconforming process outputs, products and services.
  • Results of monitoring and measurement activities.
  • Information as evidence of the implementation of the audit programme and the audit results
  • Information as evidence of the results of management reviews.
  • Information as evidence of the nature of the nonconformities, actions taken, and the results of any corrective action.

As it can be seen from the above list, in the new version of the standard, it will not be required to create and maintain a Quality Manual, which has been around since the creation of ISO 9001 in 1987.



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ISO 20000

To meet and improve customer satisfaction, it’s essential to monitor and measure performance by using different indicators. Performance indicators for ISO 9001:2015 are tools used for determining how and to what degree an organization is meeting guidelines, policies, objectives, requirements and targets set in their ISO 9001 QMS.

Note: These performance indicators are set by the organization and they vary from one organization to another. The team at The Registrar Company (TRC) created this list as a tool for organizations to learn from and decide which performance indicators are most suitable to the nature of their industry sector and their objectives.

What should be considered is that these indicators must be measurable and achievable. They must refer to the system’s critical processes, they must accurately represent the target to be measured, and they should be quantifiable, cost-effective, reliable and allow management to review the information in real time.

Cost Indicators

Cost indicators are performance indicators that evaluate the activities that consume economic resources in different processes. For example, the spend on energy consumption or other overhead costs, the percentage return on investments, or the percentage costs of carrying out corrections for errors are all cost indicators. 

Time Indicators

Time performance indicators measure the time consumed by an activity or process and consider the time from the beginning to the end of the selected process or activity.

For example:

  • Percentage number of products or services delivered on time.
  • Percentage number of products or services delivered late.

Productivity Indicators

Productivity performance indicators measure the efficiency of resources in the operation. For example, the percentage of downtown a particular machine or process experiences.

Quality Indicators

Quality performance indicators measure the effectiveness of the development of activities or processes, delivering results based on the number of errors, or the number of perfect and flawless deliveries.

For example:

  • Percentage number of products or services needing rework.
  • Percentage of customers ‘very satisfied’.

Summary

Remember, performance indicators are set by the organization and they vary from one organization to another, and while these indicators may vary, they should serve as a tool for improving the quality of decisions regarding the processes, and the ISO 9001 QMS itself.

The Registrar CompanyLooking to expand your knowledge base? The Registrar Company, TRC, has designed over 500 courses and trained over 10,000 individuals since 1990. Our approach is based on current adult learning principles and uses proven, highly interactive participatory sessions and practical techniques that offer real behavioural change that can be implemented and applied immediately in the workplace. Learn more about training with TRC.


Learn about Performance Indicators in ISO 14001

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Top 10 Mistakes Made in Managing an ISO 9001 System - ISOUpdate.com

Here are some of the most common mistakes made by organizations when managing an ISO 9001 system:

Mistake 1. Top management is not committed to the ISO 9001 system.  If top management is not involved in quality, if they don’t provide the resources and mechanism to plan, control and improve their products, services and processes, ISO 9001 can not be sustained over time. It’s essential for top management to take decisions that demonstrate that quality, improvement and customer satisfaction are an important issue.



Mistake 2. Not training key personnel in ISO 9001. Not knowing what ISO 9001 is all about can be a big mistake. It is important for organizations to train key personnel (someone who has a decision-making role) in ISO 9001, in order to understand what ISO 9001 really is and what it requires. Not knowing nor understanding ISO 9001 can take organizations through a path of disappointment and despair.

Mistake 3. Not training all personnel. Everyone must receive training on the important quality aspects of the activities and processes they work in. Everyone must understand the importance of quality and how they can achieve it. The training must be consonant with their responsibilities and the activities they perform.

Mistake 4. Making the system complex. If the organization is working to keep the system alive, it is a sign that it is too complex and all the work of filling out forms and documenting procedures is not adding value to the organization. The system must be kept simple and practical, and it should focus on results and improvements, and not on documents.

Mistake 5. Not using the corrective action process properly. Organizations need to take the time to investigate their problems and involve the right people in the investigation process. Most problems are recurrent, so using the corrective action process correctly will reduce or eliminate their recurrence.

Mistake 6. Not knowing what customers want. One of the objectives of ISO 9001 is to improve or increase customer satisfaction, and if organizations do not take the time to listen to their customers, they will not be able to reach this goal. A long and complicated survey is not necessary nor recommended, just by asking a few key questions will give organizations enough information to determine and plan for changes that will aim to fulfill this goal.

Mistake 7. Rushing into the implementation process. To build a solid ISO 9001 management system takes work and time.Trying to implement the system in a short time will be counterproductive. Organizations need to take the necessary time to plan, do, check and act in order to implement a system that will improve their products, services and processes.

Mistake 8. Not having a trained and experienced internal auditor. In many cases, internal auditors lack the necessary training and experience to distinguish small details from big issues in the QMS. Auditors need to focus on the issues that will help organizations improve their processes and the system itself.

Mistake 9. Believing that what works for one organization will work for their own. Every organization is different and what may work for one, may not work for another. Organizations need to focus on their specific context in order to build and develop their management system around it.

Mistake 10. Leaving the responsibility of the QMS to one person. ISO 9001 needs to be the work of an entire organization. If people do not take ownership of the QMS, it will not work out. People need to incorporate quality in their work and activities and an outsider will not achieve that. Guidance and training is needed, but if quality is not done on a daily basis in every process then the system will never add value to the organization.



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How to Prepare for a Successful ISO 9001:2015 Audit - ISOUpdate.com

No matter how many audits someone has gone through, knowing that someone will be auditing your work always generates some tension and anxiety. Here are some recommendations from The Registrar Company, a North American Certification Body with over 20 years of auditing experience, to help your organization prepare for a successful ISO 9001:2015 audit.

Prepare Employees

  • Quality Policy – Review the quality policy, refresh it if needed, and make sure everyone understands it. There is no need for workers to memorize the policy, but they should have a clear understanding of what the organization has committed to in terms of quality.
  • Quality Objectives – Workers should know what the organization’s quality objectives are and how they themselves contribute to achieving them. Employees should know and be able to explain how their day to day activities can influence these objectives.
  • Training – Ensure that everyone has been properly trained to perform their tasks.
  • Documented Information – Make sure everyone knows where to find current copies of procedures, work instructions, and forms that are relevant to their position.
  • Audit Schedule – Let everyone know the scope of the audit, when they will be audited, and what the auditor may be checking in their areas.
  • Interviews – Workers should have the confidence to answer what they know, and have the same confidence to say ‘’I don’t know” when they are not sure how to respond during an audit.

Review Documented Information

  • Make sure document and record listings are up-to-date.
  • Check that all documents have been reviewed, approved, communicated, and followed by everyone involved in the process or activity.
  • Ensure obsolete documents have been removed from circulation and are no longer in use.
  • Verify that all records are being used correctly.

Ensure all Processes are Being Performed Correctly

  • Make sure that all procedures (whether they are documented or not) are being followed.
  • Ensure that critical processes are being performed in the same way (the correct way) by everyone.

Review Corrective Action Process

  • Review the findings from previous audits and make sure they have been addressed.
  • All non-conformities must be properly recorded, investigated, and actions need to be in place or concluded by the time of the audit.
  • Corrective actions that have been executed and closed should also have been verified for effectiveness.

Organize the Workplace

  • It is difficult for quality control and assurance to take place in an untidy, dirty, or unorganized workplace. Take time to organize the workplace (offices, desks, warehouse, workshop floor, etc.).
  • Make sure records, forms, procedures, and any relevant documents are on-hand or easy to access.

Practice Positivity and Professionalism

  • Make a good first impression – treat auditors professionally and with respect.
  • Do not be predisposed. Auditors are not enemies, they are there to establish conformance and to help your organization uncover any weaknesses so that you can take the necessary actions to improve.

The Registrar CompanyTRC is internationally recognized and trusted. With a large network of auditors, TRC is an international certification body with local benefits. With dedicated Client Services Managers and family-owned and entrepreneurial values, our clients are family. We take the time to understand your business and your unique needs. TRC audits are more than a checklist, we highlight your corporate strengths, and find opportunities for improved processes to ensure you stay competitive and thriving. TRC works with you to ensure minimal disruptions so you receive the highest benefits from the auditing process.



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Documented Information for ISO 9001:2015

As we move into the final months for transitioning to ISO 9001:2015, many companies are still asking themselves what documentation is required. Back with the 2008 release, most companies were comfortable with the six mandatory procedures that were expected of them as well as the need for a quality policy and manual. The update to 2015 has however removed the requirement for a quality manual and blurred the distinction between procedures and records.



With the new release, both documents and records are termed “documented information” and must be controlled and maintained. This is what will form the evidence required to show that you are conforming to the requirements of your quality management system.

Clause 4.4 of ISO 9001 requires your organization to maintain the documented information that is required to support the operation of your processes and to retain that information to be able to have confidence that those processes are being completed as planned.

So what is required by the standard?

The following is a clause-by-clause breakdown of what is required by the standard. However, some of these clauses can be excluded if the company does not perform the relevant processes:

Mandatory records:

  • 7.1.5.1 – Monitoring and measuring equipment calibration records
  • 7.2 – Records of training, skills, experience and qualifications
  • 8.2.3.2 – Product/service requirements review records
  • 8.3.2 – Record about design and development outputs review
  • 8.3.3 – Records about design and development inputs
  • 8.3.4 – Records of design and development controls
  • 8.3.5 – Records of design and development outputs
  • 8.3.6 – Design and development changes records
  • 8.5.1 – Characteristics of product to be produced and service to be provided
  • 8.5.3 – Records about customer property
  • 8.5.6 – Production/service provision change control records
  • 8.6 – Record of conformity of product/service with acceptance criteria
  • 8.7.2 – Record of nonconforming outputs
  • 9.1.1 – Monitoring and measurement results
  • 9.2 – Internal audit program
  • 9.2 – Results of internal audits
  • 9.3 – Results of the management review
  • 10.1 – Results of corrective actions

Other Mandatory Documents:

  • 4.3 – Scope of the QMS
  • 5.2 – Quality policy
  • 6.2 – Quality objectives
  • 8.4.1 – Criteria for evaluation and selection of suppliers

So what does this mean?

You should still tailor your quality management system to meet the requirements of your own business and all of the interested stakeholders. This can be done in any way that your organization sees fit; although a quality manual is still one of the easiest methods. As long as these processes and associated records can be shown to meet the requirements of ISO 9001:2015 effectively then that is fine. If not then the relevant action should be taken to ensure that all of the required clauses are covered.



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Lean System

Introduction to the Lean System

As with anything in life, you will get out as much from your ISO 9001 management system as you put into it. If you treat it as a documentation requirement and burden on your business just to get certification then you are unlikely to see any real benefits; in fact, you may even stifle your own growth.

The aim of any ISO 9001 QMS is to enhance your businesses product or service quality by standardizing and continually improving all of your business processes. This in turn will help you to increase productivity and drive out waste of all forms within your business.

Why Use Lean System with ISO 9001?

ISO 9001 outlines what is required for a certifiable QMS. However if you read ISO 9004 you will see that it suggests a huge amount more than 9001 requires as a minimum. Merely aiming for what the standard requires so that you achieve certification is not going to help you actually improve your business in a way that is going to help you grow it.

A QMS should always consider the customer first, not the standard. It should also be put in place to continually improve the business and its output. Something that is also provided through implementing a Lean system.

Lean Manufacturing has grown out of what is known as the Toyota Production System (TPS), and is why Toyota managed to dominate the world automotive market in such a short space of time. Lean is in its simplest form just another QMS; when you implement Lean you put in place the controls and systems to provide the customer exactly what they want, where they want it, when they want it, in the right quantity, without any waste or delays.

Lean provides you with a host of tools such as 5S, which helps you to set up a highly visual, organized and efficient working space, through to continuous improvement techniques such as Kaizen. Lean fits perfectly within any ISO 9001 QMS and can only help you to further improve and grow your business using proven tools and techniques.