ISO 9001 qms
What is ISO?
ISO is an independent, non-governmental international organization with a membership of 165 national standards bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.
ISO Central Secretariat is based in Geneva, Switzerland.
International Standards make things work. They give world-class specifications for products, services and systems, to ensure quality, safety and efficiency. They are instrumental in facilitating international trade.
ISO has published more than 20,500 International Standards and related documents, covering almost every industry, from technology, to food safety, to agriculture and healthcare. ISO International Standards impact everyone, everywhere.
What is ISO 9001?
The ISO 9000 family of quality management systems standards is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product. ISO 9000 deals with the fundamentals of quality management systems, including the eight management principles upon which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill.
Third-party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over one million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today.
ISO 9001 is a quality management system that can be integrated into any business. It is focused on ensuring the business delivers a consistent level of quality to its customers by having well defined and regularly reviewed processes and procedures. The system fully integrates within the existing business procedures and becomes part of the culture within the organization. Eventually a business will not perform a task to conform to the ISO 9001, it will perform the task for the good of the business. The system covers seven (7) main business principles which are:
- Customer focus
- Engagement of people
- Process approach
- Evidence-based decision making
- Relationships management
- See short video on ISO from ISO organization: https://youtu.be/oq1Zi_V4KyE
How many ISO 9001 certified companies are there world-wide?
At the end of 2014 there are total 1,138,155 ISO certificates have been issued to the companies worldwide, with China made a huge leap and became the country with the greatest number of ISO 9001 certifications issued. The country amassed 297,037 certificates in end of 2010.
Why is a revision of ISO 9001 being undertaken?
Originally developed and published in 1987, ISO 9001 was based on the quality management principles originally identified by Dr. W. Edwards Deming, Dr. Joseph M. Duran and other leading quality management system quality professionals. Since then, ISO 9001 has served as the foundation for many other sector specific management system standards, such as ISO 13485 (medical), AS 9100 (aerospace & defense), TS 16949 (automotive) and TL 9000 (telecommunications).
In recent years, the ISO Technical Committee 176 (TC 176), the committee responsible for ISO 9001, determined that a fundamental review of the standard and its underlying quality management principles was required. That review found that the standard was in active, widespread use, and had withstood the test of time well. At the same time, the review also noted that the essential principles that served as the basis for ISO 9001 had undergone considerable evolution during the 25 years since the standard’s original publication, and that the standard needed to evolve to remain relevant to modern quality management practices
What are the goals of the ISO 9001 revision?
ISO/TC 176 has articulated a number of goals that it hopes to achieve in this revision of ISO 9001.
The goals include:
- Establishing a stable core set of requirements suitable for the next 10 years and beyond
- Making sure that the standard remains relevant to organizations of all types and sizes and operating in any industry sector
- Maintaining the standard’s current focus on effective process management as the primary tool to produce desired quality outcomes
- Accounting for changes in quality management systems practices and technology since the last major revision of the standard in 2000
- Reflecting the requirements of the increasingly complex, demanding and dynamic environments in which organizations operate
- Facilitating efficient and effective implementation of quality management systems, and streamlining the conformity assessment process
- Using simplified language to aid in understanding and consistent interpretations of the standard’s requirements
- Finally, applying to the standard the framework detailed in Annex SL of ISO Directives to enhance compatibility and alignment with other ISO management systems standards
What is the current status of the revision?
ISO 9001:2015 was published on 23 September 2015. Organizations have a three-year window to modify their previously certified quality management systems to meet the requirements of the newly revised standard.
What is ISO certification?
ISO certification is a seal of approval from a 3rd party body that a company runs to one of the internationally recognized ISO management systems. The certification can be used to tender for business as a proof of a company’s credibility but also to install confidence in the potential client that you will keep your promises
What is ISO 9001 certification?
ISO 9001 certification is a seal of quality that indicates an organization’s quality management system meets the ISO 9001 requirements. It is based on an independent evaluation or audit performed by a registrar who provides written assurance that the ISO quality management system standard has been met. ISO certificates are issued for 3 years with the requirement that surveillance audits be performed on an annual basis.
A company that is ISO 9001 conforming means that they meet ISO’s quality management system requirements but have not been formally certified by an independent registrar. Although this may be acceptable for some, an official certificate tends to carry more weight in the market place.
Why Implement ISO 9001?
Improve customer satisfaction
- Improved product and service quality, including on-time delivery
- Reduce defects and product recalls
Improve financial performance
- Reduce operational costs through improved process effectiveness and efficiency
Improve employee satisfaction
- Motivate employees by clarifying their roles, responsibilities and contributions to
- the organizations’ objectives
Benefits of ISO 9001 certification
Improved market credibility
- Perceived as having higher quality products and services, and may receive preferential treatment when bidding on contracts
- Display of your ISO certification logo to a worldwide audience over the Internet
Access to new markets
Ability to bid on contracts that require ISO 9001 certification as a prerequisite for doing business
Why would I want ISO certification?
ISO certification is a statement to your stakeholders, employees and senior management that the business wishes to operate to a set framework in order to achieve its company objectives. Be this customer satisfaction objectives, production objectives or environmental objectives etc. By setting yourselves the task of maintaining an external certification you are proving the company’s commitment to these objectives as well as increasing the credibility and customer confidence in the brand / service or product.
For example, by running a quality management system, a company can stay in control of its processes and procedures, ensure if anything does go wrong it is rectified quickly, efficiently and to the satisfaction of the customer. It can also ensure a smooth line of communication between employees, suppliers and customers at all times.
Many public and private sector tenders request ISO certification as either a pre-requisite to moving to the next stage or as a filter to remove companies from the tender process. By achieving the ISO certification that your customers give weight to, ensures that you are on a ‘level playing field’ with your potential competitors and improves your chances of successfully tendering. Many companies we work with report a major internal efficiency improvement which allows them to achieve greater results both in a sales and operational capacity.
How long does it take to achieve ISO certification?
We aim for a less than 6 months’ delivery period, but again this can vary from organization to organization. We will never delay the process; however, we understand that things can happen that may mean you require a small delay. We will accommodate this where possible; however, for those who are looking to achieve the certifications as soon as possible, we will endeavour to ensure you obtain your certification within our standard timescales.
After the quotation has been accepted and the deposit payment has been received we offer all of our clients a letter that you can send to your potential clients or include with tenders, to confirm that you have entered the process and that you will be fully certified within less than 6 months. This is normally sufficient to move forward with a tender process. This can then be followed up by an announcement letter stating that you have achieved the ISO certification.
What does ISO certification cost?
Below are the main costs associated with achieving ISO certification.
Internal costs associated with planning, developing, documenting and implementing the QMS including:
- Gap Analysis
- Training and awareness
- Internal quality audits
- ISO 9000 standards
- Application fee, administrative and maintenance fees
- Pre- assessment – optional
- Certification audit – cost dependent on size and complexity of organization
- Surveillance audits – cost dependent on size and complexity of organization
- Travel expenses
- External training
- Consultant services costs associated with getting ready for it.
Various factors come into question;
- Will you hire someone?
- Do it yourself with existing personnel?
- Use a consultant?
ISO Certification costs vary dependent on the size of an organization and the level to which the company is already run with regards to processes and procedures. If you decide to implement more than one standard at the same time, there are some preferential fees available. We are a fixed fee organization, which means once we have met you to discuss your requirements and sent you a formal quotation, this fee is then set. We will not charge you any extra then what is specified, so that you know from the outset your costs and the payment method.
Due to our proposals being bespoke and the number of variables that can affect the cost of implementation, we do like to meet our potential clients so as to get to know them a little better before providing them with costings.
How do I obtain ISO certification?
MNA Quality Consulting main approach is to keep the process for you, the customer, as simple as possible. We undertake a gap analysis of the company, to see where the company currently stands with regards to the chosen ISO system. From this we make a series of recommendations on what needs to be done to become compliant (we will not make any major procedure changes unless absolutely necessary). We will then draw up a plan for implementing the recommendations.
Depend on the level of the services you want from us. If you engage with us for the full service, we will develop your mandatory documented information (as required by the standard) and then 6-8 weeks after the first initial assessment we will come back to present the documents to be implemented in your organization. I will then do the internal audit together with your selected company internal auditor who have been trained to perform the audit. Once the management review has been conducted, you will be ready certification process from this point forward. The external auditor will conduct the audit and it will take around 4 weeks or so receive your certification.
From this point, the systems are focused on continual improvement, therefore we will visit you on a regular basis to ensure that you are on track with the recommendations and ready for re-certification year on year.
How could a consultant help me?
MNA Quality Consulting has the expertise to help you getting the ISO Certification;
- Our experts will guide your organization to timely decisions and activities and reduce the time implementing your Quality Management System.
- We will show you how to avoid the typical pitfalls companies face when pursuing certification.
- We will motivate your employees to perform the tasks needed to achieve certification.
- Our experts have in-depth knowledge of the standard as it applies to your organization.
How will organizations currently holding ISO 9001 certification be affected by the changes in the new revision of the standard?
Organizations have a three-year window to modify their previously certified quality management systems to meet the requirements of the newly revised standard. MNA Quality Consulting recommends that organizations upgrade their systems to the new standard at an early stage within the scope of a regular re-certification audit.
What is an audit, and what does it generally include?
An audit is the process by which a company shows evidence of working to the required system and this is a compulsory element of the ISO systems. A qualified auditor will attend your premises in order to assess your management system against the ISO standard that you are certified to, and will request to see evidence resulting from the company’s processes and procedures to ensure the system is being used and maintained on a regular basis.
The auditor will typically compose a report, analyzing your management system and the use of, against the clauses of the standard. MNA Quality Consulting will also provide you with recommendations for improvement that will have been agreed with you to assist you to drive the system forward to enable continuous improvement, thus getting the most out of the standards.
Audits identify problems or shortcomings in the management system that could allow poor quality product to be produced and brings it to the attention of management so they can correct the problem. Audits are often preventive actions in that they identify problems before they have produced poor quality product. This is why audits are often used as part of the basis for selecting suppliers.
Why do I need to have an audit?
Auditing is a required element of the ISO standards. It is the proof that the system you have implemented is fit for purpose and continually improving. It is the regular check that you are managing the systems consistently.
The guidance that you will receive at the internal review stage will help you to effectively manage your management systems and remain compliant to the relevant standards. The auditor will help you to identify which aspects of the management system require improvement; this will provide you with the ability to develop and enhance the management system through a set of focused action points in a step by step approach.
What ISO standard do I need?
There are over 20,500 different management standards, therefore finding the ones that are right for your business can sometimes be confusing. The best place to start is ISO 9001 quality management system, as this is the core standard that most of the other well-known standards are based on. It’s focused on customer service and ensuring your customer receives the service they want, at a time that is relevant for a cost that is fair.
Should ISO 9001 certified company respond to customer complaints?
Yes. ISO 9001 certification requires organizations to have a complaint management system.
I find the standard language confusing- what should I do?
ISO standards are written using ISO terminology so that all standard users across the world will have the same interpretation of the standard requirements. If this is the first time that you have read an ISO or national standard the language could seem confusing.
However, it may not be a case of suggesting different words for the standard because some of the words used have a specific meaning for the standard. Your national mirror committee or liaison body will be aware which standard terminology can not be changed.
The guidance section has been written with the aim of translating the standard requirements into easier to understand language. Your consultant would able to help you interpret the requirements of the standard.
Does ISO certification ensure fraud protection? Can I trust an ISO certified company?
No. ISO and other standards are targeted at various aspects of business, for example, ISO 9001 deals with quality management system, ISO 14001 deals with environment management system and so forth. ISO certifications do not ensure fraud protection. For fraud protection refer consumer protection act, but that can be invoked only after you have been cheated.
How to verify if a company is ISO certified?
The first step to verify a genuine certificate is to ask the company to give you a copy of certificate. Next you can ask the company which issued the certificate. We also provide certificate verification service. This is a chargeable service.
What can I do if an ISO 9001 certified company is not responding to my complaint?
You can complain to certification body or even to accreditation body giving relevant details