What is ISO 9001?
Learn about ISO 9001, its purpose, benefits, how to implement it, get certified and more.
What is ISO 9001?
ISO 9001 is an international Standard that specifies requirements for a quality management system that applies to products and services in any business sector. ISO 9001 requirements are generic in nature and are supplementary to the requirements for products and services specified by the customer. As a layman, ISO 9001 meaning is that this standard is all about customers both at the front and back end. It is the key standard out of the ISO 9001 Standards family.
Why is ISO 9001 important?
ISO 9001 emphasizes the importance of understanding and implementing the customer requirements and applicable products/services-related statutory and regulatory requirements to sustain the business and customer loyalty. To achieve this, ISO 9001 provides processes such as “Requirements for products and services”, “customer focus”, “customer satisfaction” and indirectly “statutory and regulatory requirements”. Finally, it requires demonstration of effectiveness of these processes through monitoring, measurement, analysis and evaluation.
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What is the current ISO 9001 standard?
The current edition of ISO 9001 is 2015 which has been reconfirmed. The noteworthy change in the 2015 edition was introduction of Annex SL and risk-based thinking. Annex SL is a framework that was introduced in 2015 to provide a high-level structure for management systems. It is important for ISO standards because it provides a common language and structure for organizations to use when developing management systems.It has been created to introduce identical core text and common terms and definitions. This will streamline standards, encourage standardization, and ease the integration of management systems.
What topics does ISO 9001:2015 cover?
The topics covered are presented in the Annex SL format and include Foreword, Introduction, Scope, Normative References, Terms and Definitions, Context of the Organization, Leadership, Planning, Support, Operation, Performance evaluation and Improvement. The core clauses are Context, Leadership, Planning, Support, Operation, Performance Evaluation, and Improvement.
The nature of topics that apply to a given organization depends upon the maturity of their QMS.
What is the purpose of ISO?
ISO (International Organization for Standardization) is an independent, non-governmental international organization with a membership of 169 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 in Geneva, Switzerland.
It could be about making a product, managing a process, delivering a service or supplying materials – standards cover a huge range of activities.
Quality management standards – ISO 9001 to help work more efficiently and reduce product failures.
Environmental management standards – ISO 14001 to help reduce environmental impacts, reduce waste and be more sustainable.
Health and safety standards – ISO 45001 to help reduce accidents in the workplace.
Energy management standards – ISO 50000 to help cut energy consumption.
Food safety standards – ISO 22000 to help prevent food from being contaminated.
IT security standards to help keep sensitive information secure.
ISO 9000 vs ISO 9001
What is a Quality Management System?
A quality management system is a combination of policies (Quality Manual), procedure both for system and operation, work instructions supported by tools that include checklists, forms, templates, and database. Such a quality management system must be aligned with or guided by the strategic direction of the organization. The success of a quality management depends upon leadership commitment and employee buy-in.
Recommend reading: Core elements of a Quality Management System.
What are the main benefits of being ISO 9001 certified?
What types of businesses can benefit from using ISO 9001?
Any business that manufactures a product or delivers a service can benefit from the application of ISO 9001 based quality management system. Specifically, businesses that are heavily regulated and encompass complex processes can benefit in terms of compliance with applicable statutory and regulatory requirements. In general, any business that involves a lot of interactions and internal interfaces could benefit from a structured, disciplined, and systematic approach provided by ISO 9001.
How does ISO 9001 help a business manage risk?
ISO 9001 requires two types of risks to be addressed 1) at organization level 2) at the operational/working level using a risk-based approach. The organization risks are assessed by using SWOT and PESTLE analysis tools. The operational/working level risks are determined through process identification and then risk assessed using a proven risk assessment methodology. The organizational risks and operational risks are synchronized and operating risks are mitigated through execution of operating policies/procedures/tools.
How is ISO 9001 implemented for certification?
ISO 9001 based QMS can be implemented in several ways depending upon the nature, size and complexity of the organization. Smaller organizations implement ISO 9001 using one team for all phases of the implementation. Whereas large organizations require various types of teams such as steering committee, management team and process teams. Regardless of the size of the organization, teams must have representation from various disciplines. The implementation begins by establishing a strategic plan that will guide the design of the QMS. The key steps to develop required documentation include process identification, risk assessment of processes, determination of extent of documented information required, quality manual, quality policy, quality objectives/KPIs, system procedures, operating procedures, work instructions, supporting tools. Once the documented information is in place, management and employee awareness is offered and the QMS is rolled out. Following this, an internal audit is conducted to determine the conformance of documentation as well as level and effectiveness of implementation. Finally, a management review is conducted to ensure the QMS is appropriate, adequate and effective. At this stage, the QMS is ready for auditing by an external registrar.
Is ISO certification mandatory?
Generally, no, however, in some cases ISO certification is mandatory to be on a bidders list or be a part of the project or work on government funded projects. For the most part, the certification is voluntary but dictated by the customer prior to taking an assignment. Most organizations are embracing ISO certification now since it provides confidence to the customer that the organization has its act together to provide quality product and customer service.
How much does it cost to get certified?
The overall certification cost consists of the cost of developing and implementing plus the cost of an external certifying body for auditing and audit report. The cost of development/implementation depends upon the nature, size, and complexity of the business. For a small organization, this cost could be up to $20,000. For medium size organizations, this cost could be up to $50,000. For a large size organization, the cost could be up to $100,000. One point to remember about the cost is how much work is done by the company and the consultant as this would impact the consultant cost. The third-party registration cost is $1700 per day for stage 1 and stage 2 audits. Total number of stage 1/stage 2 audit days would determine the external certification cost.
Steps to ISO 9001 Certification
Jack Sekhon and Associates offers a 36-step strategy for developing, implementing, and getting certification of QMS from scratch. This strategy hinges on developing a bigger picture ‘strategic plan’ and then aligning the QMS with the bigger picture. Two key concepts used to develop the framework for QMS include process approach and risk-based thinking. Management commitment and employee engagement are the key for successful implementation of QMS. Other factors for successful implementation include competence of the teams, excellent facilitator and adequate and effective documented information review and control.
Consult JSA today to get started!
How do I get ISO 9001 certified?
Jack Sekhon and Associates have brought numerous organizations from various business sectors into ISO 9001 certification. Our strengths include mastering your business knowledge, upfront honesty and integrity, providing clear scope of work with the cost breakdown, unparalleled and deep understanding of the Standard, unique style of getting the job done right the first time, tactful employee engagement, thoughtful leadership coaching, expert risk assessment and master process approach. Check out how JSA Inc. has helped numerous businesses achieve quality excellence – Read case studies!
ISO 9001 Resources
- What is Quality Management Systems? – An easy guide to a Quality Management System – definition of QMS, its benefits, purpose, past of quality and more.
- Core elements of Quality Management System – Learn about the 10 clauses of a Quality Management System in detail.
- ISO 9001:2015 standard – Learn about it’s principles, how the structure has changed, risk based thinking and more.
Frequently Asked Questions
Check out answers to Frequently Asked Questions.
Yes, in some cases. When bidding on government-funded public projects, in some cases, it is mandatory for an organization either to be certified or ready to be certified to ISO 9001 to bid on the project for any potential work. Mostly the certification is voluntary, however, an increasing number of customers now are demanding their suppliers (product or service) to be ISO certified.
Yes, for sure. A custom/smartly designed QMS in line with strategic direction and supported by meaningful and measurable metrics (KPIs), and effectively implemented ISO 9001 QMS with leadership commitment/support offers a big return on your investment. The worth depends upon several factors:
- Leadership commitment and support.
- An appropriate and current strategic plan.
- Process Approach awareness.
- Risk based thinking application.
- Employee engagement in QMS.
- Results Based (Objectives & KPIs) QMS.
- Risk based QMS based on prevention and not ‘firefighting’.
- Effective internal auditing and management reviews.
- Documented and implemented Continual Improvement Program.
- Anyone entering a quality management-related career.
- Quality Managers, Coordinators and Consultants.
- Senior Management personnel who direct and control organizations.
- Human Resources/Training professionals.
- Engineers, technicians and technologists.
- Laboratory, Testing and Inspection professionals.
- Reliability personnel and Statisticians.
- Anyone seeking advanced knowledge of ISO 9001:2015 Standard.
- Internal auditors seeking to advance knowledge of ISO 9001:2015 Standard requirements.
- Auditors seeking accreditation to become external auditors employed by QMS registrars.
ISO 9001 means that the procedures that employees are required to use/follow, have been developed by considering best practices, user-friendliness, and customized for relevant equipment and work environment. These procedures make the job easier and enhance the team approach. When these procedures are followed, they cause less defects, thereby leading to successful and profitable business. That in turn creates job security and stability. That makes it a win-win, win for employees and win for the company.
ISO 9001 in summary:
- Find out what does the customer want.
- Figure out if any legislation pertaining to products/services applies.
- Establish process to meet customer needs and compliance with applicable legislation.
- Implement the process intended.
- Confirm the customer is happy with the products/services.
- Continually improve the process.
The basic requirement is to look after customers to sustain your business by keeping in mind the applicable product/service-related legislation.