ISO 9001:2015 Standard
Learn about ISO 9001 standard, who needs it & more.
What is ISO 9001:2015 Standard?
ISO 9001 Standard specifies quality management system (QMS) requirements for products and services. It basically enables an organization to consistently meet or exceed its customer requirements and statutory/regulatory requirements applicable to products and services.
8 Quality management principles of ISO 9001:2015
There are 8 quality management principles upon which ISO 9001:2015 Standard is based upon. Here are these principles:
- Customer focus
- Engagement of people
- Process approach
- Evidence-based decision making
- Relationship management
- Risk based approach
References of ISO 9001:2015 Standard to the principles
ISO 9001:2015 quality principles have been designed into the ISO 9001:2015 Standard either directly or indirectly. Here is how they are related to various ISO 9001:2015 Standard clauses:
- Customer focus – ISO 9001:2015 Clauses 5.1.2, 8.2, 9.1.2
- Leadership- ISO 9001:2015 Clauses 5, 9.3, 6.1, 6.2, 9.1
- Engagement of people-Throughout implied
- Process approach-Introduction-ISO 9001:2015 0.3, 4.4
- Improvement; ISO 9001:2015 Clauses 10, 5.1, 4.4, 6.1, 7.1.1, 9.1.3,9.3
- Evidence-based decision making-ISO 9001:2015 Clause 9.1.1, 9.1.3
- Relationship management-ISO 9001:2015 Clause 8.4
- Risk based approach-ISO 9001:2015 Clause 6.1, 0.3.3, 4.4,9.1.3, 9.3.
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Steps to ISO 9001 certification
Jack Sekhon and Associates can help your organization to get certified to ISO 9001 Standard by following steps identified below:
Step 1: Scope and Training Identify the scope of ISO 9001 based on geographical and process boundaries as well as products/services. Get training on ISO 9001 Standard to understand ISO 9001 requirements, process approach and risk-based thinking. (5 % of overall work required) – JSA Led
Step 2: Gap Analysis Conduct a gap analysis of your current quality practices against ISO 9001 requirements. (5 % of overall work required) – JSA Led
Step 3: ISO 9001 based QMS Design – Design the ISO 9001 based QMS by establishing documented information required by your organization based on process approach and risk-based thinking. The documented information could include scope, Quality Manual, QUALITY policy, QUALITY objectives, Process Lists, QUALITY Risk Register, QUALITY Legal Register, QUALITY System Procedures, QUALITY Operating Procedures, QUALITY Work Instructions and supporting tools such as forms, templates, checklists and databases. (60 % of overall work required) – JSA Led
Step 4: ISO 9001 based QMS Implementation – Implement the QMS by following established documented information and retaining records of implementation. This can be done through employee/management implementation questionnaires and assisting as necessary. (10 % of overall work required) – JSA Led
Step 5: Internal Evaluation – Train interna auditors. Conduct internal audits and address identified gaps through NCRs. Conduct management review and develop/implement action items arising from management review. (5 % of overall work required) – JSA Led
Step 6 – Stage 1 External Evaluation – External Registrar auditor conducts Documentation and Readiness Stage 1 audit and issues report-Address any identified issues. (5 % of overall work required) – External Registrar Led
Step 7 – Stage 2 External Evaluation – External Registrar auditor conducts stage 2 Implementation Effectiveness audit and issues report. Address any identified issues. (10 % of overall work required) – External Registrar Led
Step 8 – External Registrar issues Certification – The organization submits documented information demonstrating the issues have been addressed. Upon acceptance, external registrar issues Certification of your organization’s QMS to ISO 9001 Standard.
Step 9 – Sustain the Certified QMS – The organization maintains the QMS. External registrar conducts annual surveillance audits and 3-year recertification.
What is the purpose of ISO 9001:2015 certification?
Certification is a useful tool to add credibility, by demonstrating that your product or service meets the expectations of your customers. For some industries, certification is a legal or contractual requirement.
How many ISO 9001:2015 certifications have been issued worldwide? As of 2021, based on survey of ISO 9001:2015 certified companies, 1,077,884 certificates have been issued for a total number of 1,463,153 sites.
Does ISO 9001 still apply to all organizations – big, small, different sectors & different items – products, services? The concept of the standard has not changed; it’s applicable to any type of organization, regardless of the size, type or its core business.
How much does it cost to be certified?
The cost of certification for an organization depends on the scope of QMS, number of employees, nature of products and services, number of locations, amount of work done by JSA Inc and degree of being regulated.
Approximately $30,000 – Organization up to 30 Employees
Approximately $50,000 – Organization up to 100 Employees
Approximately $100,000 – Organization over 100 Employees
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How has the structure of the standard changed?
The structure has been changed to align with the common 10-clause high level structure developed by ISO to ensure greater harmonization among its many different management system standards. The new revision to ISO 14001 will also adopt this same structure, which is built around the PDCA (Plan-Do-Check-Act) sequence. All ISO management system standards are now required to adopt this structure. This will make it easier for organizations to address the requirements of more than one ISO Management System Standard within a single, integrated system.
How have the documentation requirements changed?
Specific documented procedures are no longer mentioned; it is the responsibility of the organization to maintain documented information to support the operation of its processes and to retain the documented information necessary to have confidence that the processes are being carried out as planned. The extent of the documentation that is needed will depend on the business context.
The standard does not mention a quality manual, Is it still required? A quality manual is no longer specifically required. The new standard requires the organization to maintain documented information necessary for the effectiveness of the quality management system (QMS). There are many ways to do this and a quality manual is just one. If it is convenient and appropriate for an organization to continue to describe its quality management system in a quality manual then that is perfectly acceptable.
Why has management review been moved to performance evaluation? (9.3) The sequence of the new version of ISO 9001 is based on the Plan, Do, Check, Act cycle and so, in order to evaluate quality management system performance, it makes sense for management review to follow the measurement of the system performance.
The title of management representative has been removed. How is the performance of the system reported to top management? Although the prescriptive title of a management representative has been deleted, it is up to top management to ensure that the roles and responsibilities are assigned for reporting on the performance of the QMS. Some organizations might find it convenient to maintain their current structure, with a single person carrying out this role. Others might take advantage of the additional flexibility to consider other structures depending on their organizational context.
Why has product been changed to products & services? ISO 9001:2008 already made it clear that the term product in the previous version of the standard also includes service, so there is no impact in practical terms. The term products and services is now (ISO 9001:2015) used throughout the standard to reflect the far greater use of the standard outside of the manufacturing sector, and to emphasize its applicability in the service industries.
What is risk-based thinking and why has it been introduced into the standard?
The phrase risk-based thinking is used to describe the way in which ISO 9001:2015 addresses the question of risk. The concept of risk has always been implicit in ISO 9001, by requiring the organization to plan its processes and manage its business to avoid undesirable results. Organizations have typically done this by putting greater emphasis on planning and controlling processes that have the biggest impact on the quality of the products and services they provide. The way in which organizations manage risk varies depending on their business context (e.g. the criticality of the products and services being provided, complexity of the processes, and the potential consequences of failure). Use of the phrase risk-based thinking is intended to make it clear that while an awareness of risk is important, formal risk-management methodologies and risk assessment are not necessarily appropriate for all business situations and organizations. For further information about risk-based thinking see the papers on this topic available on www.iso.org/tc176/sc02/public .
What has been changed in terms of planning?
ISO 9001:2015 requires the organization to address risks and opportunities, quality objectives and planning of changes throughout the oganization. As new products, technologies, markets and business opportunities arise, it is to be expected that organizations will want to take full advantage of these opportunities. This has to done in a controlled manner, and be balanced against the potential risks involved, which could lead to undesirable side-effects.
History of ISO 9001 Revisions
The ISO 9001/2/3 series of standards is published as a demonstration model for quality assurance systems in 20 elements.:
- ISO 9001 as a model for demonstrating quality assurance in all areas of the company: Design, development, production, assembly and customer service.
- ISO 9002 as a model for the presentation of quality assurance in production and assembly.
- ISO 9003 as a model for the presentation of quality assurance in final inspection.
The ISO 9000 series of standards is thus still the model for a whole series of sector-specific management system standards, such as IATF 16949 (automotive).
The first revision of ISO 9001 took place in 1994. At that time, however, only a few minor adjustments were made, mainly of an editorial or conceptual nature.
The change from QA = quality assurance to QM = quality management in the 1990s and the introduction of process orientation were two further significant milestones in the history of ISO 9001. The conceptual shift from assurance to management corresponded to its importance for corporate practice. Thus, ISO 9001 was finally placed in the top management, i.e. where “proper corporate management” is actually responsible.
Non-applicable requirements (for example, development) were allowed to be excluded – according to the definition of “permissible exclusions” in Section 7 of the standard. The modern understanding of quality management and its significance for business practice was contained in the “Eight Principles of Quality Management”.
ISO 9001:2008 – The publication of the fourth edition of ISO 9001 took place in 2008. A large part of the changes were mainly aimed at easier application through clarifications in the statements. The basic structure and strategic orientation of the standard remained unchanged. The requirements also remained essentially the same.
ISO 9001:2015 – With the September 2015 revision, the history of ISO 9001 continues to be written. The standard was adapted to the so-called High Level Structure, a basic structure with uniform core texts for the central requirements for management systems as well as the common designations and definitions, which has been the basis for all ISO management system standards since 2012. Key innovations are:
- The “context of the organization”, i.e. the internal and external environment of a company
- The consideration of relevant interested parties
- The focus on the responsibility of top management
- The risk-based approach, which replaces, among other things, the so-called preventive measures
- The “knowledge of the organization“, which is named as a resource for the first time
JSA can help you become a Lead Auditor
ISO 9001:2015 Auditor/Lead Auditor certification requires completion of 36- hour course provided by a Certified ISO 9001:2015 Training Provider and successful demonstration of QMS experience and auditing experience with Auditor Certifying Organization such as Exemplar Global or Individual QMS Registrar. Jack Sekhon and Associates is ISO 9001:2015 QMS Training Provider certified by Exemplar Global under TPECS scheme. Getting ISO 9001:2015 Auditor/Lead Auditor certification empowers you with skillsets for ISO 9001:2015 Management System excellence and robust company performance. You can either work as an internal auditor for your organization or as an external auditor for a Registrar. Irrespective of internal/external auditor option, certified auditors earn attractive compensation for their work. In addition, they earn higher potential for promotion being instrumental to on-going growth, due-diligence and efficiencies of the organization as an ISO 9001:2015 Auditor/Lead Auditor. Get certified today!
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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.
On 22 June 2021, the subcommittee responsible for the standard, SC 2, Quality systems, which operates under technical committee ISO/TC 176, Quality management and quality assurance, undertook a number of activities including discussions with committee members and a survey of ISO 9001 users. The result was that no revision was needed and the latest version of ISO 9001 still provides as much value to those implementing the standard as it did when it was last updated in 2015.
An organization receives an ISO 9001:2015 certificate from the ISO Registrar following successfully passing stage 1 and stage 2 audits. An auditor receives ISO 9001:2015 certificate following successful acceptance of his/her auditor application (auditor training, competence and auditing experience) by auditor certification body.
The ISO 9000 family contains these standards:
- ISO 9001:2015: Quality Management Systems – Requirements
- ISO 9000:2015: Quality Management Systems – Fundamentals and Vocabulary (definitions)
- ISO 9004:2018: Quality Management – Quality of an Organization – Guidance to Achieve Sustained Success (continuous improvement)
- ISO 19011:2018: Guidelines for Auditing Management Systems
The following fundamental concepts are pivotal for the success of ISO 9001:2015 based QMS:
- Understanding of process approach.
- Application of process approach using PDCA cycle.
- Understanding of risk-based thinking and its application.
ISO 9001:2015 virtual/ face to face certification can be achieved through gap analysis, strategic plan, process identification and risk assessment, document development, QMS training, implementation, performance evaluation and external registrar auditing. Online certification is almost as effective as face to face.
The ISO 9001:2015 requirements course provides understanding of requirements of ISO 9001:2015 Standard which is used as criteria or a benchmark for auditing. Without the knowledge and understanding of ISO 9001:2015, the auditor/lead auditor will not be able to perform an effective and efficient audit.
- Complete ISO 9001:2015 Certified Auditor or ISO 9001:2015 Certified Lead Auditor Course/Training-Jack Sekhon and Associates.
- Gain required minimum 5 years QMS experience.
- Gain required minimum ISO 9001:2015 auditing experience of 20 audit days for Auditor and additional 15 days as lead auditor for Lead Auditor application.
- Have your experience endorsed by your Supervisor/Manager.
- Apply to Auditor Certification body such as Exemplar Global