ISO 9001:2015
Quality Management System

What is ISO 9001

The adoption of a quality management system is a strategic move for a business that can enhance performance overall and serve as a solid foundation for efforts aimed at sustainable development.

HISTORY OF ISO 9001:2015

In 1987, the International Organization for Standardization (ISO) issued the first version of ISO 9001. ISO is an international organization made up of the national standards bodies of more than 160 countries. ISO 9001:2015 is the most recent version, having been published in September 2015.

The design and development control clause and other provisions were revised in ISO 9001:1994 to increase control and give more clarity. ISO 9002 and 9003 had their functions somewhat altered in the 1994 series as well. The first of these updates was made in 1994 when the ISO set out to shift the original standard’s emphasis from final product inspection to quality management systems (QMS) that monitored and checked products at every stage of the creation process. The emphasis of this shift shifted from fixing problems to ensuring quality through preventative measures. In essence, QMS shifted from a “cure” to a “prevention” mode of operation.
ISO 9001 was revised again in the year 2000. During this period, efforts were made to streamline processes and documentation in order to relieve businesses of the burden of quality control measures if they weren’t involved in developing brand-new items. One of the goals of this update was to get more of the company’s higher management involved in quality assurance efforts so that they could permeate the entire organization and serve as a unifying thread. The end result of these changes was an increase in efficiency through the application of process performance measures, where the measurement and tracking of customer satisfaction took center stage.
Issues that arose in practice during the implementation of ISO 9001:2000 were intended targets for the modification that resulted in ISO 9001:2008. Without adding any new criteria, this period in ISO 9001’s evolution saw the introduction of clearer clarifications to existing standards.

The latest version of 9001:2015

A new Quality Management System (QMS) model for the next 25 years was established in 2015, marking the most recent alteration in ISO 9001’s history. This prompted developers to start from with revised quality management principles for the next iteration of ISO 9001. The scope of the standard remained unchanged, but the fundamental terminology was revised to provide easier integration with other international management systems. With this revision, the standard is less restrictive than before and puts more emphasis on effectiveness.

The Intent of ISO 9001:2015

An effective quality management system will allow you to:

ISO 9001 Structure (QMS)

Clauses 0 to 3

Introduction, Scope, References, Terms, and Definitions.

Clause 4:

Context of the organization–This section deals with understanding the uniqueness of your organization and customizing ISO 9001 in order to implement a QMS that is most suitable for you.

Clause 5:

Leadership–It underlines the importance of top management in implementing QMS by proper risk assessment, planning actions, and assigning roles and responsibilities to the relevant staff.

Clause 6:

Planning–through analysis of the risks and opportunities, the top management is expected to design a plan that enlists the quality objectives for your organization.

Clause 7:

Support–It points out all the resources, such as human resources, infrastructure, and others, that are required for an effective QMS. This section also deals with the requirements for competence, awareness, communication, and controlling documented information.

Clause 8:

Operation–This section deals with the execution part of the planning for QMS. It includes product requirements review, keeping a check on external providers, reviewing the product before release, and so on.

Clause 9:

Performance evaluation–This section deals with the ways by which you can ensure the effective functioning of your QMS. It involves regular management reviews, monitoring and measurement techniques, etc.

Clause 10:

Improvement–This section ensures that your QMS is upgraded and able to meet the current market requirements. It involves regular reviews to identify gaps and performing corrective actions to close those gaps for continual improvement.

QUALITY PRINCIPLES OF ISO 9001:2015

ENGAGEMENT OF PEOPLE

Management systems, such as ISO 9001, encourage everyone in a business to take part in shaping its procedures. As a result, it is essential to have honest discussions about issues and to exchange information and experience with your team if you want to get the most out of your quality management ISO. For your organization to succeed, each employee must understand their role and value their contributions. This will show your company’s commitment to improving standards and help you achieve certification.

CUSTOMER FOCUS

Putting the customer first is a great way to prove your dedication to providing high-quality service. Consumers’ opinions, favorable and negative, should be gathered and analyzed in order to improve the company’s operations and ultimately its performance.

LEADERSHIP

In order to be an effective leader, you need to have a firm grasp on where you want to take your company. Assuring that all members of your team are working towards the same goals can be accomplished by describing this vision and the result is a rise in morale and output from workers.

PROCESS APPROACH

The PDCA cycle, as outlined in the ISO 9001 Standard, can help you create a process-oriented company culture. This is a tested method of controlling and organizing all of your interactions and procedures.

IMPROVEMENT

As the foundation of the ISO 9001 quality management system, constant advancement should be your company’s top priority. Establishing procedures for finding and fixing non-conformities, measuring and monitoring progress, and identifying risks and opportunities can all help your company thrive.

EVIDENCE-BASED DECISION MAKING

Accurate information is essential for making informed decisions. To determine the root cause of a non-conformity, for instance, you need the right proof. Make sure that everyone who needs information can get it, and keep the lines of communication open.

RELATIONSHIP MANAGEMENT

Your suppliers may provide you with a strategic advantage, but doing so will require a mutually trusting alliance. Forging such long-lasting connections with suppliers and other interested parties requires a delicate balancing act between short-term cash benefits and long-term, mutually beneficial strategies.

Know all about ISO 9001

Quality – A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
Accordance – If a business is in accordance with ISO 9001, that means that it has adequately or sufficiently conformed to ISO 9001 standards and requirements.
Certification – Gaining certification means that the organization has demonstrated that its QMS is in line with ISO 9001 standards.
Competence – Competence describes a company that’s able to meet an ISO 9001 requirement through its QMS or other processes.
Compliance – Similar to competence, compliance describes an organization that has successfully fulfilled a requirement for ISO 9001. Also known as conformity.

Documentation for ISO 9001 (QMS)

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If you want to meet the requirements of ISO 9001:2015, below are the forms you need to fill out. (Some of the paperwork will not be required if the company doesn’t carry out the procedures)

QMS Scope and Objectives
Insisting on a high standard of quality
Goals related to quality
Supplier evaluation and selection criteria
Recordings of all calibrations performed on instruments used for monitoring and measuring
Documentation of education, expertise, and credentials
Documentation of product and service requirements reviews
Review Documentation for Design and Development Outputs
The documentation of design and development sources
Design and development control documentation
Documentation of completed designs and prototypes

Keeping track of revisions made during the design and development process
Specifics on the goods and services to be manufactured and offered
Information pertaining to purchased goods
Documentation of Controlled Changes in Production/Provided Services
Documentation showing that a product or service meets established standards
Log of discarded products
Observational and Quantitative Findings
In-house Auditing Procedures
The findings of in-house audits
Findings from the management audit
Outcomes after implementing changes

ISO 9001:2015 Standard in PDCA Cycle/Process

Step 1: Allocate resources for the certification

To get ISO 9001 certification, leadership must be fully invested and appropriate resources must be allocated. It can’t come to fruition without adequate backing. Find out if you have the cash on hand to hire a consultant or if you’ll have to do it all by yourself. It would be ideal for an organization to engage a consultant to ensure a smooth implementation.

Step 2: Do a gap analysis

Recognizing where you now are by doing a gap analysis is crucial. In order to become ISO 9001 certified, your company must first assess its current status and identify any outstanding requirements.

Most frequently asked questions about ISO 9001 include:
➔ How much time will be taken?
➔ If the process is tough?
➔ What exactly do we need to do?
➔ If it is cost effective or expensive?
There is no universally correct response because of the wide variety of company sizes, personnel compositions, and work settings. These questions may be answered with some careful investigation by the organisations. To determine how well the present quality management system meets the requirements of ISO, a pre-assessment is required.

Step 3: Develop and internally audit the system

In order to qualify for certification, your system must be brought up to ISO standards. This necessitates the creation of new procedures, quality assurance measures, and organisational principles in line with ISO norms.

Your system must be in compliance with ISO 9001 certification requirements before you submit it to an outside audit. Internal auditing is a crucial stage prior to certification, as a result.

Step 4: Take a formal training on ISO 9001

If you are doing the certification process on your own, it is good to have a crystal-clear understanding of all the requirements for an ISO certification. This is where an ISO 9001 course can come in very handy.
Your system must be in compliance with ISO 9001 certification requirements before you submit it to an outside audit. Internal auditing is a crucial stage prior to certification, as a result.

Step 5: Choose an accredited auditor

In order to achieve ISO 9001 certification, you must have a qualified auditor examine the quality management system at your company. These certificates can be obtained from a wide variety of organisations that have been officially recognised as credible. Find out which option is preferred by others and works well with your budget. These organizations will evaluate your entire quality management system and let you know if there are any further holes that need to be closed.

Step 6: Get the certification

In order to earn ISO 9001 certification, the accrediting auditor must determine that your organization’s quality management system meets all the standard’s standards. You’ll need to keep up with system maintenance every three years to keep this certification current.

It is important to maintain compliance with all standards even after certification has been achieved. In this context, familiarity with the ISO 9001 standard is crucial.

Benefits of ISO 9001

Relevant Industries For ISO 9001

There are no constraints on implementing ISO 9001:2015 because it can be implemented in any industry, regardless of size. For example, the food and beverage business, the oil and gas industry, the hospitality industry, the public sector, the medical device industry, the defense industry, etc.

When it comes to providing the quality goods and services, no business or organization can afford to cut corners. It is a well-known truth that any business serious about succeeding in the market will choose ISO 9001:2015, the mother standard.

Industries That Benefit from Having ISO 9001-Certified Organizations

Who should get ISO 9001 certification, and why? Puts it plainly: becoming an ISO-certified company benefits businesses of all sizes and in all fields. However, the benefits of ISO conformity vary widely depending on the target audience. Having ISO 9001 certification helps immensely in the following industries:

Construction Management

In order to meet the many different sets of client, regulatory, and statutory expectations that exist in the construction management business, ISO 9001 certification is highly beneficial. Companies that have achieved ISO certification have been shown to dramatically reduce waste costs, realize higher efficiency, and develop safer working environments.

IT Services

In the ever-develop and increasingly intricate IT services industry, employees must deal with ongoing upheaval. IT services frequently have the most to gain from standardization, and many organizations seek ISO 9001 certification in this area so that they may develop the SOPs, documentation, and disaster recovery plans they need to thrive.

Hospitality Industry

Businesses in the hospitality industry are under constant inspection from the public since their clients may quickly switch to a competitor. Businesses in the hospitality sector that have earned the ISO 9001 certification have shown their dedication to client satisfaction and enhanced their operations.

Healthcare Industry

The healthcare business places a premium on quality because of the profound impact it has on patient outcomes. Healthcare firms may benefit from ISO 9001 certification in more ways than one, including easier compliance with ever-changing regulations. Better care and more precise risk assessments for both patients and staff might arise from the documentation and standardization made possible by ISO compliance in the healthcare industry.

Community Services

For the greater good, community service organizations serve several purposes. To well serve their constituents, several organizations strive for ISO 9001 accreditation in community services. Funding agencies recognize the importance of compliance, and ISO certification may help organizations get more of the resources they need to succeed.

Engineering Firms

The engineering profession calls for precision, efficacy, and reliability. Introducing ISO 9001 certification for engineering businesses may aid organisations in enhancing these features and providing the quality assurance their clients want.
An ISO-compliant organization continuously identifies, assesses, monitors, and mitigates risks. There is less room for error when technologies handle these processes.

Manufacturing

To produce and supply high-quality goods and services, manufacturers must coordinate many processes. A misstep can have devastating consequences. Achieving ISO 9001 certification may aid factories in mitigating these dangers, bolstering the security of their employees, and cutting down on waste. Customers like seeing evidence of your dedication to quality, and ISO compliance is a fantastic way to show that to them.

Changes ISO 9001 brings in the Industrial Development in FUTURE

All ISO standards are reviewed every five years to make sure they are still current and relevant in the marketplace. That is why ISO 9001 is currently under review–at the Committee Draft stage–and an updated version is due towards the end of 2015. The Committee Draft stage is the first consultation in the development of an ISO standard, where members who have taken part in the revision will form a national position on the draft and comment on it.

Certified organizations should talk to their client managers to keep up-to-date on the proposed changes. The revised ISO 9001:2015 is much smoother,

More emphasis on leadership
ISO 9001’s coverage now further extends to senior management’s understanding of its business environment (including social, cultural, and regulatory) and its internal strengths and weaknesses. This results in the Quality Management System becoming more integrated into operational processes, quality policy, and objectives fully aligned with corporate strategy, and top management more involved in ISO 9001.

New focus on risk management
The 2015 version of the standard introduces an additional clause on risk management (clause 6.1 “Actions to address risks and opportunities”) which builds upon the ISO 9001:2008 section on preventive action. The combination of risk-based thinking and process approach refocuses the standard on performance and results, and the Plan Do Check Act cycle is employed at all strata in the organization.

Clarifications on objectives, measurement, and change
The requirements regarding quality objectives, measurement, and change are more detailed. However, this mainly involves clarifications of requirements in the 2008 version rather than new requirements.

More emphasis on communication and awareness
The two additional clauses (7.3 “Awareness” and 7.4 “Communication”) place further emphasis on these two areas.

Fewer prescriptive requirements
The new standard is less prescriptive than its predecessor and focuses more on performance and results. There are fewer explicit documentation requirements than in all previous versions, and even “quality procedures” and a “quality manual” are not even mentioned. However, the standard contains many implicit documentation requirements, which, for all practical matters, means that procedures covering most or all ISO 9001:2015 requirements should be established. Further, a so-called “Management Representative” is no longer required (though most companies will continue to assign a member of staff to fulfill this role).

New high-level structure
ISO 9001:2015 is based on Annex SL, the new high-level framework for all management systems standards, which will bring a common structure and common language to all standards. The advantage: it is now easier to integrate ISO 9001 with ISO 14001 and other ISO standards.

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