ISO 9001 Requirements Explained | Certification | PDF

What are the Requirements of ISO 9001:2015 Certification?

→ ISO 9001:2015 is an international standard that defines the requirements for a QMS.

→ QMS stands for Quality Management System.

→ Organizations and businesses use this standard to demonstrate their ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.

→ The certification process involves key requirements of a quality management system.

Table of Contents:

• What are the Requirements of ISO 9001:2015 Certification?
• Key Requirements of ISO 9001-2015 Certifications
• Scope
• Normative references
• Terms and definitions
• Context of the organization
• Leadership
• Planning
• Support
• Operation
• Performance evaluation
• Improvement
• How to Get ISO 9001 Certification?
• Benefits of ISO 9001 Certification
• Conclusion

Key Requirements of ISO 9001-2015 Certifications:

→ Requirements of certification are specified in 10 different clauses.

⏩10 Main Clauses of ISO 9001 Standard are:

1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement

01. Scope:

→  All the requirements of ISO 9001:2015 are intended to apply to any organization, Regardless of its type or size or the products and services it provides.

02. Normative Reference:

→ Normative references in ISO 9001 are other documents that are referenced within the management system standard.

→ For Normative Reference refer to the ISO 9000:2015 – Fundamentals and Vocabulary.

03. Terms and Definition:

→ For Terms & Definitions: Refer to the standard ISO 9000: 2015.

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04. Context of the organization:

→ Under the context of the organization we will learn about the different four requirements.

▶ Understanding the organization and its context:

→ Identify external and internal issues that are relevant to its purpose and strategic direction.

→ The context of the organization is a combination of internal and external issues.

▶ Understanding the needs and expectations of interested parties:

→ Determine who the interested parties are and their requirements.

→ As per this clause we have to determine the interested parties that are relevant to the Quality Management System.

→ The requirements of these interested parties that are relevant to the QMS.

▶ Determining the scope of the QMS:

→ As per this clause, we have to consider the external and internal issues and the requirements of the relevant interested parties.

→ Establish the boundaries and applicability of the QMS.

▶ QMS and its processes:

→ As per this clause we need to establish, implement, maintain, and continually improve a Quality Management System.

→ Also we need to include the processes needed and their interactions.

05. Leadership:

→ Under leadership we will learn about the different three main requirements.

▶ Leadership & Commitment:

→ Top management shall demonstrate leadership and commitment concerning the QMS.

▶ Policy:

→ Top management shall establish, implement, and maintain a Quality Policy.

→ It is appropriate to the purpose and contexts of the org. and supports its strategic direction.

→ Quality Policy provides a framework for setting quality objectives and it includes a commitment to continual improvement of the QMS.

⏩Customer focus:

→ Ensure customer requirements are determined and met to enhance customer satisfaction.

▶ Organizational Roles, Responsibilities, and Authorities:

→ Assign responsibilities and authorities within the QMS.

→ Top management shall ensure that the responsibilities and authorities for relevant Role.

→ Ensuring that the quality management system conforms to the requirements of the standard.

→ Ensuring that the processes are delivering their intended outputs.

→ Ensuring the promotion of customer focus.

06. Planning:

▶ Actions to address risks and opportunities:

→ Give assurance that the QMS can achieve its intended results and enhance desirable effects.

→ Prevent or reduce undesirable effects Achieve improvement.

▶ Quality Objectives & Planning to Achieve Them:

→ Set accountable quality objectives and plan how to achieve them.

▶ Planning of Changes:

→ Manage changes to the QMS systematically.

→ Determines the need for changes to the QMS and the changes must be carried out in the planned manner.

07. Support:

▶ Resources:

→ The org. shall determine and provide the resources needed for the establishment, implementation, maintenance, and continual improvement of the quality management system.

⏩The examples of resources are:

• People
• The infrastructure of a building,
• Machine, equipment,
• Transportation,
• Suitable Environment for the operation of processes,
• IT etc...

⏩Measurement Tractability:

→ The measuring equipment must be calibrated or verified.

→ Also, it should be identified to determine their status.

→ Measurement instruments should be safeguarded from adjustments, damage, or deterioration that would invalidate the calibration status and subsequent measurement results.

▶ Competence:

→ Determine the necessary competence of a person(s) doing work.

→ Ensure that these persons are competent based on appropriate education, training, or experience.

→ Retain appropriate documented information as evidence of competence.

▶ Awareness:

→ The persons doing work are aware of the quality policy and relevant quality objectives.

→ Their contribution to the effectiveness of the QMS, including the benefits of improved performance

▶ Communication:

→ Determine the internal and external communications relevant to the QMS.

⏩The communication should include:

• On what it will communicate
• When to communicate
• With whom to communicate
• How to communicate
• Who communicate

▶ Documented Information [DI]:

→ The QMS must include the following things.

⏩Creating and updating documents:

→ Below things that must be considered at the time of creating and updating [DI],

• Identification and description (e.g. a title, date, reference number, etc...)
• Format (e.g. language, software version, graphics)
• Media (e.g. paper, electronic)
• Review and approval for suitability and adequacy

⏩Control of documented information:

→ Documented Information shall be controlled to ensure:

• It is available
• Suitable for use,
• Where and when it is needed

⏩Control of documented information addresses the following activities:

• Distribution, access, retrieval, and use
• Storage and preservation, including preservation of legibility
• Control of changes (e.g. version control)       
• Retention and disposition

08. Operation:

▶ Operation Planning and Control:

→ The organization shall plan, implement, and control the processes.

→ Determining the requirements for the products and services.

▶ Requirements for Products:

⏩Customer Communication should include:

• Providing information relating to products and services
• Handling inquiries, contracts, or orders, including changes
• Obtaining customer feedback relating to products and services
• Handling or controlling customer property

▶ Design and development of products and Services:

→ The org. must establish, implement, and maintain the appropriate design and development of the process to ensure the subsequent provision of products and services.

⏩Design and development of products and Services includes:

• Design and development inputs
• Design and development controls
• Design and development outputs

▶ Control of Externally Provided Processes, Products, and Services:

→ The org. shall determine a process or part of a process, is provided by an external provider as a result of a decision by the organization

⏩The organization must determine and apply criteria for:

• Evaluation,
• Selection,
• Monitoring of performance and
• Re-evaluation of external providers

▶ Production and Service Provision:

⏩Refer to the below-mentioned production and service provisions:

• Control of product and service provision:
• Identification and Traceability:
• Property belonging to customer or external providers
• Preservation
• Post-delivery activities
• Control of changes

▶ The Release of Products and Services:

→ Retain documented information on the release of products and services

⏩The DI must include:

• Evidence of conformity with the acceptance criteria
• Traceability to the person(s) authorizing the release

▶ Control of Nonconforming Outputs:

→ The organization shall ensure that outputs that do not conform to its requirements are identified and controlled to prevent their unintended use or delivery

→ The organization has to take appropriate action based on the nature of the nonconformity.

⏩We can deal with nonconforming outputs like:

• Correction
• Segregation, containment, return
• Informing the customer
• Obtaining authorization for acceptance under concession
• Conformity to the requirements must be verified

⏩The organization must retain documented information that should be:

• Describes the nonconformity
• Mentions the actions taken
• Describe any concessions obtained
• Identifies the authority deciding the action in respect of the nonconformity

09. Performance Evaluation:

▶ Monitoring, Analysis, Measurement & Evaluation:

→ Now we will understand the different criteria for monitoring, analysis, measurement, and evaluation.

⏩The organization shall determine:

→ What needs to be monitored and measured

→ The methods for monitoring, measurement, analysis, and evaluation needed to ensure valid results

→ The organization must retain appropriate documented information as evidence of the results

⏩Customer satisfaction:

→ The organization shall monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled.

⏩Analysis and Evaluation:

→ The results of the analysis shall be used to evaluate:

• Conformity of product and services
• The degree of customer satisfaction
• The performance and effectiveness of the QMS
• The effectiveness of actions taken to address risks and opportunities
• The performance of external providers

▶ Internal Audit:

→ The organization must conduct internal audits at planned intervals.

→ So the organization can validate the QMS requirements.

⏩The organization shall:

→ Plan, establish, implement, and maintain an audit program including the frequency, method, responsibilities & planning requirements.

→ Select auditors and conduct audits.

→ Take appropriate corrections and corrective actions without undue delay.

→ Retain documented information as evidence of the implementation of the audit program and the audit results.

▶ Management Review:

→ Top management shall review the organization’s QMS at planned intervals.

→ So management should ensure its continuing suitability, effectiveness, and alignment with the strategic direction of the organization

→ Now we will learn about the management review inputs and outputs.

⏩Management Review Inputs:

• The status of actions from previous management reviews
• Customer satisfaction and feedback from relevant interested parties
• Non-conformities and corrective actions
• Audit results
• The performance of external providers
• Adequacy of resources
• The effectiveness of actions taken to address risks and opportunities

⏩Management Review Outputs:

• Opportunities for improvement
• Any need for changes to the QMS
• Resource needs
• Retain documented information as evidence of  the results of management reviews

10. Improvement:

→ Now we will understand the different requirements of improvement activities.

▶ General:

→ Improving products and services to meet requirements as well as to address future needs and expectations

→ Correcting, preventing, or reducing undesired effects.

→ Improving the performance and effectiveness of the QMS.

▶ Non-conformity & Corrective Action:

→ Refer to the below-mentioned actions that the organization should take for non-confirming and corrective action.

⏩The organization shall:

• Take action to control and correct it
• Deal with the consequences
• Reviewing and analyzing the nonconformity
• Determining the causes of the nonconformity
• Determining if similar nonconformities exist, or could potentially occur
• Corrective actions shall be appropriate to the effects of the nonconformities encountered
• Retain documented information as evidence

▶ Continual Improvement:

→ The organization shall continually improve the Quality Management System.

How to Get ISO 9001 Certification?

→ To achieve QMS (Quality Management System) certification, organizations need to follow a structured approach.

→ Refer to the below-mentioned 10 key steps for QMS certification.

⏩Ten Steps For ISO 9001 Certification are:

1. Understanding Requirements
2. Gap Analysis
3. Top Management Commitment
4. Establishing the QMS
5. Implementation
6. Internal Audits
7. Management Review
8. Select a Certification Body
9. Certification Audit
10. Certification

→ After certification we need to monitor our system.

→ In other words, we need to continuously monitor, measure, and improve the QMS to maintain certification and improve organizational performance.

Benefits of ISO 9001 Certification:

• Improved Product and Service Quality
• Enhanced Customer Satisfaction
• Increased Credibility and Trust
• Global Market Access
• Better Risk Management
• Continuous Improvement
• Employee Engagement and Empowerment
• Competitive Advantage
• Better Supplier Relationships

Conclusion:

→ ISO 9001 certification is a powerful tool for organizations.

→ It will help to enhance their quality management practices and improve overall performance.

→ By aligning processes with this standard, businesses can increase operational efficiency, improve product quality, and ensure customer satisfaction.

→ The certification fosters a culture of continuous improvement, risk management, and accountability.

→ That will enhance the credibility and competitiveness of the business and organization.

→ Finally, ISO 9001 certification is a strategic investment of the organization that drives the long-term success of businesses.