ISO 9001: 2015

Quality Management Systems

Want to get certified to ISO 9001 and be recognized as a leader in product / service quality and customer satisfaction? Choose us as your certification partner and get the service, help, attention and recognition to boost your competitive edge and image!

What is ISO 9001?

ISO 9001 is an internationally acclaimed standard for quality management systems, which focuses on a company’s operational productivity and efficiency to meet the quality expectations of the customer. It ensures the effectiveness of your management system and ensures a higher degree of excellence has been met. To pursue “good management practices”, companies are encouraged to meet the requirements of ISO 9001.
The system was first established in the year 1987 and has gone through several revisions in 1994 and 2008. The current version of the standard, ISO 9001:2015, is implemented by more than 1 million small to large-scale organizations globally. Compliance boosts productivity, management effectiveness and establishes a strong brand image. Getting certified to ISO 9001 shows a company’s ethical conduct, quality control and assurance in its production, service, and delivery.

Which organizational practices are covered by ISO 9001?

ISO 9001 does not only concentrate on the quality aspect of your organization, but also promotes best practice in the following organizational modules:

  • Supply chain management
  • Objectives and plans
  • Mission statement
  • Determining customer satisfaction
  • Management analysis and review
  • Strategic management
  • Documentation of the management system and implementation
  • Risk assessment
  • Data collection and subsequent analysis
  • Control of non-conformances
  • Forming and implementing corrective actions
  • Understanding customer expectations and determining their satisfaction
  • High morale and competent workforce

What Are The Main Benefits Of Getting ISO 9001?

1. Helps improve customer satisfaction: The fundamental purpose of ISO 9001 is to meet quality benchmarks and satisfy customers. Certification ensures that the company has maintained all quality control measures and followed the planned management protocols.

2. Promotes low-cost operations: ISO 9001 supports constant improvement to increase management and operational efficiency. As a result to that, the quality management system helps companies in saving unnecessary costs.

3. Supports stronger stakeholder relationships: A quality management system promotes stakeholder relationships as it engages the workforce and other internal stakeholders to act more proactively. The system increases employee morale too.

4. Win contracts: One of the main requirements for getting new contracts is offering a certified quality service. Depending on your industry and / or customer ISO 9001 certification can be a requirement for winning contracts.

5. Strengthen brand image: A company can not sustain itself in a competitive field if it fails to have a strong brand image. By constantly meeting customer demands, a company gradually earns a reputation. ISO 9001 certification helps to create and maintain a strong brand image and reputation.

6. Increase business consistency and allow business continuity: By establishing an effective quality management protocol, a company will increase its production which will be a major contributor to business continuity. Also, by documenting your management system, a company will function better in the absence or loss of key employees / contractors.

7. Ensures legal compliance: To meet the main requirements of ISO 9001, a company is forced to comply with the basic terms and conditions, which include statutory obligations. Therefore, the standard helps to ensure legal compliance in the proper manner.

What are the main requirements for getting ISO 9001?

1. Leadership

ISO 9001 requires that senior leadership are supportive, committed, and engaged, without this, it is impossible to meet ISO 9001. According to clause 5, the leadership includes the following:

  • Holding annual management reviews
  • Establishing a quality policy, objectives and plans
  • Creating and implementing a quality management system that meets the requirements of the standard and the organization
  • Communicating the policies and objectives to stakeholders.

2. Planning

The second requirement is planning to find and mitigate potential risk factors. Therefore, according to clause 6, a company must -

  • Recognize and document potential risk factors. List them according to their levels of severity and chances of occurrence.
  • Plan accordingly to prevent the risks.
  • Integrate plans for increasing the productivity

3. Organizational content

In the form of organizational content, a company must determine the following:

  • Purpose and objectives of the system.
  • The strategic direction of the organization
  • The scope of the Quality Management System (QMS)

4. Provision of resources

As per clause 7, there should be adequate resources in form of:

  • Effective and robust infrastructure.
  • Productive working environment.
  • Effective and competent personnel

5. Operation

Clause 8 covers the operations of a company and focusses on the responsibility of developing and delivering quality products / services. The operational structure should:

  • Monitor and test systems to ensure that quality benchmarks are being met
  • Set out the quality objectives and customer requirements
  • Create documentation, specifications, and / or instructions and make the needed resources available for employees

6. Performance evaluation

Clause 9 of ISO 9001 requires frequent performance evaluations for analyzing collected data from production and management to ensure among other things:

  • Customer satisfaction
  • Supplier compliance
  • Successful application of each aspect of the Quality management system
  • Supporting continual improvement

7. Continual improvement

A goal of ISO 9001 is to continually improve. For that companies must:

  • Identify in a timely manner which aspects of the system are not working as per the defined objectives and plan accordingly to improve them
  • Make contingency plans as needed.

Certification Process

The certification process is as follows:

Commitment - A trusted certification body is chosen, engaged, and an audit date is set.

Pres-assessment - If clients wish, an assessment before the stage 1 and 2 audits is performed.

Stage 1 Audit - The management system and documentation are reviewed to ensure everything is in place for the stage 2 audit, including determining whether internal audit and the management review have been performed. An audit report is prepared and issued by the auditor for review. If everything looks good, the auditor confirms the stage 2 audit.

Stage 2 Audit - After addressing any concerns or opportunities for improvement from the stage 1 audit, the stage 2 audit is conducted by the auditor. The auditor checks that the management system is implemented and is compliant with ISO 9001. If there are any non-conformities, these are shared by the auditor. Once non-conformities are addressed and the auditor can confirm that the standard is being met, the auditor recommends the company for certification.

Issuing the certification - With the successful completion of the two stages of audits, the certification body issues the certification.

Surveillance Audits - Every certification lasts for 3 years. The certification body organizes annual audit programs to ensure ongoing compliance.

How Can Blue Wolf Certification Help You To Achieve ISO 9001 in The Best Way Possible?

Blue Wolf represents renowned and accredited certification bodies and offers a detailed and friendly ISO certification service. Our experts audit your management systems and determine whether they conform to your organization’s objectives and ISO 9001’s requirements.

Why Should You Hire Us?

  • We are known for our efficient but detailed audits. Our professional auditors want to help make your ISO certification journey easier and better.
  • Great auditors. We work with our auditors to ensure they will be a great fit for you. Our auditors have been described as transparent, open, fair and supportive. Even easy to talk to and helpful.
  • A valuable audit experience. Our audits have been described as non-threatening, relaxing, straight forward, orderly, professional and painless.

Frequently Asked Questions

1. What is ISO 9001?
ISO 9001 is the global standard for quality management systems. When accredited certification to ISO 9001 is achieved customers are assured that the quality systems are compliant to the international standard and that the quality of products/services they will be receiving is more likely to meet their specifications. The requirements of the standard aim to help your organization have a fuller and more solidly built quality management framework to help ensure production and delivery meets customer expectations. Therefore, the standard outlines the practices, procedures, and fundamental requirements to implement an effective Quality Management System (QMS) in an organization. Besides focusing on the quality aspect, the standard helps to increase employee engagement, performance, and overall operational efficiency.
2. What are the main requirements of ISO 9001?
● Leadership
● Customer focus
● Context of the organization
● Planning
● Support
● Performance evaluation
● Factual decision making
● Relationship management
● Continual improvement
3. How much does it cost to get the certification?
The cost depends primarily on the number of audit days. The number of audit days is determined from other standards and industry mandatory documents. Factors that increase or decrease the number of audit days include the number of personnel, the level of risk, the type of industry your organization belongs to, and consideration of various factors (simplifications or complications) that help to understand the complexity or your organization. All of this to ensure there is adequate audit time to determine compliance to ISO 9001.
Each certification body determines their own day rate. The rates can vary depending on the standard, the availability of auditors and the amount auditors charge the certification body. Additional factors that affect cost are the certification body’s accreditation fees, admin costs, and other costs as outlined in their proposal. It is important to be aware of additional fees as they can add up. In some cases, a certification body’s day rate may be low, but additional fees can be high, so do your due diligence. Some certification bodies you may notice will charge premium pricing based on how they perceive themselves in the marketplace, however all certification bodies have the same credibility anywhere in the world because of their accreditation. Before choosing an accreditation body, it may be necessary to check with your customers if they care about the name of the certification body. It is very unlikely your customer cares about the name however as long as it is an accredited certification body.
Other costs can be the cost of travel including food, accommodation, etc. for the duration of the audit.
4. How to get ready for ISO 9001 certification?
To get ready for ISO 9001 certification, it might be best to get help from a reputed consultancy firm or have an internal expert that is experienced in ISO compliance. Following are general steps to be followed:
● Understand the requirements of the standard and prepare a comprehensive plan to accomplish all of them.
● Document policy, objectives, scope, and procedures needed for achieving certification. In addition, documentation may include process flowcharts and instructions for the workers.
● After preparing compliant and helpful documentation and processes, it is time to implement the Quality Management System (QMS) and regularly monitor it’s implementation.
● Next, internal audits should be done to check whether everything is working per the requirements, and is functioning in a manner that works for the organization.
● The final step is hiring a certification body to perform the external certification audits and grant certification as evidence of compliance.
5. What are the benefits of getting ISO 9001?
● Quality control
● Customer satisfaction
● More customers and more profit
● International acknowledgment and exposure
● Better employee engagement
● Business continuity management

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