What is ISO 9001?

ISO 9001:2015 Quality management systems – Requirements (ISO 9001) is the international standard that specifies the requirements of a QMS (quality management system). A QMS enables organisations of all types and sizes to drive operational efficiency by ensuring the consistent quality of their products and services.

ISO 9001 is the only quality management standard against which organisations can achieve independently audited certification to demonstrate that they are following its best practice. More than 1 million organisations in over 170 countries are currently certified to the Standard.

What does ISO 9001 cover?

ISO 9001 establishes process-driven methods of producing and delivering products and services with consistent results. The Standard comprises 11 clauses: 0 is the introduction, 1–3 provide context for the Standard and 4–10 specify the requirements for a QMS.

These requirements are:

 Clause 4 – Context of the organisation

Understanding the environment in which the organisation operates and defining the scope of the QMS.

 Clause 8 – Operation

Processes covering the entire lifecycle of products and services, from planning and control to evaluating whether products and services meet the quality requirements.

 Clause 5 – Leadership

The need for top management to lead the QMS project, create a quality policy, and assign roles, responsibilities and authorities relating to quality management.

 Clause 9 – Performance evaluation

Monitoring, measurement, analysis and evaluation; internal audits; and management reviews.

 Clause 6 – Planning

Risks and opportunities, and their effect on quality objectives.

 Clause 10 – Improvement

Continual improvement of the management system by addressing nonconformities.

 Clause 7 – Support

The importance of supporting the QMS by providing the necessary resources and organisational structures, and creating appropriate documentation.

These requirements are based on the seven QMPs (quality management principles) described in ISO 9000:

QMP 1 – Customer focus
QMP 2 – Leadership
QMP 3 – Engagement of people
QMP 4 – Process approach

QMP 5 – Improvement
QMP 6 – Evidence-based decision making
QMP 7 – Relationship management

Benefits of ISO 9001

Business success depends on balancing investment and returns.

Develop poor-quality goods and services and no one will buy them; create high-quality products and services and you risk pricing yourself out of the market when attempting to recoup your costs.

With an effective QMS, your products and services will meet established quality levels every time, giving you greater control over production costs and increasing customer satisfaction.

Implementing a QMS will help your organisation:

  • Accurately assess its overall context, so it can clearly state its objectives and identify new business opportunities;
  • Enhance customer satisfaction by ensuring it consistently meets their needs;
  • Improve its efficiency, and thereby reduce its operational costs, by introducing properly aligned processes and ensuring everyone understands them;
  • Demonstrate strong corporate governance;
  • Work effectively with stakeholders and supply chains; and
  • Meet its statutory and regulatory requirements.

How to get started with ISO 9001

  1. The first step in any ISO 9001 QMS implementation project is to buy a copy of the Standard. Buy your copy of ISO 9001 from IT Governance.
  2. Next, conduct a gap analysis to determine the extent to which your existing processes meet ISO 9001’s requirements and identify the areas you need to address. Use the ISO 9001 Gap Analysis Tool to find out what you need to do to meet the Standard’s requirements.
  3. As you fill the compliance gaps you have identified, you can use the ISO 9001 Documentation Toolkit to create ISO 9001-compliant documentation. Buy the ISO 9001 Documentation Toolkit.

ISO 9001 certification

ISO 9001 is the only quality management standard against which organisations can achieve independently audited certification.

Certification is not compulsory – you may decide that you benefit enough by implementing the Standard’s best practice.

However, certification is a good way of enhancing your organisation’s credibility by demonstrating that you follow processes to ensure your products and services meet quality criteria.

How much does ISO 9001 certification cost?

Each ISO 9001-compliant QMS is specific to the organisation that implements it. ISO 9001 implementation projects vary in time and cost depending on numerous factors, including:

  • The size and complexity of your organisation;
  • The extent to which you conform to the Standard already;
  • The amount of consultancy support you require;
  • The certification board you choose; and
  • The cost of ISO 9001 certification and recertification audits.

How long does ISO 9001 certification take?

As with QMS implementation costs, the duration of an ISO 9001 project varies depending on the organisation.

Generally, larger organisations can expect to reach certification in 8–12 months and smaller companies can achieve it faster – often in as little as 2 months.

Your ISO 9001 certification pathway

Follow these steps to certify to ISO 9001:

  1. Buy a copy of the Standard.
  2. Conduct a gap analysis to understand how far short of the Standard’s requirements your existing practices fall.
  3. Implement the necessary policies and processes, and create the required documentation.
  4. Train your staff so they understand what they need to do, and the importance of quality management to the business.
  5. Undergo a pre-certification audit.

Assuming the results of the pre-certification audit are positive, you should then be ready for certification.

Integration made easy

ISO 9001 follows the Annex SL structure common to many ISO management system standards.

This sets out ten high-level section headings, identical core text for sub-clauses and requirements, and a number of common terms and core definitions.

This means ISO management system standards are compatible, making it easier to implement management systems that conform to multiple standards, such as ISO 14001 (environmental management systems), ISO 27001 (information security management systems) and ISO 25001 (occupational health and safety management systems).

 

How GRC eLearning can help you with ISO 9001 certification

Educate your employees on the importance of quality management with our ISO 9001 Staff Awareness E-Learning Course.

It covers:

  • How quality management can improve an organisation’s output;
  • What ISO 9001 is, its importance and how it impacts the organisation;
  • How risk-based thinking is applied in the context of an organisation; and
  • How process improvement can be applied to ensure compliance.

Learn more

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