ISO 9001 requirements: what is needed to achieve compliance?
ISO 9001 is a critical certification for business owners who want to gain a competitive advantage over their competitors.
ISO 9001 is designed to ensure consistent, high-quality products and services for your customers. It applies to all businesses and industries – however, it is not a legal requirement for starting, owning or running a business.
ISO 9001 is recommended if you want an organised and methodical approach to business improvement — think quality, productivity, profitability, customer satisfaction and retention, and building professional relationships and partnerships. Any business can take on the ISO 9001 challenge and reap the benefits.
But what are the ISO 9001 requirements? Let’s take a deeper dive into what is needed for compliance.
ISO 9001 is based on 10 clauses and requirements — with very little room for mistakes
Image: ISO 9001 Checklists
ISO 9001 is based on 10 essential clauses, split into four simple actions: plan, do, check and act. These are the building blocks of ISO 9001 compliance and will help guide the assessment and continual improvement of your business.
You must review your business management systems on a regular basis, plan process and workflow changes to fill in ISO compliance gaps, do what needs to be done to fill the gaps, check the effectiveness of these changes, and act when these changes are not successful.
Below, we have staged out the 10 clauses as per the ISO 9001 requirements checklist.
The “planning” section of the ISO quality standards checklist sets you up to complete a wider assessment of your business as a whole. Here, you will determine the scope and objectives of the assessment, define terms and jargon relating to the business, consider the context of the business and review the performance and commitment of the leadership team.
Think of this as the “blurb” of your business assessment. Below you will find a list of considerations and topics to cover off in stage one: “planning”.
- Clause 1: Scope
- Clause 2: Normative references
- Clause 3: Terms and definitions
- Clause 4: Context of the Organisation
4.1 Understanding the organisation and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
- Clause 5: Leadership
5.1 Leadership and commitment
5.1.1 Leadership and commitment for the QMS
5.1.2 Customer focus
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.3 Organisational roles, responsibilities, and authorities
- Clause 6: Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
The “do” section of the ISO quality standards checklist covers the practical side of your business. It considers the tools and support systems needed to get the job done — from ordering stock to meeting with clients.
No business can make it 100% on its own. Resources, team members, training and the right tools for the job are required to operate the business successfully. By assessing the effectiveness of your current support and operations systems, you can determine what needs to change to become ISO compliant.
Read the clauses below and discover what you need to consider for ISO 9001 compliance.
- Clause 7: Support
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organisational knowledge
7.5 Documented information
7.5.2 Creating and updating documented information
7.5.3 Control of documented information
- Clause 8: Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products, and services
8.5 Product and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
- Clause 9: Performance Evaluation
9.1 Monitoring, measurement, analysis, and evaluation
9.1.2 Customer satisfaction
9.2 Internal audit
9.3 Management review
- Clause 10: Improvement
10.2 Nonconformity in ISO 9001
10.2 What is non-conformance?
10.2 Corrective action
10.3 Continual improvement
It may sound like a lot of paperwork but it’s not as daunting as it sounds. At QMS, we can take a closer look at your business from an outsider’s perspective and provide valuable recommendations in the form of an assessment report.
From this, we will empower you and your team to improve your existing processes and frameworks to achieve certification, compliance and ongoing business improvement.
Allow us to make the certification process simple. Get in touch for more information about our essential services.
Mandatory ISO 9001 requirements
In order to achieve ISO 9001 certification, certain documents need to be submitted to prove compliance. There are mandatory documents and non-mandatory documents.
The following documents and records MUST be submitted for review:
- Monitoring and measuring equipment calibration records
- Records of training, skills, experience, and qualifications
- Product/service requirements review records
- Record about design and development outputs review
- Record about design and development inputs
- Records of design and development controls
- Records of design and development outputs
- Design and development changes records
- Characteristics of product to be produced and service to be provided
- Records about customer property
- Production/service provision change control records
- Record of conformity of product/service with acceptance criteria
- Record of nonconforming outputs
- Monitoring measurement results
- Internal audit program
- Results of internal audits
- Results of the management review
- Results of corrective actions
These documents demonstrate your compliance and commitment to ISO international standards. It demonstrates you have put in the work to improve your business in line with the guidelines — and there are definite benefits for quality, productivity and even customer retention.
Non-mandatory ISO 9001 requirements
Non-mandatory requirements are helpful to include, but not mandatory for all businesses and industries. These include:
- Procedure for determining the context of the organisation and interested parties
- Procedure for addressing risks and opportunities
- Procedure for competence, training, and awareness
- Procedure of equipment maintenance and measuring equipment
- Procedure for document and record control
- Sales procedure
- Procedure for design and development
- Procedure for production and service provision
- Warehousing procedure
- Procedure for management of nonconformities and corrective actions
- Procedure for monitoring customer satisfaction
- Procedure for internal audit
- Procedure for management review
Whether or not you include these documents depends on how detailed and thorough you want your business gap analysis to be. A certification specialist can review these documents for you and identify whether you have a) achieved ISO 9001 certification compliance or b) require further documentation to prove compliance.
How QMS can help you navigate the ISO 9001 requirements
At QMS, we’ve been helping Australian businesses navigate the complexities of certification since 1994. We have experience across a wide range of industries including defence, construction and engineering, manufacturing, aged care, food and hospitality, facilities management, and transport.
We have contextual knowledge about your business and what’s required to achieve ISO 9001 certification within your industry. Our certification specialists will complete a gap analysis of your business and provide your business with the knowledge of what needs to be worked on to achieve compliance.
We will also consider the top ISO 9001 clauses:
- Context of the organisation
- Performance evaluation
QMS is dedicated to guiding your business toward a successful ISO 9001 application. For more information about our services, get in touch with the team from QMS.