ISO 9001 requirements is an international standard requirement for a quality management system.
Most people learn ISO 9001 requirements because customers or bosses ask for ISO 9001 certificate.
To get an ISO 9001 certificate, you need to know all the ISO 9001 requirements. Get prepared for whatever is required by the standard. Then, get an ISO 9001 certification body to send an auditor to your office for an audit. You will obtain your ISO 9001 certificate if all ISO 9001 requirements are met.
OK…
But what should you do?
Let’s explain in more detail each of them.
What is ISO 9001 QMS requirements?
All the requirements in ISO 9001 QMS are generic. Meaning it can use for any business and any size of organization.
Two (2) or 20,000 employees in a company can apply for ISO 9001 certification.
To learn more about ISO 9001 QMS requirements, you must get a copy of the ISO 9001 international standard.
You can buy the Malaysian Standards version of ISO 9001 Quality management systems requirements in Malaysia from the Malaysian Standard Online store.
MS ISO 9001:2015 standard price is RM60.
Here are the ISO 9001:2015 QMS standard contents.
4.1 Understanding the organization 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
5.1 Leadership and commitment
5.1.1 General
5.1.2 Customer focus
5.2 Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibilities and authorities
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organizational knowledge
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
8.1 Operational planning and control
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements for products and services
8.2.3 Review of the requirements for products and services
8.2.4 Changes to requirements for products and services
8.3 Design and development of products and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customer or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
8.6 Release of products and services
8.7 Control of nonconforming outputs
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.3 Management review
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
After a look at the ISO 9001 standard contents, you probably feel “blank” in your mind.
What is that? How to do?
No worry, it’s a common feeling for the first-timer when looking at the ISO 9001 standard.
Let’s move to the next part for an answer you may feel interested in.
How to prepare to fulfil ISO 9001 requirements?
As mentioned early, ISO 9001 QMS standard requirements are generic. It’s designed to be generic.
So, if you read the full details of the ISO 9001 QMS standard clauses, it only tells you.
What is needed ,not "What to do?" & "How to do?"
For a beginner like you, if appointed to handle your company’s ISO 9001 certification project. The recommendation is to engage an ISO 9001 consultant to help you set up the quality management system according to ISO 9001 requirements.
ISO 9001 certification is not one (1) man project; it must involve all the staff and processes.
An experienced ISO 9001 consultant will save you time getting things set up. Customize to your business nature and organization context. Simplify for your staff to follow. Make you easy in future upkeep.
Below are examples of “WHAT TO DO?” in fulfilling the ISO 9001 clause.
- 5.2 Policy – Prepare your written quality policy
- 6.1 Actions to address risks and opportunities – Establish your business risk assessment criteria and method
- 7.2 Competence – Prepare a training plan as per your staff competency
- 8.2 Requirements for products and services – Standardize your order process control
- 8.6 Release of products & services – Standardize your quality control process
- 9. 2 Internal audit – Train staff to do an internal audit
- 10.2 Nonconformity and corrective action – Establish your defect or complaint control
There are 7 main clauses and 64 subs and sub/sub-clauses to fulfil in ISO 9001:2015 standard.
I hope the examples give clues about what to do to fulfil the ISO 9001 requirements.
Next, let’s see when will be the right time to contact the certification auditor.
When to ask ISO 9001 certification auditors to come to audit?
You only ask the certification auditor to come to your office when you are well prepared.
What mean by well prepared?
- You have prepared all the necessary ISO 9001 documentation.
- Your staff are trained on ISO 9001 awareness and procedures.
- Your team follows ISO 9001 procedures to do their daily work and take essential records.
ISO 9001 certification body usually requires three (3) months of implementation records before they come to audit you.
So, you can start contacting the certification body after training your staff. Coordinate with the certification body to book your audit date.
If everything goes smoothly, from ISO 9001 preparation to certification, it takes about 3 – 6 months.
Final Thoughts
ISO 9001 QMS requirements standard consists of 29 pages in a copy.
You should have a copy for reference in preparing your ISO 9001 documentation, implementation and internal QMS audit.
Keep your eyes on any new updated version of ISO 9001 requirements.
If you have any other questions regarding ISO 9001 requirements, just let us know in the comment section below.
