Does your business want to get ISO 9001 certified? Then, you need to know about all the paperwork involved. Figuring out what documents you need and how to set them up can feel confusing, but we’ll help break it down simply.

ISO 9001 is an international quality standard businesses can get certified to. It shows customers you have high-standard business practices and management systems. A big part of getting that certification involves managing certain documents and records. The paperwork part can take some planning, so it’s necessary to understand exactly what docs you’ll need before getting started.

We’ll look at things like what the documentation is, what the mandatory and non-mandatory documents and records are, and the right time to review the documentation. 

What Is ISO 9001 Documentation? 

ISO 9001 documentation refers to the set of documents and records that a company must create, implement, and maintain to demonstrate that its quality management system meets the requirements of the ISO 9001:2015 international standard. Following the ISO 9001 standard helps ensure organizations consistently provide products and services that meet both customer and regulatory requirements.

It formalizes a company’s quality policies, objectives, processes, and procedures. This includes documenting things like the process of handling non-conforming products and services, managing corrective and preventative actions, and controlling the documents.

Documentation must demonstrate that the quality management system is effectively planned, operating according to plan, and being continually improved. 

Common types of ISO 9001 documents include quality manuals, documented procedures, work instructions, records of activities and results. Records must be maintained to prove requirements are being met.

Having thorough documentation in place has several key benefits:

• • It provides evidence that requirements are properly addressed and planned work is carried out according to procedures.

• • Documentation acts as an important knowledge base for training new employees and ensures all staff are aware of relevant quality policies, procedures, and responsibilities.

• • Maintaining documents and records provides transparency, allows issues to be easily traced, and supports continual improvement efforts through analysis of quality data trends over time.

Meeting documentation requirements is necessary for certification to ISO 9001, which can then be used to demonstrate an organization’s capability to consistently provide products and services of quality to its clients.

ISO 9001:2015 Standard Mandatory Documentation

Mandatory documentation refers to the requirement that a company must comply with to get the ISO 9001:2015 certification. 

There are two main types of documentation. 

• • Documents: They are the biggest plans like policies, which outline the overall way things are run, and processes that show the separate steps in jobs. Both of these describe what happens and can be adjusted later if needed. 

• • Records: They are proof of what the company did. They show the real results and can’t be changed because they must be the real facts of what truly happened.

a. Mandatory Documents

A business must submit these four documents to get the certification:

1. Quality Policy (clause 5.2.2)

The quality policy is an important part of any quality management system. It tells everyone what an organization’s approach to quality will be. For a quality policy to meet the ISO 9001 standard, it must address some key things.

Top management has to develop the policy and make a statement to show their commitment to meeting requirements and improving the system. Management ensures everyone knows the policy and what it means for their jobs by including it in employee training. This helps everyone understand their role in achieving the quality aims.

The quality policy also has to support the organization’s objectives, which means it should align with the business’ goals. What do these objectives refer to? Well, they could be customer satisfaction, minimizing errors, or improving on-time delivery. By linking the quality policy to objectives, the whole company can work toward the same aims.

The policy also has to be reviewed. Management checks if it is still relevant as things change. If objectives or requirements update, the policy may need updating too. 

2. Quality Objectives (clause 6.2)

ISO 9001 explains that organizations should establish quality objectives. These are specific, measurable targets to improve the Quality Management System or QMS. The QMS is how the company manages all the work that affects quality. Things like procedures, responsibilities, and reviews are part of the QMS.

By linking quality objectives to the company’s quality policy, everything fits together better. The policy states the overall approach to quality. The objectives then provide steps to carry out the policy. Managers can use the objectives to guide the QMS and track progress.

Objectives need to be clear and quantifiable. Everyone must know what exactly needs to be accomplished. Goals also need to keep products and services meeting customer needs. After all, satisfied customers are crucial for any business.

3. Quality Management System’s Scope (clause 4:3)

The scope defines an organization’s Quality Management System (QMS) boundaries. It shows what operations the QMS covers and any exclusions from ISO 9001 requirements. These exclusions must include justifications.

The documentation is about detailing the offered products/services and outlining the processes subject to the QMS. It can apply to an entire organization, specific departments, or functions across multiple companies.

When determining scope, consider three key factors: 

1. 1. Look at relevant external and internal issues. This includes your purpose, strategic goals, and ability to meet results. 
   2. Understand requirements from interested parties too, like customers or regulators. 
   3. Scope your offerings, like describing the products/services your company offers. 

Together, properly defining scope helps a business to manage quality effectively. It sets precise targets for staff and stakeholders. 

4. Control Procedure for Outsourced Processes (clause 8.4)

Every company must ensure that outsourced work meets their quality standards. Clause 8.4 of the ISO 9001 gives guidelines for this. It says any time another company does work for you, you need to check that it’s done right. This could be if someone else makes parts for your products, delivers a service instead of you, or does some of your work for you.

You’ll want to think about a few things. First, exactly what do you want them to supply? Be very clear about details like materials, specs, or deadlines. Also, how will you approve it? Maybe inspect samples or do a quality check when it’s done. Asking about their methods and equipment is smart too. You want to know they’ll do it safely and properly. And don’t forget to consider the skills of their workers. 

With a good control plan like this, you can feel confident that any outsourced work meets the quality your customers expect.

b. Mandatory Records

The list of mandatory records for ISO 9001:2015 certification include:

• • Maintaining and calibrating the equipment. Also, the proof of corrective measures taken for out of calibration machines. (Clause 7.1.5.1)

• • Documented proof about the competency of the employees. (Clause 7.2)

• • Products and services requirement review, which includes the requirements for a company to assess and understand the prerequisites for its products. (Clause 8.2.3.2)

• • Design and development output review that documents the outputs of product design and development stages. The records make sure that the end-products meet the required standards. (Clause 8.3.2)

• • Design and development inputs, which can be in the form of photographs, data sheets, reference to some set standards, etc. (Clause 8.3.3)

• • Control of design and development that ensures that the products meet the set standards. (Clause 8.3.4)

• • Design and development outputs. (Clause 8.3.5)

• • Design and development changes that include the description, reasons, and timing of the changes along with a few more details. (Clause 8.3.6)

• • Evidence of product/service conformity with defined criteria for acceptance. This includes traceability of the products along with regulatory and release certificates. (Clause 8.6)

• • Supplier evaluations and selections. (Clause 8.4.1)

• • Control of the way of product manufacturing and service provision. (Clause 8.5.1)

• • Changes in products or services provided. (Clause 8.5.6)

• • Protecting the property of customers, suppliers, or subcontractors, including changes. (Clause 8.5.3)

• • Non-compliance to the required standards. (Clause 8.7.2)

• • Internal audit programs for self-assessment and checking the compliance with the set standards. (Clause 9.2.2)

• • Information on performance monitoring on processes and products and measurement of success. (Clause 9.1.1)

• • Management reviews for evaluating the performance along with finding improvement areas and enforcing necessary changes. (Clause 9.3.3)

• • Corrective action taken for non-compliance and opportunities for improvement. (Clause 10.2.2)

ISO 9001:2015 Non-Mandatory Documentation

Apart from the mandatory documentation, a business may need to submit some non-mandatory documents and records. The most common ones of them include:

• • The process for deciding on the context of the company and other affiliated parties. (Clauses 4.1 and 4.2)

• • Procedure for finding out and resolving risks and opportunities. (Clause 6.1)

• • The plan of action for employee competence, training, and awareness. (Clauses 7.1.2, 7.2, 7.3)

• • The process for the control of documents and records. (Clause 7.5)

• • Procedure for upkeep and measurement of equipment. (Clause 7.1.5)

• • Sales procedure. (Clause 8.2)

• • Procedure for product/service design and development. (Clause 8.3)

• • The process for manufacturing and service provisioning. (Clause 8.5)

• • The detailed process of warehousing. (Clause 8.5.4)

• • Records that outline the details of measuring customer satisfaction. (Clause 9.1.2)

• • Internal audit procedure. (Clause 9.2)

• • The detailed procedure for reviewing the management system. (9.3)

• • The procedure for finding out, documenting, and assessing nonconformities to execute corrective measures. (Clauses 8.7 and 10.2)

Some of these non-required procedures still matter for documenting the mandatory procedures. You should do a non-mandatory process if it becomes necessary to create and manage a mandatory document. This extra documentation helps run the quality system smoothly. It makes sure your company thrives by meeting the ISO standard’s key requirements. 

What Is Document Control in ISO 9001:2015?

Document control helps make sure everyone follows the same processes and has access to the right information. With good document control, a company can better manage its most important documents like quality manuals, inspection forms, and procedures.

Some key things document control covers include approving documents, making sure the latest versions are available, and tracking any changes. It’s important to clearly show who is responsible for reviewing documents. 

The process also identifies the current versions of files compared to old ones. This prevents mix-ups where someone follows outdated information by mistake. 

Well-organized document control promotes consistency throughout an organization. 

Do Businesses Still Need the Quality Manual?

While quality manuals are no longer mandatory under the ISO 9001:2015 standard, many companies still find them useful. A quality manual provides a high-level overview of your organization’s Quality Management System (QMS). It describes how you meet customers’ needs and comply with standards through your processes, documents, and resource management.

For organizations with multiple sites, manuals promote consistency across locations by outlining how everyone should implement the same QMS. They also help onboard new employees. Rather than searching through dozens of documents, new hires can refer to the quality manual to get a quick understanding of the overall system.

Quality manuals continue to provide value during audits too. While not explicitly required, showing your quality approach in one place helps auditors verify your QMS compliance more efficiently. Your manual showcases the structure behind your daily operations and commitment to quality principles.

While not mandatory, quality manuals can still support business needs for consistency, training and demonstrating your skills to customers and auditors. A well-designed manual fits naturally into how your QMS functions on a practical level.

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