Don’t feel overwhelmed by the number of procedures required for ISO registration. The 2008 standard stipulated that certification will involve the completion of six necessary steps. The situation has changed. The documentation requirements are substantially more lenient in the 2015 standard. We go over the different kinds of documentation included in the standard and which are necessary for your company to be accredited.
Here is a list of the documentation requirements for ISO 9001; it includes both required documents as well as the ones that are most frequently utilized in ISO 9001 implementation.
ISO Certification Type
It is important to keep in mind that there are several forms of ISO registration before moving further with it, including:
- Quality control – 2008 ISO 9001
- ISO 14001: Environmental Management
- Management of information security – ISO 27001
- Management of food safety – ISO 22008
Depending on the size of your business, there are different documentation requirements for ISO 9001. Other elements that affect the paperwork required include:
- The organization’s activities, goods, and services are of what kind.
- The degree to which business operations are complex
- How the activities are structured
- Competence of individuals
Why ISO 9001 certification is required?
The ISO 9001 certification denotes the high caliber and compliance with international standards of the company’s goods and services. This certification is necessary due to:
- It serves as evidence that protocol-compliant actions were taken.
- In order to assure quality policy and deliverables, it helps the company’s management assess current processes and find opportunities for adjustment.
- It helps ensure a regulated execution of the procedure.
- Minimizes and further reduces errors
- Facilitate efficient communication between several verticals
- It establishes a standard and point of reference for the comprehension, application, and upkeep of a system.
- It facilitates achieving consistency in behavior
- It increases transparency in the operational procedures.
Different types of documents required for ISO 9001 registration
The documentation is done in four different levels as follows
- Quality Manual
The ISO 9001 document requirement is a quality manual that contains all the information about the organization’s structure. These documents must also follow the proper management procedures, outlining how the corporate goals will be achieved while upholding the caliber of the deliverables.
- Documented procedures
Second, each organization must have a detailed working protocol that is documented. The primary document needed is this record because it will also serve as a standard document. This document needs to include all the steps that are to be taken in great detail as well as the necessary quality standards.
- Work instructions
Work instructions are the third necessity. A work instruction is a comprehensive document that lists all the different tasks that must be completed inside an organization. In truth, it does explain even the most basic steps that help achieve the desired outcome.
- Records and Forms
The company was expected to provide documentation of all work completed at level four of the documentation process. Management may later utilize it to examine or assess the potential for progress. Labels, cards, workbooks, forms, tags, and other items must also be included.
Mandatory records and papers mandated by ISO 9001:2015
The documents that you must create in order to comply with ISO 9001:2015 are listed below. (Note that if the business doesn’t carry the necessary processes, some of the documentation won’t be required.)
- Scope of the QMS (clause 4.3)
- Quality policy (clause 5.2)
- Quality objectives (clause 6.2)
- Criteria for evaluation and selection of suppliers (clause 8.4.1)
And now for the records that must be kept (please note that records marked with an asterisk must be kept only in situations where the applicable clause is not excluded):
- Monitoring and measuring equipment calibration records* (clause 22.214.171.124)
- Records of training, skills, experience, and qualifications (clause 7.2)
- Product/service requirements review records (clause 126.96.36.199)
- Record about design and development outputs review* (clause 8.3.2)
- Records about design and development inputs* (clause 8.3.3)
- Records of design and development controls* (clause 8.3.4)
- Records of design and development outputs *(clause 8.3.5)
- Design and development changes record* (clause 8.3.6)
- Characteristics of product to be produced and service to be provided (clause 8.5.1)
- Records about customer property (clause 8.5.3)
- Production/service provision change control records (clause 8.5.6)
- Record of conformity of product/service with acceptance criteria (clause 8.6)
- Record of nonconforming outputs (clause 8.7.2)
- Monitoring and measurement results (clause 9.1.1)
- Internal audit program (clause 9.2)
- Results of internal audits (clause 9.2)
- Results of the management review (clause 9.3)
- Results of corrective actions (clause 10.1)
Documents that are optional
Numerous optional documents are available for use in the implementation of ISO 9001. However, I discover that the following optional documents are the most frequently used:
- Procedure for determining context of the organization and interested parties (clauses 4.1 and 4.2)
- Procedure for addressing risks and opportunities (clause 6.1)
- Procedure for competence, training and awareness (clauses 7.1.2, 7.2 and 7.3)
- Procedure for equipment maintenance and measuring equipment (clause 7.1.5)
- Procedure for document and record control (clause 7.5)
- Sales procedure (clause 8.2)
- Procedure for design and development (clause 8.3)
- Procedure for production and service provision (clause 8.5)
- Warehousing procedure (clause 8.5.4)
- Procedure for management of nonconformities and corrective actions (clauses 8.7 and 10.2)
- Procedure for monitoring customer satisfaction (clause 9.1.2)
- Procedure for internal audit (clause 9.2)
- Procedure for management review (clause 9.3)
The fundamental six steps listed by ISO are:
- Documentation management
- In charge of records
- Internal reviews
- Regulation of non-conforming goods
- Corrective measures
- Preventative measures
To receive experienced guidance on the specifics of gaining ISO certification in Tambaram, Chennai get in contact with the ISO experts at phoenixTax right now.