ISO 9001 Certification Requirement

ISO 9001 certification has become a symbol to demonstrate commitment towards quality and customer satisfaction for organizations across the world, as it reflects a structure, process oriented and risk based approach to business. ISO 9001:2015 standard provides requirements and parameters for quality management system and organizations can claim certification after them demonstrate compliance to various requirements. Organizations and companies can get certified to ISO 9001 regardless of their size. How to get certified? And what are ISO 9001 requirement for certification? Let’s talk about it.

Identify context of the organization

Review your business environment, internal issues, external issues, interested parties, needs and expectations of the interested parties etc. Identify risk to the organization in case of those issues and needs not being effectively addressed. Identify scope of your QMS to define boundaries. You can identify risk and opportunities that arise out of context, processes, services / products, operations and changes. Depending on complexity of business and environment, actions taken to address these risks and opportunities can be taken with regular review of these risks and opportunities.

Establish Quality Policy, Quality Objectives and Key Performance Indicators

Considering commitment of the organization towards customers, employees, improvement, compliance to all applicable requirements etc. a statement of intent known as Quality Policy is to be defined. It is what an organization wants to achieve and where they want to be. Communication of quality policy is important and employees must be aware of the quality policy.

Organization level, department level, process level, project level quality objectives need to be established which will provide a measurement oriented work environment. These quality objectives need to be SMART – Specific, Measurable, Achievable, Relevant and Time Bound. For every quality objective, plan for achievement of objectives to be identified and communicated to relevant employees. Tracking of the objectives against targets to be carried out at regular interval to ensure we identify to what extent we achieved and what further actions are required for an organization to realize what they want to achieve. At a regular interval quality objectives are required to be reviewed so that we identify when new objectives are to be established.

Manage Documented Information

Your first requirement would be to identify level and structure of documented information. New ISO 9001:2015 standard gives a lot of flexibility in documentation and is less on prescriptive requirements. Quality manual / 6 mandatory documented procedures etc. are no longer a mandatory requirements of the standard including some form but still some organizations decide to continue with these documented as per earlier standard. Documentation should be done in such a way, that it should satisfy the quality management system as well as the quality goals of the company. It should talk cover company’s processes, procedure, work instructions, flow charts, templates, forms, manuals, templates etc. as required and practical. It should portray that your company is continuously improving in quality management system performance through better products and services, thereby achieving satisfaction of the customers. We make ISO 9001 documentation simple and automated with MyEasyISO

Training

A proper training of employees is required for guiding them to work as per quality management systems. Consider awareness training, implementation training, internal auditor training, lead auditor training to raise competence of your employees. Training need identification on the basis of competence evaluation, role-responsibility-authority-accountability to be done with maintenance of training records like training attendance and training effectiveness evaluation.

Get Audited

This is the final requirement of certification covering regular internal audits and at least annual certification audit by ISO registration body. Number of auditors either for internal audit and external audit depends on the processes, past performance, size and number of employees in the company. During ISO 9001 audit, auditors will verify effectiveness of your QMS with ISO 9001:2015 standard and carry out process based audit. Auditors may find some non-conformances / improvement opportunities / observations in your documentation / records and implemented system. In final certification stage 2 audit depending on the severity of audit findings you may or may not get certification. With MyEasyISO, this becomes a breeze and absolutely simple to achieve as our software is validated by almost all the certification bodies globally by auditing our client organizations successfully on MyEasyISO platform for all ISO 9001 documents / records and compliance against master templates / forms / manual / procedures/ work instructions / flow charts / quality manual etc. wherever and if applicable.

ISO 9001:2015 standard does not have explicit requirement for quality manual but many organizations prefer to have a quality manual as a part of their ISO documented information for a greater linkage to business operations and QMS. This manual includes company’s scope, policy, their working procedure, and in some cases clause by clause compliance with ISO 9001 standard and polices/documented system implemented by an organization. Some organizations prepare quality manual which either includes all the procedures / SOPs / flow chart in the manual itself or some organizations give a reference to them. For more information, you can also download free ISO 9001 manual with our compliment when you buy subscription to MyEasyISO – ISO 9001 software which offers attractive pricing plans starting at just 19 US $ per month for biannual subscription package.

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