Perbedaan ISO 22000 2022 dan ISO 9001 2015

If you haven’t had a chance to review the new release of the ISO 22000:2018 version of the Food Safety Management System (FSMS) standard – Requirements for any organization in the food chain, the update in new standard is that it follows the same high-level structure (Annex SL) that is generally being used by all the updated management system ISO standards like ISO 9001, ISO 14001, ISO 27001, and many more. The first and foremost benefit is that now ISO 22000:2018 has become easier to integrate with other management system standards.

Now that’s the basic change for all the revised standards. In this article, you are going to learn what the ISO 22000:2018 standard is about, as well as similarities and differences between it and the ISO 9001:2015 standard requirements.

What is ISO 22000:2018?

ISO 22000:2018 is a standard for Food Safety Management Systems (FSMS) and provides the requirements for any organization in the food chain. That includes organizations that are either directly involved or indirectly involved with the food chain operations, for example, feed producers, animal food producers, producers of food ingredients, processors of food items, food manufacturers or retailers, food service providers, catering services, food logistics, food storage, equipment suppliers for the food industry, packaging suppliers for the food industry, and producers of animal foods and other food contact materials.

The recent update to the 2018 version is the second edition of the ISO 22000 standard; formerly, it was the ISO 22000:2005 version, which had a long history of development. Initiated in 1960 from hazard and critical control points (HACCP) in the food chain system and, later on, food safety system certification (FSSC), it was established for fulfilling the management system requirements for food safety. So, in 2005, the first edition of the standard was introduced, and the recent version is its second edition.

This standard provides strategic direction for an organization to improve its overall food safety performance based on the process approach and specified FSMS requirements in the standard. By implementing a FSMS based on ISO 22000, an organization can benefit in the following areas:

• its ability to provide safe food products and services while consistently meeting customer and applicable compliance obligations (also termed “legal and statutory requirements”)
• its ability to exhibit compliance with FSMS requirements
• identification of issues to related to food safety, addressing risks associated with its food safety system

Biggest differences in ISO 22000:2018

While it contains all of the same requirements for Quality Management Systems as the other revised standards, there are some specific technical requirements that make this standard particular for organizations in the food industry. Clause 8 of the standard specifies those requirements, which basically ensure the food safety on a technical level. These requirements are:

• Operational planning & control – how the organization plans its operations (processing) and simultaneously controls for food safety
• Prerequisites programs (PRPs) – identification of basic conditions and activities that are necessary to maintain a hygienic environment throughout the food chain
• Traceability system – a system to trace the food products uniquely
• Emergency preparedness & control – identification of all the possible emergency situations and arrangements to deal with them
• Hazard control – this includes performance of hazard analysis, definition and validation of control measures, preparation of HACCP (hazard and critical control points) and/or OPRP (operational prerequisites programs) plans.
• Updating information – to update the information regarding PRPs and to keep the hazard control plans updated
• Control of monitoring and measuring – how the organization is controlling its monitoring and measuring systems
• Verification related to PRPs and hazard control plans – how the PRPs and hazard control plans are verified and analyzed
• Control of nonconforming product and processes – how the organization controls its nonconforming products and processes, including the criteria for recall or withdrawal

These requirements are self-explanatory and give very comprehensive details regarding how you need to manage and ensure your food safety.

What are the differences and similarities between ISO 9001 and ISO 22000:2018?

Since both standards were revised based on the new high-level structure (Annex SL), it has become easier to find out the similarities and differences between the standards. Both standards have 10 clauses with the same main titles. So, if we see the clauses demonstrating the requirements of context of the organization, leadership, planning, support, performance evaluation, and improvements – generally, they are all the same.

The major difference between the standards is in clause 8. Going through the technical requirements of clause 8, we see that in ISO 22000, clause 8 provide a basic framework to ensure food safety in the entire food chain operations, while in ISO 9001, clause 8 provides a generic framework to ensure quality of processes (and those are general and can be applied to any organization of any scope).

Let’s have a quick look at the same requirements if you are going to implement both standards:

1. Context of the organization (internal & external issues, interested parties, scope)
2. Control of documented information (documents & records control)
3. Addressing risks & opportunities, planning & objectives
4. Improvement, corrective actions
5. Management review & internal audits
6. Competence, communication, training & awareness

All clauses other than clause 8 are with respect to quality and food safety mindsets. And, looking at the differences – these are technical requirements in clause 8 to ensure food safety in food chain processes.

How can ISO 9001:2015 fast track your ISO 22000:2018 implementation?

There are a lot of reasons that can be stated for how ISO 9001 can help you out in your ISO 22000:2018 implementation. But I would like to end up with the only one, which is that food safety equally depends upon the quality of the processes, too. So, if you have a good Quality Management System in place, then it’s automatically adding value. You just need to take care of the food safety requirements (clause 8) in ISO 22000; the rest is taken care of by ISO 9001.

Use this free whitepaper: Clause-by-clause explanation of ISO 9001:2015 in order to find out even more details about ISO 9001.

Perbedaan ISO 9001 : 2018 dengan ISO 9001 : 2015 sendiri merupakan salah satu yang membuat banyak perusaahan ataupun organisasi bingung. Oleh karena itu, kami akan memberikan infromasi kepada Anda tentang perbedaan antara keduanya. Berikut ini adalah rinciannya.

Ada 10 perbedaan yang tersedia pada 9001 Tahun 2008 dengan 9001 Tahun 2015, yakni :

1. Klausul 9001:2015 lebih terstruktur dan rapi

Mulai berasal dari bab dan sub-bab, serta kronologis klausul amat terstruktur dan pengelompokkan bersama dengan baik. Klausul ini memiliki tujuan memudahkan perusahaan untuk memasukkan komponen standar ISO lain yang relevan, seperti 14001:2015, 55001, dan 45001. Tidak hanya itu, kuantitas klausul terhadap ISO 9001:2015 pun bertambah. 9001:2008 miliki 8 klausul sedangkan 9001:2015 miliki 10 klausul.

2. Manajemen risiko jadi fondasi standar 9001:2015 

Pada ISO 9001:2015 ini, makna “preventive action” berubah jadi “risk management”. Seperti kita ketahui, target berasal dari proses manajemen adalah mencapai kesesuaian dan kepuasan pelanggan. Dalam mewujudkannya, 9001:2015 fokus terhadap performa perusahaan bersama pendekatan asumsi berbasis risiko (risk based thinking) dan rencana PDCA atau Plan-Do-Check-Action.

Dan juga pada ISO 9001:2015, risiko merupakan suatu kesatuan yang tidak bisa untuk mengalami pemisahan karena berasal dari sistem. Oleh sebab itulah, bersama pendekatan asumsi berbasis risiko, perusahaan harus lebih pro-aktif dalam menahan dan mengurangi efek yang perusahaan harapkan dan senantiasa memperbaiki proses secara berkesinambungan (continual improvement). Ketika manajemen risiko diterapkan bersama serius, secara otomatis tindakan pencegahan pun bakal dilakukan.

3. Leadership (Kepemimpinan) − Tidak Mewajibkan Keberadaan Management Representative

Standar ini tidak mewajibkan keberadaan management representative yang harus ditunjuk secara resmi. Setiap orang, terlebih penanggung jawab berasal dari setiap departemen perusahaan miliki tugas dan tanggung jawab yang mirip dalam menerapkan proses manajemen mutu ISO 9001:2015

4. Scope – Tidak tersedia pengecualian klausul 

Perubahan yang amat menonjol berasal dari klausul 1 (scope) ini adalah hilangnya klausul 1.2 berkenaan aplikasi pada ISO 9001:2015. Artinya, semua kriteria standar atau semua klausul di ISO 9001:2015 ini berwujud umum dan bisa diterapkan oleh organisasi/ perusahaan apapun, serta tidak lihat tipe dan ukuran organisasi/perusahaan atau bidang organisasi/ perusahaan tersebut.

5. Manual Mutu Tidak Wajib

Keberadaan manual mutu pada ISO 9001:2015 ini tidak wajib, sebab banyak pihak yang jadi manual mutu semata-mata dokumen normalitas dan tidak beri tambahan fungsi tambahan untuk perusahaan. Apabila perusahaan Anda sudah menyebabkan manual mutu bukan bermakna dokumen berikut harus dihapus, Anda tetap boleh menggunakannya kalau dibutuhkan.

Klausul 4 ISO 9001:2015 mengupas berkenaan konteks organisasi. Standar terbaru ini memperkenalkan kriteria yang mengenai bersama konteks organisasi, yaitu:

4.1 Understanding the organization and its context  4.2 Understanding the needs and expectation of interested parties

Kedua poin berikut menghendaki perusahaan untuk tahu konteks berasal dari organisasinya serta mengetahui risiko yang bisa berdampak terhadap rencana proses manajemen mutu dan mengetahui kesempatan yang bisa untuk kalian gunakan untuk memperbaiki atau mengembangkan proses manajemen mutu.

Klausul konteks organisasi termasuk menjelaskan, meski ISO 9001:2015 menunjukkan bahwa semua klausul terhadap standar ini bisa untuk semua tipe organisasi tanpa pengecualian. klausul

4.3 ISO 9001:2015 senantiasa mengizinkan adanya pengecualin pengecualian sepanjang tersedia justifikasi yang diterima.

Training ISO 9001 | Konsultan ISO 9001

7. Tidak tersedia makna 6 prosedur harus dan form wajib.

Dalam hal ini, 9001:2015 berikan kebebasan kepada perusahaan didalam menentukan Info terdokumentasi yang dibutuhkan, apakah bakal memanfaatkan SOP/prosedur atau form saja. Tidak lagi memiliki syarat harus dalam bentuk prosedur, seperti 6 prosedur wajib. Istilah “document” dan “record” terhadap 9001:2015 berganti menjadi “documented information”.

a. Pengendalian dokumen dan data

b. Pengendalian catatan mutu

d. Pengendalian Produk tidak sesuai

f. Dan yang terakhir adalah tindakan pencegahan

8. Istilah produk dan jasa berbeda

Dalam standar terbaru, tidak tersedia lagi makna “product”. ISO 9001:2015 menggantinya bersama makna  “barang (goods)” dan “jasa (services)” untuk jauhi kerancuan. Oleh Sebab itu, kebanyakan pengguna ISO 9001 sering kali salah mendeskripsikan “produk” sebagai barang yang berwujud fisik saja, padahal produk termasuk termasuk jasa.

9. Penggantian lebih dari satu istilah

Terdapat lebih dari satu makna yang mulai berganti terhadap ISO 9001:2015, antara lain adalah :“Work Environment” berganti bersama “Environment for the Operation of the Process”. Supplier” berganti bersama “External Provider”. “Purchased Product” berganti bersama “Externally Provided Products and Services”. Perubahan makna berikut berlaku tidak cuma untuk barang, namun termasuk jasa. Bila perusahaan Anda sudah menerapkan makna lama terhadap ISO 9001:2008, makna berikut tetap bisa kalian gunakan dan cocok dengan kebutuhan.

10. Operation- Persyaratan Terkait Pengadaan Barang Dibahas Lebih Jelas

Dan yang Terakhir adalah Semua hal yang mengenai bersama operasional organisasi/ perusahaan terhadap klausul 8 ISO 9001:2015. Seluruh segi operasional jadi berasal dari rencana barang atau jasa, memproses atau penyediaan jasa, pertalian bersama pelanggan. Dan pihak ketiga penyimpanan dan perlindungan produk atau jasa sampai penanganan persoalan sepanjang proses operasional lebih tahu kita bandingkan dengan ISO 9001:2008. 

BSU Konsultan merupakan perusahaan konsultan dan sertifikasi yang fokus pada Peningkatan Kinerja Perusahaan, yakni Kinerja Bisnis, Mutu, Produktivitas, Kesehatan Keselamatan Kerja (K3) dan Lingkungan. Servis lainnya berupa konsultasi dan training ISO 9001, ISO 14001, OHSAS 18001, IATF 16949, ISO 17025, ISO 13485, ISO 27001, ISO 50001, ISO 22000, GMP, AS 9100, AS 9120, dll.